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Completed

NCT Number: NCT04628741

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.

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Key information

Conditions

Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Concussion, Brain Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dynamic Coaching Model

Behavioral

This is a behavioral intervention which includes metacognitive strategy training and personalized strategy and external aid use training.

Apprenticeship Approach

Behavioral

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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2020
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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