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

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use Disorders; Mental Health; Co-occurring Mental and Substance Use Disorders
• Intervention / Treatment: Behavioral: Full MISSION-CJ; Behavioral: Peer Linkage Support

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Smelson, PsyD; Phone Number: 508-713-5420; Email: David.Smelson@umassmed.edu
• Study Contact Backup: Name: Michael Andre, MPH; Phone Number: 413-433-7866; Email: michael.andre@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Northampton, Massachusetts, United States, 01060
      • Hampshire County Jail and House of Correction
      • Contact: Patrick Cahillane; Phone Number: 413-582-7703; Email: patrick.cahillane@hsd.state.ma.us
    • West Boylston, Massachusetts, United States, 01583
      • Worceseter County Jail and House of Correction
      • Contact: Jason Butland; Phone Number: 508-854-1800; Email: jbutland@sdw.state.ma.us

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full MISSION-CJ; Participants assigned to this condition will receive full MISSION-CJ services. MISSION-CJ services include 6-months of integrated mental health and substance use treatment and treatment planning with the MISSION-CJ Case Manager (13 session curriculum) and Peer Support Specialist (11 session curriculum). Content of these sessions will be directed using the MISSION-CJ Treatment Manual and Consumer Workbooks. MISSION-CJ teams will also provide linkages and supports to treatment services within the participant's community throughout the duration of the study.	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 integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery.
Active Comparator: Peer Linkage Support; Our Linkage only arm delivered by a Peer Specialist will act as the comparison group to the MISSION-CJ arm. Participants randomized to the linkage only arm will receive 6-months of linkage care from a Peer Specialist. The Peer Specialist will provide informal treatment planning as well as linkages and support to community services, but will not provide integrated dual disorders treatment, nor will this arm utilize any MISSION-CJ materials or offer Peer led groups.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in Treatment	Measured by total days participating in each condition using fidelity logs adapted for each treatment arm.	Measured weekly through 6-months post enrollment
Engagement in Treatment	Measured by total community provider linkages	6-months post enrollment
Engagement in Treatment	Measured by total days participating in other healthcare services. Measured using an adapted version of the Treatment Services Review (TSR)	Measured at baseline, 3, 6, 9, 12-months post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Substance Use	Measured as self-reported days of use using the Timeline Follow back (TLFB)	Measured at baseline, 3, 6, 9, 12-months post enrollment
Overdose Risk	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.	Measured at baseline, 3, 6, 9, 12-months post enrollment.
Overdoses from substances	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)	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 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.	Measured at baseline, 3, 6, 9, 12-months post enrollment
Recidivism Risk	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.	Measured at baseline, 3, 6, 9, 12-months post enrollment
Current Recidivism	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).	One time data extract at study conclusion to see if any participants are currently incarcerated.
Recidivism	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.	One time data extract from MA PHDW at the conclusion of the study.
Recidivism	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.	One time data extract from MA PHDW at the conclusion of the study.
Recidivism	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.	One time data extract at the conclusion of the study.
Recidivism	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.	One time data extract at the conclusion of the study.
Mental Health Symptoms: Trauma Symptoms	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.	Measured at baseline, 3, 6, 9, 12-months post enrollment
Quality Adjusted Life Years (QALYs): health	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).	Measured at baseline, 3, 6, 9, and 12-months post enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mutual Self-Help Group Participation	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.	Measured at baseline, 3, 6, 9, 12-months post enrollment
Mutual Self-Help Group Participation	Measured using the Alcoholics Anonymous Involvement scale (AAI). The AAI also asks about number of AA groups attended, as a continuous measure of attendance.	Measured at baseline, 3, 6, 9, 12-months post enrollment
Therapeutic Alliance	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.	Measured at 3 and 6-months post enrollment
Coping Skills	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.	Measured at baseline, 3, 6, 9, 12-months post enrollment
Community Reintegration	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.	Measured at baseline, 3, 6, 9, 12-months post enrollment

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Institute on Drug Abuse (NIDA); Cornell University
• Investigators: Principal Investigator: David Smelson, PsyD, University of Massachusetts, Worcester; Principal Investigator: Paige Shaffer, PhD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mental health; substance use disorders; co-occurring disorders; MISSION-CJ; peer linkage support
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Personal Satisfaction; Substance-Related Disorders; Psychological Well-Being
• Other Study ID Numbers: STUDY00002781; R01DA064494 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Consistent with the NIH and the JCOIN Initiative, Underlying Primary Data collected from participants in this project will be made readily available to the public through regular submissions to the Methodology and Advanced Analytics Resource Center (MAARC) and Syracuse Qualitative Data Repository for both quantitative and qualitative data collected respectively. In consultation with the University of Massachusetts Chan Medical School's institutional review board (IRB), project consent forms will include relevant information for participants to be made aware that their de-identified data will be available to other investigators as a part of the JCOIN Initiative Public Access and Data Sharing Policy.
• IPD Sharing Time Frame: Data will be available upon publication or 1-2 years after the grant end date (September 2030), until 2036 (Certificate of Confidentiality)
• IPD Sharing Access Criteria: Data will be shared with authorized users within the JCOIN network.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No