About this trial

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

Qualifiers

None

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Validated Questionnaires
  • Questionnaires
  • Clinician / Medical Record Variables

Treatment groups

2,592 Participants
are divided into 2 treatment groups

Locations

6
University of California, Davis Medical Center95817, SacramentoCalifornia, United States
Children's Hospital of Philadelphia19104, PhiladelphiaPennsylvania, United States
Hasbro Children's Hospital and Brown University02903, ProvidenceRhode Island, United States
University of Texas Southwestern Medical Center75390, DallasTexas, United States

Sponsors and collaborators

University of California, Davis

Lead sponsor

Pediatric Emergency Care Applied Research Network

Collaborator