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Search / Trial NCT06370520

Screening Emotions in Adolescents at the Hospital for mTBI

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Apr 12, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Child Concussion Wounds And Injuries Brain Injuries Head Injuries Trauma Loss Of Consciousness

ClinConnect Summary

This clinical trial is focused on understanding how mild traumatic brain injuries (mTBI) can affect the mental health of adolescents aged 11 to 17 years old. The researchers want to create a tool that helps predict which young people may develop new or worsening issues like depression or anxiety after experiencing an mTBI. To do this, they will ask participants to complete questionnaires about their mental health when they visit the emergency department and then again one month and three months later. This will help identify any changes in their mood or feelings, as well as whether they are getting the mental health care they need.

Eligible participants are adolescents who have been diagnosed with an mTBI, which is defined as having a certain level of consciousness after a head injury, along with symptoms like confusion or headaches. They can also be included if they have specific brain scans showing injury. However, those with more severe injuries or who can't complete the questionnaires for any reason will not be eligible. By participating in this study, families can help researchers understand how to better support young people recovering from mTBI and ensure they receive appropriate mental health care.

Gender

ALL

Eligibility criteria

  • 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

About University Of California, Davis

The University of California, Davis (UC Davis) is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials and studies. With a strong focus on interdisciplinary collaboration, UC Davis leverages its extensive expertise in medical research, education, and patient care to drive breakthroughs in various fields, including medicine, public health, and agriculture. The university's clinical trial programs emphasize rigorous scientific methodology and ethical standards, aiming to translate research findings into impactful treatments and improved patient outcomes. Through its state-of-the-art facilities and a dedicated team of researchers and healthcare professionals, UC Davis is at the forefront of transforming healthcare practices and addressing critical health challenges.

Locations

Philadelphia, Pennsylvania, United States

Dallas, Texas, United States

Sacramento, California, United States

Houston, Texas, United States

Milwaukee, Wisconsin, United States

Providence, Rhode Island, United States

Dallas, Texas, United States

Milwaukee, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Daniel K Nishijima, MD, MAS

Principal Investigator

University of California, Davis

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported