Traumatic Brain InjuryNCT04628741
Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury
A study testing Dynamic Coaching Model and Apprenticeship Approach in people with Traumatic Brain Injury and Concussion, Brain, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Concussion, Brain
- What is being tested?
- Dynamic Coaching Model and Apprenticeship Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 14 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Traumatic Brain Injury, Concussion, Brain
- Being tested
- Dynamic Coaching Model, Apprenticeship Approach
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Coaching ModelBehavioural
This is a behavioral intervention which includes metacognitive strategy training and personalized strategy and external aid use training.
Apprenticeship ApproachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Apprenticeship Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance on a knowledge questionnaire
adapted from Knollman-Porter et al., 2017
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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)
Measured: Up to 6 months (conducted once pre-intervention and once post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start21 Jan 2021
- Primary completion14 May 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628741
- Sponsor's protocol ID
- IRB 2010102285
- Status last verified
- May 2022
- First submitted
- 5 Oct 2020
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Dynamic Coaching Model: A Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04628741
- Acronym / sponsor ID
- IRB 2010102285
- Conditions
- Traumatic Brain Injury, Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Coaching Model | Active comparator | Behavioral: Dynamic Coaching ModelThe 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). |
| Apprenticeship Approach for College Students | Experimental | Behavioral: Apprenticeship ApproachThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Coaching ModelThis is a behavioral intervention which includes metacognitive strategy training and personalized strategy and external aid use training. | Behavioural | Dynamic Coaching Model |
| Apprenticeship ApproachThis 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. | Behavioural | Apprenticeship Approach for College Students |
Primary outcome
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
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)
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)
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)
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
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Coaching Model and Apprenticeship Approach in people with Traumatic Brain Injury and Concussion, Brain, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance on a knowledge questionnaire (time frame: Up to 6 months (conducted once pre-intervention and once post-intervention)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.