Clinical Research Studies For more information and to sign-up for our research registry visit https://vr.ucdmc.ucdavis.edu or email [email protected]

Currently enrolling studies:

Type of Clinical Age Study Title and Description Study Involvement Study Diagnosis SPARK: Simons Foundation Powering Research and ☒Saliva Samples Knowledge ☒Questionnaires The SPARK study will recruit 50,000 individuals with Autism # Visits: 0 Spectrum Disorder (ASD), and their family members, from across Autism All ages Online the U.S. to join an online registry. DNA will be collected through Spectrum

saliva samples. The purpose of this national registry is to identify Disorder causes of ASD.

To participate, visit: sparkforautism.org/ucd

(SCREEN) Online Screening for Autism in the Community ☒Questionnaires The goal of this project is to test new methods of screening for ASD # Visits: optional using an online system. Parents will complete brief screening Online questionnaires online when their child is 6, 9, 12, 18, 24, & 36 (optional Birth-6 months old. Any enrolled children whose screening indicates Typical visits to months developmental concerns will be invited for visits to the MIND Development the MIND) Institute for comprehensive assessment via telehealth at 24 months and a visit to the MIND when the child is 36 months. Families must be enrolled by the time their child turns 6 months of age.

(TEDI) The Telehealth Evaluation of Development for Infants ☒ Telehealth – online The goal of this project is to develop and test a telehealth method Showing signs 6-12 study for conducting behavioral assessments of infants' early social of social and Telehealth months ☒Assessments communication and development. communication # Telehealth visits: 5 delay

LAAMB Study: Learning About Autism and ADHD Markers in ☒Questionnaires Babies ☒Assessments Older sibling Researchers at the MIND Institute are conducting a study of early # Visits: 0 with autism In person, social, language, cognitive, self-regulation, attention, and motor spectrum visits to 6-36 development of infants and toddlers from 6 through 36 months of disorder, ADD/ the MIND months age. This study is currently enrolling babies between 6-9 months of ADHD, or required age who have an older sibling with disorder (ASD), typically an older sibling with ADD/ ADHD, or a typically developing older developing sibling. older sibling.

(BRIDGE) Examining the Efficacy of Project ImPACT for Toddlers ☒Assessments Project ImPACT (Improving Parents As Communication Teachers) # Telehealth visits: 3-4 for Toddlers is a naturalistic approach designed to coach parents for parents and caregivers of 12-36 month-olds to support their child’s (care providers will also development. It uses a combination of behavioral and be included in this Autism 12-36 developmental strategies to help parents increase their child’s Telehealth study, but number of Spectrum months social-communication and play skills in daily activities. We are telehealth visits vary Disorder currently recruiting therapists who work with young children in for providers) early intervention services to participate in a research study about early intervention training. After the study is complete, participating therapists will be able to conduct Project ImPACT for Toddlers in their clinical practice with young children.

(Continued) Currently enrolling studies:

Type of Clinical Age Study Title and Description Study Involvement study Diagnosis (BRAIN) Brain Research in Autism- Investigating Neurophenotypes ☒ Autism Telehealth, Blood Draws This study examines different patterns of brain development in Spectrum in-person 2 to 3 ½ ☒MRI ASD, specifically focused on evaluating brain size. Disorder or visits to years ☒Assessments Typical the MIND # In-person visits: 3-4 Development required # Telehealth visits:1-2

(KidsFirst) KidsFirst Research Network ☒Questionnaires This online study will require families to enroll in a database and # Visits: 0 complete questionnaires regarding demographic and behavioral Autism information. Each unique response will help researchers further Spectrum understand the challenges associated with autism and other Disorder or 2 to 17 Online developmental disabilities, which may lead to more tailored developmental years treatment and intervention. disability, or developmental To participate, please visit: kidsfirst.stanford.edu concerns

(EPICC) EmPowering communication In Children through ☒Assessments Telehealth, Collaboration # visits: in-person The goal of this research study is to better understand the use of EPICC phase #1: 1 Autism 2 to 5 visits to communication tools and how collaboration occurs in settings for telehealth visit Spectrum years the MIND minimally verbal preschool students with autism. EPICC phase #2: 2 Disorder required telehealth visits, 1 in- person COVID-19 Impact on Individuals with Down Syndrome and their ☒Questionnaires Families # Visits: 0 2 to 17 It is the goal of this study to understand the unique challenges Down Online years faced by children with Down syndrome, and their caregivers, during syndrome this time, to better understand how to best support them during the COVID-19 pandemic and beyond. The Impacts of COVID-19 on the Neurodevelopmental Community ☒Questionnaires and a Plan for Continued Care # Visits: 0 The purpose of this study is to shed light on the direct impact that ADHD, Autism COVID-19 has had on the services provided to families of youth with Spectrum 2 to 18 neurodevelopmental disabilities as well as the role telehealth Disorder, Down Online years technology, like video visits, might have played during the syndrome, pandemic. The project will also begin to assess the utility of new Fragile X intervention technologies and approaches that might facilitate Syndrome access to services in the future.

(FMRP) Family Relationships and Parenting of Children with FXS ☒Telehealth – online The goal of this research is to examine how family relationships and Fragile X MALES study Online- the broader family environment influence developmental outcomes Syndrome or 3 to 7 Telehealth for young children with FXS. Fragile X years Premutation

In-person (BioMotion) Perception and execution of biological motion ☒Assessments visit to adhering to the two-thirds power law ☒Questionnaires Autism Center for The goal of this study is to examine both the perception and Spectrum 4 to 8 # In-person visits: 1-2 Mind and execution of motion in children with and without autism spectrum Disorder or years Brain disorder. Typical (Davis) Development required

Updated 8/24/21 (TOOLBOX) A Cognitive Test Battery for Intellectual Disabilities ☒Assessments Fragile X In-person The purpose of the study is to explore whether certain types of # Visits: 2-3 Syndrome, visits to 4 to 25 intellectual or cognitive tests are reliable, valid, and sensitive to Down the MIND years improvement in evaluating treatment responses among individuals syndrome, or required with . Intellectual Disability (DS+ADHD) Evaluating Phenotype of DS+ADHD for Future ☒Assessments Assessment and Medication Treatment ☒Questionnaires The purpose of this research study is to identify behavioral, In-person # In-person visits: 1 cognitive, academic, and functional impairments that differentiate Down visits to 6 to 17 children with DS and ADHD from children with DS-only. These syndrome the MIND years findings will help us to gain a better understanding of how ADHD required affects children with DS.

(DS-MPH) Evaluating Assessment and Medication Treatment of ☒Assessments ADHD in Children with Down Syndrome ☒Questionnaires In-person, Despite this higher risk of Attention Deficit Hyperactivate Disorder ☒Medication visits to (ADHD) in children with Down Syndrome (DS), rates of stimulant # In-person visits: 9 Down the MIND 6 to 17 medication treatment are disproportionately low in children with # telehealth visits: 6 syndrome required, years DS+ADHD, even though stimulants are the most efficacious ADHD *may select all in- and ADHD telehealth treatment and are recommended for use in children with person visits (optional) intellectual disability and ADHD. This trial is designed to test the safety and effectiveness of stimulant treatment in children with DS+ADHD. (MET) A Double-Blind, Placebo-Controlled Trial of Metformin in ☒Assessments In- person, Individuals with ☒Medication visits to 6 to 25 The goal of this 4-month placebo-controlled trial of metformin, a ☒Blood Draws Fragile X the MIND years common type 2 diabetes medication, is to examine whether it is # In-person visits: 3 Syndrome required beneficial for improving language, cognition, and behavior in children and adults with FXS. (STAAR) Specifying and Treating Anxiety in Autism Research ☒Blood Draws The goal of STAAR is to better characterize anxiety in ASD and In- person, ☒MRI (optional) Autism evaluate if medication or Cognitive Behavioral Therapy (CBT) is visits to ☒Assessments Spectrum 8 to 14 more effective for children with ASD and anxiety. Participants will the lab # In-person Visits: 1-2 Disorder with years be offered medication, CBT, or pill placebo. If put into pill placebo, required, lab visits symptoms of participants will be offered their choice of complimentary CBT or telehealth # Telehealth Visits: 16 anxiety study medication after completion of the study.

