Enhancing Prevention Capacity With Developmental Assets and Getting to Outcomes (AGTO)

May 8, 2015 updated by: RAND
Alcohol and other drug use among youth is costly for communities. More research is needed about how to best support community based prevention programs and how community prevention expertise can inform the research process. The National Institute on Drug Abuse has funded a 5 year collaboration of the RAND Corporation, Search Institute and its training division, Vision Training Associates, Communities for Children and Youth, and the University of Southern Maine to implement and assess the impact on prevention coalitions, the combination of two complimentary, community-based interventions: Developmental Assets, which supports community mobilization and collaboration to promote positive youth development, and Getting To Outcomes (GTO), which enhances community capacity to complete critical prevention tasks (e.g., evaluation). The purpose of the project is to investigate: 1) How well is the Assets-GTO intervention delivered, how much is it used, and what coalitions think about it; 2) The extent to which the Assets-GTO approach enhances the prevention capacity (knowledge, attitudes, and skills) of individual coalition members and the quality of prevention performance; and 3) Whether enhanced prevention capacity improves alcohol and drug outcomes among youth. Twelve community-based prevention coalitions in Maine (part of Communities for Children and Youth) will participate. Six coalitions-determined at random-will receive manuals, training, and on-site technical assistance consisting of bi-Weekly meetings between A-GTO 4 ME! and key coalition staff. The other six coalitions will continue practice as usual, but will receive an abbreviated version of the Assets-GTO intervention near the end of the project. A Community Research Workgroup made of coalition representatives will review all aspects of the study and interim findings and facilitate dissemination on A-GTO 4 ME! The project will demonstrate and evaluate strategies to strengthen the prevention capacity of community organizations that can be used broadly across many types of programs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Alcohol and drug (AOD) use is problematic in many communities. Despite the spread of evidence-based prevention, communities still face difficulty in achieving outcomes demonstrated by prevention science. This "gap" is because resources are limited, prevention is complex, and communities often lack the capacity to adapt and implement "off the shelf" programs. Also, many evidence-based programs aim to improve deficits-- despite evidence showing the need to also promote positive youth development through community-wide efforts. 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 or use community input. Therefore, building a community's prevention capacity, through greater collaboration between scientists and practitioners, with a focus on positive youth development, is a method that could improve the quality of prevention and outcomes. This project will assess the combination of two models that are specifically designed to foster such an approach: Getting To Outcomes (GTO) and Developmental Assets. They are complimentary: GTO enhances local capacity for discrete prevention tasks (e.g., evaluation); Developmental Assets supports community mobilization and collaboration to promote positive youth development. Combining the content, tools, and resources of these two SAMHSA (Best Practice) prevention planning processes has the potential to improve the quality of prevention programming and accountability more than either would do alone. Quasi - experimental and case studies of both Assets and GTO have demonstrated feasibility in community settings and yielded evidence suggesting these models can help communities mobilize and improve prevention practices and outcomes. As a next step, we propose a randomized controlled efficacy trial with elements of an effectiveness study (i.e., implementation in community-based setting) comparing 6 AOD prevention coalitions using Assets-GTO with 6 similar coalitions who are not. Such blended designs that emphasize generalizability and external validity are now recommended for community-based research. We will use a participatory research approach in which a Workgroup of coalition representatives will be actively involved in all phases of the research. Assets-GTO's impact on prevention capacity will be assessed at the program level (5 per coalition) with staff interviews and at the individual level with a Coalition Survey (each has about 54 members). A survey of schools in which the coalitions operate will assess the impact on AOD use and positive developmental outcomes among the programs' target populations. Organizational change theories will guide Assets-GTO implementation; standardized measures will track Assets-GTO adoption. Results will have implications for how to ensure that prevention programming found to be effective through research trials is successfully delivered in real world settings, a priority for NIDA and NIAAA. Project Narrative The demonstration and evaluation of the Assets-Getting To Outcomes system for the prevention of alcohol and drug (AOD) use outlined in this proposal has direct relevance to public health. This is because AOD use among youth is a significant health problem facing US communities. The Assets-Getting To Outcomes system is designed to help communities engaged in AOD prevention work to better plan, implement, and self-evaluate their prevention strategies in order to help them achieve positive results, thereby positively impacting the mortality and morbidity of youth at the local level. PUBLIC HEALTH RELEVANCE: The demonstration and evaluation of the Assets-Getting to Outcomes system for the prevention of alcohol and drug (AOD) use outlined in this proposal has direct relevance to public health. This is because AOD use among youth is a significant health problem facing US communities. The Assets-Getting To Outcomes system is designed to help communities engaged in AOD prevention work to better plan, implement, and self-evaluate their prevention strategies in order to help them achieve positive results, thereby positively impacting the mortality and morbidity of youth at the local level.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
376

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • RAND Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Related to the programs of the 12 participating coalitions, the inclusion criterion is being an AOD-related universal, selective, or indicated prevention program or initiative.

Exclusion Criteria:

The exclusion criterion is being a case identification, treatment, or after-care program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Cohort 1: receives the Assets Getting To Outcomes intervention first. The AGTO intervention includes three types of assistance which are adapted to fit the needs and priorities of the individuals involved, as well as the inner and outer setting: (1) a manual of text and tools; (2) face-to-face training, and (3) onsite technical assistance (TA). These three types of assistance aim to improve the implementation process for each program. Two full-time, Maine-based staff, one with a master's and one with a bachelor's degree, provided AGTO tools, training, and TA to the intervention coalitions and programs during the two year intervention period. The tools are in the Search Institute-published manual, Getting To Outcomes with Developmental Assets: Ten steps to measuring success in youth programs and communities, which all intervention participants received.
Other: Assets Getting To Outcomes
Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance
Active Comparator: 2
Cohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Other: Assets Getting To Outcomes
Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevention Capacity-GTO Efficacy (Intent to Treat)
Time Frame: Baseline, mid-point (1 year), posttest (2 years)
Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. GTO efficacy scale is the sum of 10 items using a three-point scale (1="would need a great deal of help to carry out this task", 2="could carry out this task, but would need some help", 3="could carry out this task without any help") asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .02 change on the original 1-3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1-3 scale.
Baseline, mid-point (1 year), posttest (2 years)
Prevention Capacity - GTO Behaviors (Intent to Treat)
Time Frame: Baseline, Mid (1 year), Post (2 years)
This scale is the sum of 11 items with seven-point scales (1="never" to 7="very often") assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale.
Baseline, Mid (1 year), Post (2 years)
Prevention Capacity - ASSETS GTO Behaviors (Intent to Treat)
Time Frame: Baseline, Mid (1 year), Post (2 years)
This scale is the sum of 11 items with seven-point scales (1="never" to 7="very often") assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale.
Baseline, Mid (1 year), Post (2 years)
Prevention Capacity - ASSETS Behaviors (Intent to Treat)
Time Frame: Baseline, Mid (1 year), Post (2 years)
This scale is the sum of 11 items with seven-point scales (1="never" to 7="very often") assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale.
Baseline, Mid (1 year), Post (2 years)
Prevention Capacity-Assets Efficacy (Intent to Treat)
Time Frame: Baseline, mid (1 year), post (2 years)
Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. Assets efficacy scale is the sum of 10 items using a three-point scale (1="would need a great deal of help to carry out this task", 2="could carry out this task, but would need some help", 3="could carry out this task without any help") asking about activities associated with doing the Developmental Assets model. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .02 change on the original 1-3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1-3 scale.
Baseline, mid (1 year), post (2 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevention Performance - Total Score (Descriptive Means)
Time Frame: baseline, baseline to mid (1 year), mid to posttest (2 years)
A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or "components") that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from "highly faithful=7" to "highly divergent=1" from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components ("highly faithful=7" to "highly divergent=1" from ideal performance)
baseline, baseline to mid (1 year), mid to posttest (2 years)
Prevention Capacity - GTO Behavior - (User v Non-User Analysis)
Time Frame: Baseline, Mid (1 year), Post (2 years)
This scale is the sum of 11 items with seven-point scales (1="never" to 7="very often") assessing the frequency with which respondents engaged in GTO activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. "Use" was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post.
Baseline, Mid (1 year), Post (2 years)
Prevention Capacity - GTO Efficacy (User vs Non-user Analyses)
Time Frame: Baseline, Mid (1 year), Post (2 years)
The GTO efficacy scale is the sum of 10 items using a three-point scale (1="would need a great deal of help to carry out this task", 2="could carry out this task, but would need some help", 3="could carry out this task without any help") asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .02 change on the original 1-3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1-3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. "Use" was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index.
Baseline, Mid (1 year), Post (2 years)
Prevention Capacity - ASSETS GTO BEHAVIORS (User vs Non-user Analyses)
Time Frame: Baseline, Mid (1 year), Post (2 years)
This scale is the sum of 11 items with seven-point scales (1="never" to 7="very often") assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. "Use" was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post.
Baseline, Mid (1 year), Post (2 years)
Prevention Capacity - Assets Behavior - (User v Non-User Analysis)
Time Frame: Baseline, Mid (1 year), Post (2 years)
This scale is the sum of 11 items with seven-point scales (1="never" to 7="very often") assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .06 change on the original 1-7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1-7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. "Use" was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post.
Baseline, Mid (1 year), Post (2 years)
Prevention Capacity - Assets Efficacy (User vs Non-user Analyses)
Time Frame: Baseline, Mid (1 year), Post (2 years)
The Assets efficacy scale is the sum of 10 items using a three-point scale (1="would need a great deal of help to carry out this task", 2="could carry out this task, but would need some help", 3="could carry out this task without any help") asking about activities associated with doing assets activities. The sum was then transformed to be on a 1-100% scale. A percentage point change is equivalent to a .02 change on the original 1-3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1-3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. "Use" was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index.
Baseline, Mid (1 year), Post (2 years)
Prevention Performance - Total Score (Percent Change)
Time Frame: baseline, baseline to mid (1 year), mid to posttest (2 years)
A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or "components") that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from "highly faithful=7" to "highly divergent=1" from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components ("highly faithful=7" to "highly divergent=1" from ideal performance)
baseline, baseline to mid (1 year), mid to posttest (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RAND

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Search Institute
Communities for Children and Youth
University of Southern Maine
Visions Training Associates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew Chinman, PhD, RAND

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIDA-023277
  • R01DA023277 (U.S. NIH Grant/Contract)

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