Clinical Trial Protocol Iranian Registry of Clinical Trials

29 Sep 2021

Development and Eﬀectiveness of cognitive, behavioral and social interventions on smoke use prevention (CIPS) among adolescents (15-19 Years Old) pirbakran city: a community-based Mixed method Study

Protocol summary Main outcome variables using smoking, Outcome expectancy, Self-regulation, Study aim Self-eﬃcacy, Self-esteem, Family and School Function Determination and comparison of mean scores of cognitive variables one and six months after the General information intervention - Determining and comparing the mean scores of social variables one and six months after the Reason for update intervention - Determination and comparison of smoking Acronym behavior in adolescents one month and six months after CIPS the intervention IRCT registration information Design IRCT registration number: IRCT20200101045980N1 Samples were categorized into two sexes and each Registration date: 2020-02-04, 1398/11/15 category 2 high school and secondary school will Registration timing: registered_while_recruiting consider as a cluster. The proportion of each school will determine by the sample size(73 persons). Since the Last update: 2020-02-04, 1398/11/15 samples studied one and six months after the Update count: 0 intervention are not necessarily the same as those Registration date before the intervention (73 persons), the researcher and 2020-02-04, 1398/11/15 the other team members have no information about the sample. Registrant information Settings and conduct Name The intervention is a community-based without a control hajar rezaei group that will take about two months. Educational Name of organization / entity intervention in the form of a city-wide exhibition on the Country outcomes of smoking, sending educational messages, Iran (Islamic Republic of) designing educational reference sites, holding paintings Phone on the outcomes of smoking in schools, educational +98 31 3744 2638 sessions, etc. for some adolescents and their parents. Email address Participants/Inclusion and exclusion criteria [email protected] Residing in Pirbakran, Adolescents age 15-19 years Intervention groups Recruitment status The intervention is a community-based without a control Recruitment complete group that will take about two months. Educational Funding source intervention in the form of a city-wide exhibition on the outcomes of smoking, sending educational messages Expected recruitment start date through social networks, establishing banners in the 2019-06-27, 1398/04/06 environment, designing educational reference sites, Expected recruitment end date holding paintings on the outcomes of smoking in schools, 2020-04-18, 1399/01/30 educational sessions, etc. Actual recruitment start date

1 empty Aqueduct., Alley Hosseinieh., Main Ave., Bagh Actual recruitment end date Abrisham., Abrisham City empty City Trial completion date Isfahan empty Province Isfehan Scientific title Postal code Development and Effectiveness of cognitive, behavioral 8178963539 and social interventions on smoke use prevention (CIPS) Approval date among adolescents (15-19 Years Old) pirbakran city: a 2019-05-15, 1398/02/25 community-based Mixed method Study Ethics committee reference number IR.MUI.RESEARCH.REC.1398.116 Public title Development and Effectiveness of cognitive, behavioral and social interventions on smoke use prevention (CIPS) Health conditions studied among adolescents (15-19 Years Old): a community- based Mixed method Study 1 Purpose Prevention Description of health condition studied Inclusion/Exclusion criteria smoking Inclusion criteria: ICD-10 code Residing in Pirbakran city adolescents 15-19 Years Old ICD-10 code description Exclusion criteria: Questionnaires are incomplete Primary outcomes Age From 15 years old to 19 years old Gender 1 Both Description Cigarette smoking behavior Phase Timepoint N/A Before intervention, one and six months after Groups that have been masked intervention No information Method of measurement Sample size research-made questionnaire Target sample size: 73 Randomization (investigator's opinion) N/A 2 Randomization description Description Blinding (investigator's opinion) Outcome expectancy in a research-made questionnaire Not blinded from a Mixed Study Blinding description Timepoint Placebo Before intervention, one and six months after Not used intervention Assignment Method of measurement Single research-made questionnaire from a Mixed Study Other design features This study is a community-based study without a control group. All participants receive educational intervention 3 directly and indirectly. Description Outcome expectation in a research-made questionnaire Secondary Ids from a Mixed Study Timepoint empty Before intervention, one and six months after intervention Ethics committees Method of measurement research-made questionnaire from a Mixed Study 1 4 Ethics committee Name of ethics committee Description Isfahan University of Medical Sciences Self-regulation in a research-made questionnaire from a Street address Mixed Study First Floor., The Second Door., Left Hand Beside The Timepoint

2 Before intervention, one and six months after reference websites, holding educational sessions. It will intervention do for some adolescent and parents. Method of measurement Category research-made questionnaire from a Mixed Study Prevention

