IMPLEMENTATION OF AN ABUSIVE HEAD TRAUMA/SHAKEN BABY SYNDROME PREVENTION PROGRAM 1

Title of Project Implementation of an Abusive Head Trauma/Shaken Baby Syndrome Prevention Program at a Level I Pediatric Trauma Center Principal Investigator (PI) Loreen K. Meyer, MSN, RN Trauma Program Manager St. Christopher's Hospital for Children 160 E Erie Avenue Philadelphia, PA 19134 USA Work phone: 215-427-3881 Fax: 215-427-8856 Email: [email protected] Total Budget Requested (U.S. Currency) The research team is requesting for $6732.08 to order educational materials. Our goal is to reach 2,000 patients with the intervention. We have budgeted $150.00 for travel expenses for research personnel to travel to community events. We have budgeted $300.00 to cover printing and advertising costs. These funds are expected to be used to print the measures utilized to collect data and advertisements for community events. We have budgeted $60.00 for travel carts and storage bins; travel carts will be utilized when the research team takes educational materials to community events and storage bins will be utilized to ensure the products are stored in an organized manner. We have budgeted $5,000.00 for statistical consulting through our institution’s affiliate, Drexel University. Drexel University will help provide statistical support for the current project, and will be responsible for performing interim and final statistical analyses for the project at $156/hour for approximately 32 hours. We have also budgeted 1% effort for two years for salary/fringe funding for the Clinical Research Coordinator’s time dedicated to the project. Lastly, the study team is requesting $500.00 to be budgeted towards a caregiver incentive for completion of the three-month follow-up survey. The $500.00 budget will allow us to purchase 25 gift cards at $20.00. Dates of Project The project will begin once Institutional Review Board (IRB) approval is obtained and funds are allocated for the purchase of educational materials. The research team anticipates for the IRB to approve of the study by April 1, 2019. The research team anticipates funds to be received by May 20, 2019. We anticipate that caregiver education should be rolled out once products are received from the National Center on Shaken Baby Syndrome. The study will tentatively conclude March 31, 2021. Research on Human/Animal Subjects An IRB Application will be submitted concurrently with the grant application. Research Team Name Credentials Institutional Affiliation Role Loreen K. Meyer MSN, RN St. Christopher’s Hospital for Children Principal Investigator L. Grier Arthur MD St. Christopher’s Hospital for Children Co-Investigator Rochelle Thompson MS St. Christopher’s Hospital for Children Co-Investigator Autumn D. Nanassy MA St. Christopher’s Hospital for Children Co-Investigator Susan Mcinerney BSN, RN St. Christopher’s Hospital for Children Research Associate Heather Lavella BSN, RN St. Christopher’s Hospital for Children Research Associate Rebecca Sandhu BSN, RN St. Christopher’s Hospital for Children Research Associate Catherine Markel BSN, RN St. Christopher’s Hospital for Children Research Associate Judith Miletto BSN, RN St. Christopher’s Hospital for Children Research Associate Michael Fong BSN, RN St. Christopher’s Hospital for Children Research Associate

IMPLEMENTATION OF AN ABUSIVE HEAD TRAUMA/SHAKEN BABY SYNDROME PREVENTION PROGRAM 1

ABSTRACT

Implementation of an Abusive Head Trauma/Shaken Baby Syndrome Prevention Program at a Level I Pediatric Trauma Center

Loreen K. Meyer, MSN, RN, Sue McInerney, BSN, RN, Autumn D. Nanassy, MA, Rochelle Thompson, MS, Heather Lavella, BSN, RN, Rebecca Sandhu, BSN, RN, Catherine Markel, BSN, RN, Michael Fong, BSN, RN, Judith Miletto, BSN, RN, Grier Arthur, MD

Purpose/Specific Aims: The primary endpoint of the study will be to improve caregiver awareness and knowledge related to Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT). Secondary endpoints will be to increase nurses’ knowledge about SBS/AHT and to measure caregiver attitudes towards infant crying utilizing pre- and post- educational intervention surveys in attempt to decrease the rates of SBS/AHT in our community. Rationale/Significance of Study: According to the National Center on Shaken Baby Syndrome (2018), SBS/AHT is the leading cause of child abuse death in the United States for children less than one years of age.1 The Commonwealth of Pennsylvania is comprised of 67 counties. Of the 40 abuse related fatalities in the state of Pennsylvania in 2017, 27.5% of the deaths occurred within Philadelphia County alone. Socioeconomic status impacts cognitive development, education and behavioral outcomes.2 Given our institution is a level I pediatric trauma center located in Philadelphia County within one of the poorest congressional districts in the country, we have a responsibility to educate and support caregivers in an attempt to reduce rates of SBS/AHT. Conceptual or Theoretical Framework: This study will utilize the Transactional Model of Stress and Coping, which is a framework for evaluating coping with stressful events.3 Core assumptions of the Transactional Model of Stress and Coping are primary appraisal , secondary appraisal, and coping efforts in reaction to a stressful event, such as the Period of PURPLE Crying. Main Research Variables: The primary endpoint seeks to measure caregiver knowledge related to concepts outlined in the Period of PURPLE Crying education. The secondary endpoint seeks to measure coping mechanisms following training. Methods (Design/Sample/Setting/Procedure): Design. This is a Longitudinal Prospective Observational Study. Setting. The project will occur in the hospital as well as in the community. Caregivers will watch the Period of PURPLE Crying video in the patient’s room prior to discharge and have the chance to discuss any questions or concerns with nursing staff. In addition to providing education in the hospital, the Trauma Services and nursing staff will perform presentations at local parenting resource centers in the community. An abundance of literature supports the use of the Period of PURPLE Crying at birthing hospitals, but there is a gap in the existing literature related to implementation and utilization at free-standing pediatric facilities and within the community. Sample. Education in the hospital will be rolled out to caregivers with children six months or younger in the household. We hope to reach approximately 2,000 caregivers who take a class in the community or are presented with this information prior to discharge from our institution with this initiative. Methods. Posters, magnets, take-home booklets, and the PURPLE Crying video (both DVD and/or app access for up to five people) in English and Spanish will be purchased ranging from $.10-$35.00 with the funds as educational resources for caregivers to take home with them following the educational intervention. Caregivers will be asked to take a brief Caregiver Attitudes Assessment prior to watching the Period of PURPLE Crying video. Caregivers will have the chance to discuss any questions or concerns with nursing staff. Caregiver knowledge will be measured using a checklist with important concepts. For education conducted at our institution, nurses will exercise the teach- back technique to ensure the key concepts were comprehended by the caregiver. For education in the community, nurses and the Injury Prevention Coordinator will facilitate a group teach-back discussion and scores on the teach- back checklists will be reported. Lastly, the research team will conduct a three-month post-education follow-up Caregiver Attitudes Assessment to determine caregiver attitudes towards crying, self-efficacy, and coping skills following the Period of PURPLE Crying education. Implications for Practice: This project will help nurses increase their own knowledge about SBS/AHT, and teach caregivers about the Period of PURPLE Crying in hopes to prevent rates of SBS/AHT in the community. IMPLEMENTATION OF AN ABUSIVE HEAD TRAUMA/SHAKEN BABY SYNDROME PREVENTION PROGRAM 1

PROJECT NARRATIVE

Purpose and Specific Aims. The primary endpoint of the study will be to improve caregiver awareness and knowledge related to Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT) through implementation of the Period of PURPLE Crying at our Level I Pediatric Trauma Center. The first secondary endpoint will be to increase nurses’ knowledge about SBS/AHT. The second secondary endpoint will be to measure caregiver attitudes towards infant crying utilizing pre- and post-educational intervention surveys in attempt to decrease the rates of SBS/AHT in our community.

Significance, Framework, and Review of Literature. Shaken Baby Syndrome (SBS) is a form of abusive head trauma (AHT) occurring when an infant is violently shaken or shaken and impacted against a hard or soft surface. Frustration with an infant’s crying is a common stimulus for shaking.4-9 Of those infants who are shaken, nearly 20-30 percent die and of those who survive about 80 percent suffer permanent brain abnormalities. Miller et al. (2018) estimated the total lifetime cost of a single non-fatal case of SBS/AHT including medical care, special education, and related direct costs to be $2.6 million. The average cost of a fatal case is upwards of $4.7 million.10 Research shows that all infants go through a stage in their development where they cry increasingly more beginning around two weeks of age, peaking around two months and leveling off around four to five months.9, 11-12 Research conducted by Ronald G. Barr, MDCM, FRCPC, along with other scientists worldwide, has contributed to the understanding that these patterns of early crying, although frustrating, are a part of normal infant development.13 The Period of PURPLE Crying is an educational program for caregivers with young children. The program was founded under the assumption that increasing caregiver knowledge about the dangers of SBS/AHT will decrease rates of SBS/AHT. Two randomized controlled trials have been conducted to examine the impact of the program on caregiver knowledge and behavior.14,15 Participants were assigned to either the experimental arm, where they received the Period of PURPLE Crying program materials, or the control arm, where the received comparable information about general infant safety. Both studies found statistically significant increases in knowledge infant crying. The USA study showed a statistically significant increase in understanding the dangers of shaking an infant. The Canadian study showed an increase in walk away behavior when the mother was frustrated. The findings both reported statistically significant changes regarding the parent’s behavior in that they were more willing to share the information with others. In Canada, information about infant crying, walking away if frustrated, and the dangers of shaking were more often shared.14,15 Further, information about walking away if frustrated and the dangers of shaking were more often shared by caregivers.14 These studies were replicated in Japan, and the findings held that crying knowledge, sharing advice to walk away if frustrated, and walking away to cope with unsoothable crying was significantly higher in the experimental group compared to the control group. 16 This study will assess three gaps in the literature: 1) it will gather data surrounding nurses’ baseline knowledge about shaken baby syndrome and abusive head trauma and assess competency following the educational intervention, 2) it will identify which key concepts of the Period of PURPLE Crying caregivers most readily remembered following the intervention, 3) it will ask caregivers about their baseline attitudes towards infant crying and soothing and compare baseline attitudes to a 3- month post-intervention educational follow-up. The Transactional Model to Stress and Coping will guide the study’s theoretical framework.3 Stress may lead to anxiety, which then can trigger a multitude of emotional responses that may result in aggressive behavior. A review of the literature shows a correlation of infants less than 6 months of age at greatest risk for SBS/AHT due to frustration with incessant crying.1 Core assumptions of the Transactional Model of Stress and Coping include a primary appraisal, secondary appraisal, and coping efforts. Primary appraisal relates to an individual’s perception of an event. Secondary appraisal assesses one’s ability to cope in a situation. Lastly, coping efforts consist of strategies to mediate between primary and secondary appraisals through emotional regulation and problem-solving skills. Based on our experience, and review of the literature, we believe that enhancing knowledge and providing an evidence-based resource such as the Period of PURPLE Crying to guide infant care will decrease the risks of SBS/AHT. Preliminary Work. Members of the research team participated in an initiative to implement the Period of PURPLE Crying at St. Christopher’s Hospital for Children. The objectives of the previous intervention were to capture improvements in nursing knowledge related to SBS/AHT, collect data related to how many key educational points caregivers were able to recall about the program, and record the number of lives touched by the intervention within the data collection period (i.e., October 10 to October 30, 2018). This intervention consisted of a pre-test for nurses related to SBS/AHT education. Following the pre-test, nurses completed online Period of PURPLE Crying Implementation training and were given a post-test following the completion of the course. A total of 48 medical/surgical unit nurses and 72 NICU nurses completed the online training as a part of this initiative. Prior to the intervention, nurses (n = 115) scored an average of 8.03 out of 10.00 on the assessment. Only 60% IMPLEMENTATION OF AN ABUSIVE HEAD TRAUMA/SHAKEN BABY SYNDROME PREVENTION PROGRAM 2 had received any prior SBS/AHT education, demonstrating the need to increase knowledge related to these concepts. Following the intervention, nurses (n = 120) scored an average of 9.00 out of 10.00 on the assessment, which demonstrated a statistically significant increase in nurses’ knowledge related to SBS/AHT; t(233) = -6.61, p < 0.001. Once nurses completed the online course, they were mentored by a Period of PURPLE Crying champion on their unit in the train the trainer fashion and began handing out the materials to caregivers with children six months or younger in the household who hadn’t previously received the education. Following the nurses providing caregivers with the education, the nurses performed teach back education and recorded how many key points parents were able to recall. On average for the one- on-one education, caregivers were able to recall 8.55 out of 12 key educational components from the Period of PURPLE Crying education. For the community education, caregivers worked together to recall 12 out of 12 key educational components from the Period of PURPLE Crying education. As previously mentioned, 50 caregivers were touched by this education and 26 apps and 21 DVDs for caregivers to take home and share with others were distributed. If the caregivers receiving the information for the first time share the education with the maximum allotted individuals on the app (i.e., the access code can be distributed up to five times), we can estimate that approximately 235 caregivers could potentially have received this education.

