Mental Disorders, SevereNCT04948853
Improving Employment Outcomes for Probationers With Mental Illnesses
A study testing Individual Placement Support - Supported Employment in people with Mental Disorders, Severe, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Employment is a key protective factor against recidivism; however, the lack of job opportunities keeps justice-involved mentally ill individuals, especially young adults of color, unemployed and at risk for future justice involvement. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Mental Disorders, Severe
- What is being tested?
- Individual Placement Support - Supported Employment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 31 Jul 2023
- 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 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- on probation and supervised by a SMHP officer;
- aged 18-99;
- interested in obtaining employment; and
- competent to provide informed consent.
Who cannot join
- Does not meet inclusion criteria; and
- Unable/unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Employment is a key protective factor against recidivism; however, the lack of job opportunities keeps justice-involved mentally ill individuals, especially young adults of color, unemployed and at risk for future justice involvement. To address these issues and grow the evidence for evidence-based practices for justice-involved adults with mental illnesses, the investigators will study the implementation and outcomes of individual placement support-supported employment (IPS-SE) combined with specialty mental health probation (SMHP) for probationers with mental illnesses.
Read the detailed description
The large and growing number of individuals with mental illnesses who are on probation have a difficult time accessing housing, employment, and health and mental health care, which is especially concerning for young adults aged 19-25 who make up just 10% of the population but 26% of those on probation. Employment is a key protective factor against recidivism; however, the lack of job opportunities keeps justice-involved mentally ill individuals, especially young adults of color, unemployed and at risk for future justice involvement. Without access to evidence-based supported employment interventions, economic inequality and poverty among justice-involved young adults with mental illnesses will remain unchanged.
To this end, an experienced multidisciplinary team will study the implementation and outcomes of individual placement support-supported employment (IPS-SE) combined with specialty mental health probation (SMHP) for probationers with mental illnesses. The investigators' long-term goal is to develop the evidence for interventions designed to improve employment outcomes among justice-involved individuals who have mental illnesses and conduct translational research with broad application to justice-involved individuals living with mental illnesses. The investigators will pursue the following specific aims:
Aim 1: Examine the barriers and facilitators to implementing IPS-SE in a probation setting. The investigators will use qualitative methods and semi-structured interviews with key stakeholders involved in the implementation of SMHP+IPS-SE to understand how IPS-SE can be embedded successfully in a probation setting.
Aim 2: Conduct a randomized trial to examine the impact of the SMHP+IPS-SE on employment and annual income for probationers with mental illnesses. The investigators will randomly assign 120 individuals to receive SMHP + treatment as usual (TAU) or SMHP+IPS-SE. The research team will test the following hypothesis - H1: SMHP+IPS-SE recipients will be more likely to obtain and sustain employment compared to SMHP+TAU recipients.
The expected outcomes include: (1) an understanding of the implementation barriers and facilitators associated with providing IPS-SE in a probation setting; (2) an understanding of how IPS-SE needs to be adapted for probationers with mental illnesses; and (3) evidence that SMHP+IPS-SE can improve employment outcomes among justice-involved probationers with mental illnesses. This research has the potential to promote the adoption and dissemination of best practices at the interface of the mental health and criminal justice systems and promises to grow the evidence for interventions that improve employment and reduce economic inequalities among a vulnerable population.
- Conditions
- Mental Disorders, Severe
- Being tested
- Individual Placement Support - Supported Employment
- Keywords
- probation, employment
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Placement Support - Supported EmploymentBehavioural
Individual, person-centered intervention designed to help individuals living with mental illnesses obtain and sustain meaningful employment. This is an evidence-based practice for individuals with severe mental illnesses.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Treatment as usual, with respect to employment, for individuals on probation typically entails the probation officer informing the probationer that probationer is responsible for obtaining employment or could entail a referral from a probation officer to an employment or job assistance service, such as vocational rehabilitation. The probationer is responsible for follow up with that service. |
| Intervention - Individual Placement Support-Supported Employment | Experimental | Subjects in this condition will receive services from a 1.5 FTE IPS-SE team that will work to provide one-on-one person-centered services to help obtain employment, including but not limited to career profiling, resume assistance, job placement, training and other activities. Receives: Behavioral: Individual Placement Support - Supported Employment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment, Time 0
Absence or presence of employment - categorical variable (full-time, part-time, none)
Measured: Baseline (Time 0)
Employment, Time 1
Absence or presence of employment - categorical variable (full-time, part-time, none)
Measured: 3-months (Time 1)
Employment, Time 2
Absence or presence of employment - categorical variable (full-time, part-time, none)
Measured: 6-months (Time 2)
Days worked in past 30 days, Time 0
Number of days worked in last 30 days
Measured: Baseline (Time 0)
Days worked in past 30 days, Time 1
Number of days worked in last 30 days
Measured: 3-months (Time 1)
Days worked in past 30 days, Time 2
Number of days worked in last 30 days
Measured: 6-months (Time 2)
Secondary outcomes (18)
Duke-UNC Functional Social Support Questionnaire (FSSQ)
This is an 8-item self-report measure of perceived social support. Scores on the FSSQ range from 8 - 40 with higher scores indicating higher levels of perceived social support.
