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

RFA-CE-23-008，开发和验证用于预测青少年轻度 TBI 后心理健康后遗症的临床工具

• 批准号: 10768334
• 负责人: Daniel Kiden Nishijima
• 金额: $ 55万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2028-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10768334
• 关键词: RFA; CE; 23; 008; Development

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.

项目总结/摘要 先前的研究表明，25-50%患有轻度创伤性脑损伤（mTBI）的青少年 严重的精神健康后遗症。此外，31-78%患有TBI的儿童 新的或恶化的精神健康问题没有得到适当的精神卫生保健，种族，民族， 以及TBI后管理和结果中存在的经济不平等。虽然大量的 儿童在mTBI后的前三个月内经历持续或恶化的心理健康问题， 没有经过验证的预后工具来评估这些患者正在进行或恶化的心理健康问题的风险。 患者我们的目标是开发和验证一种临床工具来预测精神健康后遗症， mTBI后的青少年我们将在6个PECARN中进行一项多中心、前瞻性观察性研究。 （儿科急诊应用研究网络）急诊科（ED）。我们将招收一名 4个研究中心的推导队列（n=1512）和2个研究中心的验证队列（n=1080）。患者将入组 并在首次艾德访视后1 - 2周、1个月和3个月进行随访评价。的 主要结局是新的或恶化的心理健康后遗症的复合自我报告测量（基于 mTBI后1至3个月的最小临床重要差异），如通过广泛性焦虑测量的 疾病-7和患者健康问卷-8。我们还将衡量未满足的精神卫生保健需求， 定义为患有新发或恶化焦虑症的患者未接受任何精神或行为健康护理，或 萧条我们选择了大量mTBI儿童和高比例儿童的研究中心， 不同的背景我们的研究有可能影响受伤儿童的健康和福祉 国际吧结果将立即显着，影响临床实践，指南和政策。 本研究将在PECARN研究中心进行，由PECARN数据协调中心和一个集中的 心理健康结果核心，利用现有资源和研究者，多中心，儿科 急救护理临床预测工具开发经验。