Methods and Design. This study is designed as a longitudinal prospective observational study. Members of the research team have piloted this project in two medical-surgical units and in the neonatal intensive care unit (NICU) at St. Christopher’s Hospital for Children. The research team has determined that implementing the Period of PURPLE Crying education, including educating nurses on the program, having nurses present the information to caregivers, and collecting teach-back data, are all feasible. The current study seeks to launch the educational intervention as a hospital-wide initiative and also capture baseline and follow-up parental attitude measures related to infant crying to conceptualize adaptation with utilization of the Period of PURPLE Crying education The research team will refine their approach to implementation based on experience with the pilot study.

Sample and Settings. Quantitative data will be collected at St. Christopher’s Hospital for Children in Philadelphia, PA. St. Christopher’s Hospital for Children is a Level I Pediatric Trauma and Verified Burn Center with 188 beds. Approximately 8,000 children under the age of 6 months visit St. Christopher’s every year. St. Christopher’s also has a primary care practice called the Center for the Urban Child. The practice has approximately 2,500 children 6 months of age or younger visit the clinic annually. As a part of this project, we are not only providing the Period of PURPLE Crying Education to caregivers of patients who are six months or younger, but any caregiver with a child that is six months or younger within the household. This information will be obtained by verbal confirmation from a healthcare provider. A power analysis demonstrated that we will need 53 nurses to complete the pre-assessment and competency assessment to detect a statistically significant increase in knowledge with d = 0.50 (medium effect size) and p ≤ 0.05. A power analysis to determine if coping skills have changed three months following the intervention determined that we would need 327 caregivers to complete both the Pre- and Post-Coping questionnaire with d = 0.20 (small effect size) and p ≤ 0.05. The number of key points caregivers are able to teach-bask to nurses will be described utilizing descriptive statistics, which do not require a power analysis. It is our goal to reach 2,000 caregivers with this education. One potential problem with getting the number of participants needed to make statistically meaningful comparisons will be retention. To address this potential problem, the research team is requesting $875 in funding for gift cards to compensate the caregivers for their participation in the follow-up survey. Further, the study team will recruit Drexel medical students to assist the study team with contacting caregivers who have provided email addresses or telephone numbers for follow-up.

Intervention/Independent Variables. The Period of PURPLE Crying program is the name given to the National Center on Shaken Baby Syndrome’s evidence-based SBS/AHT prevention program. This program takes a normal child development approach in helping parents and caregivers understand the frustrating features of crying in normal infants that can lead to shaking or abuse. It includes a full color 10-page booklet, parent reminder card, 10-minute PURPLE Crying video and a 17-minute Crying, Soothing, Coping: Doing What Comes Naturally video intended to be given to parents of new infants. The program has two aims: support caregivers in their understanding of early increased infant crying and reduce the incidence of shaken baby syndrome/abusive head trauma. The PURPLE video and 10 page booklet are available in 11 languages, including English closed captioning. The Crying, Soothing and Coping video is available in English, Spanish and French. IMPLEMENTATION OF AN ABUSIVE HEAD TRAUMA/SHAKEN BABY SYNDROME PREVENTION PROGRAM 3

The word “Period” is used to let parents know that this experience of increased frustrating crying is temporary, and eventually does come to an end. Each of the letters of the word PURPLE refers to one of the six characteristics or “properties” of normal infant crying that parents and caregivers often find frustrating. They are: P for Peak of Crying—Crying peaks during the second month, decreasing after that U for Unexpected—Crying comes and goes unexpectedly, for no apparent reason R for Resists Soothing—Crying continues despite all soothing efforts by caregivers P for Pain-like Face—Infants look like they are in pain, even when they are not L for Long Lasting—Crying can go on for 30-40 minutes, and often for much longer E for Evening Crying—Crying occurs more in the late afternoon and evening. The behavioral component—three action steps—guides caregivers on how to respond to their baby’s crying in order to reduce crying as much as possible and prevent shaking and abuse. These action steps are: 1. Caregivers should respond to their baby with “comfort, carry, walk and talk” behaviors. This encourages caregivers first to increase contact with their infant to reduce some of the fussing, to attend to their infant’s needs, and not to neglect them. 2. It is “OK to walk away” if and when the crying becomes too frustrating. If it is, caregivers should put the baby in a safe place and then walk away. 3. It is “Never OK to shake or hurt” your baby to stop its crying under any circumstances. This prevention program is designed as a primary community education prevention program. Testing of the program has shown that in order to accomplish a cultural change in how society understands this normal phase in a child’s development, the program needs to be distributed using the following three dose approach. Dose One: Delivery of the PURPLE Program Materials to Parents The first “dose” of the program is the delivery of the intervention materials to parents of all newly born infants via a demonstration of the materials by a trained educator or provider. This would replicate current “best practice” on the basis of available studies. The timing of each Dose delivery depends on a number of factors; the first Dose of the program needs to take place within the first two weeks of the baby’s life before the baby’s crying increases. For example, a maternity delivery setting is ideal because it is universal, meaning most babies are delivered at hospitals. Home visiting programs, pediatric well baby visits and public health, to name a few, have also been a good fit for Dose One: Delivery. Dose Two: Reinforcement of the Messages Reinforcement strengthens important messages of the program to parents, such as, “babies can still be healthy and normal even if they cry five hours per day” and the “the crying will come to an end.” Reinforcement of the messages often takes place at public and state department of health programs, home visiting, and/or pediatric well baby visits. The services available in the community will determine where parents receive the second dose. Dose Two: Reinforcement is a little more flexible in terms of timing than Dose One: Delivery, generally occurring throughout the first three months following the baby’s birth. Dose Three: Public Education Campaign Toolkit The third Dose is a public education campaign. Dose Three: Public Education is important to make sure that all other members of society hear about and understand the Period of PURPLE Crying. The online training modules have a Dose Three Public Education Campaign Toolkit with resources and downloadable assets for small or large campaigns, single events (like a radio or TV advertisement) and case studies describing events and successful campaigns. The timing for Dose Three: Public Education is not set to the timing of a baby’s birth. It is dependent upon a jurisdiction or an organization’s capacity to educate the community where Dose One: Delivery, and ideally Dose Two: Reinforcement, is occurring. As previously stated, the primary endpoint of the study will be to improve caregiver awareness and knowledge related to Shaken Baby Syndrome/Abusive Head Trauma (SBS/AHT) through implementation of the Period of PURPLE Crying. This variable, to be referred to as “Caregiver Knowledge,” will be operationalized by the number of key points caregivers are able to teach back to providers following the Period of PURPLE Crying educational intervention. The first secondary endpoint will be to increase nurses’ knowledge about SBS/AHT. This variable, to be referred to as “Nurse Knowledge,” will be operationalized by the difference of nurses’ score on the pre-assessment and competency assessment. The competency assessment will be completed following the training videos. A statistically significant increase in the number of questions correct for the sample will be considered indicative of increased knowledge. The second secondary endpoint will be to measure caregiver behaviors associated with coping with infant crying utilizing a follow-up survey in attempt to decrease the rates of SBS/AHT in our IMPLEMENTATION OF AN ABUSIVE HEAD TRAUMA/SHAKEN BABY SYNDROME PREVENTION PROGRAM 4 community. This variable, to be referred to as “Caregiver Attitudes towards Infant Crying”,” will be operationalized by comparing the Pre- and Post- Caregiver Attitudes Pre- and Post-Education Surveys completed by caregivers.

