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Improving Attendance in Community Wise

Improving Attendance in Community Wise

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05934591
Enrollment
166
Registered
2023-07-07
Start date
2023-07-06
Completion date
2024-05-24
Last updated
2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervention Engagement and Retention

Keywords

Alcohol and substance misuse treatment, treatment engagement

Brief summary

Rates of alcohol and substance misuse (ASM) in low-income, predominantly African American communities are similar to the general population. However, ASM has greater consequences (e.g., higher incarceration and HIV infection rates) for residents in these communities. We developed and optimized Community Wise (CW), a multi-level manualized behavioral intervention to decrease ASM frequency in a population of self-identified men with histories of substance use disorder (SUD) and incarceration (SUD) in Essex County, New Jersey (NJ), U.S. We propose a study to: 1) identify strategies to improve attendance and reduce ASM, and 2) to test feasibility and acceptability of CW among self-identified men and women with a history of SUD living in marginalized communities. We will achieve these aims by conducting a 23 full factorial experiment informed by MOST and CBPR. This study will identify efficient, scalable, and sustainable strategies to improve attendance and hence, maximize the interventions' effect in reducing ASM.

Detailed description

Rates of alcohol and substance misuse (ASM) in low-income, predominantly African American communities (from here on marginalized communities) are similar to the general population. However, ASM has greater consequences (e.g., higher incarceration and HIV/HCV infection rates) for residents in these communities. While the etiology underpinning this inequity is complex, the root cause of these issues has been traced to social determinants of health (SDH; e.g., stigma; poverty; barriers to education, housing, and employment). Funded by the National Institute for Minority Health Disparities (NIMHD 5R01MD010629), in partnership with the Critical Consciousness Collaborative Board (3CB), we developed Community Wise (CW), a multi-level manualized behavioral intervention to decrease ASM frequency in a population of self-identified men with histories of substance use disorder (SUD) and incarceration in Essex County, NJ, U.S. The 3CB was founded in 2010 and developed and pilot-tested the original CW. Over the past six years, our team used the multiphase optimization strategy (MOST), and community based participatory research (CBPR) principles to develop and optimize CW for efficacy in reducing ASM and cost. MOST is an innovative methodological framework that employs experimental designs to engineer efficient and effective behavioral interventions. MOST guided the optimization of CW with delivery cost of less than $2,000 per intervention cycle serving up to ten individuals simultaneously (this was the Medicaid allowable reimbursement cost for SUD group treatment services in 2015). Clinical trial results showed larger ASM reduction (Cohen's d=-2∙22, P=0∙067) in the optimized CW group. Unfortunately, attendance across the 15 intervention sessions was low (only 15% of participants attended 50% of the sessions). Low attendance was due to the intervention's closed group format, the study's randomization strategy, and instability of the study's population (homelessness, poverty). In order to improve upon our positive results and maximize our chances to successfully obtain further external funding to test CW effectiveness, we need funding to: 1) identify strategies to improve attendance and reduce ASM, and 2) to test feasibility and acceptability of CW among men and women with a history of SUD living in marginalized communities. We will achieve these aims by conducting a 23 full factorial experiment. This study will help us identify efficient strategies for improving attendance and, hence, maximize the interventions' effect in reducing ASM. As a highly efficient experimental design, a full factorial experiment will maximize study power and allow us to examine the individual and interactive contributions of each intervention delivery strategy on intervention attendance. MOST will inform which strategies will be retained, thus minimizing waste of resources. The current proposed research will also be conducted in partnership with the 3CB. As our primary individual level outcome, we will use number of sessions attended to test if different intervention delivery strategies will result in a clinically and statistically important intervention attendance with a minimum of 50% of participants attending at least 50% of the intervention. We will also compare the effect of different strategies on reducing ASM. Intervention delivery strategies include: 1) Recruiting individuals under supervision (those on parole, drug court, probation, or methadone maintenance); 2) Incentivizing intervention attendance; and 3) Delivering the intervention in an open group format. We will also compare intervention satisfaction measures between intervention strategies. We will expand eligibility criteria to include women and people with SUD living in marginalized communities who have not been previously incarcerated. While women comprise a smaller percentage of people with SUD, they experience significant barriers to SUD treatment. Our pilot study showed that women started the CW intervention with worse outcomes when compared to men but had significantly higher reductions of ASM. While the original CW intervention was developed with and for formerly incarcerated people, it addresses concepts that are relevant to all people with SUD living in marginalized communities. Hence, the 3CB has recommended that we expand our eligibility criteria to reach a more diverse group of people. Our 23 full factorial design will examine change in attendance (N=144). Data will be collected at baseline and three months post-baseline. This study will impact public health as it will improve the potency of an optimized multi-level intervention adaptable to address different health inequities.

