Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries

Study Overview
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Brief Summary
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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.

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

Conditions
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TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Behavioral: : Cognitive Support Technology (CST)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full Treatment<br>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)<br>* 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).<br>|
| Active Comparator: Abbreviated Treatment<br>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)<br>* 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).<br>|

What is the study measuring?
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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) |