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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04948853
Other study ID # 21-0972
Secondary ID 2019-MO-BX-0022
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date July 31, 2023

Study information

Verified date November 2023
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Individual Placement Support - Supported Employment
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.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill U.S. Department of Justice

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Employment, Time 0 Absence or presence of employment - categorical variable (full-time, part-time, none) Baseline (Time 0)
Primary Employment, Time 1 Absence or presence of employment - categorical variable (full-time, part-time, none) 3-months (Time 1)
Primary Employment, Time 2 Absence or presence of employment - categorical variable (full-time, part-time, none) 6-months (Time 2)
Primary Days worked in past 30 days, Time 0 Number of days worked in last 30 days Baseline (Time 0)
Primary Days worked in past 30 days, Time 1 Number of days worked in last 30 days 3-months (Time 1)
Primary Days worked in past 30 days, Time 2 Number of days worked in last 30 days 6-months (Time 2)
Secondary 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. Baseline (Time 0)
Secondary 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. 3-months (Time 1)
Secondary 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. 6-months (Time 2)
Secondary 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. Baseline (Time 0)
Secondary 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. 3-months (Time 1)
Secondary 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. 6-months (Time 2)
Secondary 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. Baseline (Time 0)
Secondary 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. 3-months (Time 1)
Secondary 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. 6-months (Time 2)
Secondary 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. Baseline (Time 0)
Secondary 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. 3-months (Time 1)
Secondary 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. 6-months (Time 2)
Secondary 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. Baseline (Time 0)
Secondary 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. 3-months (Time 1)
Secondary 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. 6-months (Time 2)
Secondary 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. Baseline (Time 0)
Secondary 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. 3-months (Time 1)
Secondary 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. 6-months (Time 2)
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