Abstract
BACKGROUND: Substance use is among the main contributors to disease among children and adolescents in the Americas region. The call for effective prevention of substance use among adolescents has resulted in numerous school-based programs, and particularly the Unplugged program has been proved to be successful in reducing the prevalence of different substances in seven European countries. The purpose of this study is to test the effectiveness of the Unplugged program in Chile ("Yo Sé Lo Que Quiero"). METHODS: This is a cluster randomized controlled trial, parallel-group type, where "Yo Sé Lo Que Quiero" is compared to standard school preventive curricula in control schools. A total of 70 schools and 8400 adolescents are expected to be randomized with 1:1 allocation. During formative work, the Unplugged program was culturally adapted to Chile, and the instrument to assess the primary and secondary outcomes was validated. The effectiveness of this program will be assessed using the European Drug Addiction Prevention Trial Questionnaire (EU-Dap), measuring substance use prevalence and risk and protective factors in baseline, post-intervention, and four months after the end of the intervention. DISCUSSION: The proposed study will be the first to test the effectiveness of a school-based substance use prevention program in Chile in a cluster randomized control trial and the first study evaluating the Unplugged program in Spanish-speaking Latin America. A model for disseminating the Unplugged program inside Europe already exists and has been implemented successfully in several countries. Thus, if the effects of the program are positive, wide implementation in Chile and Latin American countries is possible soon. TRIAL REGISTRATION: ClinicalTrials.gov NCT04236999 . Registered on January 17, 2020.