Preventing Prescription Drug Abuse in Middle School Students (MSPDA)

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.

Study Overview

• Status: Unknown
• Conditions: Substance Use; Substance Abuse; Prescription Drug Abuse (Not Dependent)
• Intervention / Treatment: Behavioral: LST Middle School Online

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 Type: Interventional
• Enrollment (Anticipated): 4500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Middle school aged-youth

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in any prescription drug use in the past year	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.	Post-test (within 2 weeks of completing final session/module of the intervention), 6-month followup, 12-month followup

Collaborators and Investigators

• Sponsor: National Health Promotion Associates, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: R44DA040358-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No