# RFA-CE-23-008, Development and Validation of a Clinical Tool to Predict Mental Health Sequelae After Mild TBI in Adolescents

> **NIH ALLCDC U01** · UNIVERSITY OF CALIFORNIA AT DAVIS · 2023 · $550,000

## Abstract

PROJECT SUMMARY/ABSTRACT
Prior studies demonstrate that 25-50% of adolescents with mild traumatic brain injuries (mTBIs) have
substantial mental health sequelae during their recoveries. Moreover, 31-78% of children with TBI who have
new or worsening mental health concerns are not receiving appropriate mental health care, with racial, ethnic,
and economic inequities existing in post-TBI management and outcomes. While a substantial number of
children experience ongoing or worsening mental health concerns in the first three months after mTBI, there
are no validated prognostic tools to assess risk of ongoing or worsening mental health concerns in these
patients. Our objective is to develop and validate a clinical tool to predict mental health sequelae in
adolescents after mTBI. We will conduct a multicenter, prospective observational study in six PECARN
(Pediatric Emergency Care Applied Research Network) emergency departments (EDs). We will enroll a
derivation cohort (n=1512) at four sites and a validation cohort (n=1080) at two sites. Patients will be enrolled
in EDs and have follow-up evaluations at 1 to 2 weeks, 1 month, and 3 months after the index ED visit. The
primary outcome is a composite self-report measure of new or worsening mental health sequelae (based on
minimal clinically important difference) 1 to 3 months after mTBI as measured by the Generalized Anxiety
Disorder-7 and the Patient Health Questionnaire-8. We will also measure unmet mental health care needs,
defined as not receiving any mental or behavioral health care in patients with new or worsening anxiety or
depression. We selected sites with large numbers of children with mTBI and a high proportion of children from
diverse backgrounds. Our study has the potential to impact the health and wellbeing of injured children
worldwide. The results will be immediately significant, affecting both clinical practice, guidelines, and policy.
The study will be conducted at PECARN sites, with the PECARN data coordinating center, and a centralized
mental health outcome core, leveraging existing resources and investigators with multicenter, pediatric
emergency care clinical prediction tool development experience.

## Key facts

- **NIH application ID:** 10768334
- **Project number:** 1U01CE003573-01
- **Recipient organization:** UNIVERSITY OF CALIFORNIA AT DAVIS
- **Principal Investigator:** Daniel Kiden Nishijima
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2023
- **Award amount:** $550,000
- **Award type:** 1
- **Project period:** 2023-09-30 → 2028-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10768334

## Citation

> US National Institutes of Health, RePORTER application 10768334, RFA-CE-23-008, Development and Validation of a Clinical Tool to Predict Mental Health Sequelae After Mild TBI in Adolescents (1U01CE003573-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10768334. Licensed CC0.

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