- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07414303
Implementation of an Evidence-Based Educational Resource for Children With Mild Traumatic Brain Injury (POCKIT)
February 10, 2026 updated by: Baylor Research Institute
The goal of this prospective, observational study is to (1) collaborate with our stakeholders to identify essential mTBI-information from existing evidence-based materials to develop a Post-mTBI Educational Resource for children with mTBI and their parents and (2) implement our Post-mTBI Educational Resource into clinical practice to determine feasibility, acceptability, and appropriateness at Baylor Scott and White (BSW) clinical sites that treat children with mTBI.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Frisco, Texas, United States, 75034
- BSW Primary Care at The Star
-
Frisco, Texas, United States, 75034
- BSW Sports Concussion Program
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Temple, Texas, United States, 76502
- McLane Children's Hospital at BSW Temple Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Potential stakeholders will be between the ages of 8 and 99 years.
Description
Inclusion Criteria:
- children and young adults who are student athletes
- they have experienced a mTBI
- parents, coaches, and professional stakeholders (e.g., athletic trainers, school nurses, school administrators, physicians, healthcare administrators, local and national entities, community partners).
- Stakeholders were part of our previous Engagement Award.
Exclusion Criteria:
- Individuals younger than 8 years old
- Anyone who does not meet the above criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Advisory Board (AB)
Our target AB of stakeholders include children and young adults who are student athletes and have experienced mTBI, parents, coaches, and professional stakeholders (e.g., athletic trainers, school nurses, school administrators, physicians, healthcare administrators, local and national entities, community partners)
|
Activate clinicians and clinic administrators at BSW clinical sites that treat children with mTBI to implement the Post-mTBI Educational Resource.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Engagement
Time Frame: through study completion, an average of 3 years
|
# of Advisory Board members
|
through study completion, an average of 3 years
|
|
Engagement
Time Frame: through study completion, an average of 3 years
|
# of Engagment Partners
|
through study completion, an average of 3 years
|
|
Engagement
Time Frame: through study completion, an average of 3 years
|
Feedback and Satisfaction on The Patient Engagement in Research Scale (PEIRS).
Total scores are calculated on a scale of 0 to 100, where higher scores indicate more meaningful engagement.
|
through study completion, an average of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2025
Primary Completion (Actual)
December 8, 2025
Study Completion (Actual)
December 8, 2025
Study Registration Dates
First Submitted
March 3, 2025
First Submitted That Met QC Criteria
February 10, 2026
First Posted (Actual)
February 17, 2026
Study Record Updates
Last Update Posted (Actual)
February 17, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90IFDV0035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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