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Autism Spectrum DisorderNCT03560453

Facilitating Employment for Youth With Autism

A study testing Project SEARCH Plus ASD Supports in people with Autism Spectrum Disorder and Autism, run by Virginia Commonwealth University.

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

This study will test the efficacy of a nationally recognized employment training and placement program (Project SEARCH) when applied to youth with Autism Spectrum Disorders. It is designed to examine a single overall research question: Research Question: To what extent does a collaborative, employer-based employment… Read more about this study

Who is it for?
Ages 18 to 22 yearsHealthy volunteers can take part
What is being tested?
Project SEARCH Plus ASD Supports
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
No sites listed yet
Study dates
1 Aug 2013to 15 Mar 2018
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 22 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

None listed.

Who cannot join

  • -

About this study

Official title: Facilitating Employment for Youth With Autism: A Replication Study of an Internship Model to Identify Evidence Based Practices

This study will test the efficacy of a nationally recognized employment training and placement program (Project SEARCH) when applied to youth with Autism Spectrum Disorders. It is designed to examine a single overall research question:

Research Question: To what extent does a collaborative, employer-based employment training and placement program improve the employment outcomes, need for support, social responsiveness, self-determination, and quality of life of young adults with ASD 18-21 served in public special education programs?

Read the detailed description

In this project, the investigators propose testing the efficacy of the Project SEARCH model that has been successfully implemented for youth with ASD at one site in a 300-bed hospital in Richmond, VA. The investigators will accomplish this by continuing the Project SEARCH study that has been implemented for youth with ASD and expanding this model to two additional sites in Virginia. The investigators also propose expanding the current randomized clinical trial protocol to the two new sites. In doing so, the investigators will be able to further develop the model while also assessing the strength of the relationship between the intervention and outcomes achieved. Additionally, the investigators will identify programmatic and individual factors that affect successful employment outcomes as well as other critical behaviors that are essential for youth with ASD to exhibit such as socialization, communication, independence and self management. Finally, through the proposed project the investigators will be able to provide evidence to guide decisions related to fidelity of implementation of the components necessary to replicate Project SEARCH for youth with ASD.

Hypotheses: There are one primary and six secondary endpoints under investigation in the proposed study: (1) Employment status upon completion of the program, 90 days post completion, and 12 months post completion (primary); (2) wage upon completion, 90 days post completion, and 12 months post completion; and (3) number of hours worked per week upon completion, 90 days post completion, and 12 months post completion. In addition, the effect of the intervention on (4) student support needs, (5) social responsiveness, and (6) self-determination will be explored. Hypotheses related to these endpoints, or dependent variables, include:

  • Hypothesis I -- Young adults 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 -- Young adults who participate in a work-based employment training and placement program will earn higher wages on average at project completion compared to those in the control condition.
  • Hypothesis III -- Young adults who participate in a work-based employment training and placement program will work more hours per week on average than those in the control condition.
  • Hypothesis IV -- Young adults who participate in a work-based employment training and placement program will reduce their need for employment supports compared to those in the control condition, as measured by the Employment Subscale of the Support Intensity Scale.
  • Hypothesis V -- Young adults who participate in a work-based employment training and placement program will increase their social responsiveness skills compared to those in the control condition, as measured by the Social Responsive Scale (SRS-2).
  • Hypothesis VI -- Young adults who participate in a work based employment training and placement program will increase their self-determination skills compared to those in the control condition, as measured by the Arc's Self-Determination Scale (Adolescent Version).
  • Hypothesis VII - Young adults who participate in a work based employment training and placement program will increase their quality of life compared to those in the control condition, as measured by the Quality Metrics Health Outcomes SF-36v2.
Being tested
Project SEARCH Plus ASD Supports
Keywords
Autism, ASD, Competitive Integrated Employment, Project SEARCH, Outcomes, Support Intensity
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome, Child Development Disorders, Pervasive

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 is an intensive 9-month job training program where youth with developmental disabilities in their last year of high school are embedded in a large community business such as a hospital, government complex, or banking center (Daston et al., 2012). Students with developmental disabilities who participate in this model rotate through three 10-12 week internships within the business where they log approximately 720 hours of internship time learning marketable skills while receiving supported employment. They also get 180 hours of classroom time at the business for a total of approximately 900 hours embedded in the business setting. In addition to these important training components, Project SEARCH requires collaboration between multiple community partners to support students in attaining employment upon completion of the program. Collaborations include students with developmental disabilities and their family, a LEA, a local CRP, the state VR, and a host business.

Study groups in NCT03560453
Study groupRoleWhat they receive
ControlNo interventionAttend assigned high school for 9 months
Project SEARCH plus ASD SupportsExperimentalAttend Project SEARCH plus ASD Supports for 9 months
Receives: Behavioral: Project SEARCH Plus ASD Supports

What is being measured

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

  1. Change in Employment Outcomes Survey from Graduation to 12 months follow-up

    Employment status (Employed Full-Time, Employed Part-Time, Not Employed/Looking for Employment, and Not Employed/Not Looking for Employment) will be measured at the point of graduation and 12 months follow-up. At these data collection points we will also collect information on hourly wage, changes in hourly wage, hours worked per week (or per month if the individual works a variable schedule), and fringe benefits received, including annual or sick leave, medical/dental benefits, retirement benefits, life insurance, and health and wellness. This is a researcher developed survey

    Measured: Graduation and 12 month follow-up

Secondary outcomes (4)

  1. Change in the Support Intensity Scale (SIS; Thompson, et al., 2004) from Graduation to 12 months follow-up

    The Supports Intensity Scale (SIS, Thompson, et al., 2004) is an interview based assessment tool that identifies the type, amount, and frequency of support required by individuals with significant disabilities, including persons with autism, to perform 57 life activities. An additional 28 items address behavioral and medical areas. The assessment is completed through an interview with the individual, as well as family, school, and community members with in-depth knowledge of the individual. The assessment generates a composite scale score and individual scale scores in the areas of home living, community living, lifelong learning, employment, health and safety, and social areas. The Composite Scale Score and the Employment Subscale Score will be used as dependent measures. Scores are presented as t-scores and are compared to a normed population of individuals with disabilities.

