Screening Emotions in Adolescents at the Hospital for mTBI

Last updated: September 22, 2025
Sponsor: University of California, Davis
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Hemorrhage

Neurologic Disorders

Treatment

Questionnaires

Clinician / Medical Record Variables

Validated Questionnaires

Clinical Study ID

NCT06370520
2122025
  • Ages 11-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 topreexisting functional limitations (e.g., severe developmental delay)

  • Previous known enrollment into the study

  • Patient or parent does not speak English or Spanish

Study Design

Total Participants: 2592
Treatment Group(s): 3
Primary Treatment: Questionnaires
Phase:
Study Start date:
May 22, 2024
Estimated Completion Date:
December 31, 2028

Study Description

This is an observational, multicenter study to develop and validate a clinical tool to predict mental health problems in adolescents (after mild traumatic brain injuries (mTBI).

The primary objective of the study is to develop and validate a clinical tool to predict which adolescents with mTBIs are at an increased risk for developing significant new or worsening mental health conditions. The investigators believe that at completion of this study they will have developed and validated a clinical prediction tool that will help clinicians define adolescents with mTBIs by risk of follow up mental health complications into low, moderate, and high-risk categories. This will provide clinicians with distinct risk categories on which make decisions about an adolescents care.

The investigators will also evaluate racial, ethnic, and social and economic differences in post-mTBI management across diverse populations of adolescents with mTBIs. The investigators believe that specific racial, ethnic, social, and economical characteristics will also be associated with unmet mental health needs in adolescents with mTBIs.

Connect with a study center

  • University of California, Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California, Davis Medical Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Hasbro Children's Hospital and Brown University

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Hasbro Children's Hospital and Brown University

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center - Children's Health

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine, Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • Baylor College of Medicine, Texas Children's Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Children's Hospital of Wisconsin-Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • The Medical College of Wisconsin, Inc.

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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