Assessing Supported Employment With Veterans With Felony Convictions and Mental Illness or Substance Abuse

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01629953
• Collaborator: North Texas Veterans Healthcare System (U.S. Fed)
• Enrollment: 140
• Location: 1
• Arms: 2
• Actual Duration (Months): 90
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

This study continues to develop and refine best practices in the delivery of vocational services to veterans with histories of felony convictions and mental health/substance abuse difficulties. There are currently over 225,000 incarcerated veterans and it is estimated 64,000 veterans are released from prisons annually. These veterans encounter significant difficulties in finding employment due to stigma, intrapersonal difficulties, and out-dated work skills. Additionally these veterans are more likely to be homeless than other population., Previous work has found that manual based, vocational groups led by trained vocational staff led to quicker employment compared to traditional vocational services and manual based self studies. To attempt to improve on previous results, this study adds principles and components of supported employment including ongoing follow-up, treatment team coordination, and community based assistance.

Condition or Disease	Intervention/Treatment	Phase
Employment	Other: Group vocational intervention; Other: Supported Employment Condition	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessing Supported Employment With Veterans With Felony Convictions and MI or SA
• Actual Study Start Date: Oct 31, 2011
• Actual Primary Completion Date: Oct 31, 2016
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group Based Vocational Rehabilitation Group vocational intervention	Other: Group vocational intervention; Group based manualized vocational rehabilitation
Experimental: Supported Employment Condition Group vocational intervention + supported employment	Other: Supported Employment Condition; Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention

Outcome Measures

Primary Outcome Measures

1. Employment [within 6 months]

   Number of veterans finding work within 6 months

2. Total Employment [1 years]

   Total amount employed over 1 year follow-up period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• history of at least one felony conviction

• diagnosis of a mental illness including substance use disorders

Exclusion Criteria:

• dementia

• active psychosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas	United States	75216

Sponsors and Collaborators

• VA Office of Research and Development
• North Texas Veterans Healthcare System

Investigators

• Principal Investigator: James P. LePage, PhD, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01629953
• Other Study ID Numbers: D7635-R
• First Posted: Jun 28, 2012
• Last Update Posted: Jun 17, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	Group Based Vocational Rehabilitation	Supported Employment Condition
Arm/Group Description	Group vocational intervention Group vocational intervention: Group based manualized vocational rehabilitation	Group vocational intervention + supported employment Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention
Period Title: Overall Study
STARTED	65	75
COMPLETED	52	60
NOT COMPLETED	13	15

Baseline Characteristics

Arm/Group Title	Group Based Vocational Rehabilitation	Supported Employment Condition	Total
Arm/Group Description	Group vocational intervention Group vocational intervention: Group based manualized vocational rehabilitation	Group vocational intervention + supported employment Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention	Total of all reporting groups
Overall Participants	52	60	112
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	51 98.1%	60 100%	111 99.1%
>=65 years	1 1.9%	0 0%	1 0.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.1 (5.4)	51.5 (5.8)	52.2 (5.7)
Sex: Female, Male (Count of Participants)
Female	0 0%	1 1.7%	1 0.9%
Male	52 100%	59 98.3%	111 99.1%
Race/Ethnicity, Customized (Count of Participants)
racial or ethnic minority	39 75%	43 71.7%	82 73.2%
Region of Enrollment (participants) [Number]
United States	52 100%	60 100%	112 100%

Outcome Measures

1. Primary Outcome

Title	Employment
Description	Number of veterans finding work within 6 months
Time Frame	within 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Based Vocational Rehabilitation	Supported Employment Condition
Arm/Group Description	Group vocational intervention Group vocational intervention: Group based manualized vocational rehabilitation	Group vocational intervention + supported employment Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention
Measure Participants	38	46
Count of Participants [Participants]	8 15.4%	21 35%

2. Primary Outcome

Title	Total Employment
Description	Total amount employed over 1 year follow-up period
Time Frame	1 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group Based Vocational Rehabilitation	Supported Employment Condition
Arm/Group Description	Group vocational intervention Group vocational intervention: Group based manualized vocational rehabilitation	Group vocational intervention + supported employment Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention
Measure Participants	52	60
Count of Participants [Participants]	19 36.5%	34 56.7%

Adverse Events

Time Frame	1 year
Arm/Group Title	Group Based Vocational Rehabilitation		Supported Employment Condition
Arm/Group Description	Group vocational intervention Group vocational intervention: Group based manualized vocational rehabilitation		Group vocational intervention + supported employment Supported Employment Condition: Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention
All Cause Mortality
	Group Based Vocational Rehabilitation		Supported Employment Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/52 (1.9%)		5/60 (8.3%)
Serious Adverse Events
	Group Based Vocational Rehabilitation		Supported Employment Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Group Based Vocational Rehabilitation		Supported Employment Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/60 (0%)

Limitations/Caveats

Continual follow-up was difficult and though all 112 had post data recorded, not all Veterans had monthly updates. This may have led to some loss of specific start dates for employment.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.