NCT07555145

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
53mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2030

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

April 13, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

MISSION-CJco-occurring disorderspeer linkage supportmental healthsubstance use disorders

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • Self-reported Substance Use

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

  • Overdose Risk

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

  • Overdoses from substances

    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 at baseline, 3, 6, 9, 12-months post enrollment

  • Recidivism Risk

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

  • +7 more secondary outcomes

Other Outcomes (5)

  • Mutual Self-Help Group Participation

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

  • Mutual Self-Help Group Participation

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

  • Therapeutic Alliance

    Measured at 3 and 6-months post enrollment

  • +2 more other outcomes

Study Arms (2)

Full MISSION-CJ

EXPERIMENTAL

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

Peer Linkage Support

ACTIVE COMPARATOR

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

Interventions

Full MISSION-CJBEHAVIORAL

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.

Full MISSION-CJ

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.

Peer Linkage Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hampshire County Jail and House of Correction

Northampton, Massachusetts, 01060, United States

Location

Worceseter County Jail and House of Correction

West Boylston, Massachusetts, 01583, United States

Location

MeSH Terms

Conditions

Psychological Well-BeingSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • David Smelson, PsyD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR
  • Paige Shaffer, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Smelson, PsyD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 29, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

August 31, 2030

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.
More information

Locations