Autism Spectrum DisorderProjSEARCH1NCT02360332
A Collaborative Public/Private Employment Training and Placement Model ASD Transition Age Youth With Autism Spectrum Disorder (ASD)
A study testing Project SEARCH plus ASD Supports in people with Autism Spectrum Disorder, run by Virginia Commonwealth University.
Trial summary
The aim of the research project is to conduct evidence-based research on a nationally known vocational rehabilitation (VR) service model (Project Search) for individuals with Autism Spectrum Disorders (ASD). Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Project SEARCH plus ASD Supports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a student in the local public school where the research was being conducted,
- Having an ASD medical diagnosis and/or educational eligibility,
- Displaying independent self-care,
- Being able to provide consent or assent,
- Having funding for supported employment through VR, and
- Having continued eligibility for public school educational services in the coming school year.
Who cannot join
- Life threatening or dangerously severe aggressive or destructive behavior
- History of fire setting
- History of substance abuse
About this study
Official title: A Collaborative Public/Private Employment Training and Placement Model for Transition Age Youth With Autism Spectrum Disorder (ASD)
The aim of the research project is to conduct evidence-based research on a nationally known vocational rehabilitation (VR) service model (Project Search) for individuals with Autism Spectrum Disorders (ASD). This information may be useful to high schools and vocational rehabilitation agencies that endeavor to use evidence based practices to serve individuals with ASD.
Read the detailed description
Autism is recognized to be a "complex disorder" as well as "a spectrum of disorders" that includes Asperger's syndrome and pervasive developmental disorder- not otherwise specified. Diagnostic criteria for autism focus on impairments affecting socialization, verbal and nonverbal communication, and restricted and repetitive patterns of behavior. The number of high school students diagnosed with autism, for example, has been increasing over time with almost 194,000 students ages 6 through 21 nationwide identified as having autism and receive special education services under the Individuals with Disabilities Education Act (IDEA). These young people create a significant need for vocational rehabilitation intervention in the decade ahead. Currently many persons with ASD continue to be. Howlin, et al. (2004) described the outcomes for 68 young adults with ASD (mean age 29), and found that a third worked and almost half were unemployed. RSA notes that in 2005 fewer than 2000 individuals with ASD received VR services. In Virginia the figure is only 255 total clients enrolled from between 2000 and 2007.
In this project the investigators will conduct a randomized clinical trial which examines the impact of intensive community-based work experiences on the employment outcomes of youth with ASD. This study will test the efficacy of a nationally recognized model of an employer based employment training and placement program (Project SEARCH) for youth with ASD. Four dependent measures will be investigated: (1) employment status upon completion of the program, at 90 days post completion and 12 months post completion (primary), (2) wage upon completion, at 90 days post completion, and 12 months post completion (secondary), (3) number of hours worked per week (secondary) upon completion, at 90 days post completion and 12 months post completion. Three specific hypotheses are proposed, and (4) intensity of supports needed at work at completion, at 90 days post completion and 12 months post completion.
Hypothesis I: Individuals who participate in an employer based employment training and placement program will demonstrate a higher rate of employment than those in the control condition.
Hypothesis II: Individuals who participate in an employer based employment training and placement program will earn higher wages on average at project completion compared to those in the control condition.
Hypothesis III: Individuals who participate in an employer based employment training and placement program will work more hours per week on average than those in the control condition.
Hypothesis IV: Individuals who participate in an employer based employment training and placement program will require less intensive work support than those in the control condition.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Project SEARCH plus ASD Supports
- Keywords
- Autism, transition to adulthood, employment, High School Seniors
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project SEARCH plus ASD SupportsBehavioural
Also called PS-ASD
Project SEARCH program (Rutkowski, Daston, Kuiken, and Riehle, 2006) is a work based learning model for high school transition that was developed at Cincinnati Children's Hospital Medical Center. The model provides complete immersion in the workplace. Students spend their entire school day at the workplace for a full school year. Consistent with principles of work based learning, Project SEARCH facilitates the development of a broad range of high-quality jobs within the employer organization and provides over 700 of supervised work experience. The model also relies on the intensive application of supported employments strategies (task analysis and customization, systematic instruction, ongoing support, etc.) to allow the participation of individuals with extensive support needs.
| Study group | Role | What they receive |
|---|---|---|
| PS-ASD | Experimental | Treatment Condition, participants assigned to this condition will receive the treatment, one school year (9 months) of Project SEARCH plus ASD Supports Receives: Behavioral: Project SEARCH plus ASD Supports |
| High School As Usual | No intervention | Control Condition, Participants assigned to this condition will have no interaction or intervention with the research team with the exception of data collection at the specified time points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Employment Status across 3 points in time (Employed or not employed)
Are subjects currently employed?
Measured: 9 months, 12 months, 21 months
Secondary outcomes (3)
Change in Hours worked weekly across 3 points in time
How many hours do subjects work weekly
Measured: 9 months, 12 months, 21 months
Change in Hourly wage earned across 3 points in time
How much money do subjects earn hourly
Measured: 9 months, 12 months, 21 months
Change in Intensity of work support required across 3 points in time
What type and how much do support do subjects require at work?
