- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01755533
Adaptation Processes in School-Based Substance Abuse Programs
The goals of this study are to develop a middle school substance use prevention curriculum for underserved rural youth and evaluate its efficacy compared to the existing, multicultural curriculum. In addition, we are studying how the curricula get taught by the teachers.
Hypothesis 1: When compared to students in the control condition, students in the treatment conditions will report less substance use, more conservative norms, less positive expectations about substance use outcomes, and better life and communication skills.
Hypothesis 2: When compared to students in the control condition, students in the researcher adaptation condition will report less substance use, more conservative norms, less positive expectations, and better life and communication skills.
Hypothesis 3: When compared to students in the control condition, students in the teacher adaptation condition will report less substance use, more conservative norms, less positive expectations, and better life and communication skills.
Hypothesis 4: Researcher adaptation will have a greater impact on substance use, norms, and expectations than teacher adaptation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goals of the proposed study are to conduct an effectiveness trial of the keepin' it REAL middle school substance use prevention curriculum among a new target audience in rural Pennsylvania and Ohio, describe how teachers adapt the curriculum when they present it, and develop, implement, and evaluate a Pennsylvania/Ohio-version of the curriculum to test whether an evidence-based universal curriculum can be improved by adapting it to local cultures. keepin' it REAL is recognized as a "model program" by SAMHSA's National Registry of Effective programs and is one of the few that are multicultural. The study will evaluate the effectiveness of the original curriculum, grounded in the cultures of the southwest and compare that to a new version, "regrounded" in the rural culture of Pennsylvania and Ohio, while studying how teachers adapt both versions. This proposal responds to NIDA PA-05-118, Drug Abuse Prevention Intervention Research that calls for investigations addressing, "1) the development of novel drug abuse prevention approaches; 2) the efficacy and effectiveness of newly developed and/or modified prevention programs; 3) the processes associated with the selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated interventions." This proposal addresses all three points.
A randomized control trial will be conducted in middle schools to accomplish these goals. First, formative research will be conducted to develop a rural Pennsylvania/Ohio-version of the curriculum. Second, 42 rural schools will be randomly assigned to one of three conditions: teacher adaptation in which the original keepin' it REAL curriculum is implemented; researcher adaptation in which a new Pennsylvania-version of the curriculum is implemented, and a control group. We hypothesized the participation in either form of the curriculum will reduce drug use and that the researcher adaptation will produce better outcomes and less teacher adaptation than the teacher adaptation. A pretest will be administered followed by posttests in 7-9th grades. Adaptation and fidelity will be measured in 3 ways: teachers completing a Program Quality and Adaptation online measure after each lesson, videotaped lessons, and attendance. The major hypothesis tests will be conducted using variants of the general linear model, taking into account the multilevel structure of the data (e.g., multilevel multiple regression), test of a mediation model, and growth modeling.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- Department of Communication Arts & Sciences, Penn State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any student enrolled in treatment or control classes
Exclusion Criteria:
- Students not enrolled in treatment or control classes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rural curriculum
Receive rural version of curriculum
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Students in schools randomly assigned to this condition receive the rural version of the curriculum.
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Experimental: Classic curriculum
Receive classic version of curriculum
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Students in schools randomly assigned to this condition receive the classic version of the curriculum.
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No Intervention: Control
Continue normal prevention activities
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in substance use
Time Frame: Between the beginning of 7th grade and the end of 9th grade
|
Self report measure
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Between the beginning of 7th grade and the end of 9th grade
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael L Hecht, PhD, Penn State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DESPR DA021670
- R01DA021670 (U.S. NIH Grant/Contract)
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