- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04628741
Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury
May 17, 2022 updated by: University of Arizona
Beyond the Dynamic Coaching Model: A Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85721
- University of Arizona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Dynamic Coaching Model
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).
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This is a behavioral intervention which includes metacognitive strategy training and personalized strategy and external aid use training.
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Experimental: Apprenticeship Approach for College Students
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in performance on a knowledge questionnaire
Time Frame: Up to 6 months (conducted once pre-intervention and once post-intervention)
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adapted from Knollman-Porter et al., 2017
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Up to 6 months (conducted once pre-intervention and once post-intervention)
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Change in performance on measures of academic achievement
Time Frame: Up to 6 months (conducted once pre-intervention and once post-intervention)
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Self-Efficacy Scale (5-point scale)
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Up to 6 months (conducted once pre-intervention and once post-intervention)
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Change in performance on measures of academic achievement
Time Frame: Up to 6 months (conducted once pre-intervention and once post-intervention)
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Self-Compassion Scale Short Form (5-point scale)
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Up to 6 months (conducted once pre-intervention and once post-intervention)
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Change in performance on measures of academic achievement
Time Frame: 2 minutes (conducted once pre-intervention and once post-intervention)
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Growth Mindset Scale (5-point scale)
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2 minutes (conducted once pre-intervention and once post-intervention)
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Change in performance on subjective confidence rankings
Time Frame: Up to 6 months (conducted once pre-intervention and once post-intervention)
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Confidence rankings on a 5-point Likert scale for therapy task performance and functional academic task performance
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Up to 6 months (conducted once pre-intervention and once post-intervention)
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Performance on subjective intervention satisfaction rankings
Time Frame: Up to 6 months (conducted one time in each intervention session; i.e., three times total)
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Subjective rankings on a 5-point Likert scale for intervention satisfaction, likelihood to recommend intervention to a friend, and desire to continue intervention.
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Up to 6 months (conducted one time in each intervention session; i.e., three times total)
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Change in performance on a measure of quality of life: QOLIBRI (Quality of Life After Brain Injury)
Time Frame: Up to 6 months (conducted once pre-intervention and once post-intervention)
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QOLIBRI (Quality of Life After Brain Injury)
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Up to 6 months (conducted once pre-intervention and once post-intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2021
Primary Completion (Actual)
May 14, 2021
Study Completion (Actual)
May 14, 2021
Study Registration Dates
First Submitted
October 5, 2020
First Submitted That Met QC Criteria
November 12, 2020
First Posted (Actual)
November 13, 2020
Study Record Updates
Last Update Posted (Actual)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 2010102285
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
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-
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University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
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