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

June 29, 2026 updated by: David Smelson, University of Massachusetts, Worcester
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Northampton, Massachusetts, United States, 01060
      • West Boylston, Massachusetts, United States, 01583
        • Worceseter County Jail and House of Correction
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Measured weekly through 6-months post enrollment
Engagement in Treatment
Time Frame: 6-months post enrollment
Measured by total community provider linkages
6-months post enrollment
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)
Measured at baseline, 3, 6, 9, 12-months post enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Measured at baseline, 3, 6, 9, 12-months post enrollment
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.
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.
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
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.
Measured at baseline, 3, 6, 9, 12-months post enrollment
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.
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.
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
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.
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.
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
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.
One time data extract at the conclusion of the study.
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.
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
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
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).
Measured at baseline, 3, 6, 9, and 12-months post enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Measured at baseline, 3, 6, 9, 12-months post enrollment
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.
Measured at baseline, 3, 6, 9, 12-months post enrollment
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.
Measured at 3 and 6-months post enrollment
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.
Measured at baseline, 3, 6, 9, 12-months post enrollment
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.
Measured at baseline, 3, 6, 9, 12-months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Smelson, PsyD, University of Massachusetts, Worcester
  • Principal Investigator: Paige Shaffer, PhD, University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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