e-Motiva-PREV Pilot Cluster-RCT

Objectives: The e-Motiva-PREV program is a school-based psychoeducational intervention aimed at preventing antisocial and violent behavior in adolescents while fostering autonomous motivation and emotional regulation. This pilot study evaluates the feasibility, fidelity, and preliminary efficacy of the program using a cluster-randomized controlled trial (c-RCT) design.Methods: Ten classes (329 students, grades 8–9) were randomly assigned to either the intervention or waitlist control group. The program includes 10 weekly sessions grounded in Self-Determination Theory (SDT) and Cognitive-Behavioral Therapy (CBT), focusing on empathy, cognitive reappraisal, non-violent conflict resolution, and internalization of prosocial values. Primary outcomes are antisocial behavior and hostile attribution bias; secondary outcomes include autonomous motivation, emotional regulation, well-being, resilience, and psychosocial adjustment. Assessments occur at baseline (T0), post-intervention (T1), and 3-month follow-up (T2). Analyses follow an intention-to-treat approach using hierarchical linear models (HLM) and generalized estimating equations (GEE), with multiple imputation for missing data and exploratory false discovery rate (FDR) control. Mediation analyses will explore emotional regulation and autonomous motivation as mechanisms of change.Results: As a pilot study, preliminary analyses will focus on estimating intraclass correlation coefficients (ICC), effect sizes, and feasibility outcomes, rather than definitive hypothesis testing. Expected outcomes include reductions in antisocial behavior, improved cognitive and motivational processes, and enhanced psychological well-being.Conclusions: This study will provide critical feasibility and parameter estimates to guide the design of a future full-scale efficacy trial of the e-Motiva-PREV intervention, supporting the integration of evidence-based school programs targeting adolescent violence prevention and psychosocial development.Keywords school-based intervention, cognitive-behavioral therapy, self-determination theory, antisocial behavior, emotional regulation, adolescent resiliencePublic Significance Statement1.The e-Motiva-PREV program provides a structured, school-based approach to prevent antisocial behavior and promote emotional regulation among adolescents.2.Preliminary evidence from this pilot cluster-RCT will inform the feasibility, implementation, and potential efficacy of SDT- and CBT-based interventions in real-world school settings.3.Findings can guide educators, school psychologists, and policymakers in designing evidence-based strategies to support adolescent well-being, social competence, and violence prevention.