跳至主要内容
临床试验/NCT05934591
NCT05934591已完成不适用

Improving Attendance in Community Wise

University of Illinois at Urbana-Champaign1 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2023年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
166
试验地点
1
主要终点
Number of Participants Attending at Least 50% of Sessions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Supervision/Paid/Open Group

Experimental

A group of 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.

干预措施: Community Wise (Behavioral)

Supervison/Paid/Closed Group

Experimental

A group of 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.

干预措施: Community Wise (Behavioral)

Supervision/Not Paid/Open Group

Experimental

A group of people under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open format groups of the Community Wise intervention without receiving an incentive.

干预措施: Community Wise (Behavioral)

Supervision/Not Paid/Closed Group

Experimental

A group of people under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed format groups of the Community Wise intervention without receiving an incentive.

干预措施: Community Wise (Behavioral)

Not Under Supervision/Paid/Open Group

Experimental

A group of people not 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.

干预措施: Community Wise (Behavioral)

Not Under Supervision/Paid/Closed Group

Experimental

A group of people not 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.

干预措施: Community Wise (Behavioral)

Not Under Supervision/Not Paid/Open Group

Experimental

A group of people not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend open format groups of the Community Wise intervention without receiving an incentive.

干预措施: Community Wise (Behavioral)

Not Under Supervision/Not Paid/Closed Group

Experimental

A group of people not under supervision (those on parole, drug court, probation, or methadone maintenance) will attend closed format groups of the Community Wise intervention without receiving an incentive.

干预措施: Community Wise (Behavioral)

结局指标

主要结局

Number of Participants Attending at Least 50% of Sessions

时间窗: nine weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liliane Cambraia Windsor

Professor

University of Illinois at Urbana-Champaign

研究点 (1)

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