Measured: 9 months, 12 months, 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startOct 2009
- Primary completionSep 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Henrico County Public Schools, Virginia Department of Aging and Rehabilitative Services, Chesterfield County Public Schools
- Responsible party
- Sponsor
- Investigators
- Paul Wehman, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360332
- Sponsor's protocol ID
- NIDDRDRRP09-13
- Acronym
- ProjSEARCH1
- Status last verified
- Feb 2015
- First submitted
- 15 Jan 2015
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schall, C. M. (2010). Positive behavior support: Supporting adults with autism spectrum disorders in the workplace. Journal of Vocational Rehabilitation, 32, 109-115.
Schall, C. M. & McDonough, J. T. (2010). Autism Spectrum Disorders in Adolescence and Early Adulthood: Characteristics and Issues. Journal of Vocational Rehabilitation, 32, 81-88.
Schall C, Wehman P, McDonough JL. Transition from school to work for students with autism spectrum disorders: understanding the process and achieving better outcomes. Pediatr Clin North Am. 2012 Feb;59(1):189-202, xii. doi: 10.1016/j.pcl.2011.10.009.
PubMed 22284802Wehman, P., Schall, C., McDonough, J., Molinelli, A., Riehle, E., Ham, W., & Thiss, W. (2014). Project SEARCH for youth with autism spectrum disorders: Increasing competitive employment on transition from high school. Journal of Positive Behavior Intervention, 15, 144-155.
Wehman, P., Schall, C., Carr, S., Targett, P., West, M., & Cifu, G., (2014). Transition from school to adulthood for youth with ASD: What we know and what we need to know. Journal of Disability Policy Studies, 25, 30-40; DOI: 10.1177/1044207313518071.
Wehman PH, Schall CM, McDonough J, Kregel J, Brooke V, Molinelli A, Ham W, Graham CW, Erin Riehle J, Collins HT, Thiss W. Competitive employment for youth with autism spectrum disorders: early results from a randomized clinical trial. J Autism Dev Disord. 2014 Mar;44(3):487-500. doi: 10.1007/s10803-013-1892-x.
PubMed 23893098Ham, W., McDonough, J., Molinelli, A., Schall, C., & Wehman, P. (2014). Employment Supports for Young Adults with ASD: Two Case Studies. Journal of Vocational Rehabilitation. DOI: 10.3233/JVR-140677.
Wehman P, Schall CM, McDonough J, Graham C, Brooke V, Riehle JE, Brooke A, Ham W, Lau S, Allen J, Avellone L. Effects of an employer-based intervention on employment outcomes for youth with significant support needs due to autism. Autism. 2017 Apr;21(3):276-290. doi: 10.1177/1362361316635826. Epub 2016 Jul 9.
PubMed 27154907
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Public/Private Employment Training and Placement Model for Transition Age Youth With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT02360332
- Acronym / sponsor ID
- ProjSEARCH1 / NIDDRDRRP09-13
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, transition to adulthood, employment, High School Seniors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Henrico County Public Schools, Virginia Department of Aging and Rehabilitative Services, Chesterfield County Public Schools
- Study start
- Oct 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the research project is to conduct evidence-based research on a nationally known vocational rehabilitation (VR) service model (Project Search) for individuals with Autism Spectrum Disorders (ASD). This information may be useful to high schools and vocational rehabilitation agencies that endeavor to use evidence based practices to serve individuals with ASD.
Detailed description
Autism is recognized to be a "complex disorder" as well as "a spectrum of disorders" that includes Asperger's syndrome and pervasive developmental disorder- not otherwise specified. Diagnostic criteria for autism focus on impairments affecting socialization, verbal and nonverbal communication, and restricted and repetitive patterns of behavior. The number of high school students diagnosed with autism, for example, has been increasing over time with almost 194,000 students ages 6 through 21 nationwide identified as having autism and receive special education services under the Individuals with Disabilities Education Act (IDEA). These young people create a significant need for vocational rehabilitation intervention in the decade ahead. Currently many persons with ASD continue to be. Howlin, et al. (2004) described the outcomes for 68 young adults with ASD (mean age 29), and found that a third worked and almost half were unemployed. RSA notes that in 2005 fewer than 2000 individuals with ASD received VR services. In Virginia the figure is only 255 total clients enrolled from between 2000 and 2007.
In this project the investigators will conduct a randomized clinical trial which examines the impact of intensive community-based work experiences on the employment outcomes of youth with ASD. This study will test the efficacy of a nationally recognized model of an employer based employment training and placement program (Project SEARCH) for youth with ASD. Four dependent measures will be investigated: (1) employment status upon completion of the program, at 90 days post completion and 12 months post completion (primary), (2) wage upon completion, at 90 days post completion, and 12 months post completion (secondary), (3) number of hours worked per week (secondary) upon completion, at 90 days post completion and 12 months post completion. Three specific hypotheses are proposed, and (4) intensity of supports needed at work at completion, at 90 days post completion and 12 months post completion.
