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Not yet recruiting NCT07555145

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

No phase Interventional Mental Health Substance Use Disorders Co-occurring Mental and Substance Use Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Full MISSION-CJ, Peer Linkage Support.
Who it may be relevant to
Registry conditions: Mental Health, Substance Use Disorders, Co-occurring Mental and Substance Use Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Full MISSION-CJ
    MISSION-CJ is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery and address criminogenic risk. The MISSION-CJ treatment curriculum integrates 3 evidence-based practices: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integra
  • Behavioral Peer Linkage Support
    Linkage only is provided via Peer Specialists whom have lived experiences similar to that of our participants. Linkage only includes informal treatment planning and linkages and supports to needed community services.

Primary outcome measures

  • Engagement in Treatment [Time frame: Measured weekly through 6-months post enrollment]
  • Engagement in Treatment [Time frame: 6-months post enrollment]
  • Engagement in Treatment [Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment]
Secondary outcome measures (12)
  • Self-reported Substance Use [Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment]
  • Overdose Risk [Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment.]
  • Overdoses from substances [Time frame: 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 [Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment]
  • Recidivism Risk [Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment]
  • Current Recidivism [Time frame: One time data extract at study conclusion to see if any participants are currently incarcerated.]
  • Recidivism [Time frame: One time data extract from MA PHDW at the conclusion of the study.]
  • Recidivism [Time frame: One time data extract from MA PHDW at the conclusion of the study.]
  • Recidivism [Time frame: One time data extract at the conclusion of the study.]
  • Recidivism [Time frame: One time data extract at the conclusion of the study.]
  • Mental Health Symptoms: Trauma Symptoms [Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment]
  • Quality Adjusted Life Years (QALYs): health [Time frame: Measured at baseline, 3, 6, 9, and 12-months post enrollment]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Hampshire County Jail and House of Correction — Northampton
  • Worceseter County Jail and House of Correction — West Boylston

Identifiers

NCT: NCT07555145 · STUDY00002781 · R01DA064494

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