Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

NCT04628741 | Completed

• 1 other identifier: IRB 2010102285
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Concussion, Brain

Outcome Measures

Primary Outcomes (7)

• Change in performance on a knowledge questionnaire

  adapted from Knollman-Porter et al., 2017

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

• Change in performance on measures of academic achievement

  Self-Efficacy Scale (5-point scale)

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

• Change in performance on measures of academic achievement

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

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

• Change in performance on measures of academic achievement

  Growth Mindset Scale (5-point scale)

  2 minutes (conducted once pre-intervention and once post-intervention)

• Change in performance on subjective confidence rankings

  Confidence rankings on a 5-point Likert scale for therapy task performance and functional academic task performance

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

• 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.

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

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

  QOLIBRI (Quality of Life After Brain Injury)

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

Study Arms (2)

Dynamic Coaching Model

ACTIVE COMPARATOR

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

Apprenticeship Approach for College Students

EXPERIMENTAL

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

Dynamic Coaching Model BEHAVIORAL

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

Dynamic Coaching Model

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.

Apprenticeship Approach for College Students

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: November 13, 2020
• Study Start: January 21, 2021
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

US (1)