5 Recruitment centers Description Self-eﬃcacy in a research-made questionnaire from a 1 Mixed Study Recruitment center Timepoint Name of recruitment center Before intervention, one and six months after Pir Bakran City Schools intervention Full name of responsible person Method of measurement Hajar Rezaei research-made questionnaire from a Mixed Study Street address First Floor., The Second Door., Left Hand Beside The 6 Aqueduct., Alley Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City Description City Self-esteem in a research-made questionnaire from a Isfahan Mixed Study Province Timepoint Isfehan Before intervention, one and six months after Postal code intervention 8178963539 Method of measurement Phone research-made questionnaire from a Mixed Study +98 31 3744 2638 Email 7 [email protected] Description Web page address Family Function in a research-made questionnaire from a http://nocigarette.blogfa.com Mixed Study Timepoint Sponsors / Funding sources Before intervention, one and six months after intervention 1 Method of measurement research-made questionnaire from a Mixed Study Sponsor Name of organization / entity 8 Esfahan University of Medical Sciences Full name of responsible person Description Shaghayegh Haghjooy Javanmard School Function in a research-made questionnaire from a Street address Mixed Study Isfahan University of Medical Sciences., Hezar Jerib Timepoint Ave Before intervention, one and six months after City intervention Isfahan Method of measurement Province research-made questionnaire from a Mixed Study Isfehan Postal code Secondary outcomes 8174673461 Phone empty +98 31 3668 0048 Email Intervention groups [email protected] Web page address Grant name 1 Grant code / Reference number Description Is the source of funding the same sponsor Educational intervention in the form of a city-wide organization/entity? exhibition on the outcomes of smoking, sending Yes educational messages through social networks, drawing Title of funding source competitions on the consequences of smoking and Esfahan University of Medical Sciences secondhand smoke in schools, designing educational Proportion provided by this source

3 100 Isfahan Public or private sector Province Public Isfehan Domestic or foreign origin Postal code Domestic 8178963539 Category of foreign source of funding Phone empty +98 31 3744 2638 Country of origin Email Type of organization providing the funding [email protected] Academic Person responsible for updating data Person responsible for general inquiries Contact Contact Name of organization / entity Name of organization / entity Esfahan University of Medical Sciences Esfahan University of Medical Sciences Full name of responsible person Full name of responsible person Hajar Rezaei Hajar Rezaei Position Position PhD Candidate, Health Education and Health PhD Candidate, Health Education and Health Promotion, Department of Health Education and Promotion, Department of Health Education and Promotion Promotion Latest degree Latest degree Master Master Other areas of specialty/work Other areas of specialty/work Health Promotion Health Promotion Street address Street address First Floor., The Second Door., Left Hand Beside The First Floor., The Second Door., Left Hand Beside The Aqueduct., Alley Hosseinieh., Main Ave., Bagh Aqueduct., Alley Hosseinieh., Main Ave., Bagh Abrisham., Abrisham City Abrisham., Abrisham City City City Isfahan Isfahan Province Province Isfehan Isfehan Postal code Postal code 8178963539 8178963539 Phone Phone +98 31 3744 2638 +98 31 3744 2638 Email Email [email protected] [email protected] Sharing plan Person responsible for scientific inquiries Deidentified Individual Participant Data Set (IPD) Yes - There is a plan to make this available Contact Study Protocol Name of organization / entity Yes - There is a plan to make this available Esfahan University of Medical Sciences Statistical Analysis Plan Full name of responsible person Yes - There is a plan to make this available Hajar Rezaei Informed Consent Form Position Yes - There is a plan to make this available PhD Candidate, Health Education and Health Clinical Study Report Promotion, Department of Health Education and Yes - There is a plan to make this available Promotion,F Analytic Code Latest degree Yes - There is a plan to make this available Master Data Dictionary Other areas of specialty/work Yes - There is a plan to make this available Health Promotion Title and more details about the data/document Street address Participants' data file, consent form, codes used in the First Floor., The Second Door., Left Hand Beside The analysis, data classification system, and statistical Aqueduct., Alley Hosseinieh., Main Ave., Bagh analysis plan will provide to the responsible persons if Abrisham., Abrisham City necessary for accuracy of the information and... The City study protocol will publish as a rational model of

4 education to prevent smoking in adolescents The results - Considering the development of the questionnaire the of this study and the clinical trial report will publish in the use of this questionnaire in future studies - the use of form of an article. interventions to prevent smoking in adolescents When the data will become available and for how From where data/document is obtainable long E-mail the Research Committees and the journal From the second half of the year 1399 responsible for the validity of the study results To whom data/document is available What processes are involved for a request to access Research committees and responsible for the journal to data/document verify the results of the study Valid e-mail-related research organizations Under which criteria data/document could be used Comments