Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Beyond the Dynamic Coaching Model: A Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628741
• Other study ID #: IRB 2010102285
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: May 14, 2021

Study information

• Verified date: May 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Brain
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Dynamic Coaching Model
This is a behavioral intervention which includes metacognitive strategy training and personalized strategy and external aid use training.
• Apprenticeship Approach
This is a behavioral intervention which includes explicit education about traumatic brain injury, its symptoms, and individuals who may provide assistance post-injury, metacognitive strategy training and personalized strategy and external aid use training.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in performance on a knowledge questionnaire	adapted from Knollman-Porter et al., 2017	Up to 6 months (conducted once pre-intervention and once post-intervention)
Primary	Change in performance on measures of academic achievement	Self-Efficacy Scale (5-point scale)	Up to 6 months (conducted once pre-intervention and once post-intervention)
Primary	Change in performance on measures of academic achievement	Self-Compassion Scale Short Form (5-point scale)	Up to 6 months (conducted once pre-intervention and once post-intervention)
Primary	Change in performance on measures of academic achievement	Growth Mindset Scale (5-point scale)	2 minutes (conducted once pre-intervention and once post-intervention)
Primary	Change in performance on subjective confidence rankings	Confidence rankings on a 5-point Likert scale for therapy task performance and functional academic task performance	Up to 6 months (conducted once pre-intervention and once post-intervention)
Primary	Performance on subjective intervention satisfaction rankings	Subjective rankings on a 5-point Likert scale for intervention satisfaction, likelihood to recommend intervention to a friend, and desire to continue intervention.	Up to 6 months (conducted one time in each intervention session; i.e., three times total)
Primary	Change in performance on a measure of quality of life: QOLIBRI (Quality of Life After Brain Injury)	QOLIBRI (Quality of Life After Brain Injury)	Up to 6 months (conducted once pre-intervention and once post-intervention)