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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

+ E Cig Use
+ Prescription Drug Misuse
From 7 to 11 Years
+2 Eligibility Criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2026

Summary

Principal SponsorChristopher Williams
Study ContactChristopher Williams, PhD, MPH
Last updated: September 9, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2026Actual 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 
Principal SponsorChristopher Williams
Study ContactChristopher Williams, PhD, MPH
Last updated: September 9, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 7 to 11 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Vaping
E Cig Use
Prescription Drug Misuse
Criteria
1 inclusion criteria required to participate
tudents will be eligible for participation if they attend a school enrolled in the trial and they are between ages 7-11

1 exclusion criteria prevent from participating
ll 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
2 intervention groups 

are 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).
Group II
No Intervention
Students attending schools randomized to the control group will attend existing health education programming.
Study Objectives
Primary Objectives

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.

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.

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.

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.

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 AssociatesWhite Plains, United StatesSee the location

Recruiting soonOne Study Center