Actively Recruiting

Age: 11Years - 17Years
All Genders
ID06370520

Screening Emotions in Adolescents Receiving Care at the Hospital for Mild Traumatic Brain Injury (SEARCH-mTBI)

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

2592

Participants Needed

6

Research Sites

13 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

Researchers are investigating mental health risks in adolescents aged 11 to less than 18 years who have experienced mild traumatic brain injury (mTBI). This observational, multicenter study aims to develop and validate a clinical tool that predicts which adolescents are more likely to develop new or worsening depression or anxiety after mTBI. The study also explores how racial, ethnic, social, and economic factors affect mental health care needs following mTBI. Participants diagnosed with mTBI in the emergency department will be enrolled and divided into two groups: a derivation cohort and a validation cohort. Both groups will complete validated questionnaires assessing anxiety, depression, quality of life, post-concussion symptoms, and behavioral functioning. Data about the injury and medical history will also be collected. Questionnaires will be completed at the emergency visit, and again approximately 30 and 90 days later. During the study, adolescents and their parents or caregivers will complete mental health questionnaires at the emergency department visit and at one and three months afterward. Researchers will measure changes in depression and anxiety, unmet mental health care needs, quality of life, persistent symptoms, and emotional or behavioral changes. The study will continue until December 2028, with assessments focused on identifying those at risk for mental health complications after mTBI.

CONDITIONS

Brief 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 aged 11 to less than 18 years
  • Meet CDC definition of mild traumatic brain injury (mTBI) with Glasgow Coma Scale score 13 to 15
  • Head injury with neurological signs or symptoms such as headache, nausea, loss of consciousness, confusion, dizziness, amnesia
  • Traumatic intracranial abnormalities on CT or MRI such as hemorrhage, skull fracture, or diffuse axonal injury (imaging not required for enrollment)
Not Eligible

You will not qualify if you...

  • Presentation to emergency department more than 72 hours after injury
  • Traumatic brain injury requiring emergency neurosurgical intervention
  • 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 the study
  • Patient or parent does not speak English or Spanish

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline visit

Participants complete validated questionnaires and provide medical history related to mild traumatic brain injury to help develop a clinical prediction tool.

1 visit (in-person at emergency department)

Long-term Monitoring

Duration - Approximately 3 months

Participants are monitored through questionnaires assessing mental health, quality of life, and symptoms at approximately 30 and 90 days after the baseline visit.

2 follow-up visits (in-person or remote) at ~30 days and ~90 days

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

N

Nathan Kuppermann, MD, MPH

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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