In this administrative supplement application, we propose to expand the original aims of our Florida Development in Early Childhood: Adversity and Drug Exposure (FL-DECADE) Study (R34DA050299) to accomplish NIDA research objectives related to the 2019 Novel Coronavirus (2019-nCoV, also known as COVID-19). As part of Phase I of the Healthy Brain and Child Development (HBCD) Study, the proposed activities of this supplement will provide additional information related to the feasibility of a long-term cohort study of pregnant women and children (HBCD Phase II). COVID-19 will assuredly impact families through the planned enrollment period of Phase II, thus the knowledge gained from the activities proposed in this administrative supplement are critical to the early success of the Phase II cohort. Through this administrative supplement, we will gain a broad understanding of stress and anxiety faced by pregnant and parenting women in Florida, and how their daily lives and prenatal care has changed during the pandemic. We will assess the feasibility of using a very large clinical data research network to identify pregnant women who are COVID-19 positive in the event it is decided to target this population for recruitment in Phase II. Finally, we will also test the feasibility of using innovative ways to remotely collect data from the home, which will be valuable in developing a long-term cohort study.
COVID-19, either directly or indirectly, will almost assuredly impact families for years. Thus, it is imperative to expand the scope of our original Healthy Brain and Child Development (HBCD) Phase I Study to develop an improved understanding of the impact of COVID-19 on pregnant and parenting women, and how we should potentially refocus recruitment and assessment protocols as we plan for the subsequent large Phase II cohort study. Through this supplement, we will 1) gain a broad understanding of stress and anxiety faced by pregnant and parenting women in Florida, 2) assess the feasibility of using a large clinical data research network to identify pregnant women who are COVID-19 positive, and 3) test the feasibility of using innovative ways to remotely collect data from the home.
