TerminatedNot Applicable

Implementation of an Evidence-Based Educational Resource for Children With Mild Traumatic Brain Injury

Stopped: PI transitioned to a new institution

United States14 participantsStarted 2025-03-04

Plain-language summary

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.

Who can participate

Age range

8 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Engagement

Timeframe: through study completion, an average of 3 years

Engagement

Timeframe: through study completion, an average of 3 years

Engagement

Timeframe: through study completion, an average of 3 years

Trial details

NCT IDNCT07414303

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-08

View on ClinicalTrials.gov More Concussion, Mild Traumatic Brain Injury trials

Plain-language summary

Who can participate

Age range

8 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.