Implementation of Evidence Based ProgramsPREPNCT02135991
Preparing to Run Effective Prevention
A study testing Getting To Outcomes and Project CHOICE in people with Implementation of Evidence Based Programs, run by RAND at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Implementation of Evidence Based Programs
- What is being tested?
- Getting To Outcomes and Project CHOICE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2013to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 10-14 and attends a participating boys and girls club
Who cannot join
- Younger than 10, older than 14, does not attend a participating boys and girls club
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
BGC of Buena Park
Buena Park, California, 90620
BGC of Burbank and Greater E Valley
Burbank, California, 91504
BGC of Carson
Carson, California, 90810
BGC of South Bay
Harbor City, California, 90710
BGC of East LA
Los Angeles, California, 90022
Challengers Boys and Girls Club
Los Angeles, California, 90037
Salesian BGC
Los Angeles, California, 90063
BGC of Santa Monica
Los Angeles, California, 90401
BGC of West Valley
Los Angeles, California, 91303
East Valley Boys and Girls Club
Los Angeles, California, 91744
BGC of Santa Ana
Los Angeles, California, 92703
BGC of LA Harbor
San Pedro, California, 90731
BGC Stanton
Stanton, California, 90680
BGC of Westminster
Westminster, California, 92683
BGC of Whittier
Whittier, California, 90602
About this study
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.
Read the 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.
- Being tested
- Getting To Outcomes, Project CHOICE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Getting To OutcomesBehavioural
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 CHOICEBehavioural
Sites will receive standard training for Project CHOICE.
| Study group | Role | What they receive |
|---|---|---|
| Project CHOICE + Getting To Outcomes | Experimental | 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 Receives: Behavioral: Getting To Outcomes; Behavioral: Project CHOICE |
| Project CHOICE only | Active comparator | Boys and Girls Club sites will receive a) training and materials for Project CHOICE Receives: Behavioral: Project CHOICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use
initiation and past month prevalence of alcohol use, marijuana use, perceptions of their friends' use of alcohol and marijuana, and resistance self-efficacy
Measured: Baseline, 3 months, 6 months
Secondary outcomes (2)
Fidelity
(1) Adherence - local data collectors will rate how closely BGC staff adhered to the protocol as designed. (2) Dosage - BGC staff will record attendance of each participant (noting late arrivals/early leavers) and number minutes spent teaching each module. (3) Quality of delivery - Local data collectors will audio record visited sessions and send recordings to be rated by trained raters on the Motivational Interviewing Treatment Integrity Scale 3.1 (MITI).
Measured: 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.
Capacity
We will use the Capacity Interview to assess BGC staff capacity to conduct high-quality programming. Capacity ratings are made at the program level since programs operate as a unit. The ratings are made using a structured interview with key program personnel. The Capacity Interview has 14 items ("components") tied to each of the ten steps of the GTO model, averaging to a Total Score. Each component has seven responses, described with specific observable behaviors, ranging from "highly faithful" to "highly divergent" from ideal prevention practice.
Measured: Annually for the first four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Implementation of Evidence Based ProgramsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Chinman, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135991
- Sponsor's protocol ID
- R01AA022353
- Acronym
- PREP
- Status last verified
- Nov 2018
- First submitted
- 6 May 2014
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32323166Herman 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.
PubMed 31865544Cannon 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.
PubMed 31473932Chinman 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.
PubMed 30348227
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing to Run Effective Prevention
- ClinicalTrials.gov ID
- NCT02135991
- Acronym / sponsor ID
- PREP / R01AA022353
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 990 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project CHOICE + Getting To Outcomes | Experimental | Behavioral: Getting To Outcomes, Behavioral: Project CHOICEBoys 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 |
| Project CHOICE only | Active comparator | Behavioral: Project CHOICEBoys and Girls Club sites will receive a) training and materials for Project CHOICE |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age 10-14 and attends a participating boys and girls club
Key exclusion criteria (1 listed)
- Younger than 10, older than 14, does not attend a participating boys and girls club
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Getting To OutcomesThese 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. | Behavioural | Project CHOICE + Getting To Outcomes |
| Project CHOICESites will receive standard training for Project CHOICE. | Behavioural | Project CHOICE + Getting To Outcomes, Project CHOICE only |
Primary outcome
Drug use
Time frame: Baseline, 3 months, 6 months
initiation and past month prevalence of alcohol use, marijuana use, perceptions of their friends' use of alcohol and marijuana, and resistance self-efficacy
2 secondary outcomes
Fidelity
Time frame: 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.
Capacity
Time frame: Annually for the first four years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Derived from this study: PubMed 32323166Acosta 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.
- Derived from this study: PubMed 31865544Herman 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.
- Derived from this study: PubMed 31473932Cannon 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.
- Derived from this study: PubMed 30348227Chinman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Chinman, PhD principal investigator
RAND
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Getting To Outcomes and Project CHOICE in people with Implementation of Evidence Based Programs, run by RAND at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug use (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135991, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.