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Adaptation Processes in School-based Substance Abuse Prevention

Adaptation Processes in School-based Substance Abuse Prevention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02715206
Acronym
kiR
Enrollment
2827
Registered
2016-03-22
Start date
2006-07-31
Completion date
2015-01-31
Last updated
2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Abuse Problem

Keywords

rural adolescents, substance use, prevention, adaptation

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.

Interventions

BEHAVIORALkeepin' 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

BEHAVIORALkeepin' 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.

BEHAVIORALcontrol

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

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

\- all 7th grade students in implementation middle

Exclusion criteria

* lack of parental consent * lack of student assent

Design outcomes

Primary

MeasureTime frameDescription
Recent use of alcohol30 daysSelf report measure of recent use of alcohol
Recent use of tobacco30 daysSelf report measure
Recent use of marijuana30 daysSelf report

Secondary

MeasureTime frameDescription
Perceptions of number of peers using drugs2 yearsSelf report
Perception of self efficacy resisting drug offers2 yearsSelf report measure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026