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Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury, Concussion, Brain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic Coaching Model
Apprenticeship Approach
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dynamic Coaching Model

Apprenticeship Approach for College Students

Arm Description

The Dynamic Coaching Model is an established treatment approach that entails training college students with executive function impairments (e.g., those with a history of traumatic brain injury) to rely on their own executive functions in order to problem solve and reason in real-life situations requiring them to do so (e.g., taking college classes).

The Apprenticeship Approach is a novel treatment approach that incorporates explicit education about: (a) traumatic brain injury definition; (b) traumatic brain injury symptomatology; and (c) individuals who may be able to provide assistance to the individual with traumatic brain injury into the existing Dynamic Coaching Model.

Outcomes

Primary Outcome Measures

Change in performance on a knowledge questionnaire
adapted from Knollman-Porter et al., 2017
Change in performance on measures of academic achievement
Self-Efficacy Scale (5-point scale)
Change in performance on measures of academic achievement
Self-Compassion Scale Short Form (5-point scale)
Change in performance on measures of academic achievement
Growth Mindset Scale (5-point scale)
Change in performance on subjective confidence rankings
Confidence rankings on a 5-point Likert scale for therapy task performance and functional academic task performance
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.
Change in performance on a measure of quality of life: QOLIBRI (Quality of Life After Brain Injury)
QOLIBRI (Quality of Life After Brain Injury)

Secondary Outcome Measures

Full Information

First Posted
October 5, 2020
Last Updated
May 17, 2022
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT04628741
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Concussion, Brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic Coaching Model
Arm Type
Active Comparator
Arm Description
The Dynamic Coaching Model is an established treatment approach that entails training college students with executive function impairments (e.g., those with a history of traumatic brain injury) to rely on their own executive functions in order to problem solve and reason in real-life situations requiring them to do so (e.g., taking college classes).
Arm Title
Apprenticeship Approach for College Students
Arm Type
Experimental
Arm Description
The Apprenticeship Approach is a novel treatment approach that incorporates explicit education about: (a) traumatic brain injury definition; (b) traumatic brain injury symptomatology; and (c) individuals who may be able to provide assistance to the individual with traumatic brain injury into the existing Dynamic Coaching Model.
Intervention Type
Behavioral
Intervention Name(s)
Dynamic Coaching Model
Intervention Description
This is a behavioral intervention which includes metacognitive strategy training and personalized strategy and external aid use training.
Intervention Type
Behavioral
Intervention Name(s)
Apprenticeship Approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in performance on a knowledge questionnaire
Description
adapted from Knollman-Porter et al., 2017
Time Frame
Up to 6 months (conducted once pre-intervention and once post-intervention)
Title
Change in performance on measures of academic achievement
Description
Self-Efficacy Scale (5-point scale)
Time Frame
Up to 6 months (conducted once pre-intervention and once post-intervention)
Title
Change in performance on measures of academic achievement
Description
Self-Compassion Scale Short Form (5-point scale)
Time Frame
Up to 6 months (conducted once pre-intervention and once post-intervention)
Title
Change in performance on measures of academic achievement
Description
Growth Mindset Scale (5-point scale)
Time Frame
2 minutes (conducted once pre-intervention and once post-intervention)
Title
Change in performance on subjective confidence rankings
Description
Confidence rankings on a 5-point Likert scale for therapy task performance and functional academic task performance
Time Frame
Up to 6 months (conducted once pre-intervention and once post-intervention)
Title
Performance on subjective intervention satisfaction rankings
Description
Subjective rankings on a 5-point Likert scale for intervention satisfaction, likelihood to recommend intervention to a friend, and desire to continue intervention.
Time Frame
Up to 6 months (conducted one time in each intervention session; i.e., three times total)
Title
Change in performance on a measure of quality of life: QOLIBRI (Quality of Life After Brain Injury)
Description
QOLIBRI (Quality of Life After Brain Injury)
Time Frame
Up to 6 months (conducted once pre-intervention and once post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States

12. IPD Sharing Statement

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Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

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