Brain Dynamics of Sensory Processing in Autism In person ☒Assessments The goal of this study is to learn more about the types of unusual visits to ☒Questionnaires Autism sensory experiences common in people on the autism spectrum, as the Center # Visits: 1 visit to the Spectrum 10 to 14 well as their neural and cognitive underpinnings for Mind MIND and 2 visits to Disorder or years and Brain the Center for Mind Typical in Davis and Brain in Davis Development required (FXLA 2.0) Language Development in Fragile X Syndrome ☒Blood Draw The goal of the study is to learn more about how certain abilities, ☒Assessments experiences, and biological aspects affect language abilities in In- person ☒Questionnaires 16 to 23 individuals with fragile X syndrome and their transition into Fragile X or # Visits: 2 visits to years adulthood. Syndrome Telehealth MIND/telehealth, 2 home visits

Updated 8/24/21 (Fidget) Can fidgeting lead to enhanced attention and emotional ☒Assessments regulation in adult ADHD? ☒Questionnaires In- person The project studies how natural movement relates to cognitive and # Visits: 1 visits to 18 to 35 emotional functioning in adults with ADHD and if movement and ADHD the MIND years access to a "fidget device" can improve cognitive and emotional required regulation in ADHD.

(TRAX) Trajectories and Markers of Neurodegeneration in Fragile X ☒Blood Draws Premutation Carriers ☒MRIs In- person, This study examines changes in the brain and cognition associated ☒Assessments Fragile X visits to with aging, in males with and without the fragile X premutation. MALES ☒Questionnaires premutation, the MIND The study consists of two 2-day visits to the MIND and two 45+ # In-person visits: 2 Typical required, telehealth visits over the course of five years, to observe changes in # Telehealth visits: 2 Development telehealth the brain and cognition occurring over time.

Updated 8/24/21 Studies temporarily not recruiting due to COVID-19– check back for updates:

Type of Study Age Study Title and Description Diagnosis study Involvement (PLAY-DS) Early Childhood Communication Outcome Measures for Down ☒Assessments syndrome # Visits: 1-2 2½ to 7 The goal of this research study is to learn more about how samples of Down years early communication and spoken language skills can be used to measure syndrome change over time in individuals with Down syndrome. (MMID) Memory Measures for Intellectual Disabilities ☒Assessments Typical The goal of this study is to develop a comprehensive, computerized # Visits: 3 Development, 3 to 17 memory assessment for use in populations with intellectual disabilities. Fragile X years Syndrome, or Down Syndrome (VRAM) Virtual Reality Attention Management ☒ Assessments The goal of this study is to identify and pilot key tasks and operational ☒Questionnaires 8 to 12 design for distractor resistance training, in a virtual reality (VR) classroom, # Visits: 3-4 ADHD years with participants who have attention problems and/or ADHD with 4-6 weeks at significant inattention. This study is a preliminary assessment of VR home w/ headset training feasibility and intervention outcomes. (COCOA) Cognitive Control in Autism ☒MRI Autism The purpose of the study is to gain a better understanding of cognitive ☒Assessments Spectrum 12 to 15 functioning of individuals with Autism Spectrum Disorder (ASD) during the ☒Questionnaires Disorder or years transition from adolescence to adulthood. # Visits: 3 Typical Development

(MINT) Mapping Impulsivity Neurodevelopmental Trajectories ☒MRI The purpose of the MINT Study is to better understand how self-control ☒ ADHD or 18 to 30 Assessments develops in young adults with and without ADHD. Typical years # Visits: 10-12 Development

(MARBLES) Markers of Autism Risk in Babies-Learning Early Signs ☒Blood Draws Women who This study enrolls pregnant women or those likely to become pregnant ☒Assessments have given soon who have a child diagnosed with ASD. The purpose of this study is to # Visits: 10 home birth to a child learn about risk factors occurring during pregnancy that may be associated with ASD and 18 years visits, 2 visits to with ASD. The babies will be followed for 3 years. are currently or older the MIND pregnant or likely to become pregnant soon

Updated 8/24/21