Clinical trial NCT02135991: Preparing to Run Effective Prevention
Official title: Preparing to Run Effective Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implementation of Evidence Based Programs
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 990
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Youth participants

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

Primary outcomes:
measure: Drug use
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Fidelity
timeFrame: Each site will implement the 5 sessions of Project Choice twice (one time a year, for two years). In each year, we will collect fidelity data on two of the five sessions, for a total of 4 sessions rated over the two year period, for each site.
measure: Capacity
timeFrame: Annually for the first four years
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: BGC of Buena Park
state: California
city: Burbank
country: United States
facility: BGC of Burbank and Greater E Valley
state: California
city: Carson
country: United States
facility: BGC of Carson
state: California
city: Harbor City
country: United States
facility: BGC of South Bay
state: California
city: Los Angeles
country: United States
facility: BGC of East LA
state: California
city: Los Angeles
country: United States
facility: Challengers Boys and Girls Club
state: California
city: Los Angeles
country: United States
facility: Salesian BGC
state: California
city: Los Angeles
country: United States
facility: BGC of Santa Monica
state: California
city: Los Angeles
country: United States
facility: BGC of West Valley
state: California
city: Los Angeles
country: United States
facility: East Valley Boys and Girls Club
state: California
city: Los Angeles
country: United States
facility: BGC of Santa Ana
state: California
city: San Pedro
country: United States
facility: BGC of LA Harbor
state: California
city: Stanton
country: United States
facility: BGC Stanton
state: California
city: Westminster
country: United States
facility: BGC of Westminster
state: California
city: Whittier
country: United States
facility: BGC of Whittier
state: California
Study officials:
affiliation: RAND
name: Matthew Chinman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Acosta J, Chinman M, Ebener PA, Malone PS, Cannon JS, D'Amico EJ. Sustaining an Evidence-Based Program Over Time: Moderators of Sustainability and the Role of the Getting to Outcomes(R) Implementation Support Intervention. Prev Sci. 2020 Aug;21(6):807-819. doi: 10.1007/s11121-020-01118-2.
citation: Herman PM, Chinman M, Cannon J, Ebener P, Malone PS, Acosta J, D'Amico EJ. Cost Analysis of a Randomized Trial of Getting to Outcomes Implementation Support of CHOICE in Boys and Girls Clubs in Southern California. Prev Sci. 2020 Feb;21(2):245-255. doi: 10.1007/s11121-019-01082-6.
citation: Cannon JS, Gilbert M, Ebener P, Malone PS, Reardon CM, Acosta J, Chinman M. Influence of an Implementation Support Intervention on Barriers and Facilitators to Delivery of a Substance Use Prevention Program. Prev Sci. 2019 Nov;20(8):1200-1210. doi: 10.1007/s11121-019-01037-x.
citation: Chinman M, Ebener P, Malone PS, Cannon J, D'Amico EJ, Acosta J. Testing implementation support for evidence-based programs in community settings: a replication cluster-randomized trial of Getting To Outcomes(R). Implement Sci. 2018 Oct 22;13(1):131. doi: 10.1186/s13012-018-0825-7.