What this study is
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.
What's being tested
- School-based Hybrid Intervention to Prevent Vaping and Prescription Drug Misuse
Intervention · BEHAVIORAL
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 details
- Sponsor
- Christopher Williams
- Conditions
- Vaping · E Cig Use · Prescription Drug Misuse
- Enrolling
- 3,000 people
- Starts
- 2026-01
- Est. completion
- 2028-08
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 7 Years – 11 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Students will be eligible for participation if they attend a school enrolled in the trial and they are between ages 7-11.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNational Health Promotion Associates
White Plains, New York, United States
- Christopher Williams, PhD, MPH · Contact914-421-2525cwilliams@nhpamail.com
- Nina S Daley, BS · Contact914-421-2525 ext. 218ndaley@nhpamail.com
Study team
Sponsor
Christopher Williams
Study ID 61665-01-2024
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.