Empowering 5th Graders for a Vape- and Smoke-Free Future: Intervention Development and Randomized Controlled Trial

Empowering 5th Graders for a Vape- and Smoke-Free Future: Intervention Development and Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Empowering 5 th Graders for a Vape- and Smoke-Free Future: Intervention Development and Randomized Controlled Trial Marina Hinssen, Julia Kohn, Josef Mohammad, Valentin Jakob Vecera, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6227852/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 06 May, 2026 Read the published version in Scientific Reports → Version 1 posted You are reading this latest preprint version Abstract Background: The potential of e-cigarettes to introduce nicotine use to non-smoking adolescents is currently met by a lack of evaluated prevention interventions. Meanwhile, social disparities in smoking and vaping persist. School-based smoking prevention programs have proven moderately effective, but difficult to implement in already strained school settings of lower socioeconomic status. Here, we describe the development and evaluation protocol for a school-based vaping and smoking prevention program. Methods: We developed the intervention following Intervention Mapping Adapt, including qualitative interviews with N = 62 students and N = 54 experts; as well as feasibility testing of the developed program in N = 13 classes, conducting online-surveys before and after the program. A longitudinal, cluster randomized controlled trial will be conducted with at least N = 1,500 students from at least N = 26 lower SES schools in Berlin, Germany, randomly assigned 1:1 to the intervention or active control group (standard curriculum). General mixed effect regression analyses will be conducted to investigate the intervention effects on students’ intention to be vape- and smoke-free (primary endpoint at 12 months), susceptibility and vaping and smoking. We will test mediators underlying program effects and examine group specific risk and protective factors, intervention effects and mediators by students’ social determinants of health. Results: The intervention consists of three interactive workshops delivered by external interventionists visiting classrooms. Based on the needs assessment, we a) lowered the target age b) implemented a program focus on e-cigarettes; resistance skills, social norms, critical thinking, and stress management, and c) designed materials and procedures to meet the needs of lower SES schools. The interview and feasibility studies proved the program to be acceptable and feasible and, with minor refinements, ready for the main trial. Conclusions: The planned evaluation study will enhance knowledge on vaping prevention, mediating mechanisms, and differential needs of students related to their social determinants of health. It may thus enable effective, economic, and personalized future prevention. Trial registration: This trial has been registered prospectively (OSF Registries; 25/11/2023) and retrospectively (German Clinical Trials Register, DRKS00036358; 06/03/2025). Smoking prevention Vaping prevention School Social determinants of health Children Adolescents Full Text Additional Declarations No competing interests reported. Supplementary Files Additionalfile1.docx Additionalfile2.docx Cite Share Download PDF Status: Published Journal Publication published 06 May, 2026 Read the published version in Scientific Reports → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6227852","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":442974196,"identity":"e51db87d-e4ea-42c7-b6b5-cd8b314a210b","order_by":0,"name":"Marina 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Meanwhile, social disparities in smoking and vaping persist. School-based smoking prevention programs have proven moderately effective, but difficult to implement in already strained school settings of lower socioeconomic status. Here, we describe the development and evaluation protocol for a school-based vaping and smoking prevention program.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e We developed the intervention following Intervention Mapping Adapt, including qualitative interviews with \u003cem\u003eN\u003c/em\u003e = 62 students and \u003cem\u003eN\u003c/em\u003e = 54 experts; as well as feasibility testing of the developed program in \u003cem\u003eN\u003c/em\u003e = 13 classes, conducting online-surveys before and after the program. A longitudinal, cluster randomized controlled trial will be conducted with at least \u003cem\u003eN\u003c/em\u003e = 1,500 students from at least \u003cem\u003eN\u003c/em\u003e = 26 lower SES schools in Berlin, Germany, randomly assigned 1:1 to the intervention or active control group (standard curriculum). General mixed effect regression analyses will be conducted to investigate the intervention effects on students’ intention to be vape- and smoke-free (primary endpoint at 12 months), susceptibility and vaping and smoking. We will test mediators underlying program effects and examine group specific risk and protective factors, intervention effects and mediators by students’ social determinants of health.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e The intervention consists of three interactive workshops delivered by external interventionists visiting classrooms. 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