Screening Emotions in Adolescents at the Hospital for mTBI

Official title

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

Overview

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.

Interventions

• Behavioral Validated Questionnaires
  Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-8 (PHQ-8), The Rivermead Post Concussion Symptom Questionnaire (Rivermead), Pediatric Quality of Life Inventory (PedsQL), Strengths and Difficulties Questionnaire (SDQ)
• Behavioral Questionnaires
  Early Physical Activity/Return to School Questionnaire, Mental Health Utilization Questionnaire
• Other Clinician / Medical Record Variables
  Medical History, Emergency Department Clinical Variables

Primary outcome measures

• New or worsening depression or anxiety [Time frame: 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.]
• Unmet mental health care needs in patients with new or worsening depression or anxiety [Time frame: The Mental Health Utilization Questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.]

Secondary outcome measures (4)

• Decline in quality of life [Time frame: 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.]
• Persistent mTBI symptoms [Time frame: The Rivermead Post Concussion Questionnaire is measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.]
• New deficits in emotional/behavioral functioning or hyperactivity/inattention [Time frame: The Strengths and Difficulties Questionnaire (SDQ) is measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.]
• Parent Perception of Unmet Mental Health Needs [Time frame: The Mental Health Utilization Questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

United States · 6 centers

• University of California, Davis Medical Center — Sacramento
• Children's Hospital of Philadelphia — Philadelphia
• Hasbro Children's Hospital and Brown University — Providence
• University of Texas Southwestern Medical Center — Dallas
• Baylor College of Medicine, Texas Children's Hospital — Houston
• The Medical College of Wisconsin, Inc. — Milwaukee

Publications

• Nishijima DK, Kuppermann N, Suskauer SJ, Arbogast KB, Badawy M, Casper TC, Cruz AT, Corwin DJ, Johnson TJ, Rosenthal ED, Ruest SM, Tancredi DJ, Thomas DG, Zonfrillo MR, Slomine BS; SEARCH-mTBI Study Group. Screening Emotions in Adolescents Receiving Care at the Hospital for mild Traumatic Brain Injury (SEARCH-mTBI): protocol for a multicenter observational study. BMC Pediatr. 2026 Apr 7;26(1):450. PMID 41943020

Identifiers

NCT: NCT06370520 · 2122025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