Prevention of alcohol use and promotion of well-being among middle school students: a study protocol for a randomized...

Alcohol use during adolescence has both immediate as well as long-term negative effects; in turn, delaying onset and preventing hazardous use in early adolescence is one essential avenue to protect and bolster adolescents' socioemotional growth and neurodevelopment. This trial examines the effectiveness, feasibility and acceptability of a novel neurodevelopmentally informed intervention - Adolescent Developmentally-Appropriate health Promotion Therapy (ADAPT) among students in middle school. We hypothesize that, compared to the delayed treatment condition (DT), ADAPT students will show statistically significant behavior change across measures, including: intentions to drink (primary outcome), alcohol use and alcohol-related consequences, well-being and life satisfaction (secondary outcomes) from baseline to 3 months.

The study employs a 2-condition cluster randomized controlled trial comparing: (1) ADAPT with a (2) DT condition. Approximately N = 1000 8th grade students (ages 13-15) will be recruited from public middle schools in a global region with elevated rates of adolescent drinking (Denmark; during the school year 2025/2026). Data evaluating primary and secondary outcome measures (e.g., intentions to drink, alcohol use, alcohol-related consequences, well-being, life satisfaction) will be collected via online questionnaires at baseline, and 1- and 3-months post intervention. Feasibility and acceptability will be assessed via attendance in ADAPT group sessions and parent meetings, student surveys, and interviews with middle school staff.

This is the first trial to examine effectiveness of the novel neurodevelopmentally informed intervention ADAPT on adolescent drinking and well-being. Novel interventions are needed to address the high prevalence of early drinking and the past decade decline in adolescent well-being, particularly in regions of the globe with elevated adolescent drinking rates. The findings of the study hold substantial significance for the health and well-being of adolescents and can inform evidence-based decisions on alcohol prevention policy, and professional health care practices in Scandinavia and throughout the globe. The trial was registered at ClinicalTrials.gov on August 11^th , 2025.

gov Identifier: NCT07132866.