- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04948853
Improving Employment Outcomes for Probationers With Mental Illnesses
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gary S Cuddeback, Ph.D.
- Phone Number: 919-260-9913
- Email: gcuddeba@email.unc.edu
Study Contact Backup
- Name: Tonya VanDeinse, PhD
- Phone Number: 919-962-6428
- Email: tbv@email.unc.edu
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria include:
- on probation and supervised by a SMHP officer;
- aged 18-99;
- interested in obtaining employment; and
- competent to provide informed consent.
Exclusion criteria:
- Does not meet inclusion criteria; and
- Unable/unwilling to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment as usual
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.
|
|
Experimental: Intervention - Individual Placement Support-Supported Employment
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Employment, Time 0
Time Frame: Baseline (Time 0)
|
Absence or presence of employment - categorical variable (full-time, part-time, none)
|
Baseline (Time 0)
|
Employment, Time 1
Time Frame: 3-months (Time 1)
|
Absence or presence of employment - categorical variable (full-time, part-time, none)
|
3-months (Time 1)
|
Employment, Time 2
Time Frame: 6-months (Time 2)
|
Absence or presence of employment - categorical variable (full-time, part-time, none)
|
6-months (Time 2)
|
Days worked in past 30 days, Time 0
Time Frame: Baseline (Time 0)
|
Number of days worked in last 30 days
|
Baseline (Time 0)
|
Days worked in past 30 days, Time 1
Time Frame: 3-months (Time 1)
|
Number of days worked in last 30 days
|
3-months (Time 1)
|
Days worked in past 30 days, Time 2
Time Frame: 6-months (Time 2)
|
Number of days worked in last 30 days
|
6-months (Time 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Time Frame: Baseline (Time 0)
|
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.
|
Baseline (Time 0)
|
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Time Frame: 3-months (Time 1)
|
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.
|
3-months (Time 1)
|
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Time Frame: 6-months (Time 2)
|
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.
|
6-months (Time 2)
|
Symptom Checklist (SCL-10-R)
Time Frame: Baseline (Time 0)
|
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.
|
Baseline (Time 0)
|
Symptom Checklist (SCL-10-R)
Time Frame: 3-months (Time 1)
|
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.
|
3-months (Time 1)
|
Symptom Checklist (SCL-10-R)
Time Frame: 6-months (Time 2)
|
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.
|
6-months (Time 2)
|
Rosenberg Self-Esteem Scale (RSE)
Time Frame: Baseline (Time 0)
|
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.
|
Baseline (Time 0)
|
Rosenberg Self-Esteem Scale (RSE)
Time Frame: 3-months (Time 1)
|
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.
|
3-months (Time 1)
|
Rosenberg Self-Esteem Scale (RSE)
Time Frame: 6-months (Time 2)
|
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.
|
6-months (Time 2)
|
Quality of Life (QOL)
Time Frame: Baseline (Time 0)
|
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.
|
Baseline (Time 0)
|
Quality of Life (QOL)
Time Frame: 3-months (Time 1)
|
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.
|
3-months (Time 1)
|
Quality of Life (QOL)
Time Frame: 6-months (Time 2)
|
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.
|
6-months (Time 2)
|
Employment Motivation/Readiness (EMR)
Time Frame: Baseline (Time 0)
|
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.
|
Baseline (Time 0)
|
Employment Motivation/Readiness (EMR)
Time Frame: 3-months (Time 1)
|
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.
|
3-months (Time 1)
|
Employment Motivation/Readiness (EMR)
Time Frame: 6-months (Time 2)
|
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.
|
6-months (Time 2)
|
Internalized Stigma of Mental Illness (ISMI)
Time Frame: Baseline (Time 0)
|
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.
|
Baseline (Time 0)
|
Internalized Stigma of Mental Illness (ISMI)
Time Frame: 3-months (Time 1)
|
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.
|
3-months (Time 1)
|
Internalized Stigma of Mental Illness (ISMI)
Time Frame: 6-months (Time 2)
|
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.
|
6-months (Time 2)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Gary S Cuddeback, Ph.D., Virginia Commonwealth University
- Principal Investigator: Tonya VanDeinse, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-0972
- 2019-MO-BX-0022 (Other Grant/Funding Number: Department of Justice)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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