- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04980963
Cognitive Support Technology for Postsecondary Students With Autism Spectrum Disorder
Cognitive Support Technology for Postsecondary Students With Autism Spectrum Disorder: A Randomized Clinical Trial at the Intervention Efficacy Stage of Research
This study will fill important knowledge gaps in the availability of best practices that use innovative methods to integrate the cognitive and vocational needs of students with Autism Spectrum Disorder (ASD) who will be transitioning from 2- and 4-year postsecondary education to employment. Best practices exist from the assistive technology (AT) field to help people compensate for cognitive impairments, and from the vocational rehabilitation (VR) field to enhance employment outcomes for individuals with disabilities. However, these practices have not been integrated to provide needed supports and services to improve the employment outcomes of students with ASD. The study's goal is to expand the availability of innovative practices by testing the efficacy of a technology-driven, long-term, and resource-rich individualized support program that merges assistive technology for cognition and vocational rehabilitation practices. The end products will include technology application guidelines, training and procedural manuals, and resource information that rehabilitation professionals and students with ADS can utilize to enhance technology and mentoring proficiency, academic success, self-determination, and long-term career success for students with ASD.
The knowledge to be gained from this research will have a beneficial impact on students with ASD, rehabilitation professionals, higher education personnel, case managers, and employers who work with people with ASD. There is strong potential for the students to develop skills that will help them succeed in learning as well as employment settings. The ultimate benefit of research activities for the target population will be seen in the improved capacity for postsecondary students with ADS to utilize state-of-the-art technology to accommodate disability-related limitations, address career readiness, and to prepare for and obtain employment after graduation.
Because the risks to subjects are no greater than those associated with everyday life and because the study staff will refer students who are in psychological distress or medical emergency situations to appropriate resources in the community, the minimal risks of this study justify the considerable benefits that this study will yield. Not only will the study benefit participating students, it stands to make important contributions to the knowledge bases in the fields of assistive technology and rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mykal Leslie, PhD
- Phone Number: 3306725798
- Email: mleslie8@kent.edu
Study Contact Backup
- Name: Phillip Rumrill, PhD
- Phone Number: 3306720600
- Email: prumrill@kent.edu
Study Locations
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-
Ohio
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Kent, Ohio, United States, 44242-0001
- Recruiting
- Kent State University
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Contact:
- Phillip Rumrill, PhD
- Phone Number: 3306720600
- Email: prumrill@kent.edu
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Contact:
- Mykal J Leslie, PhD
- Phone Number: 330-672-5798
- Email: mleslie8@kent.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be a post-secondary student enrolled in degree programs at two-year and four-year colleges or universities within a 60-mile radius of Kent, Ohio
- Must have a clinical diagnosis of Autism Spectrum Disorder
Exclusion Criteria:
- No other exclusion criteria will be applied
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Full Treatment
Steps of the Intervention Condition.
Following an in-person session in which a pretest assessment is completed, each member of the intervention group will participate in three face-to-face sessions with the interventionist at the student's campus or at the interventionist's office to complete the CST component of the intervention.
Taking into consideration available psychoeducational assessment data, functional assessments from other agencies, and the participant's self-report regarding the functional difficulties that result from his or her ASD-related cognitive impairments, Scherer's (2012) Matching Person and Technology (MPT) protocol will guide the CST assessment.
For purposes of the CST component of this intervention, the technological platform for cognitive accommodations will be an iPad II that is provided to each intervention-group participant at no charge (including wireless access if needed).
The interventionist will provide training in the use of the iPad if necessary.
|
Cognitive Support Technology (CST) products and strategies are used to help people with disabilities compensate for or accommodate cognitive limitations (including those related to interpersonal communication and social cognition) that present difficulties for them in the performance of desired social roles, especially education and employment.
CSTs may be mainstream everyday technologies such as tablet computers or they may be specialized devices designed for specific goals such as step-by-step instruction in the performance of a particular task (Scherer, 2012).
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|
Active Comparator: Abbreviated Treatment
Steps of the Control Condition.
Following an in-person session in which the pretest assessment is completed, each member of the control group will participate in two telephone or Skype sessions with the interventionist to discuss her or his needs for electronic cognitive supports.
An abbreviated version of Scherer's (2012) MPT assessment will be administered via telephone or Skype in the first of these virtually-administered sessions.
In the second telephone or Skype session, the interventionist will summarize the results of the abbreviated MPT assessment, suggest a variety of cognitive enhancement apps for tablet computers or smart phones that the control group participant can consider.
|
Cognitive Support Technology (CST) products and strategies are used to help people with disabilities compensate for or accommodate cognitive limitations (including those related to interpersonal communication and social cognition) that present difficulties for them in the performance of desired social roles, especially education and employment.
CSTs may be mainstream everyday technologies such as tablet computers or they may be specialized devices designed for specific goals such as step-by-step instruction in the performance of a particular task (Scherer, 2012).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grade Point Average (GPA)
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Participant GPA
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Current academic standing
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
|
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Post-Secondary Enrollment Status
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
% of participants still enrolled in a postsecondary program
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
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Satisfaction with current living status and transportation access
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Measured using single item 5-point Likert question on questionnaire
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
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Satisfaction with Social Support
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Measured using single item 5-point Likert question on questionnaire
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
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Current Employment Status
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Three items on questionnaire including dichotomous employment question (e.g., are you employed?), if yes, number of hours employed and weekly earnings.
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Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
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% of Participants Receiving Disability Benefits
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
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Whether participants receive SSDI and/or SSI benefits or not
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
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Depression Symptoms
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Measured using Beck Depression Inventory- II (BDI-II)
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
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Overall Health Status
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Measured using RAND 36-item Health Survey
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
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Perceived Stress
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Measured using Perceived Stress Scale- 10
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
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Acceptance of Disability
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Measured using the Acceptance of Disability Scale- Short Form
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
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Quality of Life (QoL)
Time Frame: Baseline (enrollment in study), 6 months, and 1 year (study completion)
|
Measured using the Qualify of Life Scale
|
Baseline (enrollment in study), 6 months, and 1 year (study completion)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-069
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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