Instruments. Shaken Baby Syndrome and Abusive Head Trauma Pre-Competency Assessment Variable: Nurse Knowledge Scoring: The assessment is comprised of eleven items. The SBS/AHT knowledge items will be scored with a 0 for incorrect or a 1 for correct, with a maximum score for each nurse of 10.The 11th question on the assessment asks whether or not nurses have received SBS/AHT education. This question will be scored with 1 = yes, 2 = no, and 3 = not sure. The number of each response will be tallied and reported. Validity/Reliability: The Pre-Competency Assessment was developed by the Trauma Research Coordinator, Injury Prevention Coordinator, and Principal Investigator utilizing the competency assessment’s question bank of 31 possible questions for the Shaken Baby Syndrome and Abusive Head Trauma Competency Assessment created by the National Center for Shaken Baby Syndrome. See the attached email thread (Appendix- Permission to Use Measure from Julie Noble) for permission to use the questions in this assessment. The questions chosen from the question bank were not altered in any way to preserve their validity and reliability. Shaken Baby Syndrome and Abusive Head Trauma Competency Assessment Variable: Nurse Knowledge Scoring: The assessment is comprised of ten items. The items will be scored with a 0 for incorrect or a 1 for correct, with a maximum score for each nurse of 10. Validity/Reliability: The Pre-Competency Assessment was developed by the National Center for Shaken Baby Syndrome. The 10 possible questions come from a question bank comprised of 31 potential questions. Given the Pre- Competency Assessment is comprised of questions from the same bank, there is a possibility that nurses may receive the same question on the Pre-Competency Assessment as they do on the Competency Assessment, but the research team does not perceive for there to be a threat to reliability or validity given the Pre-Competency Assessment does not provide nurses with feedback about correct responses. Period of PURPLE Crying Key Point Checklist Variable: Parental Knowledge Scoring: The checklist is comprised of 7 items associated with the 7 key points outlined for the training. The items will be scored with a 0 for incorrect or a 1 for correct. The total number of correctly reiterated responses will be recorded and a raw score on a scale of 1 to 7, with a 7 meaning that the individual reiterated each point correctly. This number will be the score for parental knowledge. A sub analysis of the number of correct responses about what the acronym PURPLE stands for will also be recorded as a raw score on a scale from 0 to 6, 6 meaning the individual reiterated each point correctly. Validity/reliability: This checklist was created based on the key points outlined by the National Center on Shaken Baby Syndrome (see 10-Minute Talking Points appendix). The checklist also operationalized what PURPLE stands for in the Period of PURPLE Crying to ensure caregivers receive partial credit for the key point asking individuals to define the acronym. We believe this instrument is both valid and reliable because of its content validity. Further, it was a successful measure in the pilot study. Caregiver Attitudes Pre- and Post-Education Survey Variable: Caregiver Attitudes about Infant Crying Scoring: The Caregiver Attitudes Pre- and Post-Education Surveys are assessments given at two different points in time (e.g., baseline and at 3-month follow-up).The Caregiver Attitudes Pre-Education Survey and Caregiver Attitudes Post- Education Survey are both comprised of 6 demographic questions, 6 items related to attitudes about infant crying, one question about self-efficacy, and one question to determine parental coping style (e.g., problem-focused versus emotion-focused coping). The Caregiver Attitudes Post-Education Survey only differs from the Pre-Education Survey by also asking caregivers is they have used the educational materials following discharge or community engagement, and how many other individuals they have shared the information with. Age in years, the number of children in the household, and the number of people caregivers shared information with will be coded as raw numbers. The multiple choice demographic questions and coping style question will be coded by assigning a number to each category (e.g., 1 = male, 2 = female, 3 = Other; for other options, a separate column with free text responses to other will be recorded). Answer options for attitudes and self-efficacy rage from “Strongly Disagree” to “Strongly Agree.” “Strongly Disagree” IMPLEMENTATION OF AN ABUSIVE HEAD TRAUMA/SHAKEN BABY SYNDROME PREVENTION PROGRAM 5

will be coded as a 1 and “Strongly Agree” will be coded as a 5. Scores for each response will be averaged across the sample and compared. Validity/Reliability: This checklist was created by the Research Coordinator, who has a background in research methodology, based on the key points outlined by the National Center on Shaken Baby Syndrome CRYING, SOOTHING, and COPING™ Video and Period of PURPLE Crying curriculum (see 10-Minute Talking Points appendix). We believe this instrument is both valid and reliable because of its content validity. Further, the questionnaire was reviewed and approved by a Child Abuse Pediatrician at SCHC. The Child Abuse Pediatrician agreed that the questions were well-structured, relevant to the current topic, address the theory, and are easy to understand. To ensure the survey is easy to understand, the research team also tested the complexity of the content and the survey demonstrated a 6.5 Flesch-Kincaid Grade Level (i.e., understandable at a 6th grade reading level). The survey was ultimately approved by the Principal Investigator.

Data Collection Schedule and Procedures. Nurses who have not yet completed the Period of PURPLE Crying training as a part of the pilot study will be assigned the training by their unit’s Nurse Educator. Prior to completing the training, nurses will be asked to complete a pre-assessment via email to test their baseline knowledge of SBS/AHT. This ten-item assessment was developed by the Trauma Research Coordinator with assistance from the National Center on Shaken Baby Syndrome utilizing the competency assessment’s question bank. Ten questions were chosen to build this assessment and were not altered to ensure reliability and validity. Following the completion of the baseline assessment, nurses will complete the Period of PURPLE Crying training. This training is required of all individuals who will be educating parents about the program. The training consists of watching approximately 45 minutes of videos and completing a ten-item competency assessment. The training videos include the Period of PURPLE Crying® Video, CRYING, SOOTHING, and COPING™ Video, and Lines of evidence and rationale for the Period of PURPLE Crying video. Scores on the pre-assessment will be compared to the competency assessment to determine if there is a statistically significant difference in the number of questions correct, which translates to an increase in knowledge about SBS/AHT. Following the online training, nurses will participate in a train-the-trainer in-person training about how to deliver the information. This training session will help to standardize delivery of the information across units within the hospital and data collection. Caregivers will be approached during their visit to St. Christopher’s Hospital for Children by a nurse who has completed the Period of PURPLE Crying education. The nurse will introduce the educational intervention to the parents in the patient’s room. The nurse will ask the family to fill out the Caregiver Attitudes Pre-Education Survey and provide an email address and/or phone number to complete the Post- Attitudes Survey (which the family may decline). If caregivers have not received the education previously, the nurse will then introduce the concept of the teach-back method and start the education by playing the Period of PURPLE Crying video. Following the conclusion of the video, the nurse will ask the caregiver if they would like materials to take with them in the form of an app or DVD. The nurse will return and review the key points of the Period of PURPLE Crying with the caregiver using the book provided. Following the explanation of the program, the nurse will ask the caregiver if they have any questions. Once all questions are answered, the nurse will ask the caregiver to teach each of the key points back and will record the number of correct responses on the Teach-back Checklist. The nurse will clarify any missed points with the caregiver and give them the materials to take home with them and share with other individuals who care for the child. Caregivers who have already received the education will receive additional reinforcement of the key concepts of the Period of PURPLE Crying (see Period of PURPLE Crying Reinforcement appendix) as well as a flyer with information to access the Period of PURPLE Crying website. Nurses will document that reinforcement was provided to these families. Nurses will record how long ago the parents received the Period of PURPLE Crying education and ask the caregiver to fill out a Post- Attitudes Survey. The same process will also be followed for education in the community. Community education interventions will be performed in the Injury Prevention Center at St. Christopher’s Hospital for Children and other community organizations. In total, the research team will provide five community educational sessions. The only deviation from the aforementioned protocol will be that the teach-back will be performed as a group (e.g., caregivers can participate as a group to teach the information back to the individual performing education) and recorded. Approximately three months after the educational intervention, the Caregiver Attitudes Post-Education Survey will be sent to the email address provided during the Caregiver Attitudes Pre-Education Survey. If caregivers provide a phone number instead of an email address, a medical student will call the caregiver and complete the online survey with the caregiver over the phone. At the time of competition, caregivers will have the opportunity to be entered for a chance to win 1 of the 25 gift cards valued at $20.00 in exchange for their participation, pending IRB approval. IMPLEMENTATION OF AN ABUSIVE HEAD TRAUMA/SHAKEN BABY SYNDROME PREVENTION PROGRAM 6

Data Analysis and Interpretation. Caregiver Knowledge Parental knowledge will be determined using descriptive statistics (e.g., mean and standard deviation). Nurse Knowledge Nurses’ scores on the Shaken Baby Syndrome and Abusive Head Trauma Pre-Competency Assessment will be compared to nurses’ scores on the Shaken Baby Syndrome and Abusive Head Trauma Competency Assessment utilizing t-tests or Wilcoxon signed rank tests for means with equal or unequal variance, respectively. Descriptive statistics will also be calculated. Caregiver Attitudes about Infant Crying Caregiver responses from the Caregiver Attitudes Pre- and Post-Education Survey will be compared on an item-by- item basis. T-tests or Wilcoxon signed rank tests will be performed for means with equal or unequal variance, respectively, to determine if there is a statistically significant change in attitudes towards coping with infant crying.

Facilities and Resources (Environment). This project will be a single-institution study at St. Christopher’s Hospital for Children in Philadelphia, PA. The Trauma Services Department comprised of seven computers and workstations will be able to be utilized to perform study- related tasks. The Principal Investigator is ultimately responsible for oversight of data collection, and the Trauma Research Coordinator will assist with data entry and management. The institution will cover staff time to perform educational tasks associated with Period of PURPLE Crying education. Medical students will be recruited to assist with the three-month follow- up surveys and additional data entry. The research team is requesting funding statistical consulting services will be provided by Drexel University.

Implications for Practice and Research. Nurses have an opportunity to educate caregivers during their child’s inpatient admissions, community-wide education events, and other educational opportunities. The education will encourage parents that the “period” of PURPLE crying has a beginning and an end.17 Nurses play a significant role in the neonatal intensive care unit (NICU) due to extensive hospitalizations from medical complications and/or pre-term births. Research has shown NICU hospitalizations can be intense for caregivers who have yet to bond with their newborn to establish a relationship.18 An infant’s extensive hospitalization and medical conditions can place the child at a higher risk for head traumas.18 These situations complicate family dynamics, increase stress levels and impact the utilization of effective coping mechanisms. Recognizing triggers for stress and methods for coping especially during early infancy are critical to health promotion. Nurses’ function as an integral role in injury prevention and education of caregivers related to infant behaviors, coping strategies, and methods of consoling infant crying. It is an important time to encourage parents to develop an emergency plan if frustration arises before it gets out of control The project will increase nursing education related to SBS/AHT and the importance of implementing the Period of PURPLE Crying education. This grant will enhance opportunities for professional development for future research on child abuse. The hospital-wide initiative, outpatient services, and community organizations will benefit from evidence-based research on methods to decrease SBS/AHT. Research has shown the effectiveness of infant crying that increases the risk for SBS/AHT. The Period of PURPLE Crying hospital-wide project will provide data on the intervention utilized that can implicate the effectiveness of prevention and reduction in the number of SBS/AHT cases reported within the community. Seeking additional funding will be warranted for professional training and materials for high-school parenting course, OB/GYN office visits, newborn check-up, emergency room visits, inpatient admissions, and nursing community service efforts. Funding is also required for seminars and conferences for professional development and educating a larger scale of professionals in one setting to adopt the model of the Period of PURPLE Crying nationally. Upon completion of this two-year grant project, the results will be gathered and analyzed for statistical significance. There are a significant number of opportunities to disseminate the findings of the project that will educate a large audience of providers. The intent is to report these findings through abstract submissions at local, regional and national conferences with a completion of a manuscript written for submission to the Journal of Trauma Nursing by the third year.

