TBI (Traumatic Brain Injury)NCT05054855
Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries
A study testing : Cognitive Support Technology (CST) in people with TBI (Traumatic Brain Injury), run by Kent State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- : Cognitive Support Technology (CST)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No exclusion criteria will be applied
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kent State University
Kent, Ohio, 44242-0001
Mykal J Leslie, PhD, 330-672-5798, mleslie8@kent.edu
Phillip D Rumrill, PhD, 3306720600, prumrill@kent.edu
About this study
Official title: 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.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- : Cognitive Support Technology (CST)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
: Cognitive Support Technology (CST)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Full Treatment | Experimental | 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. Receives: Behavioral: : Cognitive Support Technology (CST) |
| Abbreviated Treatment | Active comparator | 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. Receives: Behavioral: : Cognitive Support Technology (CST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Grade Point Average (GPA)
Participant GPA
Measured: Baseline (enrollment in study) and 1 year (study completion)
Secondary outcomes (10)
Change in Post-Secondary Enrollment Status
% of participants still enrolled in a postsecondary program
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline (enrollment in study) and 1 year (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Mar 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054855
- Sponsor's protocol ID
- 20-068
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Support Technology for Postsecondary Students With Traumatic Brain Injuries (CSTPSTBI): A Randomized Clinical Trial at the Intervention Efficacy Stage of Research
- ClinicalTrials.gov ID
- NCT05054855
- Acronym / sponsor ID
- 20-068
- Conditions
- TBI (Traumatic Brain Injury)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Full Treatment | Experimental | Behavioral: : Cognitive Support Technology (CST)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. |
| Abbreviated Treatment | Active comparator | Behavioral: : Cognitive Support Technology (CST)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria will be applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| : 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). | Behavioural | Abbreviated Treatment, Full Treatment |
Primary outcome
Change in Grade Point Average (GPA)
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Participant GPA
10 secondary outcomes
Change in Post-Secondary Enrollment Status
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Change in Satisfaction with transportation access
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Change in Satisfaction with Social Support
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Change in Current Employment Status
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Change in % of Participants Receiving Disability Benefits
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Change in Overall health status
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Change in Depression Symptoms
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Change in Acceptance of disability
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Change in Perceived Stress
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Change in Quality of Life (QoL)
Time frame: Baseline (enrollment in study) and 1 year (study completion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing : Cognitive Support Technology (CST) in people with TBI (Traumatic Brain Injury), run by Kent State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mykal Leslie (3306725798, mleslie8@kent.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Grade Point Average (GPA) (time frame: Baseline (enrollment in study) and 1 year (study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.