Screening Emotions in Adolescents with Mild Brain Injury
Screening Emotions in Adolescents at the Hospital for mTBI
Recruiting
Observational Study
Brain Injury Traumatic MildBrain InjuriesBrain Injuries, AcuteHead Injury With Intracranial HemorrhageHead Injury TraumaBrain Injury Traumatic Focal With Loss of ConsciousnessSkull FracturesDiffuse Axonal InjuryIntracranial HemorrhagesHead Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
11 – 17
Sex
Any
Study type
Observational
Participants needed
2,592 (estimated)
Sponsor
University of California, Davis · Other
Who this trial is looking for
This trial is looking for teenagers aged 11 to under 18 who have had a mild brain injury. Taking part involves filling out questionnaires about mental health at the hospital and again one and three months later.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 11 and less than 18 years old.
I have been diagnosed with a mild traumatic brain injury.
I have a Glasgow Coma Scale score of 13 to 15.
I experienced symptoms like headache, nausea, or confusion after my injury.
I may have brain injury findings on a CT or MRI.
I can complete questionnaires with my parent or caregiver.
You may not be able to join if
I went to the emergency department more than 72 hours after my injury.
I need immediate surgery for my injury.
I or my parent cannot fill out the questionnaires accurately due to limitations.
I have been part of this study before.
I do not speak English or Spanish.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.