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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-11
SponsorChristopher Williams

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: Classroom Sessions and E-learning ModulesExperimental treatment 1 intervention
Group B: Control ConditionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Pre-test (prior to participating in the first session/module of the intervention)
2

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.

Time frame
Post-test (within 2 weeks of completing final session/module of the intervention)
3

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.

Time frame
6-month followup (within-in 6-7 months of completing final session of interventioon)
4

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christopher Williams

Lead sponsor

National Health Promotion Associates, Inc.

Sponsor institution

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: