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.

项目概要 该 K23 奖项将巩固申请人进行以患者为中心的独立、 该提案的重点是针对心理健康状况的多成分膳食补充剂临床试验。 儿童注意力缺陷/多动障碍（ADHD）是早期因果路径的核心要素。 未来的抑郁症、焦虑症、药物滥用、工作和人际关系失败、慢性健康问题， 因此，自杀和过早死亡可能是对公共卫生影响最大的一个问题。 ADHD 的特点是极度的情绪失调，它是一种跨疾病且难以治疗的疾病 （愤怒、喜怒无常和易怒）。候选人已对患有多动症的儿童和成人进行了临床试验。 和情绪失调，这些都显示出含有所有已知成分的多营养素膳食补充剂的益处 维生素和必需矿物质限制了这种有前途的干预措施的范围和普遍性。 研究涵盖了大多数白人、非西班牙裔参与者；并且数据不精确； 该提案解决了这些关键问题。 提出了一项基于社区的定性研究，利用黑人和西班牙裔父母的焦点小组来征求他们的意见 有关孩子心理健康的优先事项以及参与目标 2 和 3 提案的障碍。 针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（试点临床试验）。 研究设计将根据焦点小组反馈进行测试，实时评估家长报告的行为变化。 Aim 3 根据家长确定的目标问题对孩子的家庭生物样本收集进行测试。 血液和尿液以启动免疫和神经递质生物标志物信号的检查。 发展领域与研究目标密切相关，包括社区参与和培训 确定不同社区心理健康优先事项的混合方法； 影响心理健康的神经免疫因素，以便启动生物标志物研究和专业； 包括领导力和资助写作技能在内的职业发展将发生在资源丰富的地方。 该应用程序得到了由知识分子组成的跨学科导师团队的支持。 虽然该提案侧重于多动症和情绪失调。 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生物标志物的机械信号。 该 K23 将为申请人提供培训和初步数据，以便在 R01 研究中具有竞争力 使用精细数据和生物样本收集方法在更大范围内进行有前途的多营养素干预 该应用程序将基于获奖结果，在测试生物标志物假设的同时使用不同的样本。 申请人推进一项更大的研究计划，调查患者的多成分 CIH 干预措施 心理健康诊断中情绪失调的人群。