References

1. National Center on Shaken Baby Syndrome: Facts & Info. National Center on Shaken Baby Syndrome website. https://www.dontshake.org/learn-more/itemlist/category/13- facts-info Published n.d. Accessed January 24, 2019. 2. Blair C, Raver CC. Poverty, stress, and brain development: New directions for prevention and intervention. Acad Pediatr. 2016; 16: 30-36. 3. Lazarus RS, Folkman S. Transactional theory and research on emotions and coping. Eur J Pers. 1987; 1: 141-169. 4. Klevens J. Prevention of inflicted neurotrauma: What we know, what we don’t know, and what we need to know. In: Reece RM, Nicholson CE, ed. Inflicted Childhood Neurotrauma. Elk Grove Village, IL: American Academy of Pediatrics; 2003: 269-279. 5. Dias MS, Smith K, deGuehery K, Mazur P, Li V, Shaffer L. Preventing abusive head trauma in infants and young children: A hospital-based parent education program. Pediatrics. 2005; 115: 470-477. 6. Barr RG, Trent RB, Cross J. Age-related incidence curve of hospitalized shaken baby syndrome cases: Convergent evidence for crying as a trigger to shaking. Child Abuse Negl. 2006; 30: 7-16. 7. Lee C, Barr RG, Catherine N, Wicks A. Age-related incidence of publicly-reported shaken baby syndrome cases: Is crying a trigger for shaking? J Dev Behav Pediatr. 2007; 28: 288-293. 8. Talvik I, Alexander RC, Talvik T. Shaken baby syndrome and a baby’s cry. Acta Paediatr. 2008; 97: 782-785. 9. Barr RG. Crying behavior and its importance for psychosocial development in children. In: Tremblay RE, Barr RG, Peters RD, ed. Encyclopedia on Early Childhood Development. Montreal, QC: Centre of Excellence for Early Childhood Development; 2006: 1-10. 10. Miller, TR, Steinbeigle, R, Lawrence, BA, Peterson, C, Florence, C, Barr, M, & Barr, RG. Lifetime cost of abusive head trauma at ages 0–4, USA. Prevention Science. 2018; 19: 695-704. 11. Barr RG. The normal crying curve: What do we really know? Dev Med Child Neurol. 1990; 32: 356-362. 12. Barr RG. Excessive crying. In: Sameroff AJ, Lewis M, Miller SM, ed. Handbook of Developmental Psychopathology. 2nd ed. New York, NY: Kluwer Academic/ Plenum Press; 2000: 327-350. 13. Tremblay RE, topic ed. Aggression – Synthesis. Encyclopedia on Early Childhood Development [online]. CEECD, SKC-ECD. April 2012. URL: http://www.child- encyclopedia.com/crying-behaviour. Accessed 14 January, 2019.

14. Barr RG, Rivara FP, Barr M, Cummings P, Taylor J, Lengua LJ, Meredith-Benitz, E. 2009. Effectiveness of educational materials designed to change knowledge and behaviors regarding crying and shaken-baby syndrome in mothers of newborns: a randomized, controlled trial. Pediatrics. 2009; 123: 972-980. 15. Barr RG, Barr M, Fujiwara T, Conway J, Catherine N, Brant R. Do educational materials change knowledge and behaviour about crying and shaken baby syndrome? A randomized controlled trial. CMAJ. 2009; 180: 727-733. 16. Fujiwara T, Yamada F, Okuyama M, Kamimaki I, Shikoro N, Barr RG. (2012). Effectiveness of educational materials designed to change knowledge and behavior about crying and shaken baby syndrome: A replication of a randomized controlled trial in Japan. Child Abuse Negl. 2012; 36: 613-620. 17. Allen K. The neonatal nurse’s role in preventing abusive head trauma. Adv Neonatal Care. 2014; 14: 336-342. 18. Altimier L. Shaken Baby Syndrome. J Perinat Neonatal Nurs. 2008; 22: 68-76. Implementation of an Abusive Head Trauma/Shaken Baby Syndrome Prevention Program at a Level I Pediatric Trauma Center Timetable

Year 1 Year 2 Implementation Activities* Apr- Jul- Oct- Jan- Apr- Jul- Oct- Jan- Jun Sept Dec Mar Jun Sept Dec Mar 2019 2019 2019 2020 2020 2020 2020 2021 Anticipated IRB Approval X Anticipated Receipt of Funds X Plan Community Education X Anticipated Product Arrival X Nursing Pre-Competency Assessments X Nursing Competency Assessments X Period of PURPLE Crying Launch X Caregiver Education X X X X X Data Collection X X X X X X Interim Analyses X X Prepare Final Results/Reports X X Closeout Funding Reports X Begin Manuscript Preparation X Draw Winners for Caregiver Incentive X X

*Note: The timetable is based on the projected start date of April 1, 2019, but may be subject to change pending the date of IRB approval.

Department of Epidemiology and Biostatistics Janell Mensinger, PhD Associate Research Professor Director, Biostatistics Service Center January 22, 2019

Society of Trauma Nurses 446 East High Street, Suite 10 Lexington, Kentucky 40507

RE: Implementation of an Abusive Head Trauma/Shaken Baby Syndrome Prevention Program at a Level I Pediatric Trauma Center, Letter of Support from Drexel University Department of Epidemiology and Biostatistics To whom it may concern,

On behalf of Drexel University, an affiliate of St. Christopher’s Hospital for Children, I would like to offer commitment to provide support for the project titled, “Implementation of an Abusive Head Trauma/Shaken Baby Syndrome Prevention Program at a Level I Pediatric Trauma Center” to be executed at St. Christopher’s Hospital for Children in Philadelphia, PA. Contingent upon funding, the research team will have access to statistical support through the Biostatistics Service Center in the Department of Epidemiology and Biostatistics at Dornsife School of Public Health, Drexel University. The Biostatistics Service Center works with health, biological, and social science researchers across Drexel University and other academic health centers, pharmaceutical companies, medical research organizations, and managed care organizations. We provide professional, high quality data analysis, biostatistical computing, and data management services to a wide range of clients across multiple research disciplines.

Statistical services are available on a short term, per hour basis ($156/hour), or long-term services within an ongoing contractual arrangement (i.e., % effort of faculty or staff time). Work completed by graduate students (with faculty oversight) is discounted 50%. Services we provide include:  Design analysis strategies for research proposals involving quantitative research studies  Selecting and implementing appropriate statistical methods for applications to research data  Statistical and graphical analysis of data  Statistical writing and/or review of manuscripts  Tables and figures for manuscripts  Power calculations and sample-size estimation

The department is committed to helping the research team with statistical consulting to ensure the proper use of statistical techniques, analyses, and review of statistical writing for the current project. Please accept this letter as our commitment to support this project, contingent upon grant funding.

Sincerely,

Janell L. Mensinger, PhD Associate Research Professor Director, Biostatistics Service Center

3600 Market Street, Science Center, 7th Floor, #749, Philadelphia, PA 19104 | Tel: 267.359.6341 | Fax: 267.359.6201 | publichealth.drexel.edu Biographical Sketch

Heather Lavella BSN, RN, CPN Nurse Manager Medical Surgical Units 4 North and 5 North, St. Christopher’s Hospital for Children

Heather Lavella BSN, RN, CPN is the Nurse Manager for two medical surgical units at St. Christopher’s Hospital for Children (SCHC). Ms. Lavella graduated from The Bryn Mawr Hospital School of Nursing with a diploma degree, later returning to Immaculata University to complete her BSN. She graduated Summa cum laude in 2012. Currently Ms. Lavella is attending Drexel University working towards her MSN with a focus in Leadership in Health Systems Management. She is scheduled to graduate in the spring of 2019.

Ms. Lavella started working as a clinical nurse on a medical surgical unit at SCHC in June, 1985. She spent fifteen years as a clinical nurse caring for patients and families. During that time she acted as a charge nurse for the unit, a scheduling committee co-chair and a primary preceptor orienting new clinical nursing staff. In September, 2000, Ms. Lavella was promoted to a Clinical Coordinator role where she oversaw the daily operations of five medical surgical units. Since that time, the role has transformed into a Nurse Manager title, with the responsibility of managing two medical surgical units, a total of 60 inpatient beds, and a staff of 90. As a nurse manager at SCHC, Ms. Lavella has had the opportunity to be involved in various initiatives. She has served as a member of various committees such as the Ethics Committee, Nursing Leadership Council, Standards of Conduct Committee, Trauma Committee and more. She has functioned as the chair of the Nursing Clinical Ladder Committee, the project lead for creating an Observation Unit, and most recently an initiative to Cohort Trauma Patients. She is also an active member and contributor to the Magnet designation process at SCHC. Ms. Lavella has worked with interdisciplinary teams to publish manuscripts on trauma cohorting, improving nursing council communication, and managing pain in the pediatric patient. She has presented poster and podium presentations both locally and internationally. Ms. Lavella is committed to her staff as well as their pediatric patients and their families. She strives to inspire her staff to become involved to make a difference in the lives of those they care for. She and her team aspire to prevent traumatic injuries by educating parents and families within the SCHC community and beyond.

Ms. Lavella assisted with the prior pilot study, as well as drafting and revising this grant application. She will oversee the implementation of nursing education both online and in-person for train-the-trainer sessions on the medical/surgical units. She will supervise the nursing educators in the collection of pre- and post- competency training results. Ms. Lavella will also assist with operationalizing the process to implement caregiver education and dissemination of the educational materials. Ms. Lavella will be one of the many nurses responsible for educating caregivers about the Period of PURPLE Crying. She will be primarily responsible for oversight of ensuing standardization in the medical/surgical units and spearheading nursing involvement in the initiative. She will also assist with miscellaneous tasks to help ensure study completion within the grant timeframe.

Ms. Lavella’s grant experience is as follows:  $750 Pacesetter Grant to implement nursing and caregiver education surrounding Abusive Head Trauma and Shaken Baby Syndrome at SCHC, July, 2018

Biographical Sketch

Catherine Markel BSN, RNC-NIC Clinical Nurse IV and Nurse Educator Neonatal Intensive Care Unit (NICU), St. Christopher’s Hospital for Children

Catherine Markel, is a Clinical Nurse IV as well as a NICU Educator at St. Christopher’s Hospital for Children (SCHC). Ms. Markel graduated from Holy Family University with honors with her a BSN degree in May 1988. Ms. Markel started her career as a pediatric registered nurse in a medical surgical unit with infants and toddlers. Ms. Markel spent 7 years caring for infants and toddlers on the medical surgical unit before expanding her knowledge and moving into the NICU where she has spent the last 23 years educating the novice nurse and patient’s families.

Ms. Markel has participated in numerous unit performance projects including presenting at the HAP Conference in October 2018 on Unplanned Extubations in the Neonatal Intensive Care Unit: A Multidisciplinary Quality Improvement Initiative. She has worked extensively on other performance improvement including Developmental Care initiatives that included neonatal fellows, neonatal providers and clinical nursing staff. Inputting and summarizing NICU data collection on NICU performance improvement and reporting back to staff with visuals on current state and areas that need to improve. Ms. Markel also follows up with nursing errors to include a mass email “This Happened Here.” This email provides all staff with the facts of any event and provides a re-education so that the same mistake is not repeated.

Ms. Markel continues to be a champion for performance improvement initiatives in the NICU and strives for excellence at the bedside. She actively participates in the Nurse Residency Education Program with lectures and skills stations for the novice clinical nurses along with critical care lectures for clinical nurses.

Ms. Markel assisted with the prior pilot study, as well as drafting and revising this grant application. She will oversee the implementation of nursing education both online and in-person for train-the-trainer sessions in the NICU. She will be responsible for in the collection of pre- and post- competency training results in the NICU. Ms. Markel will also assist with operationalizing the process to implement caregiver education and dissemination of the educational materials. She will be primarily responsible for accounting for educational materials in the NICU. She will also assist with miscellaneous tasks to help ensure study completion within the grant timeframe.