Hypothesis I: Individuals who participate in an employer based employment training and placement program will demonstrate a higher rate of employment than those in the control condition.
Hypothesis II: Individuals who participate in an employer based employment training and placement program will earn higher wages on average at project completion compared to those in the control condition.
Hypothesis III: Individuals who participate in an employer based employment training and placement program will work more hours per week on average than those in the control condition.
Hypothesis IV: Individuals who participate in an employer based employment training and placement program will require less intensive work support than those in the control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS-ASD | Experimental | Behavioral: Project SEARCH plus ASD SupportsTreatment Condition, participants assigned to this condition will receive the treatment, one school year (9 months) of Project SEARCH plus ASD Supports |
| High School As Usual | No intervention | –Control Condition, Participants assigned to this condition will have no interaction or intervention with the research team with the exception of data collection at the specified time points. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being a student in the local public school where the research was being conducted,
- Having an ASD medical diagnosis and/or educational eligibility,
- Displaying independent self-care,
- Being able to provide consent or assent,
- Having funding for supported employment through VR, and
Key exclusion criteria (3 listed)
- Life threatening or dangerously severe aggressive or destructive behavior
- History of fire setting
- History of substance abuse
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 |
|---|---|---|
| Project SEARCH plus ASD SupportsAlso: PS-ASDProject SEARCH program (Rutkowski, Daston, Kuiken, and Riehle, 2006) is a work based learning model for high school transition that was developed at Cincinnati Children's Hospital Medical Center. The model provides complete immersion in the workplace. Students spend their entire school day at the workplace for a full school year. Consistent with principles of work based learning, Project SEARCH facilitates the development of a broad range of high-quality jobs within the employer organization and provides over 700 of supervised work experience. The model also relies on the intensive application of supported employments strategies (task analysis and customization, systematic instruction, ongoing support, etc.) to allow the participation of individuals with extensive support needs. | Behavioural | PS-ASD |
Primary outcome
Change in Employment Status across 3 points in time (Employed or not employed)
Time frame: 9 months, 12 months, 21 months
Are subjects currently employed?
3 secondary outcomes
Change in Hours worked weekly across 3 points in time
Time frame: 9 months, 12 months, 21 months
Change in Hourly wage earned across 3 points in time
Time frame: 9 months, 12 months, 21 months
Change in Intensity of work support required across 3 points in time
Time frame: 9 months, 12 months, 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- BackgroundSchall, C. M. (2010). Positive behavior support: Supporting adults with autism spectrum disorders in the workplace. Journal of Vocational Rehabilitation, 32, 109-115.
- BackgroundSchall, C. M. & McDonough, J. T. (2010). Autism Spectrum Disorders in Adolescence and Early Adulthood: Characteristics and Issues. Journal of Vocational Rehabilitation, 32, 81-88.
- Background: PubMed 22284802Schall C, Wehman P, McDonough JL. Transition from school to work for students with autism spectrum disorders: understanding the process and achieving better outcomes. Pediatr Clin North Am. 2012 Feb;59(1):189-202, xii. doi: 10.1016/j.pcl.2011.10.009.
- BackgroundWehman, P., Schall, C., McDonough, J., Molinelli, A., Riehle, E., Ham, W., & Thiss, W. (2014). Project SEARCH for youth with autism spectrum disorders: Increasing competitive employment on transition from high school. Journal of Positive Behavior Intervention, 15, 144-155.
- BackgroundWehman, P., Schall, C., Carr, S., Targett, P., West, M., & Cifu, G., (2014). Transition from school to adulthood for youth with ASD: What we know and what we need to know. Journal of Disability Policy Studies, 25, 30-40; DOI: 10.1177/1044207313518071.
- Background: PubMed 23893098Wehman PH, Schall CM, McDonough J, Kregel J, Brooke V, Molinelli A, Ham W, Graham CW, Erin Riehle J, Collins HT, Thiss W. Competitive employment for youth with autism spectrum disorders: early results from a randomized clinical trial. J Autism Dev Disord. 2014 Mar;44(3):487-500. doi: 10.1007/s10803-013-1892-x.
- BackgroundHam, W., McDonough, J., Molinelli, A., Schall, C., & Wehman, P. (2014). Employment Supports for Young Adults with ASD: Two Case Studies. Journal of Vocational Rehabilitation. DOI: 10.3233/JVR-140677.
- Derived from this study: PubMed 27154907Wehman P, Schall CM, McDonough J, Graham C, Brooke V, Riehle JE, Brooke A, Ham W, Lau S, Allen J, Avellone L. Effects of an employer-based intervention on employment outcomes for youth with significant support needs due to autism. Autism. 2017 Apr;21(3):276-290. doi: 10.1177/1362361316635826. Epub 2016 Jul 9.
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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.
Paul Wehman, PhD principal investigator
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
A study testing Project SEARCH plus ASD Supports in people with Autism Spectrum Disorder, run by Virginia Commonwealth University.
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 6 inclusion and 3 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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Employment Status across 3 points in time (Employed or not employed) (time frame: 9 months, 12 months, 21 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 NCT02360332, which also lists 8 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 10 Feb 2015.