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Substance AbusePhase 2AGTONCT00780338

Enhancing Prevention Capacity With Developmental Assets and Getting to Outcomes

A Phase 2 study testing Assets Getting To Outcomes in people with Substance Abuse, run by RAND at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Substance Abuse
What is being tested?
Assets Getting To Outcomes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
1 siteUnited States
Study dates
Jun 2008to Mar 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • RAND Corporation

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.

Read the 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.

Conditions
Substance Abuse
Being tested
Assets Getting To Outcomes
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assets Getting To OutcomesOther

    Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance

Study groups in NCT00780338
Study groupRoleWhat they receive
1ExperimentalCohort 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.
Receives: Other: Assets Getting To Outcomes
2Active comparatorCohort 2: receives the Assets Getting To Outcomes intervention second, after Cohort 1 is done receiving the intervention.
Receives: Other: Assets Getting To Outcomes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevention Capacity-GTO Efficacy (Intent to Treat)

    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.

    Measured: Baseline, mid-point (1 year), posttest (2 years)

  2. Prevention Capacity - GTO Behaviors (Intent to Treat)

    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.

    Measured: Baseline, Mid (1 year), Post (2 years)

  3. Prevention Capacity - ASSETS GTO Behaviors (Intent to Treat)

    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.

    Measured: Baseline, Mid (1 year), Post (2 years)

  4. Prevention Capacity - ASSETS Behaviors (Intent to Treat)

    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.

    Measured: Baseline, Mid (1 year), Post (2 years)

  5. Prevention Capacity-Assets Efficacy (Intent to Treat)

    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.

    Measured: Baseline, mid (1 year), post (2 years)

Secondary outcomes (7)
  1. Prevention Performance - Total Score (Descriptive Means)

    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)

    Measured: baseline, baseline to mid (1 year), mid to posttest (2 years)

  2. Prevention Capacity - GTO Behavior - (User v Non-User Analysis)

    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.

    Measured: Baseline, Mid (1 year), Post (2 years)

  3. Prevention Capacity - GTO Efficacy (User vs Non-user Analyses)

    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.

    Measured: Baseline, Mid (1 year), Post (2 years)

  4. Prevention Capacity - ASSETS GTO BEHAVIORS (User vs Non-user Analyses)

    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.

    Measured: Baseline, Mid (1 year), Post (2 years)

  5. Prevention Capacity - Assets Behavior - (User v Non-User Analysis)

    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.

    Measured: Baseline, Mid (1 year), Post (2 years)

  6. Prevention Capacity - Assets Efficacy (User vs Non-user Analyses)

    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.

    Measured: Baseline, Mid (1 year), Post (2 years)

  7. Prevention Performance - Total Score (Percent Change)

    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)

    Measured: baseline, baseline to mid (1 year), mid to posttest (2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2013
  4. Study completionMar 2014

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00780338
Sponsor's protocol ID
NIDA-023277
Other IDs
R01DA023277
Acronym
AGTO
Status last verified
May 2015
First submitted
24 Oct 2008
Last updated
1 Jun 2015
Data monitoring committee
No

Publications

  • Chinman M, Acosta J, Ebener P, Q Burkhart, Clifford M, Corsello M, Duffey T, Hunter S, Jones M, Lahti M, Malone PS, Paddock S, Phillips A, Savell S, Scales PC, Tellett-Royce N. Establishing and evaluating the key functions of an interactive systems framework using an assets-getting to outcomes intervention. Am J Community Psychol. 2012 Dec;50(3-4):295-310. doi: 10.1007/s10464-012-9504-z.

    PubMed 22446975
  • Acosta J, Chinman M, Ebener P, Malone PS, Paddock S, Phillips A, Scales P, Slaughter ME. An intervention to improve program implementation: findings from a two-year cluster randomized trial of Assets-Getting To Outcomes. Implement Sci. 2013 Aug 7;8:87. doi: 10.1186/1748-5908-8-87.

    PubMed 23924279
  • Chinman M, Acosta J, Ebener P, Burkhart Q, Malone PS, Paddock SM, Clifford M, Corsello M, Duffey T, Hunter S, Jones M, Lahti M, Phillips A, Savell S, Scales PC, Tellett-Royce N. Intervening with practitioners to improve the quality of prevention: one-year findings from a randomized trial of assets-getting to outcomes. J Prim Prev. 2013 Jun;34(3):173-91. doi: 10.1007/s10935-013-0302-7.

    PubMed 23605473

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Assets Getting To Outcomes in people with Substance Abuse, run by RAND at 1 site 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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Prevention Capacity-GTO Efficacy (Intent to Treat) (time frame: Baseline, mid-point (1 year), posttest (2 years)). The study lists 5 primary outcomes in all. 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 NCT00780338, which also lists 3 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 1 Jun 2015.

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