COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04628741
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
University of Arizona

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Concussion, Brain Behavioral: Dynamic Coaching Model Behavioral: Apprenticeship Approach Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Beyond the Dynamic Coaching Model: A Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury
Estimated Study Start Date : January 21, 2021
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Behavioral: Dynamic Coaching Model
This is a behavioral intervention which includes metacognitive strategy training and personalized strategy and external aid use training.

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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in performance on a knowledge questionnaire [ Time Frame: Up to 6 months (conducted once pre-intervention and once post-intervention) ]
    adapted from Knollman-Porter et al., 2017

  2. Change in performance on measures of academic achievement [ Time Frame: Up to 6 months (conducted once pre-intervention and once post-intervention) ]
    Self-Efficacy Scale (5-point scale)

  3. Change in performance on measures of academic achievement [ Time Frame: Up to 6 months (conducted once pre-intervention and once post-intervention) ]
    Self-Compassion Scale Short Form (5-point scale)

  4. Change in performance on measures of academic achievement [ Time Frame: 2 minutes (conducted once pre-intervention and once post-intervention) ]
    Growth Mindset Scale (5-point scale)

  5. Change in performance on subjective confidence rankings [ Time Frame: Up to 6 months (conducted once pre-intervention and once post-intervention) ]
    Confidence rankings on a 5-point Likert scale for therapy task performance and functional academic task performance

  6. Performance on subjective intervention satisfaction rankings [ Time Frame: Up to 6 months (conducted one time in each intervention session; i.e., three times total) ]
    Subjective rankings on a 5-point Likert scale for intervention satisfaction, likelihood to recommend intervention to a friend, and desire to continue intervention.

  7. 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) ]
    QOLIBRI (Quality of Life After Brain Injury)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628741


Contacts
Layout table for location contacts
Contact: Kristen Ackley, M.S. 2406608885 ackleykl@email.arizona.edu
Contact: Jessica Brown, Ph.D. (520) 626-9015 jessicabrown@email.arizona.edu

Locations
Layout table for location information
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85721
Contact: Kristen L Ackley, M.S.    240-660-8885    ackleykl@email.arizona.edu   
Contact: Jessica A Brown, Ph.D.    (520) 626-9015    jessicabrown@email.arizona.edu   
Sponsors and Collaborators
University of Arizona
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT04628741    
Other Study ID Numbers: IRB 2010102285
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Central Nervous System Diseases
Nervous System Diseases