Optimizing Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children with ADHD and Emotional Dysregulation

项目总结 这项K23奖项将巩固申请者进行以患者为中心的独立、 多组分膳食补充剂对精神健康状况的临床试验。这项提案的重点是 儿童的注意力缺陷/多动障碍(ADHD)。ADHD是早期致病途径中的一个中心因素 未来的抑郁症，焦虑症，滥用药物，工作和关系失败，慢性健康问题， 自杀和过早死亡。因此，这是一项重大的公共卫生优先事项。可能是最令人不快的单曲 ADHD的特点是极度的情绪调节失调，它跨越了各种障碍，仍然很难治疗 (愤怒、喜怒无常和易怒)。这位候选人已经在患有ADHD的儿童和成人身上进行了临床试验 和情绪失调，已经显示出对含有所有已知的 维生素和必需矿物质。限制了这一有希望的干预措施的覆盖范围和推广能力，以前的 研究包括大多数非西班牙裔白人参与者；不准确的行为改变数据；以及有限的 检查多种营养素的作用机制。这项提案解决了这些关键问题。目标1 提出了一项基于社区的定性研究，使用黑人和西班牙裔父母的焦点小组来引发他们的 优先考虑其子女的心理健康和参与研究的障碍。目标2和目标3提出 对黑人和西班牙裔儿童进行干预的可行性和可接受性研究(试行临床试验)。这个 研究设计将由焦点小组反馈通知。AIM 2测试实时父母报告的行为变化 根据父母确定的有针对性的问题在他们的孩子身上。AIM 3测试在家收集的生物样品 以启动免疫和神经递质生物标志物信号的检查。职业生涯 发展领域与研究目标密切一致，并包括社区参与和 确定不同社区心理健康优先事项的混合方法；调解人/调解人模式和 影响心理健康的神经免疫因素，以启动生物标记物调查；以及专业 发展包括领导力和资助金撰写技能。职业发展将发生在资源丰富的地方 学术医学中心。该应用程序得到了一个跨学科的智力指导团队的支持， 种族和民族多元化的个人。虽然这项建议关注的是ADHD和情绪失调 对于儿童，申请人的培训和提案结果预计将广泛推广到CIH研究，因为 NCCIH优先考虑增加研究参与者的多样性，并检查机械信号的生物标记物。 K23将为申请者提供培训和初步数据，使其具有竞争力，以进行R01研究 前景看好的多营养素干预使用精炼数据和生物样品收集方法在更大范围内， 多样化的样本，同时测试生物标记物假说，建立在奖项发现的基础上。此应用程序将启用 申请推进一项更大规模的研究计划，为患者调查多组分的CIH干预 精神健康诊断中情绪失调的人群。

PROJECT SUMMARY This K23 award will solidify the applicant’s capacity to conduct independent patient-focused, multicomponent dietary supplement clinical trials for mental health conditions. This proposal focuses on attention-deficit/hyperactivity disorder (ADHD) in children. ADHD is a central element in an early causal pathway to future depression, anxiety disorders, substance misuse, job and relationship failures, chronic health problems, suicide, and premature death. It is, therefore, a major public health priority. Perhaps the most impairing single feature of ADHD, which cuts across disorders and remains difficult to treat, is extreme emotional dysregulation (anger, moodiness, and irritability). The candidate has conducted clinical trials in children and adults with ADHD and emotional dysregulation that have shown benefit for a multinutrient dietary supplement containing all known vitamins and essential minerals. Limiting the reach and generalizability of this promising intervention, previous studies have included a majority of white, non-Hispanic participants; imprecise behavior change data; and limited examination of the multinutrients’ mechanisms of action. This proposal addresses these key issues. Aim 1 proposes a community-based, qualitative study using focus groups with Black and Hispanic parents to elicit their priorities concerning their child’s mental health and barriers to participation in research. Aims 2 and 3 propose a feasibility and acceptability study (pilot clinical trial) of the intervention in Black and Hispanic children. The study design will be informed by focus group feedback. Aim 2 tests real-time parent-reported behavior change in their child based on a targeted problem identified by the parent. Aim 3 tests the at-home biospecimen collection of blood and urine to initiate an examination of immune and neurotransmitter biomarker signals. Career development areas align closely with the research aims, and include training in community engagement and mixed methods to identify mental health priorities of diverse communities; mediator/moderator models and neuroimmune factors that affect mental health in order to initiate biomarker investigation; and professional development including leadership and grant writing skills. Career development will occur at a resource-rich academic medical center. The application is bolstered by an interdisciplinary mentor team of intellectually, racially, and ethnically diverse individuals. While this proposal focuses on ADHD and emotional dysregulation in children, the applicant’s training and proposal results are expected to generalize to CIH research broadly, as the NCCIH prioritizes increasing research participant diversity and examining biomarkers for mechanistic signals. This K23 will provide the applicant with the training and preliminary data to be competitive for an R01 study of the promising multinutrient intervention using refined data and biospecimen collection methods in a larger, diverse sample while testing biomarker hypotheses, building on the award findings. This application will enable the applicant to advance a larger program of research investigating multicomponent CIH interventions for patient populations with emotional dysregulation across mental health diagnoses.