A Hybrid Program to Prevent Substance Use Risk Among Upper Elementary School Students Using a Positive Youth Development Approach
Condition(s) studied
Investigational drug(s) / intervention(s)
School-based Hybrid Intervention to Prevent Vaping and Prescription Drug Misuse: Psychosocial school-based hybrid intervention which includes traditional classroom sessions and online e-learning modules to reduce risk of vaping and prescription drug misuse among upper elementary school students.
Study 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.
Eligibility
Primary outcome measure(s)
- Vaping, e-cigarette use, and prescription drug misuse behaviors, norms, and attitudes at baseline — Pre-test (prior to participating in the first session/module of the intervention)
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding vaping, e-cigarette use, and prescription drug misuse behaviors and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group. - Change in baseline baseline vaping, e-cigarette, and prescription drug misue behaviors, norms, and attitudes at post-intervention — Post-test (within 2 weeks of completing final session/module of the intervention)
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding vaping, e-cigarette use, and prescription drug misuse behaviors and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group. - Change in bse line vaping, e-cigarette use, and prescription drug misuse behaviors, norms, and attitudes at 6-month followup — 6-month followup (within-in 6-7 months of completing final session of interventioon)
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding vaping, e-cigarette use, and prescription drug misuse behaviors and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group. - Change in baseline vaping, e-cigarette use, and prescription drug misuse behaviors, norms, and attitudes at 12-month followup — 12-month followup (within 12-13 months of completing final session of intervention)
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding vaping, e-cigarette use, and prescription drug misuse behaviors and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| National Health Promotion Associates | White Plains | New York |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07162155 on ClinicalTrials.gov ↗ ← All trials in the USA