This study is not yet accepting patients

Screening Emotions in Adolescents at the Hospital for mTBI

a study on Brain Injury Intracranial Hemorrhage Head Injury Trauma Skull Fractures Diffuse Axonal Injury Head Injury Traumatic Brain Injury

Summary

Eligibility
for people ages 11-17 (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Daniel K Nishijima, MD, MAS (ucdavis)

Description

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.

Official Title

Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI (SEARCH-mTBI)

Details

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.

Keywords

Brain Injury Traumatic Mild, Brain Injuries, Brain Injuries, Acute, Head Injury With Intracranial Hemorrhage, Head Injury Trauma, Brain Injury Traumatic Focal With Loss of Consciousness, Skull Fractures, Diffuse Axonal Injury, Intracranial Hemorrhages, Head Injury, Child, Concussion, Wounds and Injuries, Head Injuries Trauma, Loss of Consciousness, Craniocerebral Trauma, Unconsciousness, Traumatic Brain Injuries, Traumatic Intracranial Hemorrhage, Hemorrhage, Clinician / Medical Record Variables

Eligibility

You can join if…

Open to people ages 11-17

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

*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.

You CAN'T join if...

  • 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

Locations

  • University of California, Davis Medical Center
    Sacramento California 95817 United States
  • University of Texas Southwestern Medical Center
    Dallas Texas 75390 United States

Lead Scientist at University of California Health

  • Daniel K Nishijima, MD, MAS (ucdavis)
    Professor, Emergency Medicine, School of Medicine. Authored (or co-authored) 120 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06370520
Study Type
Observational
Participants
Expecting 2592 study participants
Last Updated