Adaptation Processes in School-based Substance Abuse Prevention

NCT ID: NCT02715206

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2827 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Substance Abuse Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

middle schools not receiving keepin' it REAL; continue their own programs if any.

Group Type EXPERIMENTAL

control

Intervention Type BEHAVIORAL

control group continues to teach whatever prevention curriculum they were using prior to study

keepin' it REAL classic

middle schools will implement keepin' it REAL classic drug prevention curriculum

Group Type EXPERIMENTAL

keepin' it REAL classic

Intervention Type BEHAVIORAL

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

keepin' it REAL rural

middle schools will implement the keepin' it REAL rural curriculum

Group Type EXPERIMENTAL

keepin' it REAL rural

Intervention Type BEHAVIORAL

keepin' it REAL rural drug prevention curriculum consists for 10 lessons taught in 7th grade and 4 booster sessions taught in 8th grade.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

control

control group continues to teach whatever prevention curriculum they were using prior to study

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- all 7th grade students in implementation middle

Exclusion Criteria

* lack of parental consent
* lack of student assent
Minimum Eligible Age

11 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Michael L. Hecht

Distinguished Professor of Communication Arts and Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael L Hecht, PhD

Role: PRINCIPAL_INVESTIGATOR

The Pennsylvania State University

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

The Pennsylvania State University

University Park, Pennsylvania, United States

Site Status

Countries

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United States

References

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Graham JW, Pettigrew J, Miller-Day M, Krieger JL, Zhou J, Hecht ML. Random assignment of schools to groups in the drug resistance strategies rural project: some new methodological twists. Prev Sci. 2014 Aug;15(4):516-25. doi: 10.1007/s11121-013-0403-9.

Reference Type BACKGROUND
PMID: 23722619 (View on PubMed)

Shin Y, Miller-Day M, Pettigrew J, Hecht ML, Krieger JL. Typology of delivery quality: latent profile analysis of teacher engagement and delivery techniques in a school-based prevention intervention, keepin' it REAL curriculum. Health Educ Res. 2014 Dec;29(6):897-905. doi: 10.1093/her/cyu061. Epub 2014 Sep 30.

Reference Type BACKGROUND
PMID: 25274721 (View on PubMed)

Choi HJ, Krieger JL, Hecht ML. Reconceptualizing efficacy in substance use prevention research: refusal response efficacy and drug resistance self-efficacy in adolescent substance use. Health Commun. 2013;28(1):40-52. doi: 10.1080/10410236.2012.720245.

Reference Type BACKGROUND
PMID: 23330857 (View on PubMed)

Krieger JL, Coveleski S, Hecht ML, Miller-Day M, Graham JW, Pettigrew J, Kootsikas A. From kids, through kids, to kids: examining the social influence strategies used by adolescents to promote prevention among peers. Health Commun. 2013;28(7):683-95. doi: 10.1080/10410236.2012.762827. Epub 2013 Aug 27.

Reference Type BACKGROUND
PMID: 23980520 (View on PubMed)

Colby M, Hecht ML, Miller-Day M, Krieger JL, Syvertsen AK, Graham JW, Pettigrew J. Adapting school-based substance use prevention curriculum through cultural grounding: a review and exemplar of adaptation processes for rural schools. Am J Community Psychol. 2013 Mar;51(1-2):190-205. doi: 10.1007/s10464-012-9524-8.

Reference Type BACKGROUND
PMID: 22961604 (View on PubMed)

Hopfer S, Hecht ML, Lanza ST, Tan X, Xu S. Preadolescent drug use resistance skill profiles, substance use, and substance use prevention. J Prim Prev. 2013 Dec;34(6):395-404. doi: 10.1007/s10935-013-0325-0.

Reference Type BACKGROUND
PMID: 23990398 (View on PubMed)

Miller-Day M, Pettigrew J, Hecht ML, Shin Y, Graham J, Krieger J. How prevention curricula are taught under real-world conditions: Types of and reasons for teacher curriculum adaptations. Health Educ (Lond). 2013;113(4):324-344. doi: 10.1108/09654281311329259.

Reference Type BACKGROUND
PMID: 26290626 (View on PubMed)

Moreland JJ, Raup-Krieger JL, Hecht ML, Miller-Day MM. The conceptualization and communication of risk among rural appalachian adolescents. J Health Commun. 2013;18(6):668-85. doi: 10.1080/10810730.2012.743620. Epub 2013 Feb 28.

Reference Type BACKGROUND
PMID: 23448190 (View on PubMed)

Pettigrew J, Miller-Day M, Shin Y, Hecht ML, Krieger JL, Graham JW. Describing teacher-student interactions: a qualitative assessment of teacher implementation of the 7th grade keepin' it REAL substance use intervention. Am J Community Psychol. 2013 Mar;51(1-2):43-56. doi: 10.1007/s10464-012-9539-1.

Reference Type BACKGROUND
PMID: 22739791 (View on PubMed)

Pettigrew J, Miller-Day M, Krieger J, Hecht ML. The Rural Context of Illicit Substance Offers: A Study of Appalachian Rural Adolescents. J Adolesc Res. 2012 Jul;27(4):523-550. doi: 10.1177/0743558411432639.

Reference Type BACKGROUND
PMID: 25620838 (View on PubMed)

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 BACKGROUND
PMID: 21552345 (View on PubMed)

Miller-Day M, Hecht ML, Krieger JL, Pettigrew J, Shin Y, Graham J. Teacher Narratives and Student Engagement: Testing Narrative Engagement Theory in Drug Prevention Education. J Lang Soc Psychol. 2015 Dec 1;34(6):604-620. doi: 10.1177/0261927X15586429. Epub 2015 May 14.

Reference Type RESULT
PMID: 26690668 (View on PubMed)

Pettigrew J, Graham JW, Miller-Day M, Hecht ML, Krieger JL, Shin YJ. Erratum to: Adherence and Delivery: Implementation Quality and Program Outcomes for the Seventh-Grade keepin' it REAL Program. Prev Sci. 2015 Jan;16(1):100. doi: 10.1007/s11121-014-0506-y. No abstract available.

Reference Type RESULT
PMID: 25274060 (View on PubMed)

Other Identifiers

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R01DA021670

Identifier Type: NIH

Identifier Source: org_study_id

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