+1 Recommend
1 collections

      To submit your manuscript, please click here

      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Tobacco-Free Duo Adult-Child Contract for Prevention of Tobacco Use Among Adolescents and Parents: Protocol for a Mixed-Design Evaluation


      Read this article at

          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.



          Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important 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 has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent’s commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves.


          To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program’s implementation.


          A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and 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 in order to compare smoking incidence in the schools participating in the experiment with that of a convenience sample of schools that were not part of the experimental study. Diverse secondary outcomes at both adolescent and adult levels were also included.


          The study was approved by the Umeå Regional Ethics Review Board (registration number 2017/255-31) in 2017. Recruitment of schools started in fall 2017 and continued until June 2018. In total, 43 schools were recruited to the experimental study, and 16 schools were recruited to the observational study. Data collection started in the fall 2018, is ongoing, and is planned to be finished in spring 2021.


          Methodological, ethical, and practical implications of the evaluation protocol were discussed, especially the advantage of combining several sources of data, to triangulate the study questions. The results of these studies will help revise the agenda of this program as well as those of similar programs.

          Trial Registration

          International Standard Randomized Controlled Trial Number (ISRCTN) 52858080; https://doi.org/10.1186/ISRCTN52858080

          International Registered Report Identifier (IRRID)


          Related collections

          Most cited references38

          • Record: found
          • Abstract: found
          • Article: not found

          GRADE guidelines: 2. Framing the question and deciding on important outcomes.

          GRADE requires a clear specification of the relevant setting, population, intervention, and comparator. It also requires specification of all important outcomes--whether evidence from research studies is, or is not, available. For a particular management question, the population, intervention, and outcome should be sufficiently similar across studies that a similar magnitude of effect is plausible. Guideline developers should specify the relative importance of the outcomes before gathering the evidence and again when evidence summaries are complete. In considering the importance of a surrogate outcome, authors should rate the importance of the patient-important outcome for which the surrogate is a substitute and subsequently rate down the quality of evidence for indirectness of outcome. Copyright © 2011 Elsevier Inc. All rights reserved.
            • Record: found
            • Abstract: found
            • Article: found
            Is Open Access

            Triangulation in aetiological epidemiology

            Abstract Triangulation is the practice of obtaining more reliable answers to research questions through integrating results from several different approaches, where each approach has different key sources of potential bias that are unrelated to each other. With respect to causal questions in aetiological epidemiology, if the results of different approaches all point to the same conclusion, this strengthens confidence in the finding. This is particularly the case when the key sources of bias of some of the approaches would predict that findings would point in opposite directions if they were due to such biases. Where there are inconsistencies, understanding the key sources of bias of each approach can help to identify what further research is required to address the causal question. The aim of this paper is to illustrate how triangulation might be used to improve causal inference in aetiological epidemiology. We propose a minimum set of criteria for use in triangulation in aetiological epidemiology, summarize the key sources of bias of several approaches and describe how these might be integrated within a triangulation framework. We emphasize the importance of being explicit about the expected direction of bias within each approach, whenever this is possible, and seeking to identify approaches that would be expected to bias the true causal effect in different directions. We also note the importance, when comparing results, of taking account of differences in the duration and timing of exposures. We provide three examples to illustrate these points.
              • Record: found
              • Abstract: not found
              • Article: not found

              Robust research needs many lines of evidence


                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                October 2020
                29 October 2020
                : 9
                : 10
                : e21100
                [1 ] Department of Global Public Health Karolinska Institutet Stockholm Sweden
                [2 ] Centre for Epidemiology and Community Health Stockholm Sweden
                [3 ] Department of Epidemiology and Global Health Umeå University Umeå Sweden
                Author notes
                Corresponding Author: Maria Rosaria Galanti rosaria.galanti@ 123456ki.se
                Author information
                ©Maria Rosaria Galanti, Anni-Maria Pulkki-Brännström, Maria Nilsson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.10.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 5 June 2020
                : 15 September 2020

                tobacco use,prevention,school,social influence,public commitment,cluster randomized trial,observational study


                Comment on this article