Actively Recruiting
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
Eligibility Criteria
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)
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
AI-Powered 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
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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