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Adaptation Processes in School-based Substance Abuse Prevention (kiR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02715206
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
Michael L. Hecht, Penn State University

Brief Summary:
The purpose of this study is to determine if a new substance use prevention curriculum for rural middle schools is effective in reducing substance use and to study how prevention curriculum get implemented by teachers.

Condition or disease Intervention/treatment Phase
Substance Abuse Problem Behavioral: keepin' it REAL classic Behavioral: keepin' it REAL rural Behavioral: control Not Applicable

Detailed Description:

The goals of the proposed study are to conduct an effectiveness trial of the keepin' it REAL (refuse, explain, avoid, leave) 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 (Substance Abuse and Mental Health Services Administration'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, "re-grounded" in the rural culture of Pennsylvania and Ohio, while studying how teachers adapt both versions. This proposal responds to NIDA (National Institute on Drug Abuse) PA-05-118 (Program Announcement), 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, 39 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 post-tests 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, test of a mediation model, and growth modeling.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2827 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adaptation Processes in School-based Substance Abuse Prevention
Study Start Date : July 2006
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Control
middle schools not receiving keepin' it REAL; continue their own programs if any.
Behavioral: control
control group continues to teach whatever prevention curriculum they were using prior to study

Experimental: keepin' it REAL classic
middle schools will implement keepin' it REAL classic drug prevention curriculum
Behavioral: keepin' it REAL classic
keepin' it REAL consists of 10 classroom lessons implemented in 7th grade and 4 booster sessions implemented in 8th grade by the classroom teacher following training

Experimental: keepin' it REAL rural
middle schools will implement the keepin' it REAL rural curriculum
Behavioral: keepin' it REAL rural
keepin' it REAL rural drug prevention curriculum consists for 10 lessons taught in 7th grade and 4 booster sessions taught in 8th grade.

Primary Outcome Measures :
  1. Recent use of alcohol [ Time Frame: 30 days ]
    Self report measure of recent use of alcohol

  2. Recent use of tobacco [ Time Frame: 30 days ]
    Self report measure

  3. Recent use of marijuana [ Time Frame: 30 days ]
    Self report

Secondary Outcome Measures :
  1. Perceptions of number of peers using drugs [ Time Frame: 2 years ]
    Self report

  2. Perception of self efficacy resisting drug offers [ Time Frame: 2 years ]
    Self report measure

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

- all 7th grade students in implementation middle

Exclusion Criteria:

  • lack of parental consent
  • lack of student assent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02715206

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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
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Principal Investigator: Michael L Hecht, PhD The Pennsylvania State University
Publications of Results:
Other Publications:

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Responsible Party: Michael L. Hecht, Distinguished Professor of Communication Arts and Sciences, Penn State University Identifier: NCT02715206    
Other Study ID Numbers: R01DA021670 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Michael L. Hecht, Penn State University:
rural adolescents, substance use, prevention, adaptation
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders