Actively Recruiting

Age: 11Years - 17Years
All Genders
NCT06370520

Screening Emotions in Adolescents at the Hospital for mTBI

Led by University of California, Davis · Updated on 2025-09-26

2592

Participants Needed

6

Research Sites

236 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

P

Pediatric Emergency Care Applied Research Network

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Screening Emotions in Adolescents at the Hospital for mTBI

Who Can Participate

Age: 11Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children 11 to less than 18 years old who meet the CDC definition of mild traumatic brain injury (mTBI)
  • Glasgow Coma Scale (GCS) score of 13 to 15
  • Head injury with neurological signs/symptoms such as headache, nausea, loss of consciousness, confusion, dizziness, or amnesia
  • Or traumatic intracranial abnormalities on CT or MRI (e.g., hemorrhage, skull fracture, diffuse axonal injury)
Not Eligible

You will not qualify if you...

  • Presentation to the emergency department more than 72 hours after injury
  • Traumatic brain injury requiring emergency neurosurgical intervention at enrollment
  • Other injuries requiring emergency surgery at enrollment
  • Parent or child unable to complete study questionnaires due to severe developmental delay or functional limitations
  • Previous enrollment in this study
  • Patient or parent does not speak English or Spanish

AI-Screening

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Trial Site Locations

Total: 6 locations

1

University of California, Davis Medical Center

Sacramento, California, United States, 95817

Actively Recruiting

2

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

3

Hasbro Children's Hospital and Brown University

Providence, Rhode Island, United States, 02903

Actively Recruiting

4

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

5

Baylor College of Medicine, Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

6

The Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

D

Daniel K Nishijima, MD, MAS

CONTACT

N

Nathan Kuppermann, MD, MPH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Screening Emotions in Adolescents at the Hospital for mTBI | DecenTrialz