Preventing Prescription Drug Abuse in Middle School Students

Not Applicable

• Conditions: Substance Use; Substance Abuse; Prescription Drug Abuse (Not Dependent)
• Interventions: Behavioral: LST Middle School Online

• Registration Number: NCT03129334
• Lead Sponsor: National Health Promotion Associates, Inc.

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

• Middle school aged-youth

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LST Middle School Online	LST Middle School Online	Students will participate in a series of e-learning modules plus classroom sessions related to drug abuse prevention, including prescription drug abuse

Primary Outcome Measures

Name	Time	Method
Change in any prescription drug use in the past year	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.