Evaluating Vocational Materials for Incarcerated Veterans With Mental Illness or Substance Abuse

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00648115
• Collaborator: (none)
• Enrollment: 111
• Location: 1
• Arms: 3
• Actual Duration (Months): 99.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this research is to test the usefulness of a vocational rehabilitation program for veterans with a history of felonies who also have a mental illness or have substance dependency.

Condition or Disease	Intervention/Treatment	Phase
Mental Illness	Other: Basic Vocational Services; Other: Self-Study; Other: Group Program	N/A

Detailed Description

The Department of Justice's Bureau of Justice Statistics (BOJS, 2000) reported in 2000 over 225,000 veterans were incarcerated in the nations' criminal facilities; 1 in 5 of these veterans saw combat during service. Approximately 78,000 veterans annually will be released from incarceration with 30% of those released from incarceration are re-arrested within 3 months, 44.1% re-arrested at one year, and 67.5% within 3 years. These numbers are higher with those with serious mental illnesses: 54.3% re-arrest rates at one year and 72% at 3 years.

The living status that many of these veterans with felonies return to is dire. In a survey of dually diagnosed and mentally ill offenders, 22% of mentally ill offenders and 43% of mentally ill offenders with substance addiction believed they would be homeless upon release. Ex-felons often return to more disadvantaged communities where employment is scarce (La Vigne, Mamalian, Travis, & Visher, 2003). Employers are reluctant to hire those with a history of incarceration due to biases against ex-offenders or due to legal liability (Connerley, Arvey, & Bernardy, 2001) or other biases (Holzer, 1996). Overall, employers have been shown to be less likely to hire ex-convicts than those with little work experience or those who are receiving welfare benefits (Holtzer, 1996).

The goal of this study is to identify successful vocational re-integration modalities for mental health and/or substance dependent veterans recently released from incarceration and those with felony histories. Specific Goals are 1) test time to employment between manual conditions; 2) test total time employed over the 12 months following training period; and 3) test economic impact between manual conditions The study will be a controlled 3 group randomized design. The independent variable will be the amount of vocational services received. Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) self-study of the manualized program; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.

Three primary dependent variables will be used. The first is the time till employment. The second is the total time employed during the 12 months following training. The third will be the economic impact of the training through differences in services required (e.g. emergency room visits, food stamps, cost of shelters, costs of rearrests) and income earned. Type of job skills, job history, and time incarcerated are some of the variables that potentially will be statistically controlled.

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluating Vocational Materials for Incarcerated Veterans With Mental Illness
• Actual Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Sep 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Basic Vocational Services Veteran receives basic vocational services	Other: Basic Vocational Services; Vocational services
Active Comparator: Self-Study Veteran participates in self-study vocational program	Other: Self-Study; Veteran receives self-study resources
Active Comparator: Group program Group based vocational program	Other: Group Program; Veteran participates in group vocational program

Outcome Measures

Primary Outcome Measures

1. Time Till Employment in Days [12 months]

   Number of days until first day of competitive employment

Secondary Outcome Measures

1. Test Economic Impact Between Manual Conditions (e.g., Cost-benefit Ratio) [12 months]

   overall economic impact, in dollars, will be evaluated by the following formula: income - healthcare cost - cost of incarceration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• underemployed or unemployed

• has a mental health or substance dependence diagnosis

• desires to enter the workforce through competitive employment.

• History of at least one felony conviction

Emphasis will be placed on returning OEF/OIF veterans, combat veterans, and women veterans. Veterans entering the study can be recruited regardless of living situation.

Exclusion Criteria:

• pursuing disability benefits due to unemployability

• diagnosis of dementia or evidence of severe cognitive impairment

• impaired reality testing due to psychosis

• actively suicidal or homicidal.

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

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

• Garcia-Rea E, LePage JP. Reliability and validity of World Health Organization Quality of Life-100 in homeless substance-dependent veteran population. J Rehabil Res Dev. 2008;45(4):619-25.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00648115
• Other Study ID Numbers: D6192-R; 08-004
• First Posted: Apr 1, 2008
• Last Update Posted: Dec 18, 2017
• Last Verified: Nov 1, 2017

• 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
• Keywords provided by VA Office of Research and Development: Veterans; Substance-Related Disorders; Mental Health
• Additional relevant MeSH terms: Mental Disorders

Study Results

Participant Flow

Recruitment Details	Veterans recruited throughout medical center
Pre-assignment Detail	Veterans must have completed a one week follow-up after enrollment to be randomized and included in the analyses.

Arm/Group Title	Basic Vocational Services	Self-Study	Group Program
Arm/Group Description	Basic vocational services but no manualized vocational program	Self-study of vocational materials comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.	a full program consisting of the manualized program with vocational staff and peer vocational support specialists comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.
Period Title: Overall Study
STARTED	42	42	27
COMPLETED	42	42	27
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Basic Vocational Services	Self-Study	Group Program	Total
Arm/Group Description	Basic vocational services but no manualized vocational program	Self-study of vocational materials comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.	a full program consisting of the manualized program with vocational staff and peer vocational support specialists comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.	Total of all reporting groups
Overall Participants	42	42	27	111
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.4 (4.7)	50.4 (4.5)	51.2 (5.3)	51.0 (4.7)
Sex: Female, Male (Count of Participants)
Female	1 2.4%	0 0%	2 7.4%	3 2.7%
Male	41 97.6%	42 100%	25 92.6%	108 97.3%
Race/Ethnicity, Customized (participants) [Number]
Racial/Ethnic Minority	39 92.9%	38 90.5%	24 88.9%	101 91%
White/Non-Minority	3 7.1%	4 9.5%	3 11.1%	10 9%
Region of Enrollment (participants) [Number]
United States	42 100%	42 100%	27 100%	111 100%

Outcome Measures

1. Primary Outcome

Title	Time Till Employment in Days
Description	Number of days until first day of competitive employment
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basic Vocational Services	Self-Study	Group Program
Arm/Group Description	Basic vocational services but no manualized vocational program	Self-study of vocational materials comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.	a full program consisting of the manualized program with vocational staff and peer vocational support specialists comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.
Measure Participants	42	42	27
Mean (95% Confidence Interval) [number of days to first employment]	308	301	214

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Basic Vocational Services, Self-Study, Group Program
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Pearson chi square
	Estimated Value	7.3
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Test Economic Impact Between Manual Conditions (e.g., Cost-benefit Ratio)
Description	overall economic impact, in dollars, will be evaluated by the following formula: income - healthcare cost - cost of incarceration
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Basic Vocational Services	Self-Study	Group Program
Arm/Group Description	Basic vocational services but no manualized vocational program	Self-study of vocational materials comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.	a full program consisting of the manualized program with vocational staff and peer vocational support specialists comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.
Measure Participants	42	42	27
Mean (Standard Deviation) [dollars]	944 (3548)	304 (1549)	4698 (11620)

Adverse Events

Arm/Group Title	Arm 1		Arm 2		Arm 3
Arm/Group Description	Basic vocational services but no manualized vocational program		Self-study of vocational materials comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.		a full program consisting of the manualized program with vocational staff and peer vocational support specialists comparison of vocational programs: Veterans will be randomly assigned to one of three conditions: 1) Basic vocational services but no manualized vocational program; 2) a self-study of the manualized program materials; and 3) a full program consisting of the manualized program with vocational staff and peer vocational support specialists. All veterans enrolled in the study will have access to a Veteran's Employment Resource Center to provide infrastructure for job search.
All Cause Mortality
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/42 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/42 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

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.