NCT05054855

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
1 year until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

4.3 years

First QC Date

September 21, 2020

Last Update Submit

September 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Grade Point Average (GPA)

    Participant GPA

    Baseline (enrollment in study) and 1 year (study completion)

Secondary Outcomes (10)

  • Change in Post-Secondary Enrollment Status

    Baseline (enrollment in study) and 1 year (study completion)

  • Change in Satisfaction with transportation access

    Baseline (enrollment in study) and 1 year (study completion)

  • Change in Satisfaction with Social Support

    Baseline (enrollment in study) and 1 year (study completion)

  • Change in Current Employment Status

    Baseline (enrollment in study) and 1 year (study completion)

  • Change in % of Participants Receiving Disability Benefits

    Baseline (enrollment in study) and 1 year (study completion)

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: : Cognitive Support Technology (CST)

Interventions

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).

Abbreviated TreatmentFull Treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kent State University

Kent, Ohio, 44242-0001, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Mykal Leslie

CONTACT

Phillip D Rumrill

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 23, 2021

Study Start

March 1, 2020

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations