- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523337
MISSION-CJ for Justice-Involved Homeless Veterans (MISSION-CJ)
A Randomized Controlled Trial of MISSION-CJ for Justice-Involved Homeless Veterans With Co-Occurring Substance Use and Mental Health Disorders
Study Overview
Status
Detailed Description
VHA Mental Health Residential Rehabilitation Treatment Programs (MH RRTPs) serve Veterans with an estimated 50% having criminal justice involvement annually. Justice-involved Veterans (JIVs) receive assistance with their addiction and behavioral health needs, but MH RRTP programs do not directly address their antisocial behaviors and cognitions. Furthermore, MH RRTP discharge is a vulnerable transition and no national transitional approach facilitates Veteran's engagement in prosocial community behaviors that sustain MH RRTP gains, ultimately reducing revolving door service use.
Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice version (MISSION-CJ) is a new case manager and peer delivered team-based treatment for JIVs with a co-occurring substance use and mental health disorder (COD). While MISSION-CJ derives in part from an evidence-based treatment for homeless individuals (MISSION), it includes a new conceptual framework and numerous new and differentiating features for a CJ population including: (1) a treatment planning tool focused on criminogenic needs that monitors progress and tunes service delivery elements; (2) a prosocial treatment curriculum; and (3) tools/resources to address JIVs' legal issues. With MISSION-CJ, this study attempts to change the practice paradigm and transform care for JIVs by moving beyond the current model of linking Veterans to VA care and tracking behavioral health outcomes, to a hybrid treatment/linkage approach that addresses criminogenic needs, supports engagement in VA and non-VA care, and targets recidivism as an outcome-the gold standard for CJ research.
Using a Hybrid Type 1 design, this project will test the effectiveness of MISSION-CJ in a three-site RCT (Bedford, Palo Alto, and Little Rock VAs) with JIVs with a COD, admitted to an MH RRTP, and previously arrested and charged and/or released from incarceration in the past 5-years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205-5484
- Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
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California
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Palo Alto, California, United States, 94304-1207
- VA Palo Alto Health Care System, Palo Alto, CA
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Massachusetts
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Bedford, Massachusetts, United States, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (a) are entering a Mental Health Residential Rehabilitation Treatment Program (MH RRTP)
- (b) were arrested and charged and/or released from incarceration in the past 5 years
- (c) have a co-occurring substance use and mental health disorder (COD)
Exclusion Criteria:
- The only exclusion criterion is being too cognitively impaired to understand the informed-consent process and other study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: MISSION-CJ
Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice version (MISSION-CJ) programming targets co-occurring substance use and mental health disorders and other related health outcomes faced by justice-involved homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based services.
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Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice version (MISSION-CJ) programming targets co-occurring substance use and mental health disorders and other related health outcomes faced by justice-involved homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based services.
Patients will receive 2 hours of MISSION-CJ services per week during and after their stay in the mental health residential rehabilitation program (total of 6-months).
Services are delivered using a Critical Time Intervention stepdown approach.
Other Names:
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Experimental: Enhanced Usual Care
Usual care provided by the mental health residential rehabilitation treatment programs, with patients in both groups are enrolled in, in addition to peer support and community outreach case management.
Patients receive 2 Peer Support Curriculum sessions per week (24 sessions total).
Patients will receive unstructured community outreach and linkage support while enrolled in the mental health residential rehabilitation program.
After discharge, patients will continue to receive 1 hour of weekly linkage support per week.
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The MISSION Peer Support Curriculum is rolling entry, and includes 24, one-hour exercises focused on co-occurring substance use and mental health disorders, recovery, and community integration.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Criminal recidivism
Time Frame: through study completion, on average 15-months
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Number of arrests based on records from the California and Massachusetts Department of Corrections records; and arrest and incarceration records from the National Crime Information Center.
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through study completion, on average 15-months
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Criminal recidivism
Time Frame: through study completion, on average 15-months
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Number of charges based on records from the California and Massachusetts Department of Corrections records; and arrest and incarceration records from the National Crime Information Center.
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through study completion, on average 15-months
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Criminal Recidivism
Time Frame: through study completion, on average 15-months
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Number of nights in jail or prison based on records from the California and Massachusetts Department of Corrections records; and arrest and incarceration records from the National Crime Information Center.
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through study completion, on average 15-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Substance use (Alcohol Use Timeline Follow-back -TLFB)
Time Frame: Baseline, 6-months, 15-months
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Quantity of patients' self-reported alcohol use in the past 90 days.
Frequency and quantity will be combined to measure alcohol use severity.
