Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use
NCT ID: NCT02951455
Last Updated: 2022-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
602 participants
INTERVENTIONAL
2017-01-17
2020-01-20
Brief Summary
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Detailed Description
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Specific aims include:
Aim 1: Use a highly efficient experimental design to estimate the unique contribution of key components of Community Wise in: a) reducing AIDU frequency and b) increasing the percentage of participants abstinent over five months. Components tested are the presence or absence of: (a) Critical Dialogue; (b) Quality-of-Life-Wheel; (c) Capacity Building Project; and (d) group facilitation by a peer versus a licensed clinician. A factorial experiment will be used to detect effects of individual components and three-way interactions.
Aim 2: Informed by MOST, Community Wise will be optimized for scalability and sustainability-- the most efficacious combination of components that can be delivered for less than $2000 per intervention cycle serving up to eleven individuals simultaneously (as per recommendations by the Substance Abuse and Mental Health Services Administration (SAMHSA).
This 2x2x2x2 factorial design will be fully powered to detect change in AIDU in a sample of 528 men with substance use disorders and a history of incarceration residing in distressed communities with predominantly Black populations. Participants will be randomly assigned to one of sixteen experimental conditions. The first eight conditions will be facilitated by a licensed facilitator. The remaining conditions will be facilitated by a peer facilitator. Each set of eight conditions will include the following components: (1) Critical Dialogue (CD) only; (2) Quality-of-Life-Wheel (QLW) only; (3) Capacity Building Project (CBP) only; (4) CD+QLW; (5) CD+CBP; (6) QLW+CBP; (7) CD+QLW+CBP; and (8) no components. Data will be collected at baseline plus five post-baseline monthly follow-ups. This study has potential to impact public health; the use of CBPR and MOST will generate action-oriented implications and an optimized multi-level intervention adaptable to address different health inequalities.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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CD-LC
Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Licensed Clinician (LC).
Critical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
LC
Whether the intervention is delivered by a licensed clinician.
CBP- LC
Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Licensed Clinician (LC)
Capacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
LC
Whether the intervention is delivered by a licensed clinician.
QLW- LC
Group intervention where participants learn to develop and implement personal goals that are measurable, attainable, realistic, and time bound. Intervention includes 9 sessions. Quality of Life Wheel, Licensed Clinician (LC)
Quality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
LC
Whether the intervention is delivered by a licensed clinician.
CD & CBP- LC
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Critical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Capacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
LC
Whether the intervention is delivered by a licensed clinician.
CD & QLW- LC
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Critical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Quality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
LC
Whether the intervention is delivered by a licensed clinician.
QLW & Capacity Building ProjectCBP- LC
Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks. Licensed Clinician (LC)
Capacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
Quality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
LC
Whether the intervention is delivered by a licensed clinician.
QLW & CD & CBP-LC
Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Critical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Capacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
Quality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
LC
Whether the intervention is delivered by a licensed clinician.
LC
This condition will include 3 core sessions that are not a part of the components being tested. These are support sessions to the components being tested and is hypothesized to have the smallest impact on substance use outcomes.Licensed Clinician (LC)
LC
Whether the intervention is delivered by a licensed clinician.
CD- PF
Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Peer Facilitator (PF)
Critical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
PF
Whether the intervention is delivered by a peer facilitator.
CBP- PF
Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Peer Facilitator (PF)
Capacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
PF
Whether the intervention is delivered by a peer facilitator.
QLW-PF
Group intervention where participants learn to develop and implement personal goals that are measurable, attainable, realistic, and time bound. Intervention includes 9 sessions. Quality of Life wheel, Peer Facilitator (PF)
Quality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
PF
Whether the intervention is delivered by a peer facilitator.
CD & CBP- PF
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions. Peer Facilitator (PF)
Critical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Capacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
PF
Whether the intervention is delivered by a peer facilitator.
CD & QLW- PF
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Critical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Quality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
PF
Whether the intervention is delivered by a peer facilitator.
QLW & CBP- PF
Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks.Peer Facilitator (PF)
Capacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
Quality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
PF
Whether the intervention is delivered by a peer facilitator.
CD & QLW & CBP- PF
Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Critical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Capacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
Quality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
PF
Whether the intervention is delivered by a peer facilitator.
PF
This condition will include 3 core sessions that are not a part of the components being tested. These are support sessions to the components being tested and is hypothesized to have the smallest impact on substance use outcomes. Peer Facilitator (PF)
PF
Whether the intervention is delivered by a peer facilitator.
Interventions
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Critical Dialogue
Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
Capacity Building Project
Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
Quality of Life Wheel
Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
PF
Whether the intervention is delivered by a peer facilitator.
LC
Whether the intervention is delivered by a licensed clinician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Residence in Essex County, NJ
* Willingness to be voice recorded during group sessions
* Ability to speak English
* Having a substance use disorder measured by the Global Appraisal of Individual Needs-Substance Problem Scale (GAIN-SPS).
* Having been released from incarceration in the past 4 years. This is due to research that shows that people are more likely to be re-incarcerated within the first 4 years of release from incarceration.
Exclusion Criteria
* Gross cognitive impairment as measured by the Mini Mental State Exam.
* Sexual identification as female
18 Years
MALE
Yes
Sponsors
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National Development and Research Institutes, Inc.
OTHER
University of Michigan
OTHER
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
North Jersey Community Research Initiative
OTHER
University of Illinois at Urbana-Champaign
OTHER
Responsible Party
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Liliane Cambraia Windsor
Associate Professor
Principal Investigators
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Liliane Windsor, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois Urbana-Champaign
Locations
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Integrity House
Newark, New Jersey, United States
Countries
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References
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Windsor LC, Benoit E, Pinto RM, Gwadz M, Thompson W. Enhancing behavioral intervention science: using community-based participatory research principles with the multiphase optimization strategy. Transl Behav Med. 2021 Aug 13;11(8):1596-1605. doi: 10.1093/tbm/ibab032.
Windsor LC, Benoit E, Smith D, Pinto RM, Kugler KC; Newark Community Collaborative Board (NCCB). Optimizing a community-engaged multi-level group intervention to reduce substance use: an application of the multiphase optimization strategy. Trials. 2018 Apr 27;19(1):255. doi: 10.1186/s13063-018-2624-5.
Provided Documents
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