Adaptation Processes in School-based Substance Abuse Prevention (kiR)
Primary Purpose
Substance Abuse Problem
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
keepin' it REAL classic
keepin' it REAL rural
control
Sponsored by
About this trial
This is an interventional prevention trial for Substance Abuse Problem focused on measuring rural adolescents, substance use, prevention, adaptation
Eligibility Criteria
Inclusion Criteria:
- all 7th grade students in implementation middle
Exclusion Criteria:
- lack of parental consent
- lack of student assent
Sites / Locations
- The Ohio State University
- The Pennsylvania State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Control
keepin' it REAL classic
keepin' it REAL rural
Arm Description
middle schools not receiving keepin' it REAL; continue their own programs if any.
middle schools will implement keepin' it REAL classic drug prevention curriculum
middle schools will implement the keepin' it REAL rural curriculum
Outcomes
Primary Outcome Measures
Recent use of alcohol
Self report measure of recent use of alcohol
Recent use of tobacco
Self report measure
Recent use of marijuana
Self report
Secondary Outcome Measures
Perceptions of number of peers using drugs
Self report
Perception of self efficacy resisting drug offers
Self report measure
Full Information
NCT ID
NCT02715206
First Posted
February 25, 2016
Last Updated
April 18, 2017
Sponsor
Penn State University
1. Study Identification
Unique Protocol Identification Number
NCT02715206
Brief Title
Adaptation Processes in School-based Substance Abuse Prevention
Acronym
kiR
Official Title
Adaptation Processes in School-based Substance Abuse Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse Problem
Keywords
rural adolescents, substance use, prevention, adaptation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2827 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
middle schools not receiving keepin' it REAL; continue their own programs if any.
Arm Title
keepin' it REAL classic
Arm Type
Experimental
Arm Description
middle schools will implement keepin' it REAL classic drug prevention curriculum
Arm Title
keepin' it REAL rural
Arm Type
Experimental
Arm Description
middle schools will implement the keepin' it REAL rural curriculum
Intervention Type
Behavioral
Intervention Name(s)
keepin' it REAL classic
Intervention Description
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
Intervention Name(s)
keepin' it REAL rural
Intervention Description
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
Intervention Name(s)
control
Intervention Description
control group continues to teach whatever prevention curriculum they were using prior to study
Primary Outcome Measure Information:
Title
Recent use of alcohol
Description
Self report measure of recent use of alcohol
Time Frame
30 days
Title
Recent use of tobacco
Description
Self report measure
Time Frame
30 days
Title
Recent use of marijuana
Description
Self report
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Perceptions of number of peers using drugs
Description
Self report
Time Frame
2 years
Title
Perception of self efficacy resisting drug offers
Description
Self report measure
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- all 7th grade students in implementation middle
Exclusion Criteria:
lack of parental consent
lack of student assent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Hecht, PhD
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23722619
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.
Results Reference
background
PubMed Identifier
25274721
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.
Results Reference
background
PubMed Identifier
23330857
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.
Results Reference
background
PubMed Identifier
23980520
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.
Results Reference
background
PubMed Identifier
22961604
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.
Results Reference
background
PubMed Identifier
23990398
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.
Results Reference
background
PubMed Identifier
26290626
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.
Results Reference
background
PubMed Identifier
23448190
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.
Results Reference
background
PubMed Identifier
22739791
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.
Results Reference
background
PubMed Identifier
25620838
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.
Results Reference
background
PubMed Identifier
21552345
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.
Results Reference
background
PubMed Identifier
26690668
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.
Results Reference
result
PubMed Identifier
25274060
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.
Results Reference
result
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Adaptation Processes in School-based Substance Abuse Prevention
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