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Peer Navigation for Individuals With Serious Mental Illness Leaving Jail

Primary Purpose

Individuals With Serious Mental Illness Leaving Jails

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer navigation intervention
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Individuals With Serious Mental Illness Leaving Jails

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Genesee County JailRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer navigation

Standard of Care

Arm Description

Those who are assigned to the intervention arm will receive peer navigation service by a trained peer navigator who will link them with mental health, medical and substance use services in the community.

SOC consists of TAU + monitoring and emergency referral, as is required to fulfil ethical obligations to trial participants. To determine the naturalistic effects and costs of adding peer navigation intervention, participants in both conditions can receive any other treatment available to them and we will not exclude participants receiving other treatment. We will carefully characterize TAU for each condition as part of our service utilization assessment.

Outcomes

Primary Outcome Measures

Feasibility: Client Satisfaction
Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction
Feasibility: End of treatment
End of Treatment Questionnaire: this is a descriptive measure, positive experiences described meaning higher feasibility of the service
Acceptability: Client Satisfaction Questionnaire
Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction
Acceptability: End of treatment
End of Treatment Questionnaire this is a descriptive measure, positive experiences described meaning better acceptability of the treatment

Secondary Outcome Measures

Service linkage outcomes
Number of visits to outpatient as assessed by Treatment History Interview
Service linkage outcomes
Number of visits to emergency department as assessed by Treatment History Interview (THI)
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.
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.
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.
Clinical outcomes
Adherence to psychotropic medications as assessed by Brief Adherence Rating Scale; more days missed indicating poor adherence.
Clinical outcomes
Functioning as assessed by the 12-item WHO-Disability Assessment Schedule; scores range from 0-48, higher scores indicating greater functional impairment.
Clinical outcomes
Number of hospitalizations as assessed by Treatment History Interview
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.
Clinical outcomes
Substance use (alcohol) as assessed by the Alcohol Use Disorders Identification Test
Clinical outcomes
Substance use (drugs) as assessed and Drug Use Disorders Identification Test
Target mechanisms
Self Stigma of Mental Illness Short Form
Life context outcomes
Number of nights unstably housed as measured by using calendar-based interview.
Life context outcomes
Days until rearrest as measured by using calendar-based interview.

Full Information

First Posted
January 6, 2020
Last Updated
July 14, 2023
Sponsor
Michigan State University
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT04256954
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Individuals With Serious Mental Illness Leaving Jails

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer navigation
Arm Type
Experimental
Arm Description
Those who are assigned to the intervention arm will receive peer navigation service by a trained peer navigator who will link them with mental health, medical and substance use services in the community.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
SOC consists of TAU + monitoring and emergency referral, as is required to fulfil ethical obligations to trial participants. To determine the naturalistic effects and costs of adding peer navigation intervention, participants in both conditions can receive any other treatment available to them and we will not exclude participants receiving other treatment. We will carefully characterize TAU for each condition as part of our service utilization assessment.
Intervention Type
Behavioral
Intervention Name(s)
Peer navigation intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility: Client Satisfaction
Description
Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction
Time Frame
6 months after release
Title
Feasibility: End of treatment
Description
End of Treatment Questionnaire: this is a descriptive measure, positive experiences described meaning higher feasibility of the service
Time Frame
6 months after release
Title
Acceptability: Client Satisfaction Questionnaire
Description
Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction
Time Frame
6 months after release
Title
Acceptability: End of treatment
Description
End of Treatment Questionnaire this is a descriptive measure, positive experiences described meaning better acceptability of the treatment
Time Frame
6 months after release
Secondary Outcome Measure Information:
Title
Service linkage outcomes
Description
Number of visits to outpatient as assessed by Treatment History Interview
Time Frame
Baseline, 3 months and 6 months
Title
Service linkage outcomes
Description
Number of visits to emergency department as assessed by Treatment History Interview (THI)
Time Frame
Baseline, 3 months and 6 months
Title
Clinical outcomes
Description
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.
Time Frame
Baseline, 3 months and 6 months
Title
Clinical outcomes
Description
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.
Time Frame
Baseline, 3 months and 6 months
Title
Clinical outcomes
Description
Depressive symptoms as assessed by Quick Inventory of Depressive Symptoms; 16 questions, scores range from 0-27, higher scores indicating severity of depressive symptoms.
Time Frame
Baseline, 3 months and 6 months
Title
Clinical outcomes
Description
Adherence to psychotropic medications as assessed by Brief Adherence Rating Scale; more days missed indicating poor adherence.
Time Frame
Baseline, 3 months and 6 months
Title
Clinical outcomes
Description
Functioning as assessed by the 12-item WHO-Disability Assessment Schedule; scores range from 0-48, higher scores indicating greater functional impairment.
Time Frame
Baseline, 3 months and 6 months
Title
Clinical outcomes
Description
Number of hospitalizations as assessed by Treatment History Interview
Time Frame
Baseline, 3 months and 6 months
Title
Clinical outcomes
Description
Number of suicide attempts as assessed by Columbia Suicide Severity Rating Scale; scores range from 2-25, higher number indicating more intense suicidal ideation.
Time Frame
Baseline, 3 months and 6 months
Title
Clinical outcomes
Description
Substance use (alcohol) as assessed by the Alcohol Use Disorders Identification Test
Time Frame
Baseline, 3 months and 6 months
Title
Clinical outcomes
Description
Substance use (drugs) as assessed and Drug Use Disorders Identification Test
Time Frame
Baseline, 3 months and 6 months
Title
Target mechanisms
Description
Self Stigma of Mental Illness Short Form
Time Frame
baseline, three months and six months.
Title
Life context outcomes
Description
Number of nights unstably housed as measured by using calendar-based interview.
Time Frame
Baseline, 3 months and 6 months
Title
Life context outcomes
Description
Days until rearrest as measured by using calendar-based interview.
Time Frame
Baseline, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Genesee County Jail
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Capt. Jill Macey
Phone
810-257-3439
Email
JMacey@geneseecountymi.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Peer Navigation for Individuals With Serious Mental Illness Leaving Jail

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