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Improving Employment Outcomes for Probationers With Mental Illnesses

Primary Purpose

Mental Disorders, Severe

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individual Placement Support - Supported Employment
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorders, Severe focused on measuring probation, employment

Eligibility Criteria

19 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual

Intervention - Individual Placement Support-Supported Employment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Employment, Time 0
Absence or presence of employment - categorical variable (full-time, part-time, none)
Employment, Time 1
Absence or presence of employment - categorical variable (full-time, part-time, none)
Employment, Time 2
Absence or presence of employment - categorical variable (full-time, part-time, none)
Days worked in past 30 days, Time 0
Number of days worked in last 30 days
Days worked in past 30 days, Time 1
Number of days worked in last 30 days
Days worked in past 30 days, Time 2
Number of days worked in last 30 days

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 23, 2021
Last Updated
May 15, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
U.S. Department of Justice
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1. Study Identification

Unique Protocol Identification Number
NCT04948853
Brief Title
Improving Employment Outcomes for Probationers With Mental Illnesses
Official Title
Improving Employment Outcomes for Probationers With Mental Illnesses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
U.S. Department of Justice

4. Oversight

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

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Severe
Keywords
probation, employment

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention - Individual Placement Support-Supported Employment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual Placement Support - Supported Employment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Employment, Time 0
Description
Absence or presence of employment - categorical variable (full-time, part-time, none)
Time Frame
Baseline (Time 0)
Title
Employment, Time 1
Description
Absence or presence of employment - categorical variable (full-time, part-time, none)
Time Frame
3-months (Time 1)
Title
Employment, Time 2
Description
Absence or presence of employment - categorical variable (full-time, part-time, none)
Time Frame
6-months (Time 2)
Title
Days worked in past 30 days, Time 0
Description
Number of days worked in last 30 days
Time Frame
Baseline (Time 0)
Title
Days worked in past 30 days, Time 1
Description
Number of days worked in last 30 days
Time Frame
3-months (Time 1)
Title
Days worked in past 30 days, Time 2
Description
Number of days worked in last 30 days
Time Frame
6-months (Time 2)
Secondary Outcome Measure Information:
Title
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Description
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.
Time Frame
Baseline (Time 0)
Title
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Description
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.
Time Frame
3-months (Time 1)
Title
Duke-UNC Functional Social Support Questionnaire (FSSQ)
Description
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.
Time Frame
6-months (Time 2)
Title
Symptom Checklist (SCL-10-R)
Description
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.
Time Frame
Baseline (Time 0)
Title
Symptom Checklist (SCL-10-R)
Description
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.
Time Frame
3-months (Time 1)
Title
Symptom Checklist (SCL-10-R)
Description
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.
Time Frame
6-months (Time 2)
Title
Rosenberg Self-Esteem Scale (RSE)
Description
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.
Time Frame
Baseline (Time 0)
Title
Rosenberg Self-Esteem Scale (RSE)
Description
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.
Time Frame
3-months (Time 1)
Title
Rosenberg Self-Esteem Scale (RSE)
Description
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.
Time Frame
6-months (Time 2)
Title
Quality of Life (QOL)
Description
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.
Time Frame
Baseline (Time 0)
Title
Quality of Life (QOL)
Description
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.
Time Frame
3-months (Time 1)
Title
Quality of Life (QOL)
Description
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.
Time Frame
6-months (Time 2)
Title
Employment Motivation/Readiness (EMR)
Description
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.
Time Frame
Baseline (Time 0)
Title
Employment Motivation/Readiness (EMR)
Description
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.
Time Frame
3-months (Time 1)
Title
Employment Motivation/Readiness (EMR)
Description
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.
Time Frame
6-months (Time 2)
Title
Internalized Stigma of Mental Illness (ISMI)
Description
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.
Time Frame
Baseline (Time 0)
Title
Internalized Stigma of Mental Illness (ISMI)
Description
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.
Time Frame
3-months (Time 1)
Title
Internalized Stigma of Mental Illness (ISMI)
Description
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.
Time Frame
6-months (Time 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary S Cuddeback, Ph.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tonya VanDeinse, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will become available 24 calendar months after completion of the study. The data will be available for up to 5 years.
IPD Sharing Access Criteria
Upon request for the data to be shared and evidence of ethics approval, a data-sharing agreement will be required. Researchers with a convincing scientific interest in the data will be eligible to receive the data, without regard for the type of research question.

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Improving Employment Outcomes for Probationers With Mental Illnesses

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