NCT06370520 Screening Emotions in Adolescents at the Hospital for mTBI
| NCT ID | NCT06370520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Brain Injury Traumatic Mild |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,592 participants |
| Start Date | 2024-05-22 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,592 participants in total. It began in 2024-05-22 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Daniel K Nishijima, MD, MAS
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06370520 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 17 Years, studying Brain Injury Traumatic Mild. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06370520 currently recruiting?
Yes, NCT06370520 is actively recruiting participants. Contact the research team at dnishijima@health.ucdavis.edu for enrollment information.
Where is the NCT06370520 trial being conducted?
This trial is being conducted at Sacramento, United States, Philadelphia, United States, Providence, United States, Dallas, United States and 2 additional locations.
Who is sponsoring the NCT06370520 clinical trial?
NCT06370520 is sponsored by University of California, Davis. The principal investigator is Daniel K Nishijima, MD, MAS at University of California, Davis. The trial plans to enroll 2,592 participants.