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

Part of paid clinical trials in White Plains, New York.

Sponsor
Christopher Williams
Study ID
NCT07162155
Status
Not Yet Recruiting

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Conditions

  • E Cig Use
  • Prescription Drug Misuse
  • Vaping

Eligibility Criteria

Sex
ALL
Age
7 Years - 11 Years
Healthy Volunteers
Accepted

Interventions

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

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Aug 2025
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Classroom Sessions and E-learning Modules
    Students will: attend 1 classroom session per week for 6 weeks (lecture, discussion, small group activities, skills practice) and complete 1 e-learning module per week for 6 weeks (animated didactic content).
  • No Intervention: Control Condition
    Students attending schools randomized to the control group will attend existing health education programming.

Primary Outcome Measure

Vaping, e-cigarette use, and prescription drug misuse behaviors, norms, and attitudes at baseline [ Time Frame: Pre-test (prior to participating in the first session/module of the intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Health Promotion AssociatesWhite PlainsNew York10604
Christopher Williams, PhD, MPH
[email protected]
914-421-2525
Nina S Daley, BS
[email protected]
914-421-2525

Find similar trials in White Plains, NY

By research site
National Health Promotion Associates· White Plains, NY

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