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Starting soon Not applicable

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

NCT07162155 · tracked via the Priya Life Science USA tracker
Sponsor
Christopher Williams
Phase
Not applicable
Started
2026-01
Last updated
2025-09-09

Condition(s) studied

VapingE Cig UsePrescription Drug Misuse

Investigational drug(s) / intervention(s)

School-based Hybrid Intervention to Prevent Vaping and Prescription Drug Misuse

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

Sex
ALL
Min age
7 Years
Max age
11 Years
Healthy volunteers
Accepted
Inclusion Criteria: Students will be eligible for participation if they attend a school enrolled in the trial and they are between ages 7-11. Exclusion Criteria: All students will be eligible to participate in intervention implmentation, but survey responses will be excluded from the formal analysis with documentation of significant cognitive impairment as determined by school officials.

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)

FacilityCityRegionStatus
National Health Promotion Associates White Plains New York
Official registry record

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