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

August 29, 2025 updated by: Christopher Williams

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This SBIR Fast-Track proposal is designed to address the urgent problems of vaping and prescription drug misuse (PDM) among youth in the U.S. There is a dearth of primary prevention programs for vaping and PDM that have demonstrated changes in behavior as part of a rigorously designed evaluation. Research shows that the age of onset for these behaviors is decreasing and rates are increasing among the youngest cohorts. While there are a number of substance use prevention programs, there are no evidence-based programs that focus on these problems among upper elementary school students from a positive youth development perspective. Furthermore, due to growing constraints on classroom time, new evidence-based hybrid prevention programs are needed that flexibly incorporate the use of online digital technology and classroom components. In the proposed project, we will develop and test a hybrid adaptation of the evidence-based Life Skills Training (LST) substance abuse prevention program for upper elementary school students. The LST program has been extensively tested and found to effectively prevent substance abuse in a series of randomized controlled trials with behavioral effects reported in over 30 peer-reviewed publications. The proposed hybrid preventive intervention will: 1) utilize both online e-learning modules and traditional classroom sessions to reduce risk of vaping and PDM as part of a broader positive youth development substance use prevention model; 2) teach students about the harms of vaping and the importance of safe and appropriate prescription medication use; 3) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios; and 4) incorporate online booster sessions. In Phase I, we will develop prototypes of e-learning modules and classroom materials and focus group test them with upper elementary school students, teachers, and parents to demonstrate feasibility, relevance, usability, and appeal. Materials will be revised based on focus group feedback and fully developed, and then we will conduct a rigorous national randomized trial of the prevention program in Phase II. Elementary schools (N=30) will be randomized into either an intervention group that will receive the new 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, we will compare both groups on changes in behaviors, norms, attitudes, and knowledge regarding vaping and appropriate prescription medication use. This research offers the potential to identify an innovative, effective, interactive, and engaging hybrid preventive intervention program that reduces the time burden for classroom prevention by incorporating e-learning modules as part of an evidence-based prevention model. The intervention materials may help to reduce risk for emergent substance use behaviors among upper elementary school youth. The program can be widely disseminated throughout the country and ultimately decrease the harms of substance misuse among youth.

Study Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kenneth W Griffin, PhD, MPH
  • Phone Number: 703-993-4032
  • Email: kgriff4@gmu.edu

Study Locations

  • United States
    • New York
      • White Plains, New York, United States, 10604
        • National Health Promotion Associates
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Behavioral: 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.
No Intervention: Control Condition
Students attending schools randomized to the control group will attend existing health education programming.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
12-month followup (within 12-13 months of completing final session of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christopher Williams

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

August 29, 2025

First Submitted That Met QC Criteria

August 29, 2025

First Posted (Estimated)

September 9, 2025

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61665-01-2024
  • R44DA061665 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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