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

优化针对患有多动症和情绪失调的种族和民族多元化儿童的多营养素研究中的研究方法

• 批准号: 10700135
• 负责人: Jeanette M Johnstone
• 金额: $ 17.49万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-07 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10700135
• 关键词: 12 year old; Academic Medical Centers; Address; Adult; Affect; Anger; Anxiety Disorders; Area; Attention deficit hyperactivity disorder; Award; Behavioral; Biological; Biological Markers; Black race; Blood; Blood capillaries; Caregivers; Caring; Cessation of life; Child; Child Behavior; Child Mental Health; Childhood; Chronic; Clinical Trials; Collaborations; Collection; Communities; Complementary Health; Conduct Clinical Trials; Data; Data Collection; Development; Devices; Diagnosis; Dietary Component; Disease; Ecological momentary assessment; Elements; Enrollment; Ensure; Evaluation; Failure; Family; Feasibility Studies; Feedback; Focus Groups; Foundations; Frequencies; Future; Goals; Grant; Health; Health Priorities; Healthcare; Hispanic; Home; Hour; Immune; Impairment; Individual; Integrative Medicine; Intervention; Intervention Studies; Investigation; K-Series Research Career Programs; Leadership; Measures; Mediator; Mental Depression; Mental Health; Mental disorders; Mentored Patient-Oriented Research Career Development Award; Mentors; Methods; Minerals; Modeling; National Center for Complementary and Integrative Health; Neurodevelopmental Disorder; Neuroimmune; Neuroimmune system; Neurotransmitters; Not Hispanic or Latino; Nutrient; Occupations; Outcome; Parents; Participant; Pathway interactions; Patients; Plasma; Population; Population Heterogeneity; Preparation; Problem behavior; Process; Protocols documentation; Public Health; Randomized, Controlled Trials; Recovery; Reporting; Research; Research Design; Research Methodology; Resources; Sampling; Self Administration; Signal Transduction; Specimen; Suicide; Supplementation; Symptoms; Testing; Theoretical model; Time; Training; Urine; Vitamins; Writing; acceptability and feasibility; addiction; behavior change; career development; community engagement; cytokine; design; dietary supplements; emotion dysregulation; ethnic diversity; improved; mindfulness; neuroinflammation; novel; open label; patient population; physical conditioning; potential biomarker; premature; programs; public health priorities; racial diversity; randomized, clinical trials; recruit; response; sample collection; side effect; skills; standard care; substance misuse

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.

项目摘要 这个K23奖将巩固申请人的能力，进行独立的病人为中心， 多组分膳食补充剂的临床试验，用于精神健康状况。该提案的重点是 注意力缺陷多动障碍（ADHD）儿童。ADHD是早期因果通路的核心要素 未来的抑郁症，焦虑症，药物滥用，工作和关系失败，慢性健康问题， 自杀和过早死亡因此，这是一个重大的公共卫生优先事项。也许是最有害的单一 多动症的一个特征是极端的情绪失调，它跨越了各种疾病，仍然很难治疗 （愤怒、喜怒无常和易怒）。候选人已经在患有ADHD的儿童和成人中进行了临床试验 和情绪失调，已经显示出有益的多营养素膳食补充剂含有所有已知的 维生素和必需矿物质。限制了这一有希望的干预措施的范围和普遍性， 研究包括大多数白色，非西班牙裔参与者;不精确的行为改变数据;和有限的 检查多营养素的作用机制。这项建议涉及这些关键问题。要求1 提出了一个以社区为基础的定性研究，使用焦点小组与黑人和西班牙裔父母，以引出他们的 儿童的心理健康和参与研究的障碍。目标2和3提出 在黑人和西班牙裔儿童中进行干预的可行性和可接受性研究（试点临床试验）。的 研究设计将参考焦点小组的反馈意见。Aim 2测试父母报告的实时行为变化 在他们的孩子基于一个有针对性的问题所确定的父母。目标3测试在家里的生物标本收集 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相关，包括社区参与培训， 确定不同社区的精神卫生优先事项的混合方法;调解人/调解人模型， 影响心理健康的神经免疫因素，以启动生物标志物调查;和专业 发展包括领导能力和赠款写作技能。职业发展将发生在资源丰富的 学术医疗中心该应用程序是由智力， 种族和人种多样的个体。虽然这项提案的重点是多动症和情绪失调， 儿童，申请人的培训和建议的结果预计将推广到CIH的研究广泛，因为 NCCIH优先考虑增加研究参与者的多样性，并检查生物标志物的机械信号。 本K23将为申请人提供培训和初步数据，以竞争R 01研究， 在一个更大的， 多样的样本，同时测试生物标志物的假设，建立在奖项的发现。该应用程序将使 申请人将推进一项更大的研究计划，调查患者的多组分CIH干预措施， 在精神健康诊断中情绪失调的人群。