Interventions

BEHAVIORALCommunity Wise

The intervention received by each group will be Community Wise, a multi-level manualized behavioral intervention to decrease alcohol and substance misuse frequency

Sponsors

Comprehensive Behavioral Health Center
CollaboratorUNKNOWN
University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Living in St. Clair County, Illinois (IL) * Over 18 * English- speaker * Under supervision (parole, probation, drug court or methadone maintenance) * Having an alcohol or substance misuse disorder

Exclusion criteria

* Not living in St. Clair County, IL * Not able to speak English * Not able or willing to provide consent * Not having an alcohol or substance misuse disorder * Under 18

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Attending at Least 50% of Sessionsnine weeksWe will test if different intervention delivery strategies will result in a clinically and statistically important intervention attendance with a minimum of 50% of participants attending at least 50% of the intervention

Countries

United States

Participant flow

Participants by arm

ArmCount
Supervision/Paid/Open Group
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open format groups of the Community Wise intervention.
15
Supervision/Paid/Closed Group
People under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed format groups of the Community Wise intervention.
20
Supervision/Not Paid/Open Group
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without an incentive.
25
Supervision/Not Paid/Closed Group
People under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without an incentive.
22
Not Under Supervision/Paid/Open Group
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend open groups of the Community Wise intervention.
32
Not Under Supervision/Paid/Closed Group
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will receive an incentive to attend closed groups of the Community Wise intervention.
22
Not Under Supervision/Not Paid/Open Group
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open groups of the Community Wise intervention without receiving an incentive
15
Not Under Supervision/Not Paid/Closed Group
People not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed groups of the Community Wise intervention without receiving an incentive. Period Title: Overall Study
15
Total166

Baseline characteristics

CharacteristicTotalSupervision/Paid/Closed GroupSupervision/Paid/Open GroupSupervision/Not Paid/Open GroupSupervision/Not Paid/Closed GroupNot Under Supervision/Paid/Open GroupNot Under Supervision/Paid/Closed GroupNot Under Supervision/Not Paid/Open GroupNot Under Supervision/Not Paid/Closed Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants1 Participants1 Participants
Age, Categorical
Between 18 and 65 years
162 Participants20 Participants15 Participants25 Participants21 Participants32 Participants21 Participants14 Participants14 Participants
Race/Ethnicity, Customized
African American
63 Participants5 Participants6 Participants4 Participants5 Participants21 Participants12 Participants5 Participants5 Participants
Race/Ethnicity, Customized
Alaskan/Native American
3 Participants1 Participants0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Black/Caribbean
42 Participants6 Participants5 Participants9 Participants3 Participants3 Participants5 Participants5 Participants6 Participants
Race/Ethnicity, Customized
Missing
3 Participants0 Participants0 Participants1 Participants0 Participants1 Participants1 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Other
2 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants
Race/Ethnicity, Customized
White
52 Participants7 Participants4 Participants11 Participants13 Participants6 Participants3 Participants4 Participants4 Participants
Region of Enrollment
United States
166 participants20 participants15 participants25 participants22 participants32 participants22 participants15 participants15 participants
Sex: Female, Male
Female
49 Participants5 Participants5 Participants5 Participants12 Participants5 Participants7 Participants5 Participants5 Participants
Sex: Female, Male
Male
117 Participants15 Participants10 Participants20 Participants10 Participants27 Participants15 Participants10 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 200 / 250 / 220 / 320 / 220 / 150 / 15
other
Total, other adverse events
0 / 150 / 200 / 250 / 222 / 320 / 220 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 200 / 250 / 220 / 320 / 220 / 150 / 15

Outcome results

Primary

Number of Participants Attending at Least 50% of Sessions

We will test if different intervention delivery strategies will result in a clinically and statistically important intervention attendance with a minimum of 50% of participants attending at least 50% of the intervention

Time frame: nine weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Supervision/Paid/Open GroupNumber of Participants Attending at Least 50% of Sessions8 Participants
Supervision/Paid/Closed GroupNumber of Participants Attending at Least 50% of Sessions6 Participants
Supervision/Not Paid/Open GroupNumber of Participants Attending at Least 50% of Sessions1 Participants
Supervision/Not Paid/Closed GroupNumber of Participants Attending at Least 50% of Sessions4 Participants
Not Under Supervision/Paid/Open GroupNumber of Participants Attending at Least 50% of Sessions19 Participants
Not Under Supervision/Paid/Closed GroupNumber of Participants Attending at Least 50% of Sessions12 Participants
Not Under Supervision/Not Paid/Open GroupNumber of Participants Attending at Least 50% of Sessions5 Participants
Not Under Supervision/Not Paid/Closed GroupNumber of Participants Attending at Least 50% of Sessions4 Participants

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026