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临床试验/NCT04523337
NCT04523337已完成不适用

A Randomized Controlled Trial of MISSION-CJ for Justice-Involved Homeless Veterans With Co-Occurring Substance Use and Mental Health Disorders

VA Office of Research and Development3 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2021年7月1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
134
试验地点
3
主要终点
Criminal Recidivism

研究概览

简要总结

The purpose of this study is to determine whether Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking - Criminal Justice version (MISSION-CJ) is effective for reducing criminal recidivism and improving other health-related outcomes (substance use, mental health, housing, employment, community integration) among justice-involved, homeless Veterans with a co-occurring substance use and mental health disorder.

详细描述

VHA Mental Health Residential Rehabilitation Treatment Programs (MH RRTPs) serve Veterans with an estimated 50% having criminal justice involvement annually. Justice-involved Veterans (JIVs) receive assistance with their addiction and behavioral health needs, but MH RRTP programs do not directly address their antisocial behaviors and cognitions. Furthermore, MH RRTP discharge is a vulnerable transition and no national transitional approach facilitates Veteran's engagement in prosocial community behaviors that sustain MH RRTP gains, ultimately reducing revolving door service use.

Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice version (MISSION-CJ) is a new case manager and peer delivered team-based treatment for JIVs with a co-occurring substance use and mental health disorder (COD). While MISSION-CJ derives in part from an evidence-based treatment for homeless individuals (MISSION), it includes a new conceptual framework and numerous new and differentiating features for a CJ population including: (1) a treatment planning tool focused on criminogenic needs that monitors progress and tunes service delivery elements; (2) a prosocial treatment curriculum; and (3) tools/resources to address JIVs' legal issues. With MISSION-CJ, this study attempts to change the practice paradigm and transform care for JIVs by moving beyond the current model of linking Veterans to VA care and tracking behavioral health outcomes, to a hybrid treatment/linkage approach that addresses criminogenic needs, supports engagement in VA and non-VA care, and targets recidivism as an outcome-the gold standard for CJ research.

Using a Hybrid Type 1 design, this project will test the effectiveness of MISSION-CJ in a three-site RCT (Bedford, Palo Alto, and Little Rock VAs) with JIVs with a COD, admitted to an MH RRTP, and previously arrested and charged and/or released from incarceration in the past 5-years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Research assistants conducting the 6- and 15-month outcome assessments are blinded to the condition assignment.

入排标准

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

入选标准

  • (a) are entering a Mental Health Residential Rehabilitation Treatment Program (MH RRTP)
  • (b) were arrested and charged and/or released from incarceration in the past 5 years
  • (c) have a co-occurring substance use and mental health disorder (COD)

排除标准

  • The only exclusion criterion is being too cognitively impaired to understand the informed-consent process and other study procedures.

研究组 & 干预措施

MISSION-CJ

Experimental

Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice version (MISSION-CJ) programming targets co-occurring substance use and mental health disorders and other related health outcomes faced by justice-involved homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based services.

干预措施: Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice (Behavioral)

Enhanced Usual Care

Experimental

Usual care provided by the mental health residential rehabilitation treatment programs, with patients in both groups are enrolled in, in addition to peer support and community outreach case management. Patients receive 2 Peer Support Curriculum sessions per week (24 sessions total). Patients will receive unstructured community outreach and linkage support while enrolled in the mental health residential rehabilitation program. After discharge, patients will continue to receive 1 hour of weekly linkage support per week.

干预措施: Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking Peer Support (Behavioral)

结局指标

主要结局

Criminal Recidivism

时间窗: through study completion, on average 15-months

Number of nights in jail or prison based on records from the California and Massachusetts Department of Corrections records; and arrest and incarceration records from the National Crime Information Center.

Criminal recidivism

时间窗: through study completion, on average 15-months

Number of arrests based on records from the California and Massachusetts Department of Corrections records; and arrest and incarceration records from the National Crime Information Center.

次要结局

  • Change in Trauma Symptoms (PTSD Checklist for DSM-5 - PCL-5)(Baseline, 6-months, 15-months)
  • Change in Depression (Patient Health Questionnaire-9 - PHQ-9)(Baseline, 6-months, 15-months)
  • Change in Mental Health Symptoms (Behavior and Symptom Identification Scale-24 - BASIS-24)(Baseline, 6-months, 15-months)
  • Change in Recidivism risk (Level of Service Inventory-Revised)(Baseline, 6-months, 15-months)
  • Change in Medication Adherence Rating Scale (MARS)(Baseline, 6-months, 15-months)
  • Treatment Engagement (MISSION Treatment Services Tracking Sheet(Up to 12 months)
  • Treatment Engagement (MISSION Treatment Services Tracking Sheet)(Up to 12 months)
  • Change in Antisocial Attitudes (Measures of Criminal Attitudes and Associates - MCAA)(Baseline, 6-months, 15-months)
  • Treatment Engagement (Healthcare Continuing Care Utilization)(12-month period prior to, and ending 15 months after, study enrollment)
  • Treatment Engagement (MH RRTP Completion)(12-month period prior to, and ending 15 months after, study enrollment)
  • Change in Community Integration Measure (CIM)(Baseline, 6-months, 15-months)
  • Change in Affiliations with Antisocial Peers (Measures of Criminal Attitudes and Associates: MCAA)(Baseline, 6-months, 15-months)
  • Change in Substance use (Alcohol Use Timeline Follow-back -TLFB)(Baseline, 6-months, 15-months)
  • Change in Substance Use (Illicit Drug Use Timeline Follow back - TLFB)(Baseline, 6-months, 15-months)
  • Change in Housing Status (Residential Timeline Follow back)(Baseline, 6-months, 15-months)
  • Change in Employment (Maudsley Addiction Profile)(Baseline, 6-months, 15-months)
  • Change in Treatment Engagement (Alcoholics Anonymous Involvement Scale - AAI)(Baseline, 6-months, 15-months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (3)

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