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Teen brain injury study seeks to predict hidden mental health risks

NCT ID NCT06370520

Knowledge-focused Sponsor: University of California, Davis Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study follows over 2,500 teens aged 11 to 17 who come to the emergency room with a mild traumatic brain injury (mTBI). Researchers want to see if they develop new or worsening depression or anxiety in the months after injury. Teens and their parents fill out questionnaires about mood, symptoms, and quality of life at the ER visit, then again at one and three months later. The goal is to create a tool that flags those at highest risk, so they can get mental health support sooner.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a screening tool that helps doctors identify teens at risk for mental health issues after a mild brain injury, enabling early support.
What could go wrong
This is an observational study, not testing a treatment. It may not find clear predictors, and results might not apply to all teens or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,592 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants are injured children aged 11 to 17 years old who present with a Mild traumatic brain injury (mTBI), including concussion, as defined by the Centers for Disease Control and Prevention as an acute brain injury resulting in neurological symptoms such as confusion or disorientation, loss of consciousness, amnesia, seizure, or other signs or symptoms combined with a Glasgow Coma Scale (GCS) score of 13 to 15 to one of six emergency departments (EDs) throughout the United States.

Ages

11 to 17 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Children 11 to less than 18 years old who meet the Centers for Disease Control and Prevention (CDC) definition of mTBI\*. In brief, this is defined as a Glasgow Coma Scale (GCS) score of 13 to 15 with: \- Head injury (e.g., direct blow or sudden deceleration/acceleration) plus any neurological sign and/or symptom such as headache, nausea, history of loss of consciousness, confusion, dizziness, amnesia (not limited to these symptoms/signs) AND/OR \- Traumatic intracranial abnormalities on CT or MRI (such as intracranial hemorrhage, skull fracture, or diffuse axonal injury) \*mTBI is defined as an acute brain injury resulting in neurological symptoms such as confusion or disorientation, headache, nausea, loss of consciousness, amnesia, seizure, focal signs or symptoms, and/or have traumatic intracranial abnormalities on CT or MRI imaging. mTBI patients have GCS scores of 13 to 15. Per CDC precedent, we will use the term mTBI which encompasses other commonly used terms such as "concussion" or "minor head injury". This will include patients who may have neuroimaging findings of traumatic abnormalities (e.g., intracranial hemorrhage, diffuse axonal injury, skull fractures) which are risk factors for mental health problems; however, neuroimaging is not required for enrollment into the study. Exclusion Criteria: * Presentation to the ED \>72 hours post-injury * TBI requiring emergent neurosurgical intervention at the time of enrollment * Other injuries requiring emergent surgery at the time of enrollment * Parent or child unable to accurately complete the study questionnaires due to preexisting functional limitations (e.g., severe developmental delay) * Previous known enrollment into the study * Patient or parent does not speak English or Spanish

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Conditions

The condition(s) this trial relates to.

Brain Concussion brain injury Craniocerebral Trauma Diffuse Axonal Injury head injury injury intracerebral hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Skull Fractures traumatic brain injury Unconsciousness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain injuries Brain injuries, acute Brain injury traumatic focal with loss of consciousness Brain injury traumatic mild Diffuse axonal injury Head injury Head injury trauma Head injury with intracranial hemorrhage Intracranial hemorrhages Skull fractures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine, Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Hasbro Children's Hospital and Brown University

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • The Medical College of Wisconsin, Inc.

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • University of California, Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

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