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Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries

Primary Purpose

TBI (Traumatic Brain Injury)

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 TBI (Traumatic Brain Injury)

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of TBI
  • Enrolled in a degree program at two-year and four-year colleges or universities
  • Live within a 60-mile radius of Kent, Ohio

Exclusion Criteria:

  • No 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.

Steps of the Control Condition. Following an inperson 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

Change in Grade Point Average (GPA)
Participant GPA

Secondary Outcome Measures

Change in Post-Secondary Enrollment Status
% of participants still enrolled in a postsecondary program
Change in Satisfaction with transportation access
Measured using single item 5-point Likert question on questionnaire
Change in Satisfaction with Social Support
Measured using single item 5-point Likert question on questionnaire
Change in 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.
Change in % of Participants Receiving Disability Benefits
Whether participants receive SSDI and/or SSI benefits or not
Change in Overall health status
Measured using RAND 36-item Health Survey 1.0 All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Change in Depression Symptoms
Measured using Beck Depression Inventory- II (BDI-II) The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63. A higher score indicates a higher level of depressive symptomology.
Change in Acceptance of disability
Measured using the Acceptance of Disability Scale- Short Form There are 50 self-report items. Each item, provides a single score that ranges from 1 (low acceptance of disability) to 6 (high acceptance of disability). An overall acceptance of disability score is derived by summing all items, with 300 as the highest possible score. Low acceptance scores fall below 175, whereas high acceptance scores range from 176 to 300
Change in Perceived Stress
Measured using the Perceived Stress Scale- 10. PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. The highest score possible is 40 while the lowest score possible is 0. Higher score indicates higher levels of perceived stress.
Change in Quality of Life (QoL)
Measured using the Quality of Life Scale There are 16 items scored on a seven-point Likert scale. The seven responses are "delighted" (7), "pleased" (6), "mostly satisfied" (5),"mixed" (4), "mostly dissatisfied" (3), "unhappy" (2),"terrible" (1).The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112 with higher scores representing a higher reported quality of life.

Full Information

First Posted
September 21, 2020
Last Updated
September 17, 2021
Sponsor
Kent State University
Collaborators
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT05054855
Brief Title
Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries
Official Title
Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries (CSTPSTBI): A Randomized Clinical Trial at the Intervention Efficacy Stage of Research
Study Type
Interventional

2. Study Status

Record Verification Date
September 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 TBI 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 TBI. 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 TBI can utilize to enhance technology and mentoring proficiency, academic success, self-determination, and long-term career success for students with TBI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury)

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.
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.
Arm Title
Abbreviated Treatment
Arm Type
Active Comparator
Arm Description
Steps of the Control Condition. Following an inperson 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
Change in Grade Point Average (GPA)
Description
Participant GPA
Time Frame
Baseline (enrollment in study) and 1 year (study completion)
Secondary Outcome Measure Information:
Title
Change in Post-Secondary Enrollment Status
Description
% of participants still enrolled in a postsecondary program
Time Frame
Baseline (enrollment in study) and 1 year (study completion)
Title
Change in Satisfaction with transportation access
Description
Measured using single item 5-point Likert question on questionnaire
Time Frame
Baseline (enrollment in study) and 1 year (study completion)
Title
Change in Satisfaction with Social Support
Description
Measured using single item 5-point Likert question on questionnaire
Time Frame
Baseline (enrollment in study) and 1 year (study completion)
Title
Change in 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) and 1 year (study completion)
Title
Change in % of Participants Receiving Disability Benefits
Description
Whether participants receive SSDI and/or SSI benefits or not
Time Frame
Baseline (enrollment in study) and 1 year (study completion)
Title
Change in Overall health status
Description
Measured using RAND 36-item Health Survey 1.0 All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time Frame
Baseline (enrollment in study) and 1 year (study completion)
Title
Change in Depression Symptoms
Description
Measured using Beck Depression Inventory- II (BDI-II) The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63. A higher score indicates a higher level of depressive symptomology.
Time Frame
Baseline (enrollment in study) and 1 year (study completion)
Title
Change in Acceptance of disability
Description
Measured using the Acceptance of Disability Scale- Short Form There are 50 self-report items. Each item, provides a single score that ranges from 1 (low acceptance of disability) to 6 (high acceptance of disability). An overall acceptance of disability score is derived by summing all items, with 300 as the highest possible score. Low acceptance scores fall below 175, whereas high acceptance scores range from 176 to 300
Time Frame
Baseline (enrollment in study) and 1 year (study completion)
Title
Change in Perceived Stress
Description
Measured using the Perceived Stress Scale- 10. PSS-10 scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. The highest score possible is 40 while the lowest score possible is 0. Higher score indicates higher levels of perceived stress.
Time Frame
Baseline (enrollment in study) and 1 year (study completion)
Title
Change in Quality of Life (QoL)
Description
Measured using the Quality of Life Scale There are 16 items scored on a seven-point Likert scale. The seven responses are "delighted" (7), "pleased" (6), "mostly satisfied" (5),"mixed" (4), "mostly dissatisfied" (3), "unhappy" (2),"terrible" (1).The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112 with higher scores representing a higher reported quality of life.
Time Frame
Baseline (enrollment in study) and 1 year (study completion)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of TBI Enrolled in a degree program at two-year and four-year colleges or universities Live within a 60-mile radius of Kent, Ohio Exclusion Criteria: No exclusion criteria will be applied
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mykal Leslie
Phone
3306725798
Email
mleslie8@kent.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Phillip D Rumrill
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 D 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 Traumatic Brain Injuries

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