Preventing Prescription Drug Abuse in Middle School Students

NCT ID: NCT03129334

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-06-30

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.

Conditions

Prescription Drug Abuse (Not Dependent); Substance Use; Substance Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

LST Middle School Online

Intervention Type: BEHAVIORAL

The adapted intervention will (1) utilize both online e-learning module (self-guided) and classroom-based sessions (facilitator led) to address PDA and concurrent ATOD abuse; (2) positively change social norms and challenge positive expectancies regarding PDA and ATOD abuse; (3) discourage diversion of prescription medications; (4) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios; and (5) incorporate booster sessions.

Treatment as Usual (Control)

Students will not participate in the e-learning modules. They will receive any standard classroom instruction on drug abuse/health education.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LST Middle School Online

The adapted intervention will (1) utilize both online e-learning module (self-guided) and classroom-based sessions (facilitator led) to address PDA and concurrent ATOD abuse; (2) positively change social norms and challenge positive expectancies regarding PDA and ATOD abuse; (3) discourage diversion of prescription medications; (4) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios; and (5) incorporate booster sessions.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Health Promotion Associates, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Kenneth W Griffin

Senior Research Scientiest

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

R44DA040358-01

Identifier Type: NIH

Identifier Source: org_study_id

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