Development of a school program for vaping and smoking prevention and protocol for a cluster randomized controlled trial in fifth grade students.

This article presents the intervention development study and protocol for a longitudinal cluster-randomized controlled trial of a school-based vaping and smoking prevention program based in Germany. E-cigarette use is rapidly increasing among adolescents who have never smoked, yet well-evaluated prevention interventions are lacking. Although school-based prevention programs are moderately effective, they are often difficult to implement in schools facing high structural burden. Using Intervention Mapping, we developed a vaping and smoking prevention program intended for a broad range of schools, including lower-SES settings. Development drew on qualitative interviews with students (N = 62) and experts (N = 54), followed by feasibility testing in 13 classrooms with pre- and post-intervention surveys (N = 92). The resulting intervention comprises three classroom sessions delivered by trained facilitators. Interview and feasibility data supported: (i) lowering the prevention target age to Grade 5; (ii) emphasizing e-cigarettes, resistance skills, social norms, and stress management; (iii) adapting materials to improve fit with schools serving lower-SES student populations; and (iv) the intervention's high acceptability and feasibility, suggesting readiness for full-scale evaluation. The intervention will next be tested in a cluster-randomized controlled trial with at least 1500 students across 26 Berlin schools, randomized (1:1) to intervention or active control group.