An interventional study of Full MISSION-CJ and Peer Linkage Support in Mental Health, Substance Use Disorders and Co-occurring Mental and Substance Use Disorders, sponsored by University of Massachusetts, Worcester. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Treatment
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.
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.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 240 is above the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Compared within Psychological Well-Being, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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.
Engagement in Treatment
Measured by total days participating in each condition using fidelity logs adapted for each treatment arm.
Time frame: Measured weekly through 6-months post enrollment
Engagement in Treatment
Measured by total community provider linkages
Time frame: 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)
Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment
Self-reported Substance Use
Measured as self-reported days of use using the Timeline Follow back (TLFB)
Time frame: 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.
Time frame: 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)
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
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Measured at baseline, 3, 6, 9, and 12-months post enrollment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at baseline, 3, 6, 9, 12-months post enrollment
Plan to share: Yes — 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.
Time frame: Data will be available upon publication or 1-2 years after the grant end date (September 2030), until 2036 (Certificate of Confidentiality)
Access criteria: Data will be shared with authorized users within the JCOIN network.
Data sharing details ↗ · qdr.syr.edu
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for May 2030, 43 months after the start.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 43 months is above that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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