Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use
1 other identifier
interventional
602
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedStudy Start
First participant enrolled
January 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2020
CompletedResults Posted
Study results publicly available
December 23, 2022
CompletedDecember 23, 2022
November 1, 2022
3 years
October 27, 2016
September 29, 2022
November 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
5 months
Secondary Outcomes (1)
Number of People Abstinent From Alcohol and Drug Use
5 months
Study Arms (16)
CD-LC
EXPERIMENTALGroup behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Licensed Clinician (LC).
CBP- LC
EXPERIMENTALGroup community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Licensed Clinician (LC)
QLW- LC
EXPERIMENTALGroup 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)
CD & CBP- LC
EXPERIMENTALCombination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
CD & QLW- LC
EXPERIMENTALCombination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
QLW & Capacity Building ProjectCBP- LC
EXPERIMENTALCombination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks. Licensed Clinician (LC)
QLW & CD & CBP-LC
EXPERIMENTALCombination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
LC
EXPERIMENTALThis 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)
CD- PF
EXPERIMENTALGroup behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Peer Facilitator (PF)
CBP- PF
EXPERIMENTALGroup community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Peer Facilitator (PF)
QLW-PF
EXPERIMENTALGroup 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)
CD & CBP- PF
EXPERIMENTALCombination of group behavioral intervention and community mobilization intervention including 15 weekly sessions. Peer Facilitator (PF)
CD & QLW- PF
EXPERIMENTALCombination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
QLW & CBP- PF
EXPERIMENTALCombination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks.Peer Facilitator (PF)
CD & QLW & CBP- PF
EXPERIMENTALCombination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
PF
EXPERIMENTALThis 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)
Interventions
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.
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.
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).
Whether the intervention is delivered by a peer facilitator.
Whether the intervention is delivered by a licensed clinician.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Integrity House
Newark, New Jersey, 07102, United States
Related Publications (2)
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.
PMID: 33837786DERIVEDWindsor 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.
PMID: 29703237DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Only self-identified men were included in the study and it is critical to conduct comparable studies with people who identify with all genders. Further, future research is needed to replicate these findings and expand their generalizability to other regions, marginalised communities, and outcomes.
Results Point of Contact
- Title
- Liliane Windsor
- Organization
- University of Illinois Urbana Champaign
Study Officials
- PRINCIPAL INVESTIGATOR
Liliane Windsor, PhD
University of Illinois Urbana-Champaign
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 27, 2016
First Posted
November 1, 2016
Study Start
January 17, 2017
Primary Completion
January 20, 2020
Study Completion
January 20, 2020
Last Updated
December 23, 2022
Results First Posted
December 23, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
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.