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RECRUITING
NCT06370520

Screening Emotions in Adolescents at the Hospital for mTBI

Sponsor: University of California, Davis

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

11 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

2592

Start Date

2024-05-22

Completion Date

2028-12

Last Updated

2025-09-26

Healthy Volunteers

Not specified

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

Locations (6)

University of California, Davis Medical Center

Sacramento, California, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Hasbro Children's Hospital and Brown University

Providence, Rhode Island, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine, Texas Children's Hospital

Houston, Texas, United States

The Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, United States