Clinical trial NCT04256954: Peer Navigation for Individuals With Serious Mental Illness Leaving Jail
Official title: Peer Navigation for Individuals With Serious Mental Illness Leaving Jail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Individuals With Serious Mental Illness Leaving Jails
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2020-02-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Serious mental illness (SMI) is a burdensome and widely prevalent public health problem among incarcerated men and women. Incarcerated individuals with SMI re-entering the community after jail stay experience the double stigma of criminal justice involvement and having the diagnosis of SMI. As a result, they are likely to disengage with community level mental health, medical care and substance use services at re-entry. This study proposes the development and pilot test of peer navigator intervention to increase linkages to community level mental health, medical care and substance use services.

Detailed description: Serious Mental Illness (SMI) is a stigmatized and disabling health condition that reduces average life expectancy by 25 years. SMI is also a prevalent public health problem affecting 25% of jail populations. Re-entry to the community following incarceration is a vulnerable time for justice-involved individuals with SMI, and SMI requires prompt and ongoing access to mental health and other healthcare services. Individuals with SMI who are re-entering the community following jail experience multiple barriers to access to community mental health, medical care (preventive and curative) and social services due to their debilitating symptoms, practical challenges accessing community services, and the stigma associated with being diagnosed with SMI. Peer navigation has been found to improve access to the mental health and medical care among individuals with SMI in the community. However, no peer support interventions for SMI have been tested to assist with mental health service linkage during re-entry to the community after incarceration. This study will develop and pilot test a peer navigator intervention for individuals with SMI re-entering the community after jail stay, providing formative work for a larger randomized controlled clinical trial evaluating the effectiveness of peer navigator intervention for justice-involved individuals with SMI. The intervention is based on social support theory. The project will: (a) develop a peer navigation intervention and evaluate its feasibility, acceptability, and potential engagement of target mechanisms for enrollment in mental health, medical care and substance use services among individuals with SMI re-entering the community after jail release and (b) conduct a randomized pilot trial in a sample of 40 individuals with SMI re-entering the community after jail release. Proposed target mechanisms include increased instrumental, informational, and emotional support for treatment engagement and recovery, as well as increased perception of social norms promoting treatment engagement and recovery. The control condition will be Standard Of Care (SOC). In addition to feasibility and acceptability, other outcomes include: (1) health service outcomes (primary) including enrollment/engagement/utilization of community mental health (primary), medical care and substance use services; and shorter days between release and first contact with healthcare provider; (2) Clinical outcomes: reduced psychiatric symptoms, increased functioning, adherence to psychiatric medications, fewer substance using days, fewer hospitalizations and suicide attempts; (3) Life context outcomes: nights unstably housed, and time until rearrest and (4) Potential target mechanisms that include instrumental, informational, and emotional support for treatment engagement and social norms about treatment engagement and recovery. Addressing the needs of re-entering individuals with SMI is a pressing priority for both the mental health and criminal justice systems. Peer navigators could play a critical role in continuing recovery and successful reintegration, reducing the impact of criminal justice involvement and mental health challenges.

Eligibility criteria: Inclusion Criteria:

* Incarcerated in the Genesee County Jail,
* Aged 18 or above,
* Has a lifetime DSM-5 diagnosis of SMI (including primary psychotic disorder \[schizophrenia, schizoaffective disorder, or delusional disorder\], bipolar disorder, and/or a major depressive disorder with psychotic features) as assessed by the Structured Clinical Interview for DSM-5 (SCID-5) and
* Anticipating release in the following two months.

Exclusion Criteria:

* Expect to be sentenced to prison (i.e., expect to go directly to prison, not home, from the jail),
* Cannot provide the name and contact information of at least two locator persons and/or
* Do not have access to any telephone.

Primary outcomes:
measure: Feasibility: Client Satisfaction
timeFrame: 6 months after release
measure: Feasibility: End of treatment
timeFrame: 6 months after release
measure: Acceptability: Client Satisfaction Questionnaire
timeFrame: 6 months after release
measure: Acceptability: End of treatment
timeFrame: 6 months after release
Secondary outcomes:
measure: Service linkage outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Service linkage outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Clinical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Clinical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Clinical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Clinical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Clinical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Clinical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Clinical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Clinical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Clinical outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Target mechanisms
timeFrame: baseline, three months and six months.
measure: Life context outcomes
timeFrame: Baseline, 3 months and 6 months
measure: Life context outcomes
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Flint
country: United States
facility: Genesee County Jail
state: Michigan
Study officials:
References: