Clinical Trial

A Hybrid Program to Prevent Substance Use Risk Among Upper Elementary School Students Using a Positive Youth Development Approach

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Summary
The goal of this randomized controlled trial is to evaluate a psychosocial school-based hybrid intervention which includes traditional classroom sessions and online e-learning modules to reduce risk of vaping and prescription drug misuse as part of a broader positive youth development substance use prevention model. Upper elementary schools (N=30) will be randomized to either an intervention group that will receive a hybrid intervention or a treatment-as-usual control group that will receive existing health education programming. At the end of the intervention period, and at 6- and 12-month follow-up assessments, both groups will be compared on changes in behaviors, norms, attitudes, and knowledge regarding vaping and prescription medication use. The main questions the trial aims to answer are: * Does the intervention lower risk of vaping and prescription drug misuse? * Does the intervention increase pro-health norms, attitudes, and knowledge regarding vaping and prescription drug misuse? Participants will: * Attend 1 classroom session per week for 6 weeks (lecture, discussion, small group activities, skills practice). * Complete 1 e-learning module per week for 6 weeks (animated didactic content). * Students attending schools randomized to the control group will attend existing health education programming.
Trial Details
NCT Number NCT07162155
Lead Sponsor Christopher Williams
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Vaping, E Cig Use, Prescription Drug Misuse
Enrollment 3,000 participants
Start Date 2026-01
Primary Completion 2028-06 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2025-09-09