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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Search plus ASD Supports
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Transition to Employment, Employment, Project Search Plus ASD Supports

Eligibility Criteria

18 Years - 21 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Project Search + ASD Supports

Business as Usual

Arm Description

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.

Business as Usual means these youth remain in their high school programs as determined on their individualized education plans

Outcomes

Primary Outcome Measures

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.
Change in Number of hours worked
Increase in hours/week employee is engaged in paid employment
Change in hourly Wage earned
Increase in hourly wage paid to employee for work performed for employer

Secondary Outcome Measures

Change in Social responsiveness
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.
Quality of Life of Individual with ASD
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.
Change in anxiety
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.
Change in Depression
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.

Full Information

First Posted
June 20, 2019
Last Updated
June 1, 2021
Sponsor
Virginia Commonwealth University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04001790
Brief Title
Effect of a 9-Month Internship Intervention for Military Dependents With ASD
Official Title
Effect of a 9-Month Internship Intervention for Military Dependents With ASD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, Transition to Employment, Employment, Project Search Plus ASD Supports

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Project Search + ASD Supports
Arm Type
Experimental
Arm Description
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.
Arm Title
Business as Usual
Arm Type
No Intervention
Arm Description
Business as Usual means these youth remain in their high school programs as determined on their individualized education plans
Intervention Type
Behavioral
Intervention Name(s)
Project Search plus ASD Supports
Other Intervention Name(s)
PS+ASD
Intervention Description
Nine month job training program embedded on Fort Eustis military base.
Primary Outcome Measure Information:
Title
Change in Competitive Integrated Employment rates
Description
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.
Time Frame
baseline to 18 months
Title
Change in Number of hours worked
Description
Increase in hours/week employee is engaged in paid employment
Time Frame
baseline to 18 months
Title
Change in hourly Wage earned
Description
Increase in hourly wage paid to employee for work performed for employer
Time Frame
baseline to 18 months
Secondary Outcome Measure Information:
Title
Change in Social responsiveness
Description
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.
Time Frame
baseline to 18 months
Title
Quality of Life of Individual with ASD
Description
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.
Time Frame
baseline to 18 months
Title
Change in anxiety
Description
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.
Time Frame
baseline to 18 months
Title
Change in Depression
Description
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.
Time Frame
baseline to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Wehman, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol M Schall, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Director
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
End of the study and will be available indefinitely
IPD Sharing Access Criteria
Researchers with access to the NDAR database
IPD Sharing URL
http://nda.nih.gov/
Citations:
PubMed Identifier
31498390
Citation
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.
Results Reference
result
Links:
URL
http://vcurrtc.org/deployed2work/
Description
website describing project

Learn more about this trial

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

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