UnemploymentNCT03331354
Assessing the Effect of Distance Learning Vocational Rehabilitation on Employment Outcomes of Veterans With Psychiatric Illness and Histories of Legal Convictions
A study testing Distant vocational learning and Basic vocational services in people with Unemployment and Mental Illness, run by VA Office of Research and Development at 1 site in United States.
Trial summary
64,000 Veterans are released annually from jails and prisons. These Veterans have a weekly unemployment rate of up to 40-55%. However, many are unable to access traditional vocational rehabilitation, not to mention specialized vocational rehabilitation for those with felony histories. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unemployment, Mental Illness, Substance Use Disorder
- What is being tested?
- Distant vocational learning and Basic vocational services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 30 May 2023
- 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
- mental illness or substance use disorder
- history of a felony conviction or non-traffic related misdemeanor
Who cannot join
- cognitive impairment which prohibits active participation in study
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, 75216-7167
About this study
64,000 Veterans are released annually from jails and prisons. These Veterans have a weekly unemployment rate of up to 40-55%. However, many are unable to access traditional vocational rehabilitation, not to mention specialized vocational rehabilitation for those with felony histories. Distance learning may be effective in improving access to rehabilitation as well as improving employment outcomes. The Compass system was developed to incorporate both synchronous and asynchronous distance learning to provide effective services. This study will evaluate 150 Veterans with histories of legal convictions and mental illness and/or a substance use disorder. Veterans will be randomly assigned to either a basic vocational resources condition or the the Compass condition. In the basic condition, Veterans will be provided with basic information about where they can access vocational services and a paper version of a vocational reintegration manual, specifically the About Face Vocational Manual. Veterans assigned to the Compass condition will be given access to the online instruction through Videos, live chat features, and tele-health practice interviews with feedback. Veterans will be followed for 6 months. The primary outcomes are employment and interview skills.
Read the detailed description
At this time, there are over 131,000 Veterans in US prisons and over 50,000 in US jails. When discharged, these Veterans will be forced to cope with high rates of psychosocial and health issues including homelessness, divorce, mental illness, and infectious diseases.
One of the most significant consequences of incarceration is a high rate of unemployment. Evaluations of employment find those with felony histories worked, on average, between 10% and 23% fewer hours than those without felony histories. These negative employment outcomes are caused by a combination of eroded skills, poor social connections, legal restrictions, and stigma.
Though the VA offers a number of vocational rehabilitation and reintegration services, these services are typically not targeted towards Veterans with criminal histories. Also the programs have limitations restricting the range of Veterans that can be served. For example, Veterans living a great distance from a major medical center, rural Veterans, homeless Veterans, and Veterans without transportation may have difficulty accessing services.
To reach the most Veterans, tele-health and distance learning methods must be developed to bring services to the Veterans rather than bring the Veterans to the services. Already well integrated into many educational classrooms, distance learning can be a very effective method of imparting training, skills, and information while mitigating many of the logistical limitations encountered by Veterans with histories of incarceration.
To be successful distance learning should incorporate a number of different best practices. Distance learning should be engaging, avoiding long periods of reading. It should focus on small 'chunks' of information to improve learning and retention. Due to differences in learning, a multiple modality approach is most likely to be successful. Questions, short quizzes, and problem based activities with immediate feedback should be used to keep participants both engaged and to assess progress.
An important aspect to effectively implementing distance learning is to provide blended learning or a hybrid between asynchronous learning, where the participant and teacher are not interacting in real-time, and synchronous learning, where the participant and teacher are interacting directly with each other either in person or across some type of medium. Used effectively, hybrid distance learning can bring a number of positives aspects to the learning environment, including the ability to review information and lessons, practice and role playing, more time to reflect on answers, and less pressure to respond in a group.
Based on effective distance learning principles, the Compass system was developed. Compass builds on a previous pilot online system, the About Face Online System (AFOS), which placed a vocational manual into an online fillable format; however, though Veterans engaged the AFOS, a number of limitations were identified that limited Veterans' enthusiasm, including use of extended reading passages, no direct interaction with a person, and not enough focus on interviews.
Compass uses distance learning best practices including the use of both synchronous and asynchronous learning. The asynchronous components of Compass use video and online content. Veterans are also quizzed at each step of the process on what responses should be given through a multiple choice method. Synchronous components of Compass include tele-health practice interviews, phone coaching sessions, and live-chat features that are used to assist Veterans tailor their information and improving their interview skills.
