NCT04948853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

June 23, 2021

Last Update Submit

November 30, 2023

Conditions

Keywords

probationemployment

Outcome Measures

Primary Outcomes (6)

  • Employment, Time 0

    Absence or presence of employment - categorical variable (full-time, part-time, none)

    Baseline (Time 0)

  • Employment, Time 1

    Absence or presence of employment - categorical variable (full-time, part-time, none)

    3-months (Time 1)

  • Employment, 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

    Number of days worked in last 30 days

    Baseline (Time 0)

  • Days worked in past 30 days, Time 1

    Number of days worked in last 30 days

    3-months (Time 1)

  • Days worked in past 30 days, Time 2

    Number of days worked in last 30 days

    6-months (Time 2)

Secondary Outcomes (18)

  • Duke-UNC Functional Social Support Questionnaire (FSSQ)

    Baseline (Time 0)

  • Duke-UNC Functional Social Support Questionnaire (FSSQ)

    3-months (Time 1)

  • Duke-UNC Functional Social Support Questionnaire (FSSQ)

    6-months (Time 2)

  • Symptom Checklist (SCL-10-R)

    Baseline (Time 0)

  • Symptom Checklist (SCL-10-R)

    3-months (Time 1)

  • +13 more secondary outcomes

Study Arms (2)

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.

Behavioral: Individual Placement Support - Supported Employment

Interventions

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.

Intervention - Individual Placement Support-Supported Employment

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • on probation and supervised by a SMHP officer;
  • aged 18-99;
  • interested in obtaining employment; and
  • competent to provide informed consent.

You may not qualify if:

  • Unable/unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Gary S Cuddeback, Ph.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR
  • Tonya VanDeinse, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

July 2, 2021

Study Start

August 1, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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.

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.
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.

Locations