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

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).