Assessing mental health risks in adolescents with mild traumatic brain injury
Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI (SEARCH-mTBI)
This study is trying to create a tool that helps doctors predict which teens aged 11 to 17 who have had a mild brain injury might develop new or worsening mental health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2592 (estimated) |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 6 sites (Sacramento, California and 5 other locations) |
| Trial ID | NCT06370520 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a clinical tool that predicts the risk of significant new or worsening mental health conditions in adolescents aged 11 to 17 who have experienced mild traumatic brain injury (mTBI). Participants will be enrolled in the emergency department after being diagnosed with mTBI, and both the adolescent and their parent/caregiver will complete questionnaires related to mental health. The study will categorize adolescents into low, moderate, and high-risk groups based on their likelihood of developing mental health complications, while also examining disparities in care across different racial, ethnic, and socioeconomic backgrounds.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11 to less than 18 years who have been diagnosed with mild traumatic brain injury.
Not a fit: Patients who do not meet the criteria for mild traumatic brain injury or are older than 17 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of mental health issues in adolescents following mTBI.
How similar studies have performed: Other studies have explored mental health outcomes in mTBI, but this specific approach to developing a predictive tool is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sacramento, California and 5 other locations
- University of California, Davis Medical Center — Sacramento, California, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Hasbro Children's Hospital and Brown University — Providence, Rhode Island, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Baylor College of Medicine, Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- The Medical College of Wisconsin, Inc. — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Daniel K Nishijima, MD, MAS — University of California, Davis
- Study coordinator: Daniel K Nishijima, MD, MAS
- Email: dnishijima@health.ucdavis.edu
- Phone: 916-734-3884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.