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Community Wise Optimization Trial

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ClinicalTrials.gov Identifier: NCT02951455
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
National Development and Research Institutes, Inc.
North Jersey Community Research Initiative
University of Michigan
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Liliane Cambraia Windsor, University of Illinois at Urbana-Champaign

Brief Summary:
The current project seeks to implement the Multiphase Optimization Strategy (MOST) and Community Based Participatory Research (CBPR) principles to identify the most efficient, scalable, and sustainable combination of Community Wise components. Community Wise is a manualized multi-level intervention aimed at reducing health inequalities related to alcohol and illicit drug use (AIDU).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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Critical Dialogue Behavioral: Capacity Building Project Behavioral: Quality of Life Wheel Behavioral: PF Behavioral: LC Not Applicable

Detailed Description:

The current project seeks to implement the Multiphase Optimization Strategy (MOST) and Community Based Participatory Research (CBPR) principles to identify the most efficient, scalable, and sustainable combination of Community Wise components. Community Wise is a manualized multi-level intervention aimed at reducing health inequalities related to alcohol and illicit drug use (AIDU). The research will be conducted by the Newark Community Collaborative Board (NCCB), a network that developed and pilot-tested the original Community Wise. NCCB members include the principal investigators (PIs), co-investigators (Co-Is), service providers, consumers of AIDU, and community members.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 548 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use
Study Start Date : January 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: CD-LC
Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Licensed Clinician (LC).
Behavioral: 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.
Other Name: CD

Behavioral: LC
Whether the intervention is delivered by a licensed clinician.

Experimental: CBP- LC
Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Licensed Clinician (LC)
Behavioral: 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.
Other Name: CBP

Behavioral: LC
Whether the intervention is delivered by a licensed clinician.

Experimental: 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)
Behavioral: 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).
Other Name: QLW

Behavioral: LC
Whether the intervention is delivered by a licensed clinician.

Experimental: CD & CBP- LC
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Behavioral: 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.
Other Name: CD

Behavioral: 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.
Other Name: CBP

Behavioral: LC
Whether the intervention is delivered by a licensed clinician.

Experimental: CD & QLW- LC
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Behavioral: 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.
Other Name: CD

Behavioral: 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).
Other Name: QLW

Behavioral: LC
Whether the intervention is delivered by a licensed clinician.

Experimental: 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)
Behavioral: 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.
Other Name: CBP

Behavioral: 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).
Other Name: QLW

Behavioral: LC
Whether the intervention is delivered by a licensed clinician.

Experimental: QLW & CD & CBP-LC
Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Behavioral: 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.
Other Name: CD

Behavioral: 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.
Other Name: CBP

Behavioral: 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).
Other Name: QLW

Behavioral: LC
Whether the intervention is delivered by a licensed clinician.

Experimental: 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)
Behavioral: LC
Whether the intervention is delivered by a licensed clinician.

Experimental: CD- PF
Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Peer Facilitator (PF)
Behavioral: 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.
Other Name: CD

Behavioral: PF
Whether the intervention is delivered by a peer facilitator.

Experimental: CBP- PF
Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Peer Facilitator (PF)
Behavioral: 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.
Other Name: CBP

Behavioral: PF
Whether the intervention is delivered by a peer facilitator.

Experimental: 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)
Behavioral: 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).
Other Name: QLW

Behavioral: PF
Whether the intervention is delivered by a peer facilitator.

Experimental: CD & CBP- PF
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions. Peer Facilitator (PF)
Behavioral: 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.
Other Name: CD

Behavioral: 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.
Other Name: CBP

Behavioral: PF
Whether the intervention is delivered by a peer facilitator.

Experimental: CD & QLW- PF
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Behavioral: 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.
Other Name: CD

Behavioral: 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).
Other Name: QLW

Behavioral: PF
Whether the intervention is delivered by a peer facilitator.

Experimental: QLW & CBP- PF
Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks.Peer Facilitator (PF)
Behavioral: 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.
Other Name: CBP

Behavioral: 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).
Other Name: QLW

Behavioral: PF
Whether the intervention is delivered by a peer facilitator.

Experimental: CD & QLW & CBP- PF
Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Behavioral: 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.
Other Name: CD

Behavioral: 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.
Other Name: CBP

Behavioral: 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).
Other Name: QLW

Behavioral: PF
Whether the intervention is delivered by a peer facilitator.

Experimental: 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)
Behavioral: PF
Whether the intervention is delivered by a peer facilitator.




Primary Outcome Measures :
  1. Reduction in alcohol and illicit drugs use frequency [ Time Frame: 5 months ]
    Assessed via the timeline follow back scale


Secondary Outcome Measures :
  1. Number of people abstinent from alcohol and drug use [ Time Frame: 5 months ]
    Assessed via the timeline follow back scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for the factorial experiment participants in the study will include:

  • Men age 18 or older
  • 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:

  • Severe psychiatric disorders in the prior 6 months not stabilized (schizophrenia, depression with psychotic features, bipolar disorder, any psychosis), as measured by the MINI International Neuropsychiatric Interview 6 psychoticism and suicidality modules
  • Gross cognitive impairment as measured by the Mini Mental State Exam.
  • Sexual identification as female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951455


Contacts
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Contact: Liliane Windsor, PhD 217-300-1782 lwindsor@illinois.edu
Contact: Ellen Benoit, PhD 212-845-4425 benoit@ndri.org

Locations
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United States, New Jersey
Integrity House Recruiting
Newark, New Jersey, United States, 07102
Contact: Denise Fair    973-803-1927    outreach@newarkccb.org   
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
National Development and Research Institutes, Inc.
North Jersey Community Research Initiative
University of Michigan
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Liliane Windsor, PhD University of Illinois Urbana-Champaign

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liliane Cambraia Windsor, Associate Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT02951455     History of Changes
Other Study ID Numbers: 1U01MD010629-01 ( U.S. NIH Grant/Contract )
1U01MD010629-01 ( U.S. NIH Grant/Contract )
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Investigators will require a data- sharing agreement that provides for the following conditions at minimum: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate tools and computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

All data will be stripped of personal identifiers so as to be suitable for use by other investigators. Even though the database will be stripped of identifiers prior to any sharing, however, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for the above-stated commitments.


Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders