Clinical trial NCT02951455: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Development and Research Institutes, Inc.
name: University of Michigan
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: North Jersey Community Research Initiative
First posted: 2016-11-01
Enrollment: 602
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days
timeFrame: 5 months
Secondary outcomes:
measure: Number of People Abstinent From Alcohol and Drug Use
timeFrame: 5 months
Other outcomes:
Locations:
city: Newark
country: United States
facility: Integrity House
state: New Jersey
Study officials:
affiliation: University of Illinois Urbana-Champaign
name: Liliane Windsor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.