Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06370520

Conditions

Brain Injury Traumatic Mild

Brain Injuries

Brain Injuries, Acute

Head Injury With Intracranial Hemorrhage

Head Injury Trauma

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

Interventions

Validated Questionnaires

Questionnaires

Clinician / Medical Record Variables

Study Details

Brief summary:

The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions.

The main aims the study wish to answer are:

  • Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury?
  • Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires?

Participants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent/caregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment.

Conditions

Brain Injury Traumatic Mild

Brain Injuries

Brain Injuries, Acute

Head Injury With Intracranial Hemorrhage

Head Injury Trauma

Study ID

NCT06370520

Start date

May 22, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2592 participants

Anticipated

Interventions and Outcome Measures

Arms

Derivation Cohort

Four sites will enroll a derivation cohort (n=1512) of head-injured children. Qualified participants will complete or be evaluated with validated questionnaires. Data related to the mTBI event and the participants medical history will be recorded.

Validation Cohort

Three sites will enroll a validation cohort (n=1080) of head-injured children. Qualified participants will complete or be evaluated with validated questionnaires. Data related to the mTBI event and the participants medical history will be recorded.

Interventions

Validated Questionnaires

Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-8 (PHQ-8), The Rivermead Post Concussion Symptom Questionnaire (Rivermead), Pediatric Quality of Life Inventory (PedsQL), Strengths and Difficulties Questionnaire (SDQ)

Questionnaires

Early Physical Activity/Return to School Questionnaire, Mental Health Utilization Questionnaire

Clinician / Medical Record Variables

Medical History, Emergency Department Clinical Variables

Primary outcome measure

  • New or worsening depression or anxiety [ Time Frame: The Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-8 (PHQ-8) are measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit. ]
  • Unmet mental health care needs in patients with new or worsening depression or anxiety [ Time Frame: The Mental Health Utilization Questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit. ]

Central Contacts and Locations

Central contacts

Locations

University of California, Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Principal Investigator:

Daniel K Nishijima, MD, MAS

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Kristy Arbogast, PhD

Hasbro Children's Hospital and Brown University

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Principal Investigator:

Stephanie Ruest, MD, MPH

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Mohamad Badawy, MD

Baylor College of Medicine, Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Andrea Cruz, MD, MPH

832-824-5582acruz@bcm.edu

Principal Investigator:

Andrea Cruz, MD, MPH

The Medical College of Wisconsin, Inc.

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Danny G Thomas, MD, MPH

More Information

Sponsor

University of California, Davis

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Child
  • Concussion
  • Wounds and Injuries
  • Brain Injuries
  • Head Injuries Trauma
  • Loss of Consciousness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-09-02.