Measured: Baseline (Time 0)
Duke-UNC Functional Social Support Questionnaire (FSSQ)
This is an 8-item self-report measure of perceived social support. Scores on the FSSQ range from 8 - 40 with higher scores indicating higher levels of perceived social support.
Measured: 3-months (Time 1)
Duke-UNC Functional Social Support Questionnaire (FSSQ)
This is an 8-item self-report measure of perceived social support. Scores on the FSSQ range from 8 - 40 with higher scores indicating higher levels of perceived social support.
Measured: 6-months (Time 2)
Symptom Checklist (SCL-10-R)
This is a 10-item self-report measure of mental health symptom distress. Scores on the SCL-10-R range from 0 - 40 with higher scores indicating higher levels of symptom distress.
Measured: Baseline (Time 0)
Symptom Checklist (SCL-10-R)
This is a 10-item self-report measure of mental health symptom distress. Scores on the SCL-10-R range from 0 - 40 with higher scores indicating higher levels of symptom distress.
Measured: 3-months (Time 1)
Symptom Checklist (SCL-10-R)
This is a 10-item self-report measure of mental health symptom distress. Scores on the SCL-10-R range from 0 - 40 with higher scores indicating higher levels of symptom distress.
Measured: 6-months (Time 2)
Rosenberg Self-Esteem Scale (RSE)
This is a 10-item self-report measure of self-esteem. Scores on the RSE range from 10 - 40 with higher scores indicating greater self-esteem.
Measured: Baseline (Time 0)
Rosenberg Self-Esteem Scale (RSE)
This is a 10-item self-report measure of self-esteem. Scores on the RSE range from 10 - 40 with higher scores indicating greater self-esteem.
Measured: 3-months (Time 1)
Rosenberg Self-Esteem Scale (RSE)
This is a 10-item self-report measure of self-esteem. Scores on the RSE range from 10 - 40 with higher scores indicating greater self-esteem.
Measured: 6-months (Time 2)
Quality of Life (QOL)
This is a 17-item self-report measure of quality of life. Scores on the QOL range from 17 - 68 with higher scores indicating greater quality of life.
Measured: Baseline (Time 0)
Quality of Life (QOL)
This is a 17-item self-report measure of quality of life. Scores on the QOL range from 17 - 68 with higher scores indicating greater quality of life.
Measured: 3-months (Time 1)
Quality of Life (QOL)
This is a 17-item self-report measure of quality of life. Scores on the QOL range from 17 - 68 with higher scores indicating greater quality of life.
Measured: 6-months (Time 2)
Employment Motivation/Readiness (EMR)
This is a 7-item self-report measure of motivation to become employed and readiness to engage with an employment service. Scores on the EMR range from 0 - 70 with higher scores indicating greater motivation and readiness to work.
Measured: Baseline (Time 0)
Employment Motivation/Readiness (EMR)
This is a 7-item self-report measure of motivation to become employed and readiness to engage with an employment service. Scores on the EMR range from 0 - 70 with higher scores indicating greater motivation and readiness to work.
Measured: 3-months (Time 1)
Employment Motivation/Readiness (EMR)
This is a 7-item self-report measure of motivation to become employed and readiness to engage with an employment service. Scores on the EMR range from 0 - 70 with higher scores indicating greater motivation and readiness to work.
Measured: 6-months (Time 2)
Internalized Stigma of Mental Illness (ISMI)
This is a 29-item self-report measure of internalized and socialized stigma of mental illness. Scores on the ISMI range from 29 - 116 with higher scores indicating greater perceived stigma.
Measured: Baseline (Time 0)
Internalized Stigma of Mental Illness (ISMI)
This is a 29-item self-report measure of internalized and socialized stigma of mental illness. Scores on the ISMI range from 29 - 116 with higher scores indicating greater perceived stigma.
