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Autism Spectrum DisorderNCT04001790

Effect of a 9-Month Internship Intervention for Military Dependents With ASD

A study testing Project Search plus ASD Supports in people with Autism Spectrum Disorder, run by Virginia Commonwealth University 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

The aims of the project are: 1. VCU will modify the Project SEARCH Plus ASD Model to meet the needs of military dependents with ASD. 2. VCU will implement the intervention based upon the Project SEARCH plus ASD Supports manual and will measure fidelity of implementation. 3. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
11 May 2017to 19 May 2021
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 to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Has an ASD
  • Between 18 - 21 years old
  • Seeking community based employment upon graduation from high school
  • Attends participating school
  • Eligible for funding through the Virginia Department of Aging and Vocational Rehabilitation
  • Has personal independence
  • Is able to pass a drug screen and felony record check and immunizations up-to-date for employment purposes
  • Is military dependent or connected

Who cannot join

  • Unable to provide consent or assent
  • Does not meet inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Virginia Commonwealth University

    Richmond, Virginia, 23284

Other trials in United States

About this study

The aims of the project are: 1. VCU will modify the Project SEARCH Plus ASD Model to meet the needs of military dependents with ASD. 2. VCU will implement the intervention based upon the Project SEARCH plus ASD Supports manual and will measure fidelity of implementation. 3. VCU will measure the impact of the intervention on the social communication, behavioral adjustment and employment outcomes of the military dependents who participate compared to an equal control group who do not receive the intervention. Aim 1 is accomplished, and Aims 2 and 3 have been implemented. The Project SEARCH program is currently in its second year at the 773rd Mission Support Group, Joint Base Langley Eustis, Fort Eustis site. Additionally, all recruitment activities were completed for the second cohort of the project, with a total of 14 treatment group participants and 21 control group participants across the two cohorts thus far. In addition, all collaborating agencies have signed the memorandum of understanding. The relocation and deployment plan is currently is being piloted.

Read the detailed description

Background: Young people with ASD present unique challenges related to post school employment outcomes. Competitive employment rates for individuals with ASD, regardless of intellectual ability, reportedly range between 4.1 to 11.8%. Across the ability spectrum, individuals with ASD have lower rates of participation in vocational or technical education, employment, and post-secondary education in 2 or 4-year programs than their peers with other disabilities. The findings from this literature indicate individuals with ASD continue to have significant challenges in all environments related to social interaction and communication into adolescence and adulthood. Military offspring present a particular risk for poor outcomes due to the mobile nature of their parents' jobs. This greatly impacts the individual with ASD who may not be able to access programs to assist them in the transition to employment as well as their parents who may not be able to take advantage of promotions that involve moving.

Objective/Hypothesis: The objective of this proposed project is to study the impact of Project SEARCH plus ASD Supports (PS-ASD) on the social communication, behavioral, and employment outcomes of military dependents with ASD across three vocational domains (employment status, wage, number of hours worked per week) and three personal domains (social responsiveness, mental health, and quality of life).

The six hypotheses driving this project propose that Young adults who participate in an employer-based employment training and placement program will: demonstrate a higher rate of employment, work more hours, and earn a higher wage than those in the control condition. Additionally, young adults who participate in a work-based employment training and placement program will increase their social responsiveness, display lower anxiety and depression scores, and report higher quality of life scores than those in the control condition.

Specific Aims: Aim 1. VCU will modify the Project SEARCH Plus ASD Model to meet the needs of military dependents with ASD.

Aim 2. VCU will implement the intervention based upon the Project SEARCH plus ASD Supports manual and will measure fidelity of implementation.

Aim 3. VCU will measure the impact of the intervention on the social communication, behavioral adjustment and employment outcomes of the military dependents who participate compared to an equal control group who do not receive the intervention.