Ms. Markel’s grant experience is as follows:  $750 Pacesetter Grant to implement nursing and caregiver education surrounding Abusive Head Trauma and Shaken Baby Syndrome at SCHC, July, 2018

Biographical Sketch

Susan C. McInerney, BSN, RN, CPN Charge Nurse 4 North, St. Christopher's Hospital for Children

Susan C. McInerney, BSN, RN, CPN is the 4 North Charge Nurse at St. Christopher's Hospital for Children. (SCHC). 4 North is a 30 bed pediatric medical-surgical unit with a specialty patient population focused on trauma and renal disease. Mrs. McInerney graduated cum laud with her BSN in 1990 from Philadelphia University.

Mrs. McInerney started working for SCHC in 1984 as a staff nurse in the burn center for several years, then on 4 North. She has been the Charge Nurse on 4 North for the past 10 years. She has been involved in many projects throughout her career at SCHC. These include being the lead P.I. for creation and development and implementation of a multidisciplinary concussion standard of care and protocol and the driving force behind bringing the Period of PURPLE Crying program to SCHC pilot research. Additionally, she has presented multiple professional posters at local, national and international conferences. Topics presented focused on Concussion Care, the Role of the Charge Nurse, Nursing led Multidisciplinary Rounds, and Sustaining a Magnet Culture. She was a podium presenter on Concussion Care at the 2015 Sigma Theta Tau International Nursing Conference. She was the past Chair of the Magnet committee; is an active member of the hospital Nursing Leadership Council and unit Shared Governance Council. Mrs. McInerney is a speaker at the semiannual SCHC Charge Nurse Workshops. She organizes the SCHC annual school supply an backpack program for the Women’s Abuse Shelter, which the SCHC Nursing department works collaboratively with the Physician and Resident groups.

Ms. McInerney was the main advocate for bringing the Period of PURPLE Crying to SCHC and spearheaded the prior pilot study, as well as drafting and revising this grant applica- tion. She will assist with in-person for train-the-trainer sessions in the for the medical/surgical units. Ms. McInerney will also assist with operationalizing the process to implement caregiver education and dissemination of the educational materials on 4 North and 5 North. Ms. McInerney will be one of the many nurses responsible for educating caregivers about the Period of PURPLE Crying. She will be primarily responsible for accounting for educational materials in the 4 North and 5 North and mentoring nurses to become champions of the initiative. She will also assist with miscellaneous tasks to help ensure study completion within the grant timeframe.

Ms. McInerney’s grant experience is as follows:  $750 Pacesetter Grant to implement nursing and caregiver education surrounding Abu- sive Head Trauma and Shaken Baby Syndrome at SCHC, July, 2018

Biographical Sketch

Judith A. Miletto, BSN-RN, TNCC Emergency Department Manager Emergency Department, St. Christopher’s Hospital for Children

Judith A. Miletto, BSN, RN, TNCC is currently the Emergency Department Manager at St. Christopher’s Hospital for Children (SCHC). Ms. Miletto graduated from Drexel University College of Nursing while maintain a 3.69 GPA and has her BSN degree. She currently is attending Chamberlain University for her MSN in Education.

Ms. Miletto has been employed at SCHC for greater than 28 years. She has been involved with nurse driven orders for Decadron and Zofran in the emergency waiting room to help reduce a patient’s stay once placed in an examination room. She sits on the Burn Committee along with the Safety Committee and Nursing Informatics and Innovations Council. She has presented at the NCN in 2017 on Post-Operative Care of the Pediatric Spinal Fusion.

Ms. Miletto will oversee the implementation of nursing education both online and in- person for train-the-trainer sessions in the Emergency Department. She will be responsible for in the collection of pre- and post- competency training results in the Emergency Department. Ms. Miletto will also assist with operationalizing the process to implement caregiver education and dissemination of the educational materials in the Emergency Department. She will be primarily responsible for accounting for educational materials in the Emergency Department. She will also assist with miscellaneous tasks to help ensure study completion within the grant timeframe.

Biographical Sketch

Loreen K. Meyer, MSN, RN Trauma Program Manager Trauma and Burn Services, St. Christopher’s Hospital for Children

Loreen Meyer, MSN, RN is the Trauma and Burn Program Manager at St. Christopher’s Hospital for Children (SCHC). Ms. Meyer received her nursing degree in 1990. Ms. Meyer advanced her education ultimately achieving a Master’s in Nursing Faculty and Education through Drexel University in 2014. In 2014, she was inducted into the Sigma Theta Tau International, Honor Society of Nursing, Nu Eta Chapter through Drexel University.

Ms. Meyer has been a practicing Registered Nurse (RN) primarily in the field of pediatrics with a subspecialty in emergency medicine and trauma. During her tenure as a RN, she has functioned in the role as a Unit Based Emergency Department Educator. Upon receiving a MSN degree, Ms. Meyer transitioned into the role as a Trauma PI Coordinator and as adjunct faculty for Holy Family University School of Nursing. Ms. Meyer also has been a Pediatric Advanced Life Support (PALS) instructor for over 25 years.

She started working as the Trauma Program Manager in the Trauma Services Department at SCHC in March, 2016. Ms. Meyer participates in administrative, performance improvement, clinical, educational, research and outreach activities for the Trauma and Burn Programs. In 2018, Ms. Meyer in collaboration with the Plastic/Burn Attending’s and various disciplines led the organization in the verification of the Stuart J. Hulnick Pediatric Burn Center. She has been involved in: investigating areas for clinical and trauma related systems research opportunities, conceptualizing and designing trauma and burn-related research projects, drafting IRB applications and maintaining approvals, managing research databases, qualitative and quantitative data analysis, and manuscript, policy, and report drafting and revision. She is Co- Chair of the Trauma Committee and Burn Committee. Ms. Meyer has published in a peer- reviewed manuscript within the scope of trauma. She has also presented research on behalf of the Trauma and Burn Programs at local, regional and national meetings. The merit of her work with the programs has been recognized at conferences, as she has received the first place award in the Research Category at the Nursing of Children Network Conference in 2017 and 2018. She is passionate about preventing traumatic and burn injuries in children as well as translating research findings into practice.

Ms. Meyer assisted with the prior pilot study, as well as drafting and revising this grant application. As the Principal Investigator of the grant and IRB application, she will be ultimately responsible for all aspects of the project including funding allocation, nursing education, caregiver education, data collection, and the final report. She will have oversight of the implementation of nursing education both online and in-person for train-the-trainer sessions. Mrs. Meyer will supervise the ordering of educational materials and dissemination to units. She will be ultimately responsible for operationalizing the process to implement caregiver education. Mrs. Meyer will be responsible for oversight of community events. She will also oversee data collection and analyses. She will assist with miscellaneous tasks, as needed, to help ensure study completion within the grant timeframe.

Ms. Meyer’s grant experience is as follows: • $2,997 grant awarded by the American Trauma Society Pennsylvania Division to provide tourniquets and bleeding control stations to a local Philadelphia area high school, January 2019 • $2,999.88 grant awarded by the American Trauma Society Pennsylvania Division to provide scald burn prevention equipment to families with children up to the age of 6 years of age, January 2019 • $750 Pacesetter Grant to implement nursing and caregiver education surrounding Abusive Head Trauma and Shaken Baby Syndrome at SCHC, July, 2018 • $3700 grant awarded by The American Trauma Society Pennsylvania Division to provide for scald burn prevention equipment to families in prenatal and pediatric clinics, January, 2018 • $500 Pacesetter Grant for pediatric scald burn prevention at SCHC, May, 2017 • $500 Pacesetter Grant for first aid kits for injury prevention at SCHC, March, 2017

Biographical Sketch

Autumn D. Nanassy, MA Clinical Research Coordinator Trauma and Burn Services, St. Christopher’s Hospital for Children

Autumn D. Nanassy, MA is the Trauma and Burn Research Coordinator at St. Christopher’s Hospital for Children (SCHC). Ms. Nanassy graduated with honors with her BA in Psychology and a minor in National Security, Intelligence and Counter Terrorism from Rutgers University-Camden in May, 2014. Ms. Nanassy’s primary focus of research related to studying the impacts of both personality and relationships on behavior and health. In her second year of graduate school, she received the Psychology Department Teaching Assistantship Award, which included full-tuition paid ($11,821) and $25,000 stipend. She graduated with distinction from Rutgers University-Camden with her MA in Psychology in May, 2016.

She started working as the Clinical Research Coordinator in the Trauma Services Department at SCHC in August, 2016. During the last two years, Ms. Nanassy has helped to develop the research program. She has been involved in: investigating areas for clinical and trauma related systems research opportunities, conceptualizing and designing trauma and burn- related research projects, drafting IRB applications and maintaining approvals, managing research databases, qualitative and quantitative data analysis, and manuscript, policy, and report drafting and revision. She sits on the Trauma Committee, Burn Committee, Nursing Informatics and Innovation Council, and is a member of the LGBTQ Initiative at SCHC. Ms. Nanassy has published four peer-reviewed manuscripts in the last two years within the scope of trauma, burns, and surgery. She has also presented research on behalf of the Trauma and Burn Programs at regional and national meetings. The merit of her work with the programs has been recognized at conferences, as she has received the first place award in the Research Category at the Nursing of Children Network Conference in 2017 and 2018. Beyond her work at SCHC, Ms. Nanassy continues to lecture part-time in the Psychology Department at Rutgers University-Camden. She teaches Personality Psychology, Psychology of Gender, and Psychology, Health and Media courses. She is passionate about preventing traumatic and burn injuries in children as well as translating research findings into practice.

Ms. Nanassy assisted with the prior pilot study, as well as drafting and revising this grant application. She will be responsible for assisting with the implementation of nursing education both online and in-person for train-the-trainer sessions. She will work with the nursing educators to collect pre- and post- competency training results. Ms. Nanassy will also assist with operationalizing the process to implement caregiver education and dissemination of the educational materials. She will be primarily responsible for standardization of study procedures and data collection. Ms. Nanassy will assist with data entry, data cleaning, and preliminary data analyses. She will also assist with miscellaneous tasks to help ensure study completion within the grant timeframe. Ms. Nanassy’s grant experience is as follows:

 $2,997 grant awarded by the American Trauma Society Pennsylvania Division to provide tourniquets and bleeding control stations to a local Philadelphia area high school, January, 2019  $2,999.88 grant awarded by the American Trauma Society Pennsylvania Division to provide scald burn prevention equipment to families with children up to the age of 6 years of age, January, 2019  $750 Pacesetter Grant to implement nursing and caregiver education surrounding Abusive Head Trauma and Shaken Baby Syndrome at SCHC, July, 2018  $3,700 grant awarded by The American Trauma Society Pennsylvania Division to provide for scald burn prevention equipment to families in prenatal and pediatric clinics, January, 2018  $500 Pacesetter Grant for pediatric scald burn prevention at SCHC, May, 2017  $500 Pacesetter Grant for first aid kits for injury prevention at SCHC, March, 2017  Full-tuition paid ($11,821) and $25,000 stipend Psychology Department Teaching Assistantship Award, fall 2015-spring 2016  $500 Psychology Department Conference Travel Grant at Rutgers-Camden, 2015  $500 Dean’s Graduate Conference Travel Grant at Rutgers-Camden, 2015  $100 Psychology Department Achievement in Research Award at Rutgers-Camden, 2014  $500 Dean’s Graduate Conference Travel Grant at Rutgers-Camden, 2014

Biographical Sketch

L. Grier Arthur, MD Associate Trauma Program Director and Director of Undergraduate and Graduate Surgical Training Division of Pediatric General, Thoracic, and Minimally invasive Surgery, St. Christopher’s Hospital for Children

L. Grier Arthur, MD is the Associate Trauma Program Medical Director at St. Christopher’s Hospital for Children (SCHC). Dr. Arthur graduated with Cum Laude with his BA in Chemistry from Princeton University in 1994. He subsequently attended Jefferson Medical College of Thomas Jefferson University (TJU) for his MD. Dr. Arthur completed his General Surgery Residency at TJU, a Pediatric Surgical Research Fellowship at A.I. DuPont Hospital for Children, and his Pediatric Surgery Residency at Columbus Children’s Hospital of Ohio State University.

