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โ† Trials
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Screening Emotions in Adolescents at the Hospital for mTBI

Recruitingn/aAges 11 Years - 17 YearsAllUniversity of California, Davis
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 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 to preexisting functional limitations (e.g., severe developmental delay) * Previous known enrollment into the study * Patient or parent does not speak English or Spanish
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What it tests

  • Validated Questionnaires
  • Questionnaires
  • Clinician / Medical Record Variables
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Where

6 sites
University of California, Davis Medical Center
Sacramento, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Hasbro Children's Hospital and Brown University
Providence, United States
University of Texas Southwestern Medical Center
Dallas, United States
Baylor College of Medicine, Texas Children's Hospital
Houston, United States
The Medical College of Wisconsin, Inc.
Milwaukee, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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