VapingNCT07162155
A Hybrid Program to Prevent Substance Use Risk Among Upper Elementary School Students Using a Positive Youth Development Approach
A study testing School-based Hybrid Intervention to Prevent Vaping and Prescription Drug Misuse in people with Vaping and E Cig Use, run by Christopher Williams at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping, E Cig Use, Prescription Drug Misuse
- What is being tested?
- School-based Hybrid Intervention to Prevent Vaping and Prescription Drug Misuse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Health Promotion Associates
White Plains, New York, 10604
Christopher Williams, PhD, MPH, 914-421-2525, cwilliams@nhpamail.com
Nina S Daley, BS, 914-421-2525 ext. 218, ndaley@nhpamail.com
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Vaping, E Cig Use, Prescription Drug Misuse
- Being tested
- School-based Hybrid Intervention to Prevent Vaping and Prescription Drug Misuse
- Keywords
- prevention, school-based, positive youth development
- Medical subject headings
- Vaping, Prescription Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based Hybrid Intervention to Prevent Vaping and Prescription Drug MisuseBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-month followup (within 12-13 months of completing final session of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VapingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher Williams
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Christopher Williams, National Health Promotion Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162155
- Sponsor's protocol ID
- 61665-01-2024
- Other IDs
- R44DA061665
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Program to Prevent Substance Use Risk Among Upper Elementary School Students Using a Positive Youth Development Approach
- ClinicalTrials.gov ID
- NCT07162155
- Acronym / sponsor ID
- 61665-01-2024
- Conditions
- Vaping, E Cig Use, Prescription Drug Misuse
- Keywords
- prevention, school-based, positive youth development
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Christopher WilliamsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Classroom Sessions and E-learning Modules | Experimental | Behavioral: School-based Hybrid Intervention to Prevent Vaping and Prescription Drug MisuseStudents 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). |
| Control Condition | No intervention | –Students attending schools randomized to the control group will attend existing health education programming. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-based Hybrid Intervention to Prevent Vaping and Prescription Drug MisusePsychosocial 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. | Behavioural | Classroom Sessions and E-learning Modules |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-based Hybrid Intervention to Prevent Vaping and Prescription Drug Misuse in people with Vaping and E Cig Use, run by Christopher Williams at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Williams, PhD, MPH (914-421-2525 ext. 204, cwilliams@nhpamail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.