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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04256954
Other study ID # STUDY00002543
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2, 2022
Est. completion date April 1, 2024

Study information

Verified date July 2023
Source Michigan State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Peer navigation intervention
A peer navigator will assist those assigned to the intervention group access community mental health, medical care and substance use services. Peer navigators will help create linkages to services

Locations

Country Name City State
United States Genesee County Jail Flint Michigan

Sponsors (2)

Lead Sponsor Collaborator
Michigan State University Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility: Client Satisfaction Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction 6 months after release
Primary Feasibility: End of treatment End of Treatment Questionnaire: this is a descriptive measure, positive experiences described meaning higher feasibility of the service 6 months after release
Primary Acceptability: Client Satisfaction Questionnaire Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction 6 months after release
Primary Acceptability: End of treatment End of Treatment Questionnaire this is a descriptive measure, positive experiences described meaning better acceptability of the treatment 6 months after release
Secondary Service linkage outcomes Number of visits to outpatient as assessed by Treatment History Interview Baseline, 3 months and 6 months
Secondary Service linkage outcomes Number of visits to emergency department as assessed by Treatment History Interview (THI) Baseline, 3 months and 6 months
Secondary Clinical outcomes Presence of psychiatric symptoms as assessed by Altman Self-Rating Mania Scale; sum of items 1-5, with a cut off score of 6 or higher indicating presence of manic or hypomanic condition. Baseline, 3 months and 6 months
Secondary Clinical outcomes Severity of psychiatric symptoms as assessed by Altman Self-Rating Mania Scale; scores range from 0-20, with a cut off score of 6 or higher indicating severity of psychiatric symptoms. Baseline, 3 months and 6 months
Secondary Clinical outcomes Depressive symptoms as assessed by Quick Inventory of Depressive Symptoms; 16 questions, scores range from 0-27, higher scores indicating severity of depressive symptoms. Baseline, 3 months and 6 months
Secondary Clinical outcomes Adherence to psychotropic medications as assessed by Brief Adherence Rating Scale; more days missed indicating poor adherence. Baseline, 3 months and 6 months
Secondary Clinical outcomes Functioning as assessed by the 12-item WHO-Disability Assessment Schedule; scores range from 0-48, higher scores indicating greater functional impairment. Baseline, 3 months and 6 months
Secondary Clinical outcomes Number of hospitalizations as assessed by Treatment History Interview Baseline, 3 months and 6 months
Secondary Clinical outcomes Number of suicide attempts as assessed by Columbia Suicide Severity Rating Scale; scores range from 2-25, higher number indicating more intense suicidal ideation. Baseline, 3 months and 6 months
Secondary Clinical outcomes Substance use (alcohol) as assessed by the Alcohol Use Disorders Identification Test Baseline, 3 months and 6 months
Secondary Clinical outcomes Substance use (drugs) as assessed and Drug Use Disorders Identification Test Baseline, 3 months and 6 months
Secondary Target mechanisms Self Stigma of Mental Illness Short Form baseline, three months and six months.
Secondary Life context outcomes Number of nights unstably housed as measured by using calendar-based interview. Baseline, 3 months and 6 months
Secondary Life context outcomes Days until rearrest as measured by using calendar-based interview. Baseline, 3 months and 6 months