Measured: 3-months (Time 1)
Internalized Stigma of Mental Illness (ISMI)
This is a 29-item self-report measure of internalized and socialized stigma of mental illness. Scores on the ISMI range from 29 - 116 with higher scores indicating greater perceived stigma.
Measured: 6-months (Time 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Aug 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorders, SevereStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice
- Responsible party
- Sponsor
- Investigators
- Gary S Cuddeback, Ph.D., Principal investigator, Virginia Commonwealth UniversityTonya VanDeinse, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948853
- Sponsor's protocol ID
- 21-0972
- Other IDs
- 2019-MO-BX-0022
- Status last verified
- Nov 2023
- First submitted
- 23 Jun 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In the interest of reinforcing open scientific inquiry, data from this study will be made available by the Principal Investigator (PI) as freely as possible while safeguarding the confidentiality and privacy of participants. A final research data set will be prepared containing de-identified data on the \~130 expected participants. A data-sharing agreement will be required and those seeking data access will be required to obtain ethics approval. Researchers with a convincing scientific interest in the data will be eligible to receive the data. The data-sharing agreement will provide for the use of the data only for research and no other purpose, require a plan for the security of the data, forbid the further dissemination of the data without entering into an agreement, and provide a deadline for the completion of analyses and destruction of the data. Data will be made available under the auspices of the PIs by secure file transfer protocols or other secure, industry-approved means.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Employment Outcomes for Probationers With Mental Illnesses
- ClinicalTrials.gov ID
- NCT04948853
- Acronym / sponsor ID
- 21-0972
- Conditions
- Mental Disorders, Severe
- Keywords
- probation, employment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- U.S. Department of Justice
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 2 Jul 2021 (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.
Employment is a key protective factor against recidivism; however, the lack of job opportunities keeps justice-involved mentally ill individuals, especially young adults of color, unemployed and at risk for future justice involvement. To address these issues and grow the evidence for evidence-based practices for justice-involved adults with mental illnesses, the investigators will study the implementation and outcomes of individual placement support-supported employment (IPS-SE) combined with specialty mental health probation (SMHP) for probationers with mental illnesses.
Detailed description
The large and growing number of individuals with mental illnesses who are on probation have a difficult time accessing housing, employment, and health and mental health care, which is especially concerning for young adults aged 19-25 who make up just 10% of the population but 26% of those on probation. Employment is a key protective factor against recidivism; however, the lack of job opportunities keeps justice-involved mentally ill individuals, especially young adults of color, unemployed and at risk for future justice involvement. Without access to evidence-based supported employment interventions, economic inequality and poverty among justice-involved young adults with mental illnesses will remain unchanged.
To this end, an experienced multidisciplinary team will study the implementation and outcomes of individual placement support-supported employment (IPS-SE) combined with specialty mental health probation (SMHP) for probationers with mental illnesses. The investigators' long-term goal is to develop the evidence for interventions designed to improve employment outcomes among justice-involved individuals who have mental illnesses and conduct translational research with broad application to justice-involved individuals living with mental illnesses. The investigators will pursue the following specific aims:
Aim 1: Examine the barriers and facilitators to implementing IPS-SE in a probation setting. The investigators will use qualitative methods and semi-structured interviews with key stakeholders involved in the implementation of SMHP+IPS-SE to understand how IPS-SE can be embedded successfully in a probation setting.
Aim 2: Conduct a randomized trial to examine the impact of the SMHP+IPS-SE on employment and annual income for probationers with mental illnesses. The investigators will randomly assign 120 individuals to receive SMHP + treatment as usual (TAU) or SMHP+IPS-SE. The research team will test the following hypothesis - H1: SMHP+IPS-SE recipients will be more likely to obtain and sustain employment compared to SMHP+TAU recipients.
The expected outcomes include: (1) an understanding of the implementation barriers and facilitators associated with providing IPS-SE in a probation setting; (2) an understanding of how IPS-SE needs to be adapted for probationers with mental illnesses; and (3) evidence that SMHP+IPS-SE can improve employment outcomes among justice-involved probationers with mental illnesses. This research has the potential to promote the adoption and dissemination of best practices at the interface of the mental health and criminal justice systems and promises to grow the evidence for interventions that improve employment and reduce economic inequalities among a vulnerable population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Treatment as usual, with respect to employment, for individuals on probation typically entails the probation officer informing the probationer that probationer is responsible for obtaining employment or could entail a referral from a probation officer to an employment or job assistance service, such as vocational rehabilitation. The probationer is responsible for follow up with that service. |
| Intervention - Individual Placement Support-Supported Employment | Experimental | Behavioral: Individual Placement Support - Supported EmploymentSubjects in this condition will receive services from a 1.5 FTE IPS-SE team that will work to provide one-on-one person-centered services to help obtain employment, including but not limited to career profiling, resume assistance, job placement, training and other activities. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- on probation and supervised by a SMHP officer;
- aged 18-99;
- interested in obtaining employment; and
- competent to provide informed consent.
