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Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Critical Dialogue
Capacity Building Project
Quality of Life Wheel
PF
LC
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Integrity House

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

CD-LC

CBP- LC

QLW- LC

CD & CBP- LC

CD & QLW- LC

QLW & Capacity Building ProjectCBP- LC

QLW & CD & CBP-LC

LC

CD- PF

CBP- PF

QLW-PF

CD & CBP- PF

CD & QLW- PF

QLW & CBP- PF

CD & QLW & CBP- PF

PF

Arm Description

Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Licensed Clinician (LC).

Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Licensed Clinician (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)

Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)

Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)

Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks. Licensed Clinician (LC)

Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.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)

Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Peer Facilitator (PF)

Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Peer Facilitator (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)

Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions. Peer Facilitator (PF)

Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)

Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks.Peer Facilitator (PF)

Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.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)

Outcomes

Primary Outcome Measures

Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days
The primary outcome was the percentage of ASM (i.e., the percentage of days each substance was used in the past month) as operationalized by the Global Assessment of Individual needs. At each time point (baseline, five follow-ups), percentage ASM was calculated by dividing the reported number of days in the past month that participants used cannabis, heroin, alcohol, opioids, or cocaine by the number of days in the month (data were collected with the Timeline Follow-Back measure), multiplied by 100. Next, mean ASM frequency per month during 5 months of follow-up was calculated by adding the percentages for each substance and dividing by 5.31 We conducted correlations for self-reported ASM in the past 30 days with toxicology urine screens to assess validity of self-reported data.

Secondary Outcome Measures

Number of People Abstinent From Alcohol and Drug Use
Number of people abstinent from alcohol and drug use, which is assessed via the timeline follow back scale

Full Information

First Posted
October 27, 2016
Last Updated
November 29, 2022
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
National Development and Research Institutes, Inc., University of Michigan, National Institute on Minority Health and Health Disparities (NIMHD), North Jersey Community Research Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT02951455
Brief Title
Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use
Official Title
Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
National Development and Research Institutes, Inc., University of Michigan, National Institute on Minority Health and Health Disparities (NIMHD), North Jersey Community Research Initiative

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
602 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD-LC
Arm Type
Experimental
Arm Description
Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Licensed Clinician (LC).
Arm Title
CBP- LC
Arm Type
Experimental
Arm Description
Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Licensed Clinician (LC)
Arm Title
QLW- LC
Arm Type
Experimental
Arm Description
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)
Arm Title
CD & CBP- LC
Arm Type
Experimental
Arm Description
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Arm Title
CD & QLW- LC
Arm Type
Experimental
Arm Description
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Arm Title
QLW & Capacity Building ProjectCBP- LC
Arm Type
Experimental
Arm Description
Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks. Licensed Clinician (LC)
Arm Title
QLW & CD & CBP-LC
Arm Type
Experimental
Arm Description
Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Arm Title
LC
Arm Type
Experimental
Arm Description
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)
Arm Title
CD- PF
Arm Type
Experimental
Arm Description
Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Peer Facilitator (PF)
Arm Title
CBP- PF
Arm Type
Experimental
Arm Description
Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Peer Facilitator (PF)
Arm Title
QLW-PF
Arm Type
Experimental
Arm Description
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)
Arm Title
CD & CBP- PF
Arm Type
Experimental
Arm Description
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions. Peer Facilitator (PF)
Arm Title
CD & QLW- PF
Arm Type
Experimental
Arm Description
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Arm Title
QLW & CBP- PF
Arm Type
Experimental
Arm Description
Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks.Peer Facilitator (PF)
Arm Title
CD & QLW & CBP- PF
Arm Type
Experimental
Arm Description
Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Arm Title
PF
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Critical Dialogue
Other Intervention Name(s)
CD
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Capacity Building Project
Other Intervention Name(s)
CBP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life Wheel
Other Intervention Name(s)
QLW
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
PF
Intervention Description
Whether the intervention is delivered by a peer facilitator.
Intervention Type
Behavioral
Intervention Name(s)
LC
Intervention Description
Whether the intervention is delivered by a licensed clinician.
Primary Outcome Measure Information:
Title
Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days
Description
The primary outcome was the percentage of ASM (i.e., the percentage of days each substance was used in the past month) as operationalized by the Global Assessment of Individual needs. At each time point (baseline, five follow-ups), percentage ASM was calculated by dividing the reported number of days in the past month that participants used cannabis, heroin, alcohol, opioids, or cocaine by the number of days in the month (data were collected with the Timeline Follow-Back measure), multiplied by 100. Next, mean ASM frequency per month during 5 months of follow-up was calculated by adding the percentages for each substance and dividing by 5.31 We conducted correlations for self-reported ASM in the past 30 days with toxicology urine screens to assess validity of self-reported data.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Number of People Abstinent From Alcohol and Drug Use
Description
Number of people abstinent from alcohol and drug use, which is assessed via the timeline follow back scale
Time Frame
5 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liliane Windsor, PhD
Organizational Affiliation
University of Illinois Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrity House
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33837786
Citation
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.
Results Reference
derived
PubMed Identifier
29703237
Citation
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.
Results Reference
derived

Learn more about this trial

Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use

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