Clinical trial NCT02715206: Adaptation Processes in School-based Substance Abuse Prevention
Official title: Adaptation Processes in School-based Substance Abuse Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse Problem
Keywords: rural adolescents, substance use, prevention, adaptation
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 2827
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: Inclusion Criteria:

- all 7th grade students in implementation middle

Exclusion Criteria:

* lack of parental consent
* lack of student assent

Primary outcomes:
measure: Recent use of alcohol
timeFrame: 30 days
measure: Recent use of tobacco
timeFrame: 30 days
measure: Recent use of marijuana
timeFrame: 30 days
Secondary outcomes:
measure: Perceptions of number of peers using drugs
timeFrame: 2 years
measure: Perception of self efficacy resisting drug offers
timeFrame: 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Michael L Hecht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.