Adaptation Processes in School-Based Substance Abuse Programs

NCT ID: NCT01755533

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2827 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-06-30

Brief Summary

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.

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.

Conditions

Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rural curriculum

Receive rural version of curriculum

Group Type: EXPERIMENTAL

Rural curriculum

Intervention Type: OTHER

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

Classic curriculum

Receive classic version of curriculum

Group Type: EXPERIMENTAL

Classic curriculum

Intervention Type: OTHER

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

Control

Continue normal prevention activities

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rural curriculum

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

Intervention Type: OTHER

Classic curriculum

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Any student enrolled in treatment or control classes

Exclusion Criteria

• Students not enrolled in treatment or control classes

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Michael L. Hecht

Distinguished Professor of Communication Arts and Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael L Hecht, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Department of Communication Arts & Sciences, Penn State University

University Park, Pennsylvania, United States

Countries

United States

References

Pettigrew J, Miller-Day M, Krieger J, Hecht ML. Alcohol and Other Drug Resistance Strategies Employed by Rural Adolescents. J Appl Commun Res. 2011;39(2):103-122. doi: 10.1080/00909882.2011.556139.

Reference Type: RESULT

PMID: 21552345 (View on PubMed)

Other Identifiers

R01DA021670

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DESPR DA021670

Identifier Type: -

Identifier Source: org_study_id