Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries (CSTPSTBI): A Randomized Clinical Trial at the Intervention Efficacy Stage of Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054855
• Other study ID #: 20-068
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2021
• Source: Kent State University
• Contact: Mykal Leslie
• Phone: 3306725798
• Email: mleslie8[@]kent.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

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).

Locations

Country	Name	City	State
United States	Kent State University	Kent	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kent State University	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Grade Point Average (GPA)	Participant GPA	Baseline (enrollment in study) and 1 year (study completion)
Secondary	Change in Post-Secondary Enrollment Status	% of participants still enrolled in a postsecondary program	Baseline (enrollment in study) and 1 year (study completion)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)