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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

Tracking Information
First Submitted Date  ICMJE February 25, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date April 20, 2017
Study Start Date  ICMJE July 2006
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • Recent use of alcohol [ Time Frame: 30 days ]
    Self report measure of recent use of alcohol
  • Recent use of tobacco [ Time Frame: 30 days ]
    Self report measure
  • Recent use of marijuana [ Time Frame: 30 days ]
    Self report
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02715206 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • Perceptions of number of peers using drugs [ Time Frame: 2 years ]
    Self report
  • Perception of self efficacy resisting drug offers [ Time Frame: 2 years ]
    Self report measure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Adaptation Processes in School-based Substance Abuse Prevention
Official Title  ICMJE Adaptation Processes in School-based Substance Abuse Prevention
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Substance Abuse Problem
Intervention  ICMJE
  • 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
  • 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.
  • Behavioral: control
    control group continues to teach whatever prevention curriculum they were using prior to study
Study Arms  ICMJE
  • Experimental: Control
    middle schools not receiving keepin' it REAL; continue their own programs if any.
    Intervention: Behavioral: control
  • Experimental: keepin' it REAL classic
    middle schools will implement keepin' it REAL classic drug prevention curriculum
    Intervention: Behavioral: keepin' it REAL classic
  • Experimental: keepin' it REAL rural
    middle schools will implement the keepin' it REAL rural curriculum
    Intervention: Behavioral: keepin' it REAL rural
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2016)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- all 7th grade students in implementation middle

Exclusion Criteria:

  • lack of parental consent
  • lack of student assent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02715206
Other Study ID Numbers  ICMJE R01DA021670( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Michael L. Hecht, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael L Hecht, PhD The Pennsylvania State University
PRS Account Penn State University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP