Assessing mental health risks in adolescents with mild traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop and validate a clinical tool that predicts the risk of significant new or worsening mental health conditions in adolescents aged 11 to 17 who have experienced mild traumatic brain injury (mTBI). Participants will be enrolled in the emergency department after being diagnosed with mTBI, and both the adolescent and their parent/caregiver will complete questionnaires related to mental health. The study will categorize adolescents into low, moderate, and high-risk groups based on their likelihood of developing mental health complications, while also examining disparities in care across different racial, ethnic, and socioeconomic backgrounds.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, Davis Medical Center
  Sacramento, California, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Hasbro Children's Hospital and Brown University
  Providence, Rhode Island, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Baylor College of Medicine, Texas Children's Hospital
  Houston, Texas, United States Recruiting
• The Medical College of Wisconsin, Inc.
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Daniel K Nishijima, MD, MAS — University of California, Davis
• Study coordinator: Daniel K Nishijima, MD, MAS
• Email: dnishijima@health.ucdavis.edu
• Phone: 916-734-3884

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing two therapies for insomnia in veterans with traumatic brain injury

  This study is testing whether online therapy for insomnia or mindfulness techniques can help veterans with brain injuries sleep better and feel less depressed.

  Recruiting at 5 sites Johns Hopkins University · Eglin Air Force Base, Florida and 4 other locations · NCT05663034

• Co-designed wrist-hand orthosis for children with neuromotor disorders

  In children aged 6 to 14 with neuromotor conditions after brain injury, researchers are testing a wrist-hand brace designed with input from the kids to see if it fits better and is easier to use than their current orthosis.

  Recruiting IRCCS Eugenio Medea · Bosisio Parini · NCT07861958

• Biomarkers plus guidelines to reduce unnecessary brain CTs after head injury

  This trial tests whether adding GFAP and UCH-L1 biomarker results to standard guidelines can safely reduce head CT scans in adults with suspected traumatic brain injury who come to the emergency department.

  Recruiting at 6 sites University of Michigan · Sylmar, California and 5 other locations · NCT07829107

• Hyperacute Neurobiomarker Kinetics in Acute Brain Injury: What Happens in Minutes After Injury

  This study tests how early brain injury biomarkers behave in the first minutes to hours after traumatic brain injury or cardiac arrest to see if they rise quickly enough to help with early care.

  Recruiting at 4 sites University of Pecs · Pécs, Branya and 3 other locations · NCT07782216

• 5T MRI and Metabolomics to Predict Hemorrhage Risk in Moyamoya Disease

  This study tests whether advanced 5T MRI imaging and metabolomics can help predict which moyamoya patients are at higher risk of intracranial hemorrhage.

  Recruiting Beijing Hospital · Beijing, Beijing Municipality · NCT07781579

• Pediatric Skull Fracture Detection with Ultrasound in the Emergency Department

  This study tests whether point-of-care skull ultrasound can accurately detect skull fractures in children with minor head injuries compared with CT scans.

  Recruiting Istituto Giannina Gaslini · Genova, Italy · NCT07636902

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.