Screening Emotions in Adolescents at the Hospital for mTBI

Conditions

• Brain Injuries
• Brain Injuries, Acute
• Brain Injury Traumatic Focal With Loss of Consciousness
• Brain Injury Traumatic Mild
• Diffuse Axonal Injury
• Head Injury
• Head Injury Trauma
• Head Injury With Intracranial Hemorrhage
• Intracranial Hemorrhages
• Skull Fractures

Eligibility Criteria

Sex

ALL

Age

11 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Validated Questionnaires — BEHAVIORAL
  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)
• Questionnaires — BEHAVIORAL
  Early Physical Activity/Return to School Questionnaire, Mental Health Utilization Questionnaire
• Clinician / Medical Record Variables — OTHER
  Medical History, Emergency Department Clinical Variables

Study Details

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.

Key Dates

Start date

May 22, 2024

Status verified

Sep 2025

Primary completion

Sep 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

2,592 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

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. ]

Central Contacts

• Daniel K Nishijima, MD, MAS
  916-734-3884
  [email protected]
• Nathan Kuppermann, MD, MPH
  916-734-1535
  [email protected]

Locations (6)

Find similar trials in Sacramento, CA

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