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Baseline, 6-months, 15-months
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Change in Substance use (Alcohol Use Timeline Follow-back -TLFB)
Time Frame: Baseline, 6-months, 15-months
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Frequency of patients' self-reported alcohol use in the past 90 days.
Frequency and quantity will be combined to measure alcohol use severity.
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Baseline, 6-months, 15-months
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Change in Substance Use (Illicit Drug Use Timeline Follow back - TLFB)
Time Frame: Baseline, 6-months, 15-months
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Quantity of patients' self-reported illicit drug use in the past 90 days.
Frequency and quantity will be combined to measure drug use severity.
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Baseline, 6-months, 15-months
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Change in Substance Use (Illicit Drug Use Timeline Follow back - TLFB)
Time Frame: Baseline, 6-months, 15-months
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Frequency of patients' self-reported illicit drug use in the past 90 days.
Frequency and quantity will be combined to measure drug use severity.
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Baseline, 6-months, 15-months
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Change in Trauma Symptoms (PTSD Checklist for DSM-5 - PCL-5)
Time Frame: Baseline, 6-months, 15-months
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Changes in the severity of patients' PTSD symptoms.
A total severity score is computed by summing all the items.
Scores range from 0-80 with higher scores indicating higher severity.
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Baseline, 6-months, 15-months
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Change in Depression (Patient Health Questionnaire-9 - PHQ-9)
Time Frame: Baseline, 6-months, 15-months
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Changes in the degree of depression severity self-reported by patients.
Total scores range from 0-27 with higher scores indicating more severe depression.
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Baseline, 6-months, 15-months
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Change in Mental Health Symptoms (Behavior and Symptom Identification Scale-24 - BASIS-24)
Time Frame: Baseline, 6-months, 15-months
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Changes in the severity of patients' self-reported psychiatric symptoms across 6 subscales (e.g.
Depression and Functioning, Interpersonal Relationships, Self-Harm, Psychosis, Substance Abuse, and Emotional Lability) during the past week.
Patients score items on a scale of 0-4, and each subscale and mean total score range from 0-4, with higher scores indicating higher levels of severity of symptoms.
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Baseline, 6-months, 15-months
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Change in Recidivism risk (Level of Service Inventory-Revised)
Time Frame: Baseline, 6-months, 15-months
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Changes in the severity of patients' self-reported legal problems.
Self-reported arrests, charges, and months incarcerated since the baseline assessment.
Total LSI-R scores will be used.
Scores range from 0-54 with higher scores indicating greater risk.
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Baseline, 6-months, 15-months
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Change in Medication Adherence Rating Scale (MARS)
Time Frame: Baseline, 6-months, 15-months
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Patients' self-reported compliance with medication.
Questions are dichotomous yes/no.
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Baseline, 6-months, 15-months
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Change in Housing Status (Residential Timeline Follow back)
Time Frame: Baseline, 6-months, 15-months
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Quantity of patients' self-reported days homeless in the past 90 days.
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Baseline, 6-months, 15-months
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Change in Housing Status (Residential Timeline Follow back)
Time Frame: Baseline, 6-months, 15-months
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Frequency of patients' self-reported days homeless in the past 90 days.
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Baseline, 6-months, 15-months
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Change in Employment (Maudsley Addiction Profile)
Time Frame: Baseline, 6-months, 15-months
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Quantity of days worked, days absent, and days unemployed in the past 30 days, as self-reported by patients since the baseline assessment.
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Baseline, 6-months, 15-months
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Change in Employment (Maudsley Addiction Profile)
Time Frame: Baseline, 6-months, 15-months
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Frequency of days worked, days absent, and days unemployed in the past 30 days, as self-reported by patients since the baseline assessment.
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Baseline, 6-months, 15-months
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Treatment Engagement (MISSION Treatment Services Tracking Sheet
Time Frame: Up to 12 months
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Number of services for both VA and non-VA services received (pre- and post-MH RRTP).
This includes all possible services offered within MISSION-CJ and EUC (MISSION Peer Support) as well as community linkages.
Regarding linkages, the measure quantifies the number of referrals, referral type, and client engagement.
Examine change in number of services received during 12 months, collected on a weekly basis.
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Up to 12 months
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Treatment Engagement (MISSION Treatment Services Tracking Sheet)
Time Frame: Up to 12 months
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Types of services for both VA and non-VA services received (pre- and post-MH RRTP).
This includes all possible services offered within MISSION-CJ and Enhanced Usual Care (MISSION Peer Support) as well as community linkages.
