Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries

Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries (CSTPSTBI): 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 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.

Study Overview

• Status: Recruiting
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Behavioral: : Cognitive Support Technology (CST)

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mykal Leslie; Phone Number: 3306725798; Email: mleslie8@kent.edu
• Study Contact Backup: Name: Phillip D Rumrill; Phone Number: 3306720600; Email: prumrill@kent.edu

Study Locations

• United States
  • Ohio
    • Kent, Ohio, United States, 44242-0001
      • Recruiting
      • Kent State University
      • Contact: Mykal J Leslie, PhD; Phone Number: 330-672-5798; Email: mleslie8@kent.edu
      • Contact: Phillip D Rumrill, PhD; Phone Number: 3306720600; Email: prumrill@kent.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	Behavioral: : Cognitive Support Technology (CST); 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).
Active Comparator: Abbreviated Treatment; 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.	Behavioral: : Cognitive Support Technology (CST); 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
Change in Grade Point Average (GPA)	Participant GPA	Baseline (enrollment in study) and 1 year (study completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Post-Secondary Enrollment Status	% of participants still enrolled in a postsecondary program	Baseline (enrollment in study) and 1 year (study completion)
Change in Satisfaction with transportation access	Measured using single item 5-point Likert question on questionnaire	Baseline (enrollment in study) and 1 year (study completion)
Change in Satisfaction with Social Support	Measured using single item 5-point Likert question on questionnaire	Baseline (enrollment in study) and 1 year (study completion)
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.	Baseline (enrollment in study) and 1 year (study completion)
Change in % of Participants Receiving Disability Benefits	Whether participants receive SSDI and/or SSI benefits or not	Baseline (enrollment in study) and 1 year (study completion)
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.	Baseline (enrollment in study) and 1 year (study completion)
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.	Baseline (enrollment in study) and 1 year (study completion)
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	Baseline (enrollment in study) and 1 year (study completion)
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.	Baseline (enrollment in study) and 1 year (study completion)
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.	Baseline (enrollment in study) and 1 year (study completion)

Collaborators and Investigators

• Sponsor: Kent State University
• Collaborators: Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 20-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No