Skip to main content
OpenTrials
Completed

NCT Number: NCT02951455

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Integrity House

Newark, New Jersey, 07102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Critical Dialogue

Behavioral

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 names: CD

Capacity Building Project

Behavioral

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 names: CBP

Quality of Life Wheel

Behavioral

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 names: QLW

PF

Behavioral

Whether the intervention is delivered by a peer facilitator.

LC

Behavioral

Whether the intervention is delivered by a licensed clinician.

Primary outcomes

  1. Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days

    Time frame: 5 months

    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 outcomes

  1. Number of People Abstinent From Alcohol and Drug Use

    Time frame: 5 months

    Number of people abstinent from alcohol and drug use, which is assessed via the timeline follow back scale

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • National Development and Research Institutes, Inc.
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • North Jersey Community Research Initiative
  • University of Michigan

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2016
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.