Preventing Prescription Drug Abuse in Middle School Students (MSPDA)
Primary Purpose
Prescription Drug Abuse (Not Dependent), Substance Use, Substance Abuse
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LST Middle School Online
Sponsored by
About this trial
This is an interventional prevention trial for Prescription Drug Abuse (Not Dependent)
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LST Middle School Online
Treatment as Usual (Control)
Arm Description
Students will participate in a series of e-learning modules plus classroom sessions related to drug abuse prevention, including prescription drug abuse
Students will not participate in the e-learning modules. They will receive any standard classroom instruction on drug abuse/health education.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03129334
First Posted
April 17, 2017
Last Updated
February 24, 2020
Sponsor
National Health Promotion Associates, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03129334
Brief Title
Preventing Prescription Drug Abuse in Middle School Students
Acronym
MSPDA
Official Title
Preventing Prescription Drug Abuse in Middle School Students
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Health Promotion Associates, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prescription Drug Abuse (Not Dependent), Substance Use, Substance Abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LST Middle School Online
Arm Type
Experimental
Arm Description
Students will participate in a series of e-learning modules plus classroom sessions related to drug abuse prevention, including prescription drug abuse
Arm Title
Treatment as Usual (Control)
Arm Type
No Intervention
Arm Description
Students will not participate in the e-learning modules. They will receive any standard classroom instruction on drug abuse/health education.
Intervention Type
Behavioral
Intervention Name(s)
LST Middle School Online
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in any prescription drug use in the past year
Description
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.
Time Frame
Post-test (within 2 weeks of completing final session/module of the intervention), 6-month followup, 12-month followup
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Preventing Prescription Drug Abuse in Middle School Students
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