Clinical trial NCT04523337: MISSION-CJ for Justice-Involved Homeless Veterans
Official title: A Randomized Controlled Trial of MISSION-CJ for Justice-Involved Homeless Veterans With Co-Occurring Substance Use and Mental Health Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use Disorder
Mental Health Disorder
Homelessness
Keywords: Veterans
Co-Occurring Disorder
Homeless Persons
crime
substance-related disorders
mental disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-08-21
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking - Criminal Justice version (MISSION-CJ) is effective for reducing criminal recidivism and improving other health-related outcomes (substance use, mental health, housing, employment, community integration) among justice-involved, homeless Veterans with a co-occurring substance use and mental health disorder.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Criminal recidivism
timeFrame: through study completion, on average 15-months
measure: Criminal recidivism
timeFrame: through study completion, on average 15-months
measure: Criminal Recidivism
timeFrame: through study completion, on average 15-months
Secondary outcomes:
measure: Change in Substance use (Alcohol Use Timeline Follow-back -TLFB)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Substance use (Alcohol Use Timeline Follow-back -TLFB)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Substance Use (Illicit Drug Use Timeline Follow back - TLFB)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Substance Use (Illicit Drug Use Timeline Follow back - TLFB)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Trauma Symptoms (PTSD Checklist for DSM-5 - PCL-5)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Depression (Patient Health Questionnaire-9 - PHQ-9)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Mental Health Symptoms (Behavior and Symptom Identification Scale-24 - BASIS-24)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Recidivism risk (Level of Service Inventory-Revised)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Medication Adherence Rating Scale (MARS)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Housing Status (Residential Timeline Follow back)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Housing Status (Residential Timeline Follow back)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Employment (Maudsley Addiction Profile)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Employment (Maudsley Addiction Profile)
timeFrame: Baseline, 6-months, 15-months
measure: Treatment Engagement (MISSION Treatment Services Tracking Sheet
timeFrame: Up to 12 months
measure: Treatment Engagement (MISSION Treatment Services Tracking Sheet)
timeFrame: Up to 12 months
measure: Change in Treatment Engagement (Alcoholics Anonymous Involvement Scale - AAI)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Treatment Engagement (Alcoholics Anonymous Involvement Scale - AAI)
timeFrame: Baseline, 6-months, 15-months
measure: Treatment Engagement (Healthcare Continuing Care Utilization)
timeFrame: 12-month period prior to, and ending 15 months after, study enrollment
measure: Treatment Engagement (MH RRTP Completion)
timeFrame: 12-month period prior to, and ending 15 months after, study enrollment
measure: Change in Community Integration Measure (CIM)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Antisocial Attitudes (Measures of Criminal Attitudes and Associates - MCAA)
timeFrame: Baseline, 6-months, 15-months
measure: Change in Affiliations with Antisocial Peers (Measures of Criminal Attitudes and Associates: MCAA)
timeFrame: Baseline, 6-months, 15-months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
state: Arkansas
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: David A. Smelson, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Daniel M. Blonigen, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: