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Mental IllnessNCT00648115

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

A study testing Basic Vocational Services, Self-Study and Group Program in people with Mental Illness, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mental Illness
What is being tested?
Basic Vocational Services, Self-Study and Group Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteUnited States
Study dates
1 Jun 2009to 29 Sep 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216

Other trials in United States

About this study

Official title: Evaluating Vocational Materials for Incarcerated Veterans With Mental Illness

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.

Read the 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.

Conditions
Mental Illness
Being tested
Basic Vocational Services, Self-Study, Group Program
Keywords
Veterans, Substance-Related Disorders, Mental Health
Medical subject headings
Mental Disorders, Substance-Related Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Basic Vocational ServicesOther

    Vocational services

  • Self-StudyOther

    Veteran receives self-study resources

  • Group ProgramOther

    Veteran participates in group vocational program

Study groups in NCT00648115
Study groupRoleWhat they receive
Basic Vocational ServicesOtherVeteran receives basic vocational services
Receives: Other: Basic Vocational Services
Self-StudyActive comparatorVeteran participates in self-study vocational program
Receives: Other: Self-Study
Group programActive comparatorGroup based vocational program
Receives: Other: Group Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time Till Employment in Days

    Number of days until first day of competitive employment

    Measured: 12 months

Secondary outcomes (1)
  1. Test Economic Impact Between Manual Conditions (e.g., Cost-benefit Ratio)

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2008 (estimated)
  2. Study start1 Jun 2009
  3. Primary completion1 Oct 2014
  4. Study completion29 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00648115
Sponsor's protocol ID
D6192-R
Other IDs
08-004
Status last verified
Nov 2017
First submitted
27 Mar 2008
Last updated
18 Dec 2017
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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. doi: 10.1682/jrrd.2007.03.0048.

    PubMed 18712647
  • LePage JP, Washington EL, Lewis AA, Johnson KE, Garcia-Rea EA. Effects of structured vocational services on job-search success in ex-offender veterans with mental illness: 3-month follow-up. J Rehabil Res Dev. 2011;48(3):277-86. doi: 10.1682/jrrd.2010.03.0032.

    PubMed 21480102
  • LePage JP, Lewis AA, Washington EL, Davis B, Glasgow A. Effects of structured vocational services in ex-offender veterans with mental illness: 6-month follow-up. J Rehabil Res Dev. 2013;50(2):183-92. doi: 10.1682/jrrd.2011.09.0163.

    PubMed 23760999

Questions about this trial

What is this clinical trial studying?

A study testing Basic Vocational Services, Self-Study and Group Program in people with Mental Illness, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Till Employment in Days (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00648115, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.

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