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临床试验/NCT07555145
NCT07555145尚未招募不适用

Supporting Treatment Access and Recovery in Re-entry (STAR-R)

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
240
试验地点
2
主要终点
Engagement in Treatment

研究概览

简要总结

This application is aimed at testing a multicomponent intervention called "Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) or Peer Linkage Support post-release from two jails in Massachusetts for individuals with co-occurring substance use and mental health disorders (COD), given high rates of COD among incarcerated populations. The research will examine engagement in treatment, behavioral health outcomes, mediators and moderators, an economic analysis, and facilitators and barriers of MISSION-CJ implementation.

详细描述

Individuals with substance use and mental health conditions (COD) are overrepresented in criminal legal (CL) settings, including jails with 50% having a COD. Compared to having a single disorder, those with a COD have more serious criminal histories, childhood traumas, reincarceration, suicide, homelessness, unemployment, poor treatment engagement, and a tenfold increased risk of overdosing within 3 months of release. While treatments exist to address mental health, substance use, CL prosocial thinking, and social determinants of health (SDOH) needs separately, there is an absence of comprehensive re-entry approaches that address these needs simultaneously, which can result in care fragmentation, poor treatment engagement, relapses, and a vicious cycle of reincarceration. Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice version (MISSION-CJ) is a promising, cross-disciplinary multicomponent intervention, offering 6 months of COD treatment, prosocial and recovery services, and assertive outreach. Four MISSION-CJ open pilots demonstrated increased treatment engagement, improved behavioral health outcomes, and reduced recidivism for clients with a COD. The investigators also have a MISSION-CJ Manual, Workbook, Treatment Planning Tool, and Fidelity Measure and are ready to test them in this RCT. In response to RFA-DA-25-062, the proposed 5-year study, "Supporting Treatment Access and Recovery in Re-entry (STAR-R)," will randomize 240 people with COD to MISSION-CJ or Peer Linkage Support (PLS). Study aims include Aim 1: Compared to PLS, those receiving MISSION-CJ are hypothesized to show: (1a) greater engagement in treatment (measured by total days participated in each condition), and total community provider linkages sessions); (1b) Reduced substance use (measured by self-report use days); reduced overdose risk (measured by self-report Overdose Risk Questionnaire) / overdoses (self-report and corroborated with surveillance data); and reduced mental health symptoms (measured by self-report mental health symptoms); (1c) less CL recidivism (measured by fewer days in jail and fewer numbers of arrests). Aim 2: Examine mechanisms impacting Aim 1 outcomes. Treatment effects will be mediated by: (i) recidivism risk; (ii) increased affiliations with prosocial peers; (iii) reduced affiliations with antisocial peers; and (iv) increased community integration; and will be moderated by demographic factors and COD severity. Aim 3: To conduct a comprehensive economic evaluation that will (i) estimate the full implementation (start-up and ongoing) costs associated with MISSION-CJ and PLS, and (ii) evaluate the cost-effectiveness of MISSION-CJ compared to PLS, from the healthcare system and societal perspectives. Aim 4. To examine facilitators and barriers of MISSION-CJ implementation via qualitative interviews with participants (n=20) and staff (N=12). This application is responsive to NIDA priorities by proposing to improve treatment within the CL system, and to optimize continuity of care post incarceration, and the JCOIN goals of addressing the intersection of the CL system and the community-based healthcare system.

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
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

入选标准

  • 18 years or older;
  • Proficient in reading and writing in the English language;
  • Are released from one of the participating jail/s; and
  • Have a current co-occurring substance use and mental health disorder, which includes both any substance use disorder (including alcohol) and mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia) as documented by the participating jails.

排除标准

  • Are acutely suicidal based on the CSSRS; or
  • Are acutely psychotic (as this would require a higher level of care) based on SCID-5-RV.

结局指标

主要结局

Engagement in Treatment

时间窗: Measured weekly through 6-months post enrollment

Measured by total days participating in each condition using fidelity logs adapted for each treatment arm.

Engagement in Treatment

时间窗: 6-months post enrollment

Measured by total community provider linkages

Engagement in Treatment

时间窗: Measured at baseline, 3, 6, 9, 12-months post enrollment

Measured by total days participating in other healthcare services. Measured using an adapted version of the Treatment Services Review (TSR)

次要结局

  • Self-reported Substance Use(Measured at baseline, 3, 6, 9, 12-months post enrollment)
  • Overdose Risk(Measured at baseline, 3, 6, 9, 12-months post enrollment.)
  • Overdoses from substances(Self reported overdoses measured at baseline, 3, 6, 9, 12-months post enrollment. Surveillance data will be captured in a one time data request from the MA PHDW post-enrollment.)
  • Mental Health Symptoms(Measured at baseline, 3, 6, 9, 12-months post enrollment)
  • Recidivism Risk(Measured at baseline, 3, 6, 9, 12-months post enrollment)
  • Current Recidivism(One time data extract at study conclusion to see if any participants are currently incarcerated.)
  • Recidivism(One time data extract from MA PHDW at the conclusion of the study.)
  • Recidivism(One time data extract at the conclusion of the study.)
  • Mental Health Symptoms: Trauma Symptoms(Measured at baseline, 3, 6, 9, 12-months post enrollment)
  • Quality Adjusted Life Years (QALYs): health(Measured at baseline, 3, 6, 9, and 12-months post enrollment)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Smelson

Professor

University of Massachusetts, Worcester

研究点 (2)

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