Observational Study to Predict Mental Health Risks in Adolescents Aged 11 to 17 After Mild Traumatic Brain Injury
Led by University of California, Davis · Updated on 2025-09-26
2592
Participants Needed
6
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating mental health risks in adolescents aged 11 to less than 18 years who have experienced mild traumatic brain injury mTBI. This observational, multicenter study aims to develop and validate a clinical tool that predicts which adolescents are more likely to develop new or worsening depression or anxiety after mTBI. The study also explores how racial, ethnic, social, and economic factors affect mental health care needs following mTBI.
Participants diagnosed with mTBI in the emergency department will be enrolled and divided into two groups a derivation cohort and a validation cohort. Both groups will complete validated questionnaires assessing anxiety, depression, quality of life, post-concussion symptoms, and behavioral functioning. Data about the injury and medical history will also be collected. Questionnaires will be completed at the emergency visit, and again approximately 30 and 90 days later.
During the study, adolescents and their parents or caregivers will complete mental health questionnaires at the emergency department visit and at one and three months afterward. Researchers will measure changes in depression and anxiety, unmet mental health care needs, quality of life, persistent symptoms, and emotional or behavioral changes. The study will continue until December 2028, with assessments focused on identifying those at risk for mental health complications after mTBI.
CONDITIONS
Brief Title
Screening Emotions in Adolescents at the Hospital for mTBI
Research Team
D
Daniel K Nishijima, MD, MAS
N
Nathan Kuppermann, MD, MPH
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Other injuries requiring emergency surgery at enrollment
Parent or child unable to complete study questionnaires due to severe developmental delay or functional limitations
Previous enrollment in the study
Patient or parent does not speak English or Spanish
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline visit
Participants complete validated questionnaires and provide medical history related to mild traumatic brain injury to help develop a clinical prediction tool.
1 visit (in-person at emergency department)
Long-term Monitoring
Duration - Approximately 3 months
Participants are monitored through questionnaires assessing mental health, quality of life, and symptoms at approximately 30 and 90 days after the baseline visit.
2 follow-up visits (in-person or remote) at ~30 days and ~90 days
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Screening Emotions in Adolescents Receiving Care at the Hospital for mild Traumatic Brain Injury (SEARCH-mTBI): protocol for a multicenter observational study.
Daniel K Nishijima, Nathan Kuppermann, Stacy J Suskauer...