Key exclusion criteria (2 listed)
- Does not meet inclusion criteria; and
- Unable/unwilling to provide informed consent
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 |
|---|---|---|
| Individual Placement Support - Supported EmploymentIndividual, person-centered intervention designed to help individuals living with mental illnesses obtain and sustain meaningful employment. This is an evidence-based practice for individuals with severe mental illnesses. | Behavioural | Intervention - Individual Placement Support-Supported Employment |
Primary outcome
Employment, Time 0
Time frame: Baseline (Time 0)
Absence or presence of employment - categorical variable (full-time, part-time, none)
Employment, Time 1
Time frame: 3-months (Time 1)
Absence or presence of employment - categorical variable (full-time, part-time, none)
Employment, Time 2
Time frame: 6-months (Time 2)
Absence or presence of employment - categorical variable (full-time, part-time, none)
Days worked in past 30 days, Time 0
Time frame: Baseline (Time 0)
Number of days worked in last 30 days
Days worked in past 30 days, Time 1
Time frame: 3-months (Time 1)
Number of days worked in last 30 days
Days worked in past 30 days, Time 2
Time frame: 6-months (Time 2)
Number of days worked in last 30 days
18 secondary outcomes
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Time frame: Baseline (Time 0)
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Time frame: 3-months (Time 1)
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Time frame: 6-months (Time 2)
Symptom Checklist (SCL-10-R)
Time frame: Baseline (Time 0)
Symptom Checklist (SCL-10-R)
Time frame: 3-months (Time 1)
Symptom Checklist (SCL-10-R)
Time frame: 6-months (Time 2)
Rosenberg Self-Esteem Scale (RSE)
Time frame: Baseline (Time 0)
Rosenberg Self-Esteem Scale (RSE)
Time frame: 3-months (Time 1)
Rosenberg Self-Esteem Scale (RSE)
Time frame: 6-months (Time 2)
Quality of Life (QOL)
Time frame: Baseline (Time 0)
Quality of Life (QOL)
Time frame: 3-months (Time 1)
Quality of Life (QOL)
Time frame: 6-months (Time 2)
Employment Motivation/Readiness (EMR)
Time frame: Baseline (Time 0)
Employment Motivation/Readiness (EMR)
Time frame: 3-months (Time 1)
Employment Motivation/Readiness (EMR)
Time frame: 6-months (Time 2)
Internalized Stigma of Mental Illness (ISMI)
Time frame: Baseline (Time 0)
Internalized Stigma of Mental Illness (ISMI)
Time frame: 3-months (Time 1)
Internalized Stigma of Mental Illness (ISMI)
Time frame: 6-months (Time 2)
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 1 Dec 2023.
- Individual participant dataSharing planned: Yes. In the interest of reinforcing open scientific inquiry, data from this study will be made available by the Principal Investigator (PI) as freely as possible while safeguarding the confidentiality and privacy of participants. A final research data set will be prepared containing de-identified data on the ~130 expected participants. A data-sharing agreement will be required and those seeking data access will be required to obtain ethics approval. Researchers with a convincing scientific interest in the data will be eligible to receive the data. The data-sharing agreement will provide for the use of the data only for research and no other purpose, require a plan for the security of the data, forbid the further dissemination of the data without entering into an agreement, and provide a deadline for the completion of analyses and destruction of the data. Data will be made available under the auspices of the PIs by secure file transfer protocols or other secure, industry-approved means.
Related trials for Mental Disorders, Severe
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
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.
Gary S Cuddeback, Ph.D. principal investigator
Virginia Commonwealth University
Tonya VanDeinse, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Placement Support - Supported Employment in people with Mental Disorders, Severe, run by University of North Carolina, Chapel Hill 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 2 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 1 Dec 2023. 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?
Employment, Time 0 (time frame: Baseline (Time 0)). The study lists 6 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 1 Dec 2023.