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.
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
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 group | Role | What they receive |
|---|---|---|
| Basic Vocational Services | Other | Veteran receives basic vocational services Receives: Other: Basic Vocational Services |
| Self-Study | Active comparator | Veteran participates in self-study vocational program Receives: Other: Self-Study |
| Group program | Active comparator | Group based vocational program Receives: Other: Group Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Till Employment in Days
Number of days until first day of competitive employment
Measured: 12 months
Secondary outcomes (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.
- First posted1 Apr 2008 (estimated)
- Study start1 Jun 2009
- Primary completion1 Oct 2014
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James P. LePage, PhD, Principal investigator, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18712647LePage 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 21480102LePage 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Vocational Materials for Incarcerated Veterans With Mental Illness
- ClinicalTrials.gov ID
- NCT00648115
- Acronym / sponsor ID
- D6192-R
- Conditions
- Mental Illness
- Keywords
- Veterans, Substance-Related Disorders, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2009 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Posted 30 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basic Vocational Services | Other | Other: Basic Vocational ServicesVeteran receives basic vocational services |
| Self-Study | Active comparator | Other: Self-StudyVeteran participates in self-study vocational program |
| Group program | Active comparator | Other: Group ProgramGroup based vocational program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Vocational ServicesVocational services | Other | Basic Vocational Services |
| Self-StudyVeteran receives self-study resources | Other | Self-Study |
| Group ProgramVeteran participates in group vocational program | Other | Group program |
Primary outcome
Time Till Employment in Days
Time frame: 12 months
Number of days until first day of competitive employment
1 secondary outcome
Test Economic Impact Between Manual Conditions (e.g., Cost-benefit Ratio)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18712647Garcia-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.
- Results publication: PubMed 21480102LePage 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.
- Results publication: PubMed 23760999LePage 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P. LePage, PhD principal investigator
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
1 site in 1 country: see every site and its status.
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.