An interventional study of Rural curriculum and Classic curriculum in Substance Use, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 11 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-20.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
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.
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.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's enrollment of 2,827 is above the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Penn State University is the lead sponsor of 269 studies on the registry; 52 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
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Exclusion Criteria:
Receive rural version of curriculum
Other: Rural curriculum
Receive classic version of curriculum
Other: Classic curriculum
Continue normal prevention activities
Students in schools randomly assigned to this condition receive the rural version of the curriculum.
Students in schools randomly assigned to this condition receive the classic version of the curriculum.
Change in substance use
Self report measure
Time frame: Between the beginning of 7th grade and the end of 9th grade
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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