Clinical trial NCT05054855: 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
Overall status: UNKNOWN
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
First posted: 2021-09-23
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Grade Point Average (GPA)
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
Secondary outcomes:
measure: Change in Post-Secondary Enrollment Status
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
measure: Change in Satisfaction with transportation access
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
measure: Change in Satisfaction with Social Support
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
measure: Change in Current Employment Status
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
measure: Change in % of Participants Receiving Disability Benefits
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
measure: Change in Overall health status
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
measure: Change in Depression Symptoms
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
measure: Change in Acceptance of disability
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
measure: Change in Perceived Stress
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
measure: Change in Quality of Life (QoL)
timeFrame: Baseline (enrollment in study) and 1 year (study completion)
Other outcomes:
Locations:
city: Kent
country: United States
facility: Kent State University
state: Ohio
Study officials:
References: