Recruiting soon

Hybrid Program for Substance Use Prevention in Upper Elementary Students

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What is being tested

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

Behavioral
Who is being recruted

Vaping+5

+ Drug Misuse

+ Behavior

From 7 to 11 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorChristopher Williams
Study ContactChristopher Williams, PhD, MPHMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

This study aims to address the growing issues of vaping and prescription drug misuse among upper elementary school students in the U.S. It focuses on developing a preventive program from a positive youth development perspective, which has been missing in current prevention efforts. The study is important because it targets young children, among whom these risky behaviors are increasingly starting earlier. By incorporating both online learning and traditional classroom sessions, the program teaches students about the dangers of vaping, the correct use of prescription drugs, and builds social skills, aiming to prevent substance use before it begins. Participants in this study will engage with a hybrid program that includes digital learning and classroom activities designed to be interactive and engaging. The effectiveness of the program will be evaluated through a national trial, comparing students who participate in the program with those who receive standard health education. The study measures changes in behaviors, attitudes, and knowledge about vaping and prescription drug use over time. By integrating e-learning modules, the program not only reduces the demands on classroom time but also enhances reach and engagement, potentially setting a new standard for substance use prevention in schools across the country.

Official TitleA Hybrid Program to Prevent Substance Use Risk Among Upper Elementary School Students Using a Positive Youth Development Approach 
NCT07162155
Principal SponsorChristopher Williams
Study ContactChristopher Williams, PhD, MPHMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

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

3000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 7 to 11 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

VapingDrug MisuseBehaviorMental DisordersSmokingSubstance-Related DisordersPrescription Drug MisuseChemically-Induced Disorders

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Health Promotion Associates

White Plains, United StatesSee the location
Recruiting soonOne Study Center