Clinical trial NCT04628741: Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury
Official title: Beyond the Dynamic Coaching Model: A Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Concussion, Brain
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up to 28% of undergraduate college students report a suspected history of traumatic brain injury. Following traumatic brain injury, college students fail and repeat more courses and have lower grade point averages. Further complicating this problem may be the fact that college students lack knowledge of traumatic brain injury definition, its associated symptoms, and individuals involved in post-injury management. In this project, the investigators propose to compare the use of an established treatment model (i.e., the Dynamic Coaching Model) to a novel protocol (i.e., the Apprenticeship Approach) that includes explicit instruction about traumatic brain injury in college students with this population. The investigators will use a group comparison design to examine the efficacy of this instructional component. This work incorporates findings from educational psychology and speech-language pathology (e.g., the included instructional materials adhere to the principles of adult learning). As such, this work will advance the field's basic understanding of currently recommended treatment components and will systematically examine the effects of incorporating explicit instruction into an existing treatment model.


Eligibility criteria: Inclusion Criteria:

* a documented history of mild, moderate, or severe traumatic brain injury no more than 36 months prior to study initiation
* speak English as a primary language
* at least 18 years of age
* demonstrate no barriers related to hearing, vision, reading, or technology that prevent successful experimental task completion.

Exclusion Criteria:

* no documented history of mild, moderate, or severe traumatic brain injury
* injury occurred more than 36 months prior to study initiation
* do not speak English as a primary language
* are not at least 18 years of age
* demonstrate barriers related to hearing, vision, reading, or technology that prevent successful experimental task completion.

Primary outcomes:
measure: Change in performance on a knowledge questionnaire
timeFrame: Up to 6 months (conducted once pre-intervention and once post-intervention)
measure: Change in performance on measures of academic achievement
timeFrame: Up to 6 months (conducted once pre-intervention and once post-intervention)
measure: Change in performance on measures of academic achievement
timeFrame: Up to 6 months (conducted once pre-intervention and once post-intervention)
measure: Change in performance on measures of academic achievement
timeFrame: 2 minutes (conducted once pre-intervention and once post-intervention)
measure: Change in performance on subjective confidence rankings
timeFrame: Up to 6 months (conducted once pre-intervention and once post-intervention)
measure: Performance on subjective intervention satisfaction rankings
timeFrame: Up to 6 months (conducted one time in each intervention session; i.e., three times total)
measure: Change in performance on a measure of quality of life: QOLIBRI (Quality of Life After Brain Injury)
timeFrame: Up to 6 months (conducted once pre-intervention and once post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References: