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Adaptation Processes in School-Based Substance Abuse Programs

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rural curriculum
Classic curriculum
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring adolescent substance use, rural substance use, middle school prevention, implementation processes, implementation quality, adaptation of prevention curricula, dissemination

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Any student enrolled in treatment or control classes

Exclusion Criteria:

  • Students not enrolled in treatment or control classes

Sites / Locations

  • Department of Communication Arts & Sciences, Penn State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Rural curriculum

Classic curriculum

Control

Arm Description

Receive rural version of curriculum

Receive classic version of curriculum

Continue normal prevention activities

Outcomes

Primary Outcome Measures

Change in substance use
Self report measure

Secondary Outcome Measures

Full Information

First Posted
December 21, 2012
Last Updated
April 18, 2017
Sponsor
Penn State University
Collaborators
National Institute on Drug Abuse (NIDA), Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT01755533
Brief Title
Adaptation Processes in School-Based Substance Abuse Programs
Official Title
Adaptation Processes in School-Based Substance Abuse Programs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institute on Drug Abuse (NIDA), Ohio State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
adolescent substance use, rural substance use, middle school prevention, implementation processes, implementation quality, adaptation of prevention curricula, dissemination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2827 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rural curriculum
Arm Type
Experimental
Arm Description
Receive rural version of curriculum
Arm Title
Classic curriculum
Arm Type
Experimental
Arm Description
Receive classic version of curriculum
Arm Title
Control
Arm Type
No Intervention
Arm Description
Continue normal prevention activities
Intervention Type
Other
Intervention Name(s)
Rural curriculum
Intervention Description
Students in schools randomly assigned to this condition receive the rural version of the curriculum.
Intervention Type
Other
Intervention Name(s)
Classic curriculum
Intervention Description
Students in schools randomly assigned to this condition receive the classic version of the curriculum.
Primary Outcome Measure Information:
Title
Change in substance use
Description
Self report measure
Time Frame
Between the beginning of 7th grade and the end of 9th grade

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Any student enrolled in treatment or control classes Exclusion Criteria: Students not enrolled in treatment or control classes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Hecht, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Communication Arts & Sciences, Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21552345
Citation
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.
Results Reference
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Adaptation Processes in School-Based Substance Abuse Programs

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