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Clinical Trials/NCT03129334
NCT03129334
Unknown
N/A

Preventing Prescription Drug Abuse in Middle School Students

National Health Promotion Associates, Inc.0 sites4,500 target enrollmentSeptember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prescription Drug Abuse (Not Dependent)
Sponsor
National Health Promotion Associates, Inc.
Enrollment
4500
Primary Endpoint
Change in any prescription drug use in the past year
Last Updated
6 years ago

Overview

Brief Summary

This project is designed to test a primary prevention approach to the problem of prescription drug misuse and abuse (PDA) among middle school students. The intervention uses both online e-learning and small group facilitator-led intervention modalities. Middle schools will be randomized to receive the intervention or serve as controls.

Detailed Description

While there are a number of drug abuse prevention programs for middle school age youth, relatively few programs focus on preventing prescription drug abuse. Furthermore, due to growing constraints on classroom time, new evidence-based prevention programs are needed that flexibly incorporate the use of online digital technology and classroom/small-group components. The present study is developing and testing an adaptation of the evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The proposed preventive intervention for middle school PDA will (1) utilize both online digital and face-to-face intervention modalities to address PDA and concurrent ATOD use; (2) positively change social norms and challenge positive expectancies regarding PDA and ATOD use; (3) discourage diversion of prescription medications; and (4) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios. Middle schools will be randomized into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive existing health education programming. At the end of the intervention period, and at a 12-month follow-up assessments, we will compare both groups with respect to changes in behaviors, norms, attitudes, and knowledge regarding PDA and substance use.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
June 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenneth W Griffin

Senior Research Scientiest

National Health Promotion Associates, Inc.

Eligibility Criteria

Inclusion Criteria

  • Middle school aged-youth

Exclusion Criteria

  • Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites

Outcomes

Primary Outcomes

Change in any prescription drug use in the past year

Time Frame: Post-test (within 2 weeks of completing final session/module of the intervention), 6-month followup, 12-month followup

The investigators will assess (via questionnaire) key study variables regarding prescription drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group at a post-test assessment and 6- and 12-month follow-up assessments.

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