Dr. Arthur has been a physician at SCHC for over 20 years. Throughout his tenure, he has participated in the Governance Committee, Education Committee, the Credentialing Committee, Trauma Committee, and Engagement Advisory Committee. Dr. Arthur is also the chair of the Clinical Competency Committee and the Program Evaluation Committee for the Pediatric Surgery Fellowship program, and the Treasurer for the Medical Executive Committee. As Treasurer of the Medical staff, he identified lost application and credentialing fees totaling over $60,000, identified that the fee structure was below market value, and increased the medical staff dues and application fees. Dr. Arthur established a Budget subcommittee for the Medical Executive Committee, which he chairs, and increased funds for professional development, grand rounds, philanthropy, and physician wellness. Finally, he is the Surgical Director of the ECMO Program and Intestinal Rehabilitation Program at St. Christopher’s Hospital for Children. Lastly, Dr. Arthur was names one of Philadelphia’s Top Doctors in 2017.

Dr. Arthur is an Associate Professor of Surgery at Drexel University, an affiliate of SCHC. Dr. Arthur is actively involved in medical student, resident, and fellow educational activities. He has been the Director of Undergraduate and Graduate Surgical Training for the last ten years and interacts with medical students, residents, and fellows on a daily basis and provides education in both the clinic and operating room. Dr. Arthur also has extensive research experience and has published a variety of manuscripts within the scope of pediatric surgery and trauma. He has presented his work regionally, nationally, and internationally.

Dr. Arthur’s role with the project will be to help facilitate funding through Drexel University. He will also provide general oversight of the operations, nursing education, and data collection. Dr Arthur will be the research team’s primary physician liaison.

Dr. Arthur’s grant experience is as follows:

 $9,139 Sound Off Grant to promote home fire safety and start-up funds for the Injury Prevention Resource Center at SCHC Biographical Sketch

Michael Fong, BSN, RN Trauma Performance Improvement Coordinator Trauma and Burn Services, St. Christopher’s Hospital for Children

Michael Fong, BSN, RN is the Performance Improvement Coordinator for the Trauma and Burn Services at St. Christopher’s Hospital for Children. Mr. Fong graduated from Drexel University’s College of Nursing and Health professionals, receiving a Bachelor’s of Science in Nursing. After completed licensure from the state of Pennsylvania as a registered nurse, Mr. Fong started working in the emergency department of St. Christopher’s Hospital for Children. Mr. Fong transitioned to the Children’s Hospital for Children where he functioned as the Clinical Research Nurse Coordinator for the Infectious Disease department before serving as the Performance Improvement (PI) Coordinator for the Trauma and Burn Services at St. Christopher’s Hospital for Children.

During Mr. Fong’s time as the PI Coordinator, he has worked to further develop the PI process to align with the requirements of the Pennsylvania Trauma System Foundation’s accreditation standards. Mr. Fong has further refined the PI process for issue identification, development of action plans, and establishment of loop closure in order to enhance the clinical operations in the care of the traumatically injured or burned patient. He tracks, trends, and reports data based on clinical performance metrics to identify areas for growth opportunities. Mr. Fong has presented results from PI initiatives at local and regional conferences.

Mr. Fong will assist with operationalizing the process to implement caregiver education and dissemination of the educational materials for the project overall. He will assist with addressing barriers to providing caregivers with the surveys and educational materials and assist with ways to combat any process improvement issues related to the project. He will also assist with miscellaneous tasks to help ensure study completion within the grant timeframe.

Biographical Sketch

Rebecca S. Sandhu BSN, RN, CPN Nurse Educator 4 North and 5 North, St. Christopher’s Hospital for Children

Rebecca S. Sandhu BSN, RN, CPN, is a Nurse Educator at St. Christopher’s Hospital for Children (SCHC). Ms. Sandhu graduated from Drexel University with her Bachelors of Science in Nursing in June, 2005. She began working as a staff nurse at SCHC in 2005, and became a Certified Pediatric Nurse in May 2008. Since beginning her career at SCHC, Ms. Sandhu has worked on multiple projects, including LEAN Daily Management, Safe Sleep Initiative, and The Period of PURPLE Crying. Ms. Sandhu sits on the SCHC Multidisciplinary Transplant Team, Trauma Committee, Nursing Policy and Practice Council, Nursing Quality Council, Nursing Leadership Council, and Patient Safety Council. Ms. Sandhu presented her work on The Use of a Performance Improvement Tool to Improve CRAFFT Screening in Adolescents at the 2017 National Children’s Network Conference in Wilmington, Delaware. She has instructed multiple educational activities including, nurse residency, preceptor workshop, charge nurse workshop, and yearly nurse mandatories. Ms. Sandhu’s passion as a Nurse Educator is to foster the development and critical thinking of the novice nurse. Ms. Sandhu assisted with the prior pilot study, as well as drafting and revising this grant application. She will oversee the implementation of nursing education both online and in-person for train-the-trainer sessions in the medical-surgical units. She will be responsible for in the collection of pre- and post- competency training results for the medical-surgical units. Ms. Sandhu will also assist with operationalizing the process to implement caregiver education and dissemination of the educational materials. She will also assist with miscellaneous tasks to help ensure study completion within the grant timeframe.

Ms. Sandhu’s grant experience is as follows:  $750 Pacesetter Grant to implement nursing and caregiver education surrounding Abusive Head Trauma and Shaken Baby Syndrome at SCHC, July, 2018

Biographical Sketch

Rochelle Thompson, MS Injury Prevention Coordinator Trauma and Burn Services, St. Christopher’s Hospital for Children

Rochelle Thompson, MS is the Trauma and Burn Injury Prevention Coordinator at St. Christopher’s Hospital for Children (SCHC). Mrs. Thompson graduated with her BA in Psychology from LaSalle University in May 2000. After fifteen years, Mrs. Thompson went back to school to receive her MS in Psychology in September 2016 with a 3.80 GPA from University of Phoenix.

Mrs. Thompson’s career was in the pathway of Management until completing her graduate degree when she then transferred to the Trauma Service Department at St. Christopher’s Hospital for Children in February 2017 as the Injury Prevention Coordinator. During Mrs. Thompson’s role as the Injury Prevention Coordinator she has been taught the anatomy and physiologies of diagnosis to completely understand how to provide effective preventive tips to families. Mrs. Thompson has continued to grow the existing Cribs for Kids North Philadelphia and SCHC Car Seat Programs. In addition, Mrs. Thompson has educated over hundreds of families on a variety of preventative injuries such as scald burns, bike safety, pedestrian safety, home safety, fire prevention, gun safety, and fall prevention. One of the biggest accomplishments for the Trauma Program is the opening of the Injury Prevention Resource Center in September 2018 a simulated room to enhance the visual significance of what resources could be used in and out of the home to prevent or reduce injury. On the other hand, one of the biggest accomplishments for the Burn Program was the Survivors Offering Assistance Recovery (SOAR) program that has nine trained peer supporters on board. Mrs. Thompson had worked collaboratively with the Trauma team and Dr. Tyrala on the Effectiveness of a safe sleep practice educational intervention to promote behavior change accepted abstract representation at four regional and national conferences. Mrs. Thompson was able to attend the Injury Free Coalition for Kids 2018 conference for a poster presentation in Ft. Lauderdale, FL to represent the Safe Sleep theme.

Mrs. Thompson loves interacting with children and families with the ability to relate to living in the lowest poverty community. She takes pride in making a difference to help change the behavior of what could inevitably prevent an injury. Mrs. Thompson ultimate goal is to continue to promote change and increase children’s belief in not allowing society to label them by working per-diem as a Mobile Therapist for a Peer Mentoring organization.

Mrs. Thompson has assisted with the prior pilot study, as well as drafting and revising this grant application. She will be responsible for assisting with the implementation of nursing education both online and in-person for train-the-trainer sessions. Mrs. Thompson will facilitate ordering and receiving the educational materials. She will also assist with operationalizing the process to implement caregiver education and dissemination of the educational materials. Mrs. Thompson will be primarily responsible for arranging community events and will co-present the information to caregivers alongside nursing staff. She will also assist with miscellaneous tasks to help ensure study completion within the grant timeframe.

Mrs. Thompson’s grant experience is as follows:

 $2,997 grant awarded by the American Trauma Society Pennsylvania Division to provide tourniquets and bleeding control stations to a local Philadelphia area high school, January 2019  $2,999.88 grant awarded by the American Trauma Society Pennsylvania Division to provide scald burn prevention equipment to families with children up to the age of 6 years of age, January 2019  $2,000 fund awarded by SCHC Medical Staff for the Cribs for Kids North Philadelphia Program to provide education and pack ‘n play pens, December, 2018  Buckle Up for Life (BUFL) grant in providing 60 convertibles and 40 booster seats for children, June 2018  $750 Pacesetter Grant to implement nursing and caregiver education surrounding Abusive Head Trauma and Shaken Baby Syndrome at SCHC, July, 2018  $3700 grant awarded by The American Trauma Society Pennsylvania Division to provide for scald burn prevention equipment to families in prenatal and pediatric clinics, January, 2018  Buckle Up for Life (BUFL) grant in providing 60 convertibles and 40 booster seats for children, June 2017  $500 Pacesetter Grant for pediatric scald burn prevention at SCHC, May, 2017  $500 Pacesetter Grant for first aid kits for injury prevention at SCHC, March, 2017  $9,139 Sound Off Grant to promote home fire safety and start-up funds for the Injury Prevention Resource Center at SCHC

**Use this if parent has already received PURPLE **Use this if parent has already received PURPLE Crying Education** Crying Education**

Period of PURPLE Crying Reinforcement Period of PURPLE Crying Reinforcement Remind parents: Remind parents: • Infant crying is normal in the first 4-5 months. • Infant crying is normal in the first 4-5 months. • Crying increases at about 2 weeks, peaks at 2-3 months • Crying increases at about 2 weeks, peaks at 2-3 months and declines by 5 months. and declines by 5 months. • Some normal babies may cry as long as 5 hours a day, • Some normal babies may cry as long as 5 hours a day, some less. some less. • Call your doctor if you are worried about the crying. • Call your doctor if you are worried about the crying. • Shaking is very dangerous, can cause brain damage and • Shaking is very dangerous, can cause brain damage and even death. even death. • If the crying becomes too frustrating, put your infant in • If the crying becomes too frustrating, put your infant in a safe place, walk away and take a break for 5- a safe place, walk away and take a break for 5- 10 minutes. And remember, the second video provided 10 minutes. And remember, the second video provided offers advice about ways to soothe your baby. offers advice about ways to soothe your baby. • Be sure to tell everyone who cares for your infant • Be sure to tell everyone who cares for your infant about the Period of PURPLE Crying program. about the Period of PURPLE Crying program.

**Use this if parent has already received PURPLE **Use this if parent has already received PURPLE Crying Education** Crying Education**

Period of PURPLE Crying Reinforcement Period of PURPLE Crying Reinforcement Remind parents: Remind parents: • Infant crying is normal in the first 4-5 months. • Infant crying is normal in the first 4-5 months. • Crying increases at about 2 weeks, peaks at 2-3 months • Crying increases at about 2 weeks, peaks at 2-3 months and declines by 5 months. and declines by 5 months. • Some normal babies may cry as long as 5 hours a day, • Some normal babies may cry as long as 5 hours a day, some less. some less. • Call your doctor if you are worried about the crying. • Call your doctor if you are worried about the crying. • Shaking is very dangerous, can cause brain damage and • Shaking is very dangerous, can cause brain damage and even death. even death. • If the crying becomes too frustrating, put your infant in • If the crying becomes too frustrating, put your infant in a safe place, walk away and take a break for 5- a safe place, walk away and take a break for 5- 10 minutes. And remember, the second video provided 10 minutes. And remember, the second video provided offers advice about ways to soothe your baby. offers advice about ways to soothe your baby. • Be sure to tell everyone who cares for your infant • Be sure to tell everyone who cares for your infant about the Period of PURPLE Crying program. about the Period of PURPLE Crying program.

**Use this if parent has never received PURPLE crying Education**

Period of PURPLE Crying Key Point Checklist

___ PURPLE Acronym ___Peak of Crying – Crying peaks during the second month, decreasing after that ___Unexpected – Crying comes and goes unexpectedly, for no apparent reason ___Resists Soothing – Crying continues despite all soothing efforts by caregivers ___Pain-like Face – Infants look like they are in pain, even when they are not ___Long Lasting – Crying can go on for 30-40 minutes at a time, and often for much longer ___Evening Crying – Crying occurs more in the late afternoon and evening ___Early increased crying is normal ___Ways to comfort your crying baby ___Important action steps ___Why crying is frustrating ___Why shaking a baby is dangerous ___Be sure to tell others

Upon completion:

 Place in Purple Crying Binder  Complete Education Log  Ad Hoc a nursing note documenting education complete and teachback

------CUT HERE ------

**Use this if parent has never received PURPLE crying Education**

Period of PURPLE Crying Key Point Checklist

___ PURPLE Acronym ___Peak of Crying – Crying peaks during the second month, decreasing after that ___Unexpected – Crying comes and goes unexpectedly, for no apparent reason ___Resists Soothing – Crying continues despite all soothing efforts by caregivers ___Pain-like Face – Infants look like they are in pain, even when they are not ___Long Lasting – Crying can go on for 30-40 minutes at a time, and often for much longer ___Evening Crying – Crying occurs more in the late afternoon and evening ___Early increased crying is normal ___Ways to comfort your crying baby ___Important action steps ___Why crying is frustrating ___Why shaking a baby is dangerous ___Be sure to tell others

Upon completion:

 Place in Purple Crying Binder  Complete Education Log  Ad Hoc a nursing note documenting education complete and teachback Shaken Baby Syndrome and Abusive Head Trauma Competency Assessment Listed below is a set of 31 questions that will be randomly drawn in a set of 10 per quiz. A passing score of 80% or better is required. If less than 80%, another quiz with randomly selected questions is generated for user to take again until they pass with at least 80%.

1. What could the effects of shaking be on the eyes? A. Bleeding, often causing lifelong visual impairments B. Makes babies cross-eyed C. There are typically no effects on the eye D. All of the above

2. When does the crying curve begin? A. Around two months of age B. Around two weeks of age C. Around five months of age D. Around five weeks of age

3. The "R" in PURPLE stands for: A. The parent should rock the infant to comfort B. The infant resists soothing C. Acid reflux, which can cause PUPRLE crying D. All of the above

4. When an infant is crying, caregivers can do the following: A. Comfort, carry, walk, and talk with the infant B. Take the infant to the doctor if the caregivers are concerned about crying C. Remember, sometimes infant crying is unsoothable D. All of the above

5. All of the following may occur in the brain and eyes during a shaking event except: A. Retinal hemorrhaging, or bleeding in the back of the eye B. Bleeding between the brain and skull (subdural hematoma) C. New brain cells are formed D. The brain moves in opposite directions, potentially causing tearing in the nerve cells

6. Information that can help parents cope with unsoothable infant crying includes: A. The crying can be normal B. The crying is not the fault of the parent C. The crying will come to an end D. All of the above

7. Colic is: A. Not an indication of disease in the infant B. The upper end of the continuum on the crying curve C. Like the Period of PURPLE Crying, crying is improved, or reduced, after three months of age D. All of these

8. The goal of the Period of PURPLE Crying is to: A. Create a cultural change in the understanding of early infant crying B. Reduce the incidence of shaken baby syndrome by 50% C. Help all caregivers cope with early increased crying D. All of the above

9. When do crying bouts tend to cluster? A. Early morning B. Mid-day C. Evenings D. In the middle of the night

10. Nurses should encourage parents to share the Period of PUPRLE Crying video and booklet with whom of the following: A. Family members B. Temporary caregivers C. Neighbors and friends D. All of the above

11. PUPRLE crying is caused by: A. Something abnormal or wrong with the baby B. Western patterns of care giving C. The infant's sleeping environment D. Normal behavior patterns of young infants

12. All of the following statements are true about normal crying patterns except: A. Increased early infant crying has been observed in many cultures and caregiving behaviors. B. Increased early infant crying has only been observed in humans. C. Increased early infant crying is a normal behavior and not the fault of the caregiver D. Increasing carry, walk, and talk responses to crying can reduce the length of crying bouts.

13. The Period of PURPLE Crying program aims to create a cultural change in the way society understands: A. The meaning of increased crying in early infancy B. Safe sleeping environments of infants C. The danger of shaking as a response to frustration with that crying D. Both a and c

14. PURPLE crying usually starts to decrease: A. Around 2 months of age B. Around 3 months of age C. Around 5 months of age D. Around 9 months of age

15. Babies who are preterm but otherwise healthy will have crying patterns as described in the PURPLE program, but will: A. cry for more than five hours per day B. be adjusted to their corrected age C. also sleep more D. all of these 16. Which of the following babies is likely to have additional or different crying patterns from otherwise normal infants? A. The baby of a drug-exposed mother B. A baby who has known central nervous system insults C. An infant cardiac patient D. All of the above

17. The Period of PURPLE Crying program materials consist of: A. Talking point resources and TeachBack demonstration B. A three-page brochure and link to YouTube video C. PURPLE Crying video, booklet and Soothing video D. None of the above

18. Parents need to take home the program materials for the following reasons: A. To review when their baby’s crying starts to increase B. To share with other caregivers C. To share with family members D. All of the above

19. The most common stimulus for SBS/AHT is: A. Rocking chairs and bouncing games B. Prolonged crying C. Short falls D. Jogging with an infant in a stroller

20. Early infant crying is normal, though parents should: A. Have their baby examined by a doctor or health professional if they are concerned. B. Blame themselves for their baby's crying C. Not try to sooth their baby’s crying D. None of the above

21. True or False The Crying, Soothing and Coping: Doing What Comes Naturally video is designed to help parents understand the challenges of a crying baby; to provide an approach to dealing with the crying; and to give parents a “take away” that will help them when they are stressed.

22. True or False The approach to how to teach soothing is to provide principles that are easy to grasp and use, rather than being a “how to” manual.

23. The approach to how to teach soothing means which of the following? 1. To support and strengthen parent confidence and effectiveness 2. To address unsuccessful soothing 3. How to cope with the soothing experience 4. All of the above

24. The teaching of coping comes down to emphasizing a few important points. Which of the following is one of them? a. Soothing always works b. Soothing does not always work c. Soothing is easy d. Soothing works none of the time

25. A plan for teaching parents about coping should include three goals. Which of the following is not one of them? a. Parents should recognize what they are feeling b. Parents should reframe the experience c. Parents should not worry about coping d. Parents should have some strategies for coping

26. Which of the following provide additional coping information for parents and caregivers? a. PURPLEcrying.info b. Crying, Soothing and Coping: Doing What Comes Naturally video c. Military OneSource d. All of the above

27. The video addresses two very important components about parents’ abilities to cope. Which of the following is correct: a. The ability to sooth all crying and not worry about the crying b. The ability to ask for help and experience joy despite the frustration of the unsoothable crying c. The ability to read a book and ignore a crying baby d. The ability to take the baby for a walk and do laundry at the same time

28. True or False The Crying, Soothing and Coping video provides excellent teaching opportunities to reinforce the key message in early infancy that “Safety is ALWAYS a concern”.

29. Which of the following safety components is not addressed in the Crying, Soothing and Coping video? a. Burns b. Safe Sleep/Back to Sleep c. Overstimulation d. Car Seat Safety 30. True or False Commercial devices are necessary for successful soothing.

31. Which of the following AAP risk factors for safe sleep is reinforced in the video with an absence of the behavior? a. Smoking or environmental smoke b. Overheating, over bundling or covering of the face or head while sleeping c. Soft objects, loose bedding, or bumper pads d. All of the above

Caregiver Attitudes Pre-Education Survey

Please tell us about yourself by writing your answers into the space provided.

Your age (in years): ______Number of Children in your household: ______

Please tell us about yourself by placing an “X “in the box that best describes you.

Are you male or female? Male Female Other: ______

How would you describe yourself?

Black or African-American White or Caucasian Asian American Indian/Alaskan Native Hispanic/Latino Other: ______

What is your annual household income?

Less than $20,000 $20,000-$34,999 $35,000-$49,999 $50,000-$74,999 $75,000-$99,999 Over $100,000

What is your highest level of education?

 Some high school High school diploma or GED Some college, but no degree Associate degree Bachelor’s degree Advanced degree (Master’s, PhD, MD)

Please tell us much you agree with the following statements by placing an “X “in one of the boxes per question:

1) It is normal for a baby to cry more around the first two months of life and continue until the child is about four or five months old. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

2) Babies can cry for up to five hours a day and still be healthy and normal. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

3) If my baby is crying, it’s because I’m doing something wrong as a parent. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

4) Shaking a crying baby is very dangerous and can cause brain damage, or even death. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

5) I feel comfortable walking away from my baby when I get frustrated with their crying. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

6) It is important for everyone who takes care of my baby to know the potential dangers of shaking a baby when they become frustrated with crying. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

7) I am confident in my ability to react to my baby’s crying. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

8) When I get really upset about my baby crying, I deal with it by: Hoping a miracle will happen Coming up with a couple of different solutions to stop the crying Make a plan of what to do when my baby cries and follow the plan Wishing the crying will be over with

Caregiver Attitudes Post-Education Survey

Please tell us about yourself by writing your answers into the space provided.

