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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other, Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 17
View:

• 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.

Locations
United States
California
University of California, Davis Medical Center
RECRUITING
Sacramento
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Rhode Island
Hasbro Children's Hospital and Brown University
RECRUITING
Providence
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Baylor College of Medicine, Texas Children's Hospital
RECRUITING
Houston
Wisconsin
The Medical College of Wisconsin, Inc.
RECRUITING
Milwaukee
Contact Information
Primary
Daniel K Nishijima, MD, MAS
dnishijima@health.ucdavis.edu
916-734-3884
Backup
Nathan Kuppermann, MD, MPH
nkuppermann@health.ucdavis.edu
916-734-1535
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2028-12
Participants
Target number of participants: 2592
Treatments
Derivation Cohort
Four sites will enroll a derivation cohort (n=1512) of head-injured children. Qualified participants will complete or be evaluated with validated questionnaires. Data related to the mTBI event and the participants medical history will be recorded.
Validation Cohort
Three sites will enroll a validation cohort (n=1080) of head-injured children. Qualified participants will complete or be evaluated with validated questionnaires. Data related to the mTBI event and the participants medical history will be recorded.
Related Therapeutic Areas
Sponsors
Leads: University of California, Davis
Collaborators: Pediatric Emergency Care Applied Research Network

This content was sourced from clinicaltrials.gov