ClinicalTrials.Veeva

Menu

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

U

University of Illinois at Urbana-Champaign

Status

Completed

Conditions

Substance Use Disorders

Treatments

Behavioral: LC
Behavioral: Capacity Building Project
Behavioral: Quality of Life Wheel
Behavioral: PF
Behavioral: Critical Dialogue

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02951455
1U01MD010629-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

602 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

602 participants in 16 patient groups

CD-LC
Experimental group
Description:
Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Licensed Clinician (LC).
Treatment:
Behavioral: Critical Dialogue
Behavioral: LC
CBP- LC
Experimental group
Description:
Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Licensed Clinician (LC)
Treatment:
Behavioral: Capacity Building Project
Behavioral: LC
QLW- LC
Experimental group
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)
Treatment:
Behavioral: Quality of Life Wheel
Behavioral: LC
CD & CBP- LC
Experimental group
Description:
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Treatment:
Behavioral: Critical Dialogue
Behavioral: Capacity Building Project
Behavioral: LC
CD & QLW- LC
Experimental group
Description:
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Treatment:
Behavioral: Critical Dialogue
Behavioral: Quality of Life Wheel
Behavioral: LC
QLW & Capacity Building ProjectCBP- LC
Experimental group
Description:
Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks. Licensed Clinician (LC)
Treatment:
Behavioral: Quality of Life Wheel
Behavioral: Capacity Building Project
Behavioral: LC
QLW & CD & CBP-LC
Experimental group
Description:
Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Licensed Clinician (LC)
Treatment:
Behavioral: Critical Dialogue
Behavioral: Quality of Life Wheel
Behavioral: Capacity Building Project
Behavioral: LC
LC
Experimental group
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)
Treatment:
Behavioral: LC
CD- PF
Experimental group
Description:
Group behavioral intervention with 9 weekly sessions lasting 2 hours. Critical Dialogue (CD), Peer Facilitator (PF)
Treatment:
Behavioral: Critical Dialogue
Behavioral: PF
CBP- PF
Experimental group
Description:
Group community mobilizing intervention with 9 weekly sessions spread in 15 weeks. Capacity Building Project (CBP), Peer Facilitator (PF)
Treatment:
Behavioral: PF
Behavioral: Capacity Building Project
QLW-PF
Experimental group
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)
Treatment:
Behavioral: PF
Behavioral: Quality of Life Wheel
CD & CBP- PF
Experimental group
Description:
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions. Peer Facilitator (PF)
Treatment:
Behavioral: Critical Dialogue
Behavioral: PF
Behavioral: Capacity Building Project
CD & QLW- PF
Experimental group
Description:
Combination of group behavioral intervention and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Treatment:
Behavioral: Critical Dialogue
Behavioral: PF
Behavioral: Quality of Life Wheel
QLW & CBP- PF
Experimental group
Description:
Combination of goal development and implementation with community mobilization intervention including 9 weekly sessions spread across 15 weeks.Peer Facilitator (PF)
Treatment:
Behavioral: PF
Behavioral: Quality of Life Wheel
Behavioral: Capacity Building Project
CD & QLW & CBP- PF
Experimental group
Description:
Combination of group behavioral intervention, goal development and implementation, and community mobilization intervention including 15 weekly sessions.Peer Facilitator (PF)
Treatment:
Behavioral: Critical Dialogue
Behavioral: PF
Behavioral: Quality of Life Wheel
Behavioral: Capacity Building Project
PF
Experimental group
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)
Treatment:
Behavioral: PF

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems