Screening Emotions in Adolescents at the Hospital for mTBI

NCT06370520 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2592

Last updated 2025-09-26

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • Pediatric Emergency Care Applied Research Network

    collaborator NETWORK
  • University of California, Davis

    lead OTHER

Principal Investigators

  • Daniel K Nishijima, MD, MAS · University of California, Davis

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-22
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06370520 on ClinicalTrials.gov