Preparing to Run Effective Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

990 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-09-30

Brief Summary

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Young people can engage in a variety of negative behaviors-such as drug use, underage drinking, and premarital sex-that exact a high toll on local communities. These activities are often the target of community-based prevention efforts. Getting To Outcomes (GTO) is an approach that includes a toolkit, technical assistance, and training, organized around a 10-step process, that helps communities plan, implement, and evaluate the impact of their programs that attempt to prevent these negative behaviors. This study will examine the degree to which Getting To Outcomes helps Boys and Girls Clubs implement an evidence based drug prevention program.

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Detailed Description

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As a nation, the U.S. invests heavily in community-based organizations to conduct interventions, proven through research, to reduce the high rates of alcohol and drug use among teens. Much less is invested in helping communities implement these programs with quality. Although many evidence-based programs exist to address alcohol and drug use, communities face difficulty implementing them and achieving the same outcomes as researchers. This "gap" is because resources are limited, prevention is complex, and communities often lack the capacity-or the knowledge, attitudes, and skills-needed to implement "off the shelf" programs well. Common ways to bridge this gap, such as information dissemination, fail to change practice or outcomes at the local level in part because it does not sufficiently address capacity of community practitioners. Therefore, building a community's capacity is a method that could improve the quality of implementation and outcomes. Getting To Outcomes (GTO) is an implementation support intervention shown to improve the capacity of practitioners to conduct evidence-based programs, but its impact on fidelity and youth outcomes has not been studied. The study-Preparing to Run Effective Prevention (PREP)-will be a cluster randomized controlled trial using primary data from middle school youth (990) and program staff from 33 cooperating Boys and Girls Clubs sites (Sites) to assess how GTO impacts the fidelity, outcomes, and costs of an evidence-based program to prevent alcohol and drug use (Project CHOICE, PC). All 33 sites will receive training in PC. 16 Sites will conduct PC in a way typical of community-based organizations (PC only); 17 Sites will conduct PC augmented by GTO, comprised of training, onsite technical assistance, and a written GTO manual. The study will: (1) Assess the use of GTO and compare Sites' capacity between PC+GTO and PC only; (2) Compare PC fidelity between PC+GTO and PC only groups; (3) Compare alcohol and marijuana outcomes of middle-school youth in the PC+GTO (n=510) and PC only (n=480) groups; and (4) Assess the cost-effectiveness of GTO' impact. To address these aims we will collect data on the delivery and utilization of GTO (e.g., method of delivery, duration, topics); staff capacity to implement research-based interventions; observations of program delivery (fidelity monitoring); youth participants' use of, and attitudes towards, alcohol and marijuana via a survey at baseline and 3 and 6 months follow-up; and costs of both PC alone and PC+GTO. Analyses will examine differences between intervention (PC+GTO) and control (PC only) Sites' capacity, PC fidelity, outcomes, and costs over time, accounting for clustering within site. The PREP study could expand implementation research and serve as a model for how the government and other agencies support strong implementation of evidence-based programs in a wide array of domains. These outcomes are important to providing opportunities for youth to become healthy and productive adults.

Conditions

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Implementation of Evidence Based Programs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Project CHOICE + Getting To Outcomes

Boys and Girls Club sites will receive a) training and materials for Project CHOICE and b) training, ongoing technical assistance for two years, and materials for Getting To Outcomes

Group Type EXPERIMENTAL

Getting To Outcomes

Intervention Type BEHAVIORAL

These sites will receive written materials, training, and on site technical assistance to use the Getting To Outcomes process to implement Project CHOICE at their sites.

Project CHOICE

Intervention Type BEHAVIORAL

Sites will receive standard training for Project CHOICE.

Project CHOICE only

Boys and Girls Club sites will receive a) training and materials for Project CHOICE

Group Type ACTIVE_COMPARATOR

Project CHOICE

Intervention Type BEHAVIORAL

Sites will receive standard training for Project CHOICE.

Interventions

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Getting To Outcomes

These sites will receive written materials, training, and on site technical assistance to use the Getting To Outcomes process to implement Project CHOICE at their sites.

Intervention Type BEHAVIORAL

Project CHOICE

Sites will receive standard training for Project CHOICE.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Age 10-14 and attends a participating boys and girls club

Exclusion Criteria

Younger than 10, older than 14, does not attend a participating boys and girls club

Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Chinman, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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BGC of Buena Park

Buena Park, California, United States

Site Status

BGC of Burbank and Greater E Valley

Burbank, California, United States

Site Status

BGC of Carson

Carson, California, United States

Site Status