This study is a four-year project to compare the effectiveness of the Compass system to basic resources. 150 Veterans with legal convictions and mental illness and/or substance use disorders will be followed for six months. Half will receive access to the Compass system and half will receive only basic resources (i.e. a hard copy vocational manual). Outcomes evaluated are employment and interview skills.
The goals of the study are:
- Compare rates of employment of Compass to those receiving basic resources.
- Compare improvements in interviewing skills between those receiving an online program to those receiving basic resources.
Hypotheses/expected results
- Veterans using Compass will have superior rates of employment and improved interviewing skills compared to those receiving basic services.
- Conditions
- Unemployment, Mental Illness, Substance Use Disorder, Legal History
- Being tested
- Distant vocational learning, Basic vocational services
- Keywords
- employment, distance learning, incarceration
- Medical subject headings
- Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distant vocational learningBehavioural
Also called Compass
use of hybrid distance learning to facilitate successful employment outcomes
Basic vocational servicesOther
Also called Basic services
self-help manual
| Study group | Role | What they receive |
|---|---|---|
| Self-help resources | Active comparator | a self-help vocational manual Receives: Other: Basic vocational services |
| Compass | Experimental | a distant learning vocational program Receives: Behavioral: Distant vocational learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Competitive Employment Within Six Months of Random Assignment.
Competitive Employment within 6 months of randomization. Competitive employment is defined as a paid position open to anyone, at least at minimum wage, and not a sheltered work position such as the VA's Compensated Work Therapy program. Additionally, day labor type activities were not counted as success.
Measured: 6 months
Interviewing Skills
Changes in Veterans scores on an interviewing rating form (the Veteran Interview Scale) were compared one month after entry into the study. Scores range from 0 to 30. Higher values are better.
Measured: one month
Secondary outcomes (1)
Change in Job Search Self-Efficacy
Change in job-search efficacy scores were compared between systems at enrollment (point 1) and after 30 days using the systems (point 2). The Job Search Efficacy Scale was used (Cronbach's alpha= .93). Range 10 - 50; higher scores indicate more job search efficacy.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 May 2019
- Primary completion3 Oct 2022
- Study completion30 May 2023
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 UnemploymentStudies 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
- Model description
- Patients will be randomly assigned to either a distance learning program (COMPASS) or basic vocational services.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 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
- NCT03331354
- Sponsor's protocol ID
- D2451-R
- Other IDs
- RX002451
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2017
- Last updated
- 28 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Distance Learning Vocational Rehabilitation on Employment Outcomes of Veterans With Psychiatric Illness and Histories of Legal Convictions
- ClinicalTrials.gov ID
- NCT03331354
- Acronym / sponsor ID
- D2451-R
- Conditions
- Unemployment, Mental Illness, Substance Use Disorder, Legal History
- Keywords
- employment, distance learning, incarceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2019 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
64,000 Veterans are released annually from jails and prisons. These Veterans have a weekly unemployment rate of up to 40-55%. However, many are unable to access traditional vocational rehabilitation, not to mention specialized vocational rehabilitation for those with felony histories. Distance learning may be effective in improving access to rehabilitation as well as improving employment outcomes. The Compass system was developed to incorporate both synchronous and asynchronous distance learning to provide effective services. This study will evaluate 150 Veterans with histories of legal convictions and mental illness and/or a substance use disorder. Veterans will be randomly assigned to either a basic vocational resources condition or the the Compass condition. In the basic condition, Veterans will be provided with basic information about where they can access vocational services and a paper version of a vocational reintegration manual, specifically the About Face Vocational Manual. Veterans assigned to the Compass condition will be given access to the online instruction through Videos, live chat features, and tele-health practice interviews with feedback. Veterans will be followed for 6 months. The primary outcomes are employment and interview skills.
Detailed description
At this time, there are over 131,000 Veterans in US prisons and over 50,000 in US jails. When discharged, these Veterans will be forced to cope with high rates of psychosocial and health issues including homelessness, divorce, mental illness, and infectious diseases.
One of the most significant consequences of incarceration is a high rate of unemployment. Evaluations of employment find those with felony histories worked, on average, between 10% and 23% fewer hours than those without felony histories. These negative employment outcomes are caused by a combination of eroded skills, poor social connections, legal restrictions, and stigma.
