Clinical trial NCT03560453: Facilitating Employment for Youth With Autism
Official title: Facilitating Employment for Youth With Autism: A Replication Study of an Internship Model to Identify Evidence Based Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Asperger Syndrome
Pervasive Developmental Disorder
Adolescent Development
Keywords: Autism
ASD
Competitive Integrated Employment
Project SEARCH
Outcomes
Support Intensity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2018-06-18
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

Brief 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 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?

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.

Eligibility criteria: Inclusion Criteria: (1) student in a local public school where the research was being conducted, (2) had a medical diagnosis of ASD or educational identification of autism, (3) was between the ages of 18-21 on the first day of the next school year, (4) displayed independent self-care, including using the bathroom, eating, and moving from place to place independently (5) had eligibility for funding through the state vocational rehabilitation agency, and (6) had continued eligibility for public school services -

Exclusion Criteria: Unable to provide consent or assent

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Primary outcomes:
measure: Change in Employment Outcomes Survey from Graduation to 12 months follow-up
timeFrame: Graduation and 12 month follow-up
Secondary outcomes:
measure: Change in the Support Intensity Scale (SIS; Thompson, et al., 2004) from Graduation to 12 months follow-up
timeFrame: Baseline, Graduation and 12 month follow-up
measure: Change in Social Responsiveness Scale, Second Edition (Constantino & Gruber, 2012) from Graduation to 12 months follow-up
timeFrame: Baseline, Graduation, and 12 month follow-up
measure: Change in The ARC's Self-Determination Scale (Wehmeyer, 1996) from from Graduation to 12 months follow-up
timeFrame: Baseline, Graduation, and 12 month follow-up
measure: Change in The Short Form 36 Version 2 (SF-36v2, Maurish & Turner-Bowker, 2009) from from Graduation to 12 months follow-up
timeFrame: Baseline, Graduation, and 12 month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Carol M Schall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.