CClinicalTrials.gg
CompletedNCT04628741Updated May 19, 2022

Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

An interventional study of Dynamic Coaching Model and Apprenticeship Approach in Traumatic Brain Injury and Concussion, Brain, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-19.

Sponsored by University of Arizona · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 12 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
12 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralDynamic Coaching Model

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

  • BehavioralApprenticeship 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.

06

What researchers measure

Primary outcomes

  1. Change in performance on a knowledge questionnaire

    adapted from Knollman-Porter et al., 2017

    Time frame: Up to 6 months (conducted once pre-intervention and once post-intervention)

  2. Change in performance on measures of academic achievement

    Self-Efficacy Scale (5-point scale)

    Time frame: Up to 6 months (conducted once pre-intervention and once post-intervention)

  3. Change in performance on measures of academic achievement

    Self-Compassion Scale Short Form (5-point scale)

    Time frame: Up to 6 months (conducted once pre-intervention and once post-intervention)

  4. Change in performance on measures of academic achievement

    Growth Mindset Scale (5-point scale)

    Time frame: 2 minutes (conducted once pre-intervention and once post-intervention)

  5. Change in performance on subjective confidence rankings

    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)

  6. 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.

    Time frame: Up to 6 months (conducted one time in each intervention session; i.e., three times total)

  7. Change in performance on a measure of quality of life: QOLIBRI (Quality of Life After Brain Injury)

    QOLIBRI (Quality of Life After Brain Injury)

    Time frame: Up to 6 months (conducted once pre-intervention and once post-intervention)

07

Study locations

1 site
  • University of Arizona
    Tucson, Arizona 85721, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04628741
Lead sponsor
University of Arizona
Responsible party
Sponsor
First posted
Nov 13, 2020
Start date
Jan 21, 2021
Primary completion
May 14, 2021
Completion
May 14, 2021
Last update
May 19, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion