Adaptation Processes in School-based Substance Abuse Prevention

Study Overview
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Brief Summary
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The purpose of this study is to determine if a new substance use prevention curriculum for rural middle schools is effective in reducing substance use and to study how prevention curriculum get implemented by teachers.

Detailed Description
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The goals of the proposed study are to conduct an effectiveness trial of the keepin' it REAL (refuse, explain, avoid, leave) 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 (Substance Abuse and Mental Health Services Administration'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, re-grounded in the rural culture of Pennsylvania and Ohio, while studying how teachers adapt both versions. This proposal responds to NIDA (National Institute on Drug Abuse) PA-05-118 (Program Announcement), 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, 39 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 post-tests 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, test of a mediation model, and growth modeling.

Official Title
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Adaptation Processes in School-based Substance Abuse Prevention

Conditions
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Substance Abuse Problem

Intervention / Treatment
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* Behavioral: keepin' it REAL classic
* Behavioral: keepin' it REAL rural
* Behavioral: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - all 7th grade students in implementation middle Exclusion Criteria: lack of parental consent lack of student assent

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>middle schools not receiving keepin' it REAL; continue their own programs if any. | Behavioral: control<br>* control group continues to teach whatever prevention curriculum they were using prior to study<br>|
| Experimental: keepin' it REAL classic<br>middle schools will implement keepin' it REAL classic drug prevention curriculum | Behavioral: keepin' it REAL classic<br>* keepin' it REAL consists of 10 classroom lessons implemented in 7th grade and 4 booster sessions implemented in 8th grade by the classroom teacher following training<br>|
| Experimental: keepin' it REAL rural<br>middle schools will implement the keepin' it REAL rural curriculum | Behavioral: keepin' it REAL rural<br>* keepin' it REAL rural drug prevention curriculum consists for 10 lessons taught in 7th grade and 4 booster sessions taught in 8th grade.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recent use of alcohol | Self report measure of recent use of alcohol | 30 days | 
| Recent use of tobacco | Self report measure | 30 days | 
| Recent use of marijuana | Self report | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceptions of number of peers using drugs | Self report | 2 years | 
| Perception of self efficacy resisting drug offers | Self report measure | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rural adolescents, substance use, prevention, adaptation