    Measured: Baseline, Graduation and 12 month follow-up

  2. Change in Social Responsiveness Scale, Second Edition (Constantino & Gruber, 2012) from Graduation to 12 months follow-up

    The Social Responsiveness Scale, Second Edition (SRS-2), (Constantino \& Gruber, 2012) will be used to measure the effect of the treatment intervention in comparison to the control condition on subject's social awareness, social cognition, social communication and social motivation. It will be used at all four points of data collection to measure changes that occur in the individual's ability in social interactions and verbal discussions in social situations. The SRS-2 is a 65-item scale that has been used as a measure of treatment effectiveness in recent studies (Booker \& Starling, 2011; Aldridge, Gibbs, Schmidhofer, \& Williams, 2012; Gantman, Knapp, Orenski \& Laugeson, 2012). Scores are presented as t-scores and are compared to a normed population of individuals with ASD.

    Measured: Baseline, Graduation, and 12 month follow-up

  3. Change in The ARC's Self-Determination Scale (Wehmeyer, 1996) from from Graduation to 12 months follow-up

    The Arc's Self-Determination Scale (Wehmeyer, 1996b; Wehmeyer \& Kelchner, 1995) is a 72-item self-report scale that provides data on overall self-determination by measuring individual performance in the four essential characteristics of self-determined actions including autonomy, self-regulation, psychological empowerment, and self-realization. These four characteristics are subscales within the Scale. The Scale generates a total Self-Determination score as well as scores for the four subtests. The total score on the Scale will serve as a dependent measure for the proposed study. Scores are presented as t-scores and are compared to a normed population of people with and without disabilities.

    Measured: Baseline, Graduation, and 12 month follow-up

  4. Change in The Short Form 36 Version 2 (SF-36v2, Maurish & Turner-Bowker, 2009) from from Graduation to 12 months follow-up

    The SF-36v2 Health Survey is a 36 item questionnaire used to measure eight domains of health-related quality of life including Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. The information obtained from these eight health domains are further aggregated into two summary measured: the physical component summary, and the mental component summary. Data from the survey will be used to compare health outcomes between the two groups health status. It will be used in this study to measure health outcomes between the treatment and control group. Scores are presented as t-scores and are compared to a normed population of people without disabilities.

    Measured: Baseline, Graduation, and 12 month follow-up

Timeline

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

  1. First posted18 Jun 2018
  2. Study start1 Aug 2013
  3. Primary completion15 Mar 2018
  4. Study completion15 Mar 2018

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
Model description
Non-pharmacologic randomized clinical trial and followed the Non-pharmacological Consolidated Standards of Reporting Trials Statement recommendations to conduct the research (CONSORT; Boutron, Altman, Moher, Schulz, \& Ravaud, 2017)
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03560453
Sponsor's protocol ID
HM15031
Other IDs
NIDILRRDRRP13-16
Status last verified
Apr 2023
First submitted
6 Jun 2018
Last updated
3 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wehman P, Schall C, Carr S, Targett P, West M, Cifu G. Transition from school to adulthood for youth with ASD: what we know and what we need to know. J Disabil Policy Stud. 2014;25:30-40. doi:10.1177/1044207313518071.

  • 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 22284802

  • 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 23893098

  • Schall CM, Wehman P, Brooke V, Graham C, McDonough J, Brooke A, Ham W, Rounds R, Lau S, Allen J. Employment Interventions for Individuals with ASD: The Relative Efficacy of Supported Employment With or Without Prior Project SEARCH Training. J Autism Dev Disord. 2015 Dec;45(12):3990-4001. doi: 10.1007/s10803-015-2426-5.

    PubMed 25791125

  • 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

  • Schall C, Sima AP, Avellone L, Wehman P, McDonough J, Brown A. The Effect of Business Internships Model and Employment on Enhancing the Independence of Young Adults With Significant Impact From Autism. Intellect Dev Disabil. 2020 Aug 1;58(4):301-313. doi: 10.1352/1934-9556-58.4.301.

    PubMed 32750714

  • Wehman P, Schall C, McDonough J, Sima A, Brooke A, Ham W, Whittenburg H, Brooke V, Avellone L, Riehle E. Competitive Employment for Transition-Aged Youth with Significant Impact from Autism: A Multi-site Randomized Clinical Trial. J Autism Dev Disord. 2020 Jun;50(6):1882-1897. doi: 10.1007/s10803-019-03940-2.

    PubMed 30825082

Questions about this trial

What is this clinical trial studying?

A study testing Project SEARCH Plus ASD Supports in people with Autism Spectrum Disorder and Autism, 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 0 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 3 May 2023. 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 Outcomes Survey from Graduation to 12 months follow-up (time frame: Graduation and 12 month follow-up). 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 NCT03560453, which also lists 7 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 3 May 2023.

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