Skip to main content
OpenTrials
Completed

NCT Number: 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Communication Arts & Sciences, Penn State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any student enrolled in treatment or control classes

Exclusion criteria

  • Students not enrolled in treatment or control classes

Treatment and study plan

Rural curriculum

Other

Students in schools randomly assigned to this condition receive the rural version of the curriculum.

Classic curriculum

Other

Students in schools randomly assigned to this condition receive the classic version of the curriculum.

Primary outcomes

  1. Change in substance use

    Time frame: Between the beginning of 7th grade and the end of 9th grade

    Self report measure

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Ohio State University

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 24, 2012
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.