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

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ClinicalTrials.gov Identifier: NCT04001790
Recruitment Status : Active, not recruiting
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Project Search plus ASD Supports Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Effect of a 9-Month Internship Intervention for Military Dependents With ASD
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Project Search + ASD Supports
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.
Behavioral: Project Search plus ASD Supports
Nine month job training program embedded on Fort Eustis military base.
Other Name: PS+ASD

No Intervention: Business as Usual
Business as Usual means these youth remain in their high school programs as determined on their individualized education plans



Primary Outcome Measures :
  1. 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.

  2. Change in Number of hours worked [ Time Frame: baseline to 18 months ]
    Increase in hours/week employee is engaged in paid employment

  3. Change in hourly Wage earned [ Time Frame: baseline to 18 months ]
    Increase in hourly wage paid to employee for work performed for employer


Secondary Outcome Measures :
  1. Change in Social responsiveness [ Time Frame: baseline to 18 months ]
    Decrease in total scores on Social Responsiveness Scale - Second Edition, a 65 item scale that rates behaviors associated with ASD on a 4 point likert scale from not true to almost always true. Raw scores range from 0 to 126 and t-scores range from 30 to > 90. T scores 59 or lower = within normal limits, 60 - 65 = mild range of ASD, 66-75 = moderate range, and 76 or higher = severe range.

  2. Quality of Life of Individual with ASD [ Time Frame: baseline to 18 months ]
    Increase in total score on the Quality of Life Questionnaire. The Quality of Life Questionnaire (QOL-Q) is a 40-item rating scale designed to measure the overall quality of life of a person with intellectual disability. Each item is rated on a 3 point rubric with 1 being the lowest score and 3 being the highest score. The questionnaire is compose of 4 scales: Satisfaction, Competence/Productivity, Empowerment/Independence, and Social Belonging/Community Living. Higher scores indicate higher rates of satisfaction, competence/productivity, empowerment/independence, and social belonging/community integration.

  3. Change in anxiety [ Time Frame: baseline to 18 months ]
    Decrease in anxiety as assessed using the Behavior Assessment Scale for Children, Third Edition, Teacher Rating Scales, Anxiety Score. The BASC3 TRS-A is a 165 item scale that rates various behaviors displayed by individuals on a 4-point Likert scale. Items are rated as occurring never, sometimes, often, or almost always. The anxiety scores range from t scores of 20 - 120 with t = 59 or less = within normal limits, 60-69 = at risk, and 70 or higher = clinically significant.

  4. Change in Depression [ Time Frame: baseline to 18 months ]
    Decrease in depression as assessed using the Behavior Assessment Scale for Children, Third Edition, Teacher Rating Scales, Depression Score. The BASC3 TRS-A is a 165 item scale that rates various behaviors displayed by individuals on a 4-point Likert scale. Items are rated as occurring never, sometimes, often, or almost always. The depression score range from t scores of 20 - 120 with t = 59 or less = within normal limits, 60-69 = at risk, and 70 or higher = clinically significant.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001790


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Virginia Commonwealth University
United States Department of Defense
Investigators
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Principal Investigator: Paul Wehman, PhD Virginia Commonwealth University
Study Director: Carol M Schall, PhD Virginia Commonwealth University

Additional Information:
Publications of Results:
Whittenburg, H. N., Schall, C., Wehman, P., McDonough, J., & DuBois, T. Helping High-School Aged Military Dependents with Autism Gain Employment through Project SEARCH + ASD Supports. Manuscript submitted for publication.

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04001790     History of Changes
Other Study ID Numbers: HM20008778
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: End of the study and will be available indefinitely
Access Criteria: Researchers with access to the NDAR database
URL: http://nda.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Virginia Commonwealth University:
Autism Spectrum Disorder
Transition to Employment
Employment
Project Search Plus ASD Supports

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders