Clinical trial NCT06370520: Screening Emotions in Adolescents at the Hospital for mTBI
Official title: Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI (SEARCH-mTBI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: Child
Concussion
Wounds and Injuries
Brain Injuries
Head Injuries Trauma
Loss of Consciousness
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Pediatric Emergency Care Applied Research Network
First posted: 2024-04-17
Enrollment: 2592
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are injured children aged 11 to 17 years old who present with a Mild traumatic brain injury (mTBI), including concussion, as defined by the Centers for Disease Control and Prevention as an acute brain injury resulting in neurological symptoms such as confusion or disorientation, loss of consciousness, amnesia, seizure, or other signs or symptoms combined with a Glasgow Coma Scale (GCS) score of 13 to 15 to one of six emergency departments (EDs) throughout the United States.

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.

Detailed description: 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.

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

Primary outcomes:
measure: New or worsening depression or anxiety
timeFrame: The Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-8 (PHQ-8) are measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
measure: Unmet mental health care needs in patients with new or worsening depression or anxiety
timeFrame: The Mental Health Utilization Questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
Secondary outcomes:
measure: Decline in quality of life
timeFrame: The Pediatric Quality of Life Inventory Questionnaire (PedsQL) is measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
measure: Persistent mTBI symptoms
timeFrame: The Rivermead Post Concussion Questionnaire is measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
measure: New deficits in emotional/behavioral functioning or hyperactivity/inattention
timeFrame: The Strengths and Difficulties Questionnaire (SDQ) is measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
measure: Parent Perception of Unmet Mental Health Needs
timeFrame: The Mental Health Utilization Questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Hasbro Children's Hospital and Brown University
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Texas Children's Hospital
state: Texas
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin, Inc.
state: Wisconsin
Study officials:
affiliation: University of California, Davis
name: Daniel K Nishijima, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: