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

NCT07162155 | Not Yet Recruiting DMC

• 2 other identifiers: 61665-01-2024R44DA061665
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaping; E Cig Use; Prescription Drug Misuse

Keywords

prevention; school-based; positive youth development

Outcome Measures

Primary Outcomes (4)

• Vaping, e-cigarette use, and prescription drug misuse behaviors, norms, and attitudes at baseline

  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.

  Pre-test (prior to participating in the first session/module of the intervention)

• Change in baseline baseline vaping, e-cigarette, and prescription drug misue behaviors, norms, and attitudes at post-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.

  Post-test (within 2 weeks of completing final session/module of the intervention)

• Change in bse line vaping, e-cigarette use, and prescription drug misuse behaviors, norms, and attitudes at 6-month followup

  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.

  6-month followup (within-in 6-7 months of completing final session of interventioon)

• Change in baseline vaping, e-cigarette use, and prescription drug misuse behaviors, norms, and attitudes at 12-month followup

  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.

  12-month followup (within 12-13 months of completing final session of intervention)

Study Arms (2)

Classroom Sessions and E-learning Modules

EXPERIMENTAL

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).

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

Control Condition

NO INTERVENTION

Students attending schools randomized to the control group will attend existing health education programming.

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.

Classroom Sessions and E-learning Modules

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Christopher Williams: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

National Health Promotion Associates

White Plains, New York, 10604, United States

Location

MeSH Terms

Conditions

Vaping; Prescription Drug Misuse

Condition Hierarchy (Ancestors)

Smoking; Behavior; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Christopher Williams, PhD, MPH

CONTACT

914-421-2525; cwilliams@nhpamail.com

Kenneth W Griffin, PhD, MPH

CONTACT

703-993-4032; kgriff4@gmu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)