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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
National Health Promotion Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prescription Drug Abuse (Not Dependent)

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 17, 2017
    Last Updated
    February 24, 2020
    Sponsor
    National Health Promotion Associates, Inc.
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    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

    Learn more about this trial

    Preventing Prescription Drug Abuse in Middle School Students

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