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NCT Number: NCT07555145

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hampshire County Jail and House of Correction, Northampton, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full MISSION-CJ

Behavioral

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 integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery.

Peer Linkage Support

Behavioral

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 outcomes

  1. Engagement in Treatment

    Time frame: Measured weekly through 6-months post enrollment

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

  2. Engagement in Treatment

    Time frame: 6-months post enrollment

    Measured by total community provider linkages

  3. Engagement in Treatment

    Time frame: 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)

Secondary outcomes

  1. Self-reported Substance Use

    Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment

    Measured as self-reported days of use using the Timeline Follow back (TLFB)

  2. Overdose Risk

    Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment.

    Measured by self-report using the Overdose Risk Questionnaire (OdRi). The OdRi is a 25-item scale scored on a scale between 0 and 25, with greater scores indicating greater risk of overdose.

  3. 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.

    Measured as self-reported overdoses, and corroborated with surveillance data from the Vitals and MATRIS databases within the Massachusetts Public Health Data Warehouse (MA PHDW)

  4. Mental Health Symptoms

    Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment

    Measured by self-reported days of mental health symptoms using the Behavior and Symptom Identification Scale (BASIS-24). This is a 24-item measure scored on a scale of 0 to 4, with greater scores indicating more mental health problems and greater functional impairment.

  5. Recidivism Risk

    Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment

    Measured using the Level of Service Inventory-Revised scale (LSI-R). The LSI-R is scored on a scale of 0-54, with greater scores indicating greater risk of criminal and legal recidivism.

  6. Current Recidivism

    Time frame: One time data extract at study conclusion to see if any participants are currently incarcerated.

    Measured using data extracted from Vinelink. Vinelink provides information on current incarcerations. Thus, recidivism data captured will include if the participant is currently incarcerated or not (i.e. yes or no).

  7. Recidivism

    Time frame: One time data extract from MA PHDW at the conclusion of the study.

    Measured using data extracted from Massachusetts Public Health Data Warehouse (MA PHDW). Recidivism data captured from MA PHDW will include days in prison or jail during the period of enrollment.

  8. Recidivism

    Time frame: One time data extract from MA PHDW at the conclusion of the study.

    Measured using data extracted from Massachusetts Public Health Data Warehouse (MA PHDW). Recidivism data captured from MA PHDW will include number of arrests during the period of enrollment.

  9. Recidivism

    Time frame: One time data extract at the conclusion of the study.

    Measured using data extracted from participating jails. Recidivism data from participating jails will include days in prison or jail during enrollment. This data will be compared with recidivism data extracted from MA PHDW.

  10. Recidivism

    Time frame: One time data extract at the conclusion of the study.

    Measured using data extracted from participating jails. Recidivism data from participating jails will include number of arrests during enrollment. This data will be compared with recidivism data extracted from MA PHDW.

  11. Mental Health Symptoms: Trauma Symptoms

    Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment

    Measured using the Post-Traumatic Stress Disorder Checklist 5 (PCL-5). The PCL-5 is scored on a scale of 0 to 80, with greater scores indicating greater severity with post-traumatic stress symptoms.

  12. Quality Adjusted Life Years (QALYs): health

    Time frame: Measured at baseline, 3, 6, 9, and 12-months post enrollment

    Measured by self-report on the 5-level EQ-5D (EQ-5D-5L). Scores range from 0 (worst imaginable health) to 100 (best imaginable health).

Other outcomes

  1. Mutual Self-Help Group Participation

    Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment

    Measured using the Alcoholics Anonymous Involvement scale (AAI). The AAI is scored dichotomously using 8-items, with minimum scores of 0 and maximum scores of 8, with greater scores indicating greater participation in alcoholics anonymous groups.

  2. Mutual Self-Help Group Participation

    Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment

    Measured using the Alcoholics Anonymous Involvement scale (AAI). The AAI also asks about number of AA groups attended, as a continuous measure of attendance.

  3. Therapeutic Alliance

    Time frame: Measured at 3 and 6-months post enrollment

    Measured using the Working Alliance Inventory (WAI). The WAI is scored on a scale from 36 to 252, with greater scores indicating greater therapeutic alliance.

  4. Coping Skills

    Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment

    Measured using the Coping Strategies Scale (CSS). The CSS is scored on a scale of 0 to 69, with greater scores indicating greater use of coping skills.

  5. Community Reintegration

    Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment

    Measured via the Community Reintegration Measure (CIM). The CIM is scored on a scale of 10 to 50, with greater scores indicating greater community involvement and integration.

Study contacts

Contact information is provided by the study sponsor or research team.

David Smelson, PsyD

CONTACT

[email protected]

508-713-5420

Michael Andre, MPH

CONTACT

[email protected]

413-433-7866

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Cornell University
  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: STAR-R

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 29, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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