Though the VA offers a number of vocational rehabilitation and reintegration services, these services are typically not targeted towards Veterans with criminal histories. Also the programs have limitations restricting the range of Veterans that can be served. For example, Veterans living a great distance from a major medical center, rural Veterans, homeless Veterans, and Veterans without transportation may have difficulty accessing services.
To reach the most Veterans, tele-health and distance learning methods must be developed to bring services to the Veterans rather than bring the Veterans to the services. Already well integrated into many educational classrooms, distance learning can be a very effective method of imparting training, skills, and information while mitigating many of the logistical limitations encountered by Veterans with histories of incarceration.
To be successful distance learning should incorporate a number of different best practices. Distance learning should be engaging, avoiding long periods of reading. It should focus on small 'chunks' of information to improve learning and retention. Due to differences in learning, a multiple modality approach is most likely to be successful. Questions, short quizzes, and problem based activities with immediate feedback should be used to keep participants both engaged and to assess progress.
An important aspect to effectively implementing distance learning is to provide blended learning or a hybrid between asynchronous learning, where the participant and teacher are not interacting in real-time, and synchronous learning, where the participant and teacher are interacting directly with each other either in person or across some type of medium. Used effectively, hybrid distance learning can bring a number of positives aspects to the learning environment, including the ability to review information and lessons, practice and role playing, more time to reflect on answers, and less pressure to respond in a group.
Based on effective distance learning principles, the Compass system was developed. Compass builds on a previous pilot online system, the About Face Online System (AFOS), which placed a vocational manual into an online fillable format; however, though Veterans engaged the AFOS, a number of limitations were identified that limited Veterans' enthusiasm, including use of extended reading passages, no direct interaction with a person, and not enough focus on interviews.
Compass uses distance learning best practices including the use of both synchronous and asynchronous learning. The asynchronous components of Compass use video and online content. Veterans are also quizzed at each step of the process on what responses should be given through a multiple choice method. Synchronous components of Compass include tele-health practice interviews, phone coaching sessions, and live-chat features that are used to assist Veterans tailor their information and improving their interview skills.
This study is a four-year project to compare the effectiveness of the Compass system to basic resources. 150 Veterans with legal convictions and mental illness and/or substance use disorders will be followed for six months. Half will receive access to the Compass system and half will receive only basic resources (i.e. a hard copy vocational manual). Outcomes evaluated are employment and interview skills.
The goals of the study are:
- Compare rates of employment of Compass to those receiving basic resources.
- Compare improvements in interviewing skills between those receiving an online program to those receiving basic resources.
Hypotheses/expected results
- Veterans using Compass will have superior rates of employment and improved interviewing skills compared to those receiving basic services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to either a distance learning program (COMPASS) or basic vocational services.
| Arm | Type | Receives |
|---|---|---|
| Self-help resources | Active comparator | Other: Basic vocational servicesa self-help vocational manual |
| Compass | Experimental | Behavioral: Distant vocational learninga distant learning vocational program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mental illness or substance use disorder
- history of a felony conviction or non-traffic related misdemeanor
Key exclusion criteria (1 listed)
- cognitive impairment which prohibits active participation in study
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 |
|---|---|---|
| Distant vocational learningAlso: Compassuse of hybrid distance learning to facilitate successful employment outcomes | Behavioural | Compass |
| Basic vocational servicesAlso: Basic servicesself-help manual | Other | Self-help resources |
Primary outcome
Competitive Employment Within Six Months of Random Assignment.
Time frame: 6 months
Competitive Employment within 6 months of randomization. Competitive employment is defined as a paid position open to anyone, at least at minimum wage, and not a sheltered work position such as the VA's Compensated Work Therapy program. Additionally, day labor type activities were not counted as success.
Interviewing Skills
Time frame: one month
Changes in Veterans scores on an interviewing rating form (the Veteran Interview Scale) were compared one month after entry into the study. Scores range from 0 to 30. Higher values are better.
1 secondary outcome
Change in Job Search Self-Efficacy
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- 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 Distant vocational learning and Basic vocational services in people with Unemployment and 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 2 inclusion and 1 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 28 Jun 2024. 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 28 Jun 2024). 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?
Competitive Employment Within Six Months of Random Assignment. (time frame: 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?
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 28 Jun 2024.