Examine change in types of services received during 12 months, collected on a weekly basis.
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Up to 12 months
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Change in Treatment Engagement (Alcoholics Anonymous Involvement Scale - AAI)
Time Frame: Baseline, 6-months, 15-months
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Change in patients' self-reported involvement in 12-step groups for substance use.
Items are dichotomous yes/no, with yes responses indicating more involvement in 12-step groups.
Composite scores range from 0-9 with 9 indicating more involvement in 12-step groups.
Patients are also asked to indicate which of the 12-steps they have worked.
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Baseline, 6-months, 15-months
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Change in Treatment Engagement (Alcoholics Anonymous Involvement Scale - AAI)
Time Frame: Baseline, 6-months, 15-months
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Change in patients' self-reported attendance in 12-step groups for substance use over lifetime, and since the previous assessment.
Patients report an estimated number of meetings they've attended in the last year, and in their lifetime.
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Baseline, 6-months, 15-months
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Treatment Engagement (Healthcare Continuing Care Utilization)
Time Frame: 12-month period prior to, and ending 15 months after, study enrollment
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Data on SUD/MH continuing care utilization since the prior assessment will be defined as the number of sessions in each setting that the clients attend throughout the follow-up period.
Both will be obtained from: (a) CDW, for VA care and (b) service tracking sheets for VA and non-VA health care utilization.
For VA care, the electronic medical record data will be obtained from the CDW.
CDW data includes both outpatient encounter records (including the type of outpatient care - e.g., from outreach programs, office-based clinical services) and information on inpatient and residential care services used.
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12-month period prior to, and ending 15 months after, study enrollment
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Treatment Engagement (MH RRTP Completion)
Time Frame: 12-month period prior to, and ending 15 months after, study enrollment
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Healthcare utilization includes both VA and non-VA healthcare services and we will construct several measures.
MH RRTP completion will be defined as a regular discharge from the program and determined from the VA's Corporate Data Warehouse (CDW).
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12-month period prior to, and ending 15 months after, study enrollment
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Change in Community Integration Measure (CIM)
Time Frame: Baseline, 6-months, 15-months
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Patient's self-report perspective of their integration into their home and community are scored on a 5-point scale.
A single summary score (range 10-50) is computed by summing each item, with lower scores indicating
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Baseline, 6-months, 15-months
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Change in Antisocial Attitudes (Measures of Criminal Attitudes and Associates - MCAA)
Time Frame: Baseline, 6-months, 15-months
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Changes in patients' self-report of antisocial attitudes on 4 scales: violence, entitlement, antisocial intent, and associates.
Responses to MCAA Part B are dichotomous agree/disagree.
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Baseline, 6-months, 15-months
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Change in Affiliations with Antisocial Peers (Measures of Criminal Attitudes and Associates: MCAA)
Time Frame: Baseline, 6-months, 15-months
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Changes in patients' self-report of criminal associations.
Part A of the MCAA is intended to quantify criminal associations.
In Part A, respondents are asked to recall the four adults in the community with whom they spend the most free time.
For each adult, they then indicate how much of their free time is spent in their associate's company.
The respondent then answers four questions regarding the degree of criminal involvement of their associates: (a) Has this person ever committed a crime; (b) Does this person have a criminal record; (c) Has this person ever been to jail? and (d) Has this person tried to involve you in a crime?
From this information, a measure of criminal associates can be calculated.
The Number of Criminal Friends is calculated by totaling the number of friends for which the respondent answers yes to any of the questions of criminal involvement.
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Baseline, 6-months, 15-months
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Collaborators and Investigators
Investigators
- Principal Investigator: Daniel M. Blonigen, PhD MA, VA Palo Alto Health Care System, Palo Alto, CA
- Principal Investigator: David A. Smelson, PsyD, VA Bedford HealthCare System, Bedford, MA
Publications and helpful links
General Publications
- Bruzios K, Shaffer PM, Blonigen DM, Cucciare MA, Andre M, Byrne T, Smith J, Smelson D. Intervention for Justice-Involved Homeless Veterans With Co-Occurring Substance Use and Mental Health Disorders: Protocol for a Randomized Controlled Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2025 Jul 18;14:e70750. doi: 10.2196/70750.
- Shaffer PM, Andre M, Smelson D, Cucciare MA, Bruzios KE, Blonigen DM. Criminogenic risk and suicidality among justice-involved homeless veterans with comorbid mental health and substance use disorders. BMC Public Health. 2026 Feb 4;26(1):809. doi: 10.1186/s12889-026-26250-6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 18-040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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