A Hybrid Program to Prevent Substance Use Risk Among Upper Elementary School Students Using a Positive Youth Development Approach
Public ClinicalTrials.gov record NCT07162155. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07162155
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 3,000 participants
Conditions and interventions
Conditions
Interventions
Behavioral
Eligibility (public fields only)
- Age range
- 7 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2025
- Primary completion
- May 31, 2028
- Completion
- Jul 31, 2028
- Last update posted
- Sep 8, 2025
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Health Promotion Associates | White Plains | New York | 10604 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07162155, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 8, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07162155 live on ClinicalTrials.gov.