Estrogen Effects on ADHD and Cognition

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.