Individuals With Serious Mental Illness Leaving JailsNCT04256954
Peer Navigation for Individuals With Serious Mental Illness Leaving Jail
A study testing Peer navigation intervention in people with Individuals With Serious Mental Illness Leaving Jails, run by Michigan State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Individuals With Serious Mental Illness Leaving Jails
- What is being tested?
- Peer navigation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Peer navigation intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer navigation interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Peer navigation | Experimental | 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. Receives: Behavioral: Peer navigation intervention |
| Standard of Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Client Satisfaction
Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction
Measured: 6 months after release
Feasibility: End of treatment
End of Treatment Questionnaire: this is a descriptive measure, positive experiences described meaning higher feasibility of the service
Measured: 6 months after release
Acceptability: Client Satisfaction Questionnaire
Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction
Measured: 6 months after release
Acceptability: End of treatment
End of Treatment Questionnaire this is a descriptive measure, positive experiences described meaning better acceptability of the treatment
Measured: 6 months after release
Secondary outcomes (14)
Service linkage outcomes
Number of visits to outpatient as assessed by Treatment History Interview
Measured: Baseline, 3 months and 6 months
Service linkage outcomes
Number of visits to emergency department as assessed by Treatment History Interview (THI)
Measured: Baseline, 3 months and 6 months
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.
Measured: Baseline, 3 months and 6 months
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.
Measured: Baseline, 3 months and 6 months
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.
Measured: Baseline, 3 months and 6 months
Clinical outcomes
Adherence to psychotropic medications as assessed by Brief Adherence Rating Scale; more days missed indicating poor adherence.
Measured: Baseline, 3 months and 6 months
Clinical outcomes
Functioning as assessed by the 12-item WHO-Disability Assessment Schedule; scores range from 0-48, higher scores indicating greater functional impairment.
Measured: Baseline, 3 months and 6 months
Clinical outcomes
Number of hospitalizations as assessed by Treatment History Interview
Measured: Baseline, 3 months and 6 months
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.
Measured: Baseline, 3 months and 6 months
Clinical outcomes
Substance use (alcohol) as assessed by the Alcohol Use Disorders Identification Test
Measured: Baseline, 3 months and 6 months
Clinical outcomes
Substance use (drugs) as assessed and Drug Use Disorders Identification Test
Measured: Baseline, 3 months and 6 months
Target mechanisms
Self Stigma of Mental Illness Short Form
Measured: baseline, three months and six months.
Life context outcomes
Number of nights unstably housed as measured by using calendar-based interview.
Measured: Baseline, 3 months and 6 months
Life context outcomes
Days until rearrest as measured by using calendar-based interview.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 Jan 2022
- Primary completion22 Feb 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individuals With Serious Mental Illness Leaving JailsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Maji Debena, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256954
- Sponsor's protocol ID
- STUDY00002543
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2020
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Navigation for Individuals With Serious Mental Illness Leaving Jail
- ClinicalTrials.gov ID
- NCT04256954
- Acronym / sponsor ID
- STUDY00002543
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer navigation | Experimental | Behavioral: Peer navigation interventionThose 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. |
| Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer navigation interventionA 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 | Behavioural | Peer navigation |
Primary outcome
Feasibility: Client Satisfaction
Time frame: 6 months after release
Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction
Feasibility: End of treatment
Time frame: 6 months after release
End of Treatment Questionnaire: this is a descriptive measure, positive experiences described meaning higher feasibility of the service
Acceptability: Client Satisfaction Questionnaire
Time frame: 6 months after release
Client Satisfaction Questionnaire- 8: scores range from 8-32, higher scores indicating higher satisfaction
Acceptability: End of treatment
Time frame: 6 months after release
End of Treatment Questionnaire this is a descriptive measure, positive experiences described meaning better acceptability of the treatment
14 secondary outcomes
Service linkage outcomes
Time frame: Baseline, 3 months and 6 months
Service linkage outcomes
Time frame: Baseline, 3 months and 6 months
Clinical outcomes
Time frame: Baseline, 3 months and 6 months
Clinical outcomes
Time frame: Baseline, 3 months and 6 months
Clinical outcomes
Time frame: Baseline, 3 months and 6 months
Clinical outcomes
Time frame: Baseline, 3 months and 6 months
Clinical outcomes
Time frame: Baseline, 3 months and 6 months
Clinical outcomes
Time frame: Baseline, 3 months and 6 months
Clinical outcomes
Time frame: Baseline, 3 months and 6 months
Clinical outcomes
Time frame: Baseline, 3 months and 6 months
Clinical outcomes
Time frame: Baseline, 3 months and 6 months
Target mechanisms
Time frame: baseline, three months and six months.
Life context outcomes
Time frame: Baseline, 3 months and 6 months
Life context outcomes
Time frame: Baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer navigation intervention in people with Individuals With Serious Mental Illness Leaving Jails, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Client Satisfaction (time frame: 6 months after release). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.