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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.

这一补充申请是为一个项目提出的，如果短期内无法实现，我们的目标N的纵向跟踪没有完成。第一年参与者的征聘和留用该项目受到新型冠状病毒疫情的负面影响。具体来说，实验室方案和程序在新冠疫情爆发时刚刚开发出来，随后不得不进行重组，以允许远程行政管理导致初始征聘率降低。然而，随着疫情的结束，我们已经能够开始弥补参与者招募的不足。我们目前正在运行两倍的每个月预计的人数。我们目前有85名参与者已经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，数据考虑到我们平均每月至少增加6-8名参与者，我们预计到2020年，在项目的最后一年结束时，至少有80人应该有可用的数据。因此，在目前数据收集的速度，我们预计，我们应该需要额外的6-8个月，以达到我们预计的N 120，根据功效分析选择的数字，使我们能够检测到典型的小到中等影响在荷尔蒙工作中看到的。此外，考虑到无排卵周期或不完整的数据或激素问题，对于任何样品的分析（这才刚刚开始），最好有整整一年的缓冲期。试验数据和初始激素测定结果看起来很有希望，表明与目标一致的创新效果，但完整的N是至关重要的有足够的权力进行严格的短期纵向调解分析。大部分剩余的预算，或剩余的700，000中的大约500，000，被分配给激素测定，如果我们为了实现我们的目标N，正如我们目前预计的那样，我们将需要这笔资金用于激素检测以及参与者薪酬。目前尚未满足的关键需求是继续支付研究人员的工资，即项目协调员，2名研究生RA和PI，以便能够招募，保留和跟踪参与者超过一个月，运行诊断和认知实验室访问，并通过以下方式管理项目：分别提供监督和监督会议。这些费用与庞大的开支相比是微不足道的剩余的预算将用于支付参与者的费用和测定唾液中的激素，这是项目目标。鉴于试点数据的新奇性和实际重要性，研究结果表明，年轻女性ADHD的评估需要考虑到周期阶段， ADHD治疗，包括药物治疗，需要考虑女性ADHD症状的周期变化， (or出生时分配为女性）及其对认知和情感机制的相关影响，可能通过药物滴定或定时干预方法。