EmploymentNCT01629953

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

A study testing Group vocational intervention and Supported Employment Condition in people with Employment, 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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Employment
What is being tested?: Group vocational intervention and Supported Employment Condition
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2011to 1 May 2019
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

history of at least one felony conviction
diagnosis of a mental illness including substance use disorders

Who cannot join

dementia
active psychosis

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: Assessing Supported Employment With Veterans With Felony Convictions and MI or SA

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.

Conditions: Employment
Being tested: Group vocational intervention, Supported Employment Condition

What participants receive

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

Group vocational interventionOther
Group based manualized vocational rehabilitation
Supported Employment ConditionOther
Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention

Study groups in NCT01629953
Study group	Role	What they receive
Group Based Vocational Rehabilitation	Active comparator	Group vocational intervention Receives: Other: Group vocational intervention
Supported Employment Condition	Experimental	Group vocational intervention + supported employment Receives: Other: Supported Employment Condition

What is being measured

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

Employment
Number of veterans finding work within 6 months
Measured: within 6 months
Total Employment
Total amount employed over 1 year follow-up period
Measured: 1 years

Timeline

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

31 Oct 20111 May 2019

First posted28 Jun 2012 (estimated)
Study start31 Oct 2011
Primary completion31 Oct 2016
Study completion1 May 2019

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.
Other trials for EmploymentStudies 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: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01629953
Sponsor's protocol ID: D7635-R
Status last verified: Jun 2019
First submitted: 26 Jun 2012
Last updated: 17 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Employment trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing Supported Employment With Veterans With Felony Convictions and MI or SA
ClinicalTrials.gov ID: NCT01629953
Acronym / sponsor ID: D7635-R
Conditions: Employment
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: North Texas Veterans Healthcare System
Study start: 31 Oct 2011 (actual)
Primary completion: 31 Oct 2016 (actual)
Study completion: 1 May 2019 (actual)
First posted: 28 Jun 2012 (estimated)
Results: Posted 22 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group Based Vocational Rehabilitation	Active comparator	Other: Group vocational interventionGroup vocational intervention
Supported Employment Condition	Experimental	Other: Supported Employment ConditionGroup vocational intervention + supported employment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

history of at least one felony conviction
diagnosis of a mental illness including substance use disorders

Key exclusion criteria (2 listed)

dementia
active psychosis

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
Group vocational interventionGroup based manualized vocational rehabilitation	Other	Group Based Vocational Rehabilitation
Supported Employment ConditionVeterans in this condition will receive a proven group based manualized vocational rehabilitation intervention	Other	Supported Employment Condition

Primary outcome

Employment
Time frame: within 6 months
Number of veterans finding work within 6 months
Total Employment
Time frame: 1 years
Total amount employed over 1 year follow-up period

Results and safety

Results posted to the registry on 22 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group Based Vocational Rehabilitation	65	52
Supported Employment Condition	75	60

Primary outcome: Employment

Time frame: within 6 months. Count of participants. Unit: Participants

Measure	Group Based Vocational Rehabilitation n = 38	Supported Employment Condition n = 46
Value	8	21

Primary outcome: Total Employment

Time frame: 1 years. Count of participants. Unit: Participants

Measure	Group Based Vocational Rehabilitation n = 52	Supported Employment Condition n = 60
Value	19	34

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group Based Vocational Rehabilitation	0 of 52 (0%)	0 of 52 (0%)	1 of 52
Supported Employment Condition	0 of 60 (0%)	0 of 60 (0%)	5 of 60

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Group vocational intervention and Supported Employment Condition in people with Employment, 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 2 inclusion and 2 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 17 Jun 2019. 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 22 May 2018). 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?

Employment (time frame: within 6 months). The study lists 2 primary outcomes in all. 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 NCT01629953.

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 17 Jun 2019.