- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04001790
Effect of a 9-Month Internship Intervention for Military Dependents With ASD
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Richmond, Virginia, United States, 23284
- Virginia Commonwealth University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
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Nine month job training program embedded on Fort Eustis military base.
Other Names:
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NO_INTERVENTION: Business as Usual
Business as Usual means these youth remain in their high school programs as determined on their individualized education plans
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Competitive Integrated Employment rates
Time Frame: baseline to 18 months
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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.
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baseline to 18 months
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Change in Number of hours worked
Time Frame: baseline to 18 months
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Increase in hours/week employee is engaged in paid employment
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baseline to 18 months
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Change in hourly Wage earned
Time Frame: baseline to 18 months
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Increase in hourly wage paid to employee for work performed for employer
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baseline to 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Social responsiveness
Time Frame: baseline to 18 months
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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.
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baseline to 18 months
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Quality of Life of Individual with ASD
Time Frame: baseline to 18 months
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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.
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baseline to 18 months
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Change in anxiety
Time Frame: baseline to 18 months
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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.
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baseline to 18 months
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Change in Depression
Time Frame: baseline to 18 months
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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.
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baseline to 18 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Carol M Schall, PhD, Virginia Commonwealth University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20008778
- CDMRP AR150172 (OTHER_GRANT: Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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