Estrogen Effects on ADHD and Cognition

雌激素对多动症和认知的影响

基本信息

批准号：
10843375
负责人：
MICHELLE M MARTEL
金额：
$ 31.91万
依托单位：
UNIVERSITY OF KENTUCKY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-08-06 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10843375
关键词：
Adolescence Adult Affect Affective Animal Experiments Animals Attention Attention deficit hyperactivity disorder Back Basic Science Biological Biological Assay Budgets COVID-19 pandemic Childhood Clinical Cognition Cognitive Communities Data Data Collection Diagnostic Estradiol Estrogen decline Estrogens Exhibits Feasibility Studies Female Goals Gonadal Steroid Hormones Hormonal Hormones Human Impairment Impulsivity Intervention Investments Laboratories Link Longitudinal Studies Mediation Menstrual cycle Minor Neurocognitive Ovarian hormone Participant Patient Recruitments Persons Pharmaceutical Preparations Phase Prevalence Procedures Progesterone Protocols documentation Puberty Quasi-experiment Rattus Research Design Risk Risk Factors Running Sampling Short-Term Memory Symptoms Testing Thinking Titrations Translating Visit Withdrawal Woman Work animal data assigned female at birth clinical practice clinical predictors clinically significant cognitive function cognitive performance comorbidity design falls follow-up graduate student hypothalamic pituitary gonadal axis improved innovation male meetings pandemic disease participant retention perimenstrual power analysis recruit remote administration response salivary assay sex treatment response usability young adult young woman

项目摘要

This supplemental request is sought for a project for which the entire investment is at risk if the short-term longitudinal follow up of our target N is not completed. Participant recruitment and retention for the first year of the project was negatively impacted by the Covid pandemic. Specifically, laboratory protocols and procedures had just been developed when Covid began and subsequently had to be retooled to allow for remote administration with resulting slowed initial recruitment rates. However, as the pandemic has been ending, we have been able to begin making up ground with participant recruitment. We are currently running double the number of people originally projected each month. We currently have 85 participants who have completed or begun data collection and at least 60 of those participants have completed data collection and have usable data. Given we are averaging at least 6-8 additional participants per month, we expect to reach an N of 100 by the end of this final year of the project, at least 80 of whom should have usable data. Therefore, at this current rate of data collection, we project that we should need an additional 6-8 months to reach our projected N of 120, a number chosen based on power analyses to allow us to detect the small to moderate effects typically seen in hormone work. Further, allowing for anovulatory cycles or incomplete data or problems with hormone assay of any samples (which is just beginning), a full one year cushion is desirable. Pilot data and initial hormone assay results look promising, suggesting innovative effects consistent with aims, but a full N is critical to having sufficient power to conduct rigorous short term longitudinal mediation analyses. Most of the remaining budget, or approximately 500,000 of the remaining 700,000, is allocated to hormone assay and if we achieve our target N, as we are currently projected to with a one-year NCE, we will need that money for hormone assay, as well as participant pay. The critical, currently unmet need is to continue to pay study staff, namely the project coordinator, 2 graduate student RAs, and PI to be able to recruit, retain, and follow participants over one month, run diagnostic and cognitive laboratory visits, and administer the project by providing oversight and overseeing meetings respectively. These expenses are minor compared to the large remaining budget that will be used to cover paying participants and assaying saliva for hormones, core to the project aims. This investment is particularly important given the novelty and practical importance of pilot data findings, which suggest assessment of ADHD in young women needs to take into account cycle phase and that ADHD treatments, including medication, need to account for cycle changes in ADHD symptoms in women (or assigned female at birth) and associated effects on its cognitive and affective mechanisms perhaps through titration of medication or timed intervention approaches.

如果短期我们目标n的纵向随访尚未完成。参与者招募和保留第一年该项目受到共同大流行的负面影响。具体而言，实验室协议和程序刚刚开始时刚刚开发，随后必须对其进行重新进行重新处理以允许远程导致初始招聘率放缓。但是，随着大流行的结束，我们能够开始与参与者招聘构成基础。我们目前正在运行两倍最初每月投射的人数。我们目前有85名已完成或开始收集数据，其中至少60名参与者已完成数据收集并具有可用性数据。鉴于我们平均每月至少有6-8名参与者，我们希望达到100的n 该项目的最后一年结束，至少80个应该拥有可用的数据。因此，在此电流数据收集速率，我们预测我们应该再需要6-8个月才能达到我们的预计n 120，基于功率分析选择的数字，使我们能够检测到通常的中等效果在激素工作中看到。此外，允许使用无排卵周期或不完整的数据或激素问题所有样品的测定（刚刚开始），需要整整一年的垫子。试点数据和初始数据激素测定结果看起来很有希望，这表明创新效果与目标一致，但完整的N是至关重要的具有足够的能力来进行严格的短期纵向调解分析。大多数剩余的预算，或剩余700,000的剩余预算分配给激素分析，如果我们实现目标n，正如我们目前预计使用一年的NCE一样，我们将需要这笔钱激素分析以及参与者付费。目前未满足的关键需求是继续向学习人员付款，即项目协调员，2名研究生RA和PI能够招募，保留和关注参与者超过一个月，进行诊断和认知实验室访问，并通过分别提供监督和监督会议。与大型费用相比，这些费用很小剩余的预算将用于支付付费参与者并分析唾液的荷尔蒙，核心项目目标。鉴于飞行员数据的新颖性和实际重要性，这项投资尤其重要调查结果，建议对年轻女性的多动症进行评估，需要考虑周期阶段和该多动症治疗（包括药物）需要考虑女性多动症症状的周期变化（或出生时分配的女性）以及对其认知和情感机制的相关影响药物或定时干预方法的滴定。