Study Design: This is a randomized, wait-list controlled study of the efficacy of the Project Search plus ASD Supports Model (PS-ASD) in 32 adolescents and young adults aged 18 to 21 with autism spectrum disorder. Approximately 32 subjects will be enrolled and randomized in a 1:1 ratio to treatment or wait-list control groups. A sufficient number of potential subjects will be screened to achieve this number of enrolled subjects.

Clinical Impact: The PS-ASD model provides an option for youth with ASD who seek employment upon graduation from high school by providing high numbers of trials of vocational, social communication, and self-management skills using applied behavior analysis in the settings where those skills will be used. Immersion in a 9-month internship program via PS+ASD appears to improve self-management, independence, social responsiveness, work skills, and quality of life but further research like the proposed project is required to observe the impact of this model for military dependents with ASD. This proposed project will assist professionals and military personnel in identifying viable treatment models for military dependents in transition to adulthood. This is a critical need for this population of youth who frequently do not receive such intensive transition services.

Being tested
Project Search plus ASD Supports
Keywords
Autism Spectrum Disorder, Transition to Employment, Employment, Project Search Plus ASD Supports
Medical subject headings
Autism Spectrum 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

    Nine month job training program embedded on Fort Eustis military base.

Study groups in NCT04001790
Study groupRoleWhat they receive
Project Search + ASD SupportsExperimentalProject 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 where they rotate through three 10-12 week internships within the business learning marketable skills, social communication, and adaptive behavior in the business setting. In order to meet the unique needs of youth with ASD, Wehman, et al. (2014) enhanced the Project SEARCH model by adding autism supports to the original model. Those added supports were: 1) on-site, intensive, systematic instruction using the principles of applied behavior analysis, 2) on-site support and consultation from a behavior/autism specialist, and 3) intensive staff training in ASD and the Project SEARCH Model.
Receives: Behavioral: Project Search plus ASD Supports
Business as UsualNo interventionBusiness as Usual means these youth remain in their high school programs as determined on their individualized education plans

What is being measured

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

  1. Change in Competitive Integrated Employment Rates

    Increase in number of participants engaged in Full or part time work for minimum wage or higher with the same wages and benefits accorded to non-disabled workers in the same position and fully integrated with co-workers and customers without disabilities.accorded to non-disabled workers in the same position and fully integrated with co-workers and customers without disabilities.

    Measured: baseline to 18 months

Timeline

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

  1. First posted28 Jun 2019
  2. Study start11 May 2017
  3. Primary completion19 May 2021
  4. Study completion19 May 2021

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
This is a randomized, wait-list controlled study of the efficacy of the Project Search plus ASD Supports Model (PS-ASD) in 32 adolescents and young adults aged 18 to 21 with autism spectrum disorder. Approximately 32 subjects will be enrolled and randomized in a 1:1 ratio to treatment or wait-list control groups.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04001790
Sponsor's protocol ID
HM20008778
Other IDs
CDMRP AR150172
Status last verified
Oct 2024
First submitted
20 Jun 2019
Last updated
9 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: VCU will share de-identified data with the National Database for Autism Research (NDAR) after reviewing and receiving informed consent with participants. VCU will only share data if participants consent. VCU will not share any data that will reveal participant identity. VCU will assign a random number to all data that is different than any other number or code associated with data shared. Participants can refuse permission to share their data and continue to be in the study. Participants can also change their mind about sharing data at any point until the investigators close the study with our VCU Institutional Review Board.

Publications

  • Whittenburg HN, Schall CM, Wehman P, McDonough J, DuBois T. Helping High School-Aged Military Dependents With Autism Gain Employment Through Project SEARCH + ASD Supports. Mil Med. 2020 Jan 7;185(Suppl 1):663-668. doi: 10.1093/milmed/usz224.

    PubMed 31498390

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 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 8 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 9 Dec 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 9 Dec 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?

Change in Competitive Integrated Employment Rates (time frame: baseline to 18 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 NCT04001790, which also lists 1 linked publication.

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 9 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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