Preventing Prescription Drug Abuse in Middle School Students
MSPDA
1 other identifier
interventional
4,500
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedFebruary 25, 2020
February 1, 2020
4.8 years
April 17, 2017
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
LST Middle School Online
EXPERIMENTALStudents will participate in a series of e-learning modules plus classroom sessions related to drug abuse prevention, including prescription drug abuse
Treatment as Usual (Control)
NO INTERVENTIONStudents will not participate in the e-learning modules. They will receive any standard classroom instruction on drug abuse/health education.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Middle school aged-youth
You may not qualify if:
- Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Scientiest
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 26, 2017
Study Start
September 1, 2015
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
February 25, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share