Adaptation Processes in School-based Substance Abuse Prevention

Substance Abuse Problem Clinical Trial

— kiR  

Official title:

Adaptation Processes in School-based Substance Abuse Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715206
• Other study ID #: R01DA021670
• Status: Completed
• Phase: N/A
• First received: February 25, 2016
• Last updated: April 18, 2017
• Start date: July 2006
• Est. completion date: January 2015

Study information

• Verified date: April 2017
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2827
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

• all 7th grade students in implementation middle

Exclusion Criteria:

• lack of parental consent

• lack of student assent

Related Conditions & MeSH terms

• Substance Abuse Problem
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Epub 2015 May 14. — View 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. — View 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. — View 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- — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recent use of alcohol	Self report measure of recent use of alcohol	30 days
Primary	Recent use of tobacco	Self report measure	30 days
Primary	Recent use of marijuana	Self report	30 days
Secondary	Perceptions of number of peers using drugs	Self report	2 years
Secondary	Perception of self efficacy resisting drug offers	Self report measure	2 years

External Links

•   Project website