Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 5, 2020
Date Accepted: Sep 15, 2020
Date Submitted to PubMed: Oct 1, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Adult-child contract for universal prevention of tobacco use: Protocol for a mixed-design evaluation of the Swedish school-based program “Tobacco-free Duo” (TOPAS study)
ABSTRACT
ABSTRACT
Background:
Universal tobacco-prevention programs targeting youths usually involve significant adults assumed to be important vehicles of social influences. Commitment not to use tobacco or to quit use as a formal contract between an adolescent and a significant adult, is a preventive model that has not been widely practiced or explored, and even less formally evaluated. Here we present the rationale and protocol for the evaluation of the Swedish program “Tobacco-free Duo”, a multi-component school-based program, of which the core rests on a formal agreement (contract) between an adolescent and an adult.
Methods:
A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned either to the comprehensive multi-component program or to its educational component only. Primary outcome at adolescent level was “not having tried tobacco” during the three-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach, an “as treated” approach complemented with a whole school repeated cross-sectional approach, was devised as analytical methods of the trial data. Second, an observational study was added to compare the development of smoking prevalence in the schools participating in the experiment with that of a convenience sample of schools not being part of the experimental study. Diverse secondary outcomes at both adolescent and adult level were also included. Ethics and dissemination: Regional Ethics Review Board, Umeå (registration nr.2017/255-31) approved the study. Participant schools and individuals were required to give explicit informed consent to data collection, analysis and reporting prior to inclusion in the study. Dissemination plans include interim news on the funder’s website; newsletter to participant schools and students; public lectures; press-releases in relevant cases. The results will help revise the agenda of this as well as of similar programs. Trial registration: Current Controlled Trials ISRCTN52858080 Date: January 4, 2019, retrospectively registered
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