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NCT03129334 Clinical Trial

Preventing Prescription Drug Abuse in Middle School Students

Substance Abuse Clinical Trial

— MSPDA  

Official title:
Preventing Prescription Drug Abuse in Middle School Students

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03129334
Other study ID # R44DA040358-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date June 2020

Study information
Verified date February 2020
Source National Health Promotion Associates, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4500
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Health Promotion Associates, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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