The HOPE program: protocol for a stratified cluster randomized controlled trial to prevent psychoactive substance use and promote health in Moroccan middle school students

BACKGROUND: Early adolescent psychoactive substance use poses major health and social risks. School-based programs enhancing psychosocial skills are effective for prevention. This study aims to develop, implement, and evaluate "HOPE", a school-based program to prevent substance use and promote health among first-year middle school students in Fez, Morocco. METHODS: A stratified cluster randomized controlled trial will be conducted across 12 middle schools, enrolling 1,000 first-year students (500 intervention, 500 control) and 60-90 parents. Stratified cluster randomization based on sociodemographic characteristics will ensure group balance. The intervention will be delivered over two years through 22 structured in-person group sessions (15 for students, 7 for parents) at participating schools. Data collection will involve structured student questionnaires and parent focus groups to assess a range of outcomes, including knowledge acquisition, attitude change, development of psychosocial skills, substance use patterns, and related behavioral and psychological effects. Measurable objectives include improvements in knowledge and psychosocial competencies, as well as reductions in substance use and associated harms. Expected outcomes include delayed initiation of substance use and enhanced student well-being. DISCUSSION: We expect that the program will help to prevent and/or delay psychoactive substance use among first-year middle school students by reinforcing protective factors and reducing risk factors. We anticipate a reduction in current substance use, a decreased risk of abuse, and diminished physical and psychological effects. This study will evaluate the effectiveness of the "HOPE" program in reducing substance use and improving the physical and mental health of first-year middle school students in Fez. Its multi-year structure and potential positive outcomes could serve as a foundation for a national school-based prevention initiative in Morocco. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR202401711272288 (Registered on January 26, 2024).