Your age (in years): ______Number of Children in your household: ______

Please tell us about yourself by placing an “X “in the box that best describes you.

Are you male or female? Male Female Other: ______

How would you describe yourself?

Black or African-American White or Caucasian Asian American Indian/Alaskan Native Hispanic/Latino Other: ______

What is your annual household income?

Less than $20,000 $20,000-$34,999 $35,000-$49,999 $50,000-$74,999 $75,000-$99,999 Over $100,000

What is your highest level of education?

 Some high school High school diploma or GED Some college, but no degree Associate degree Bachelor’s degree Advanced degree (Master’s, PhD, MD)

Please tell us much you agree with the following statements by placing an “X “in one of the boxes per question:

1) It is normal for a baby to cry more around the first two months of life and continue until the child is about four or five months old. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

2) Babies can cry for up to five hours a day and still be healthy and normal. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

3) If my baby is crying, it’s because I’m doing something wrong as a parent. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

4) Shaking a crying baby is very dangerous and can cause brain damage, or even death. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

5) I feel comfortable walking away from my baby when I get frustrated with their crying. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

6) It is important for everyone who takes care of my baby to know the potential dangers of shaking a baby when they become frustrated with crying. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

7) I am confident in my ability to react to my baby’s crying. Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree

8) When I get really upset about my baby crying, I deal with it by: Hoping a miracle will happen Coming up with a couple of different solutions to stop the crying Make a plan of what to do when my baby cries and follow the plan Wishing the crying will be over with

Caregiver Attitudes Post-Education Survey

9) Did you watch your DVD or use your app after discharge from St. Christopher’s Hospital for Children? Yes No Not sure

10) How many people did you share information about the Period of PURPLE Crying with? ______

Period of PURPLE Crying Pre- Competency Assessment

Start of Block: Default Question Block

The following is an assessment to test your current knowledge related to Shaken Baby Syndrome/Abusive Head Trauma. Please answer the following ten questions to the best of your ability. All responses will be confidential and results will only be reported for the group as a whole.

Please select the clinical area you currently work in:

o 4N (1)

o 5N (2)

o NICU (3)

Page Break

Page 1 of 5

Q1 What could the effects of shaking be on the eyes?

o Bleeding, often causing lifelong visual impairments (1)

o Makes babies cross-eyed (2)

o There are typically no effects on the eye (3)

o All of the above (4)

Q2 When does the crying curve begin?

o Around two months of age (1)

o Around two weeks of age (2)

o Around five months of age (3)

o Around five weeks of age (4)

Q3 All of the following may occur in the brain and eyes during a shaking event except:

o Retinal hemorrhaging, or bleeding in the back of the eye (1)

o bleeding between the brain and skull (subdural hematoma) (2)

o New brain cells are formed (3)

o The brain moves in opposite directions, potentially causing tearing in the nerve cells (4)

Page 2 of 5

Q4 Information that can help parents cope with unsoothable infant crying includes:

o The crying can be normal (1)

o The crying is not the fault of the parent (2)

o The crying will come to an end (3)

o All of the above (4)

Q5 Colic is:

o Not an indication of disease in the infant (1)

o The upper end of the continuum on the crying curve (2)

o Like the Period of PURPLE Crying, crying is improved, or reduced, after three months of age (3)

o All of these (4)

Q6 When do crying bouts tend to cluster?

o Early morning (1)

o Mid-day (2)

o Evenings (3)

o In the middle of the night (4)

Page 3 of 5

Q7 PURPLE Crying is caused by:

o Something abnormal wrong with the baby (1)

o Western patterns of care giving (2)

o The infant's sleeping environment (3)

o Normal behavior patterns of young infants (4)

Q8 Which of the following babies is likely to have additional of different crying patterns from otherwise normal infants?

o The baby of a drug-exposed mother (1)

o A baby who has known central nervous system insults (2)

o An infant cardiac patient (3)

o All of the above (4)

Q9 The most common stimulus for Shaken Baby Syndrome/Abusive Head Trauma is:

o Rocking chairs and bouncing games (1)

o Prolonged crying (2)

o Short falls (3)

o Jogging with an infant stroller (4)

Page 4 of 5

Q10 A plan for teaching parents about coping should include three goals. Which of the following is not one of them?

o Parents should recognize what they are feeling (1)

o Parents should reframe the experience (2)

o Parents should not worry about coping (3)

o Parents should have some strategies for coping (4)

Q11 Have you received any education about Shaken Baby Syndrome/Abusive Head Trauma in the last 2 years?

o Yes (1)

o No (2)

o Not sure (3)

End of Block: Default Question Block

Page 5 of 5

® The Period of PURPLE Crying

A program of the

10 – Minute Classroom Talking Points

Equipment Recommended:  Demonstration Doll  Crying Audio  DVD Player  Period of PURPLE Crying Materials  Crying Curve (found in the online module, available for download)

1. Welcome and congratulations  Introduce the Period of PURPLE Crying, a new way to understand your baby’s crying.

2. Hand out the Period of PURPLE Crying program materials  Play the 10-minute video on normal infant crying

3. Go through the booklet, page by page, and point out the important messages:  PURPLE acronym  Early Increased Crying is Normal  Ways to Comfort Your Crying Baby  Important Action Steps  Why Crying is Frustrating  Why Shaking a Baby is Dangerous  Be Sure to Tell Others

4. Strongly recommend that they watch the video and read the booklet at home many times. Make sure that anyone who cares for their baby does the same. Again, this is very important and is why we are giving them their own set of program materials.

5. It is important to know that what is being discussed is based on over 25 years of research, by many medical doctors and other scientists, who specialize in child development and specifically infant crying.  The Period of PURPLE Crying is a new way to describe what has widely been known as colic, but it is important to know that all babies experience these crying patterns, some just cry much more than others.

6. Normal infant crying:  Explain the crying curve:  All babies go through the crying curve. Some cry a lot and some cry far less, but all babies go through it. The curve usually starts at about two weeks of age, peaks at two to three months, and then declines at about five months of age. Some of these babies can cry as long as five hours a day or more and still be healthy; while those at the low end of the crying curve may cry 20-minutes or less each day.  Explain how we know this about normal developing babies:

The Period of PURPLE Crying® is a registered trademark and all content is copyright protected. All Rights Reserved, Ronald G. Barr, MDCM, FRCPC and the National Center on Shaken Baby Syndrome (2004–2018). Revised 6/29/2018.  Many years of research have shown this to be true. In fact, studies of many breast feeding animals other than humans, like guinea pigs, rat pups, and chimpanzees have shown that their babies also experience a similar crying curve.  Studies with parents who did everything possible to care for their babies showed that their babies still went through the crying curve. These are mothers who breastfed the baby every 13 minutes, parents who responded to every whimper within ten seconds, and parents who kept the baby close to them with skin to skin contact. So it is not a matter of “better” care. Crying is part of normal child development.  Explain to parents that it is important to have a doctor examine their baby to be sure they are all right if they are concerned about the crying. However, if they are growing, not sick, have no fever, and/or not hurt they are very likely going through the Period of PURPLE Crying, which will come to an end at about four to five months.

7. Inconsolable crying can be very frustrating but there are other things that can add stress. Some of these things can include:  Wrong Advice. There are some magazines and books that claim if a caregiver just listens to the cry and try specific calming methods they should be able to stop the crying, “the right way.” This can give unrealistic expectations and be discouraging when it doesn’t work. Relatives and friends can be discouraging as well by saying things like, “something must be wrong with your baby because he/she cries too much.”  There are methods for soothing a crying baby, but the reality is that sometimes these work and sometimes they will not. Frustration can increase when specific soothing methods work one day and not the next. This does not mean there is something wrong with either the caregiver or the baby.  Encourage parents who want more advice about ways to sooth their baby to watch the 17- minute video called Crying, Soothing, and Coping: Doing What Comes Naturally that is found in the program materials.  Thinking that it will never end. Most can put up with a lot if we know it will end. This period of inconsolable crying will end, by about four or five months and sometimes earlier.  Thinking that you must have a bad baby or that you are a bad parent. Neither of these things is true. The crying is normal and does come to an end.

8. Just how stressful can it get?  Play the crying audio.  Ask the parent(s) to picture themselves up, again, with the crying baby.  Some good parents who never shook their baby have said they got so frustrated and angry that they found themselves leaning over the crib yelling at the baby or “almost picked him up and shook him.” Instead, they went out of the room and shut the door and cried on the couch. Other caregivers can get to this point and that is normal. It is very important to walk away for a while and gain control.  Sometimes the crying occurs just for a few days, but it can still be frustrating. Remind the parents the infant is going through the Period of PURPLE Crying, the crying will come to an end, and they will get through it.

9. Shaking is the most dangerous thing anyone can do to a baby.  Even mild shaking can cause brain damage and hard shaking can be deadly. We are not talking about tossing a baby in the air, or bumps in a car seat. It is shaking a baby (demonstrate a violent shake – use demonstration doll if available) that causes the damage. Actions such as tossing a baby in the air or playing roughly with a baby are not wise and not recommended, but they do not cause shaken baby syndrome.

The Period of PURPLE Crying® is a registered trademark and all content is copyright protected. All Rights Reserved, Ronald G. Barr, MDCM, FRCPC and the National Center on Shaken Baby Syndrome (2004–2018). Revised 6/29/2018. 10. Tell others about the Period of PURPLE Crying.  Strongly warn parents not to leave their baby with someone who gets frustrated easily. Encourage them to find someone they think can stay calm in the midst of an infant crying spell.  Let parents know they shouldn’t be embarrassed to tell others about the Period of PURPLE Crying, it can save their baby’s lives. For some, sharing the materials with others is easier. While telling the caregiver is the ideal method, this is sometimes difficult for some parents to do. For some, asking a temporary caregiver to watch the 10 minute PURPLE video or read the 10-page booklet is easier than verbally telling them.

11. Enjoy your baby  Babies are great fun and bring so much joy. The Period of PURPLE Crying will come to an end, and the parents and baby will be fine.

12. Sample Questions  I want to be sure I explained everything clearly, what do you think were the three most important things about what I just explained?  What will you tell others about the Period of PURPLE Crying program we discussed today?  In your own words, how would you describe the Period of PURPLE Crying?  What are some important action steps you can take…  …when PURPLE crying is happening?  …if you find that you are frustrated by the crying?

13 . Provide the parent(s) with the PURPLE program materials  Encourage them to review the materials again and to share the information with others who care for their baby.  If providing the web and mobile application, remind parents the activation code on the front of the booklet can be used on up to five personal devices and is available for eighteen months after activation.

14. Answer Questions  Leave time at the end to answer questions the parent(s) might have about the Period of PURPLE Crying.

The Period of PURPLE Crying® is a registered trademark and all content is copyright protected. All Rights Reserved, Ronald G. Barr, MDCM, FRCPC and the National Center on Shaken Baby Syndrome (2004–2018). Revised 6/29/2018.