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Cognitive Support Technology for Postsecondary Students With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Support Technology (CST)
Sponsored by
Kent State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kent State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full Treatment

Abbreviated Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Grade Point Average (GPA)
Participant GPA

Secondary Outcome Measures

Current academic standing
Post-Secondary Enrollment Status
% of participants still enrolled in a postsecondary program
Satisfaction with current living status and transportation access
Measured using single item 5-point Likert question on questionnaire
Satisfaction with Social Support
Measured using single item 5-point Likert question on questionnaire
Current Employment Status
Three items on questionnaire including dichotomous employment question (e.g., are you employed?), if yes, number of hours employed and weekly earnings.
% of Participants Receiving Disability Benefits
Whether participants receive SSDI and/or SSI benefits or not
Depression Symptoms
Measured using Beck Depression Inventory- II (BDI-II)
Overall Health Status
Measured using RAND 36-item Health Survey
Perceived Stress
Measured using Perceived Stress Scale- 10
Acceptance of Disability
Measured using the Acceptance of Disability Scale- Short Form
Quality of Life (QoL)
Measured using the Qualify of Life Scale

Full Information

First Posted
September 17, 2020
Last Updated
July 19, 2021
Sponsor
Kent State University
Collaborators
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT04980963
Brief Title
Cognitive Support Technology for Postsecondary Students With Autism Spectrum Disorder
Official Title
Cognitive Support Technology for Postsecondary Students With Autism Spectrum Disorder: A Randomized Clinical Trial at the Intervention Efficacy Stage of Research
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kent State University
Collaborators
Virginia Commonwealth University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A minimum total of 90 students will be recruited for the study. Study personnel will recruit 30 students in each of years 2, 3, and 4. Of the 30 students per year, 15 will be randomly assigned to the full treatment intervention and 15 students will be randomly assigned to the control group. Participants will range in age from approximately 18 years to 25 years, but all ages are welcome to participate. The selection of the target population for this research study is based on the bleak employment outcomes of students with ASD compared to students without disabilities. In addition, it is based on the lack of practices that integrate the cognitive and vocational needs of students with ASD who are pursuing postsecondary education to help them successfully complete academic requirements, address career development, enhance career readiness skills, and obtain and maintain employment.
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Abbreviated Treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Support Technology (CST)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Grade Point Average (GPA)
Description
Participant GPA
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Secondary Outcome Measure Information:
Title
Current academic standing
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
Post-Secondary Enrollment Status
Description
% of participants still enrolled in a postsecondary program
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
Satisfaction with current living status and transportation access
Description
Measured using single item 5-point Likert question on questionnaire
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
Satisfaction with Social Support
Description
Measured using single item 5-point Likert question on questionnaire
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
Current Employment Status
Description
Three items on questionnaire including dichotomous employment question (e.g., are you employed?), if yes, number of hours employed and weekly earnings.
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
% of Participants Receiving Disability Benefits
Description
Whether participants receive SSDI and/or SSI benefits or not
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
Depression Symptoms
Description
Measured using Beck Depression Inventory- II (BDI-II)
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
Overall Health Status
Description
Measured using RAND 36-item Health Survey
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
Perceived Stress
Description
Measured using Perceived Stress Scale- 10
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
Acceptance of Disability
Description
Measured using the Acceptance of Disability Scale- Short Form
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)
Title
Quality of Life (QoL)
Description
Measured using the Qualify of Life Scale
Time Frame
Baseline (enrollment in study), 6 months, and 1 year (study completion)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mykal Leslie, PhD
Phone
3306725798
Email
mleslie8@kent.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Phillip Rumrill, PhD
Phone
3306720600
Email
prumrill@kent.edu
Facility Information:
Facility Name
Kent State University
City
Kent
State/Province
Ohio
ZIP/Postal Code
44242-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mykal J Leslie, PhD
Phone
330-672-5798
Email
mleslie8@kent.edu
First Name & Middle Initial & Last Name & Degree
Phillip Rumrill, PhD
Phone
3306720600
Email
prumrill@kent.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Support Technology for Postsecondary Students With Autism Spectrum Disorder

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