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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Autism Spectrum Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Project Search + ASD Supports | Experimental | 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 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 Usual | No intervention | Business 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.
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.
- First posted28 Jun 2019
- Study start11 May 2017
- Primary completion19 May 2021
- Study completion19 May 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Paul Wehman, PhD, Principal investigator, Virginia Commonwealth UniversityCarol M Schall, PhD, Study director, Virginia Commonwealth University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a 9-Month Internship Intervention for Military Dependents With ASD
- ClinicalTrials.gov ID
- NCT04001790
- Acronym / sponsor ID
- HM20008778
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Transition to Employment, Employment, Project Search Plus ASD Supports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 11 May 2017 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Project Search + ASD Supports | Experimental | Behavioral: Project Search plus ASD SupportsProject 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. |
| Business as Usual | No intervention | –Business as Usual means these youth remain in their high school programs as determined on their individualized education plans |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to provide consent or assent
- Does not meet inclusion criteria
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+ASDNine month job training program embedded on Fort Eustis military base. | Behavioural | Project Search + ASD Supports |
Primary outcome
Change in Competitive Integrated Employment Rates
Time frame: baseline to 18 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31498390Whittenburg 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.
- website describing projectLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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
Carol M Schall, PhD study director
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
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.