Adaptation Processes in School-Based Substance Abuse Programs

This study has been completed.
Sponsor:
Collaborators:
Ohio State University
Information provided by (Responsible Party):
Penn State University
ClinicalTrials.gov Identifier:
NCT01755533
First received: December 21, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Substance Use
Other: Rural curriculum
Other: Classic curriculum
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Adaptation Processes in School-Based Substance Abuse Programs

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Change in substance use [ Time Frame: Between the beginning of 7th grade and the end of 9th grade ] [ Designated as safety issue: No ]
    Self report measure


Enrollment: 2827
Study Start Date: February 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rural curriculum
Receive rural version of curriculum
Other: Rural curriculum
Students in schools randomly assigned to this condition receive the rural version of the curriculum.
Experimental: Classic curriculum
Receive classic version of curriculum
Other: Classic curriculum
Students in schools randomly assigned to this condition receive the classic version of the curriculum.
No Intervention: Control
Continue normal prevention activities

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.

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any student enrolled in treatment or control classes

Exclusion Criteria:

  • Students not enrolled in treatment or control classes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755533

Locations
United States, Pennsylvania
Department of Communication Arts & Sciences, Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Ohio State University
Investigators
Principal Investigator: Michael L Hecht, PhD Penn State University
  More Information

Publications:
Pettigrew, J., Miller-Day, M., Hecht, M. L. & Krieger, J. (2011). Alcohol and Other Drug Resistance Strategies Employed by Rural Adolescents. Journal of Applied Communication Research, 39, 103-122.

Responsible Party: Penn State University
ClinicalTrials.gov Identifier: NCT01755533     History of Changes
Other Study ID Numbers: DESPR DA021670, R01DA021670
Study First Received: December 21, 2012
Last Updated: December 21, 2012
Health Authority: United States: Federal Government

Keywords provided by Penn State University:
adolescent substance use
rural substance use
middle school prevention
implementation processes
implementation quality
adaptation of prevention curricula
dissemination

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014