Adaptation Processes in School-based Substance Abuse Prevention

Not Applicable

Completed

• Conditions: Substance Abuse Problem
• Interventions: Behavioral: keepin' it REAL rural; Behavioral: keepin' it REAL classic; Behavioral: control

• Registration Number: NCT02715206
• Lead Sponsor: Penn State University

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 Timeline

• Study Start: 2006-07
• Primary Completion: 2014-01
• Study Completion: 2015-01
• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2827

Inclusion Criteria

• all 7th grade students in implementation middle

Exclusion Criteria

• lack of parental consent
• lack of student assent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
keepin' it REAL rural	keepin' it REAL rural	middle schools will implement the keepin' it REAL rural curriculum
keepin' it REAL classic	keepin' it REAL classic	middle schools will implement keepin' it REAL classic drug prevention curriculum
Control	control	middle schools not receiving keepin' it REAL; continue their own programs if any.

Primary Outcome Measures

Name	Time	Method
Recent use of alcohol	30 days	Self report measure of recent use of alcohol
Recent use of tobacco	30 days	Self report measure
Recent use of marijuana	30 days	Self report

Secondary Outcome Measures

Name	Time	Method
Perception of self efficacy resisting drug offers	2 years	Self report measure
Perceptions of number of peers using drugs	2 years	Self report

Trial Locations

Locations (2)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

The Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States