ENRICH-2: Stress-Reactivity and Self-Regulation in Infants with Prenatal Alcohol Exposure

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SUMMARY/ABSTRACT The new clinical guidelines for diagnosing Fetal Alcohol Spectrum Disorders (FASD) list self-regulation as one of the key behavioral deficits in children affected by prenatal alcohol exposure (PAE). There is a fundamental gap in knowledge about the underlying mechanisms, spectrum, and severity of such deficits early in life and the best analytical approaches to identify them. In addition, the effect of prenatal stress and postnatal environment on PAE-induced alterations is poorly understood. The primary focus of the parent Ethanol, Neurodevelopment, Infant, and Child Health 2 (ENRICH-2) study is on identification of neurobehavioral deficits associated with PAE early in life. This administrative supplement will allow us to examine the comorbid effect of COVID-19 pandemic and alcohol use on adverse maternal and infant outcomes in this cohort. The long-term goal of this supplement is to characterize the psycho-social effect of COVID-19 pandemic on adverse outcomes, including alcohol use, in a longitudinal birth cohort study, thus providing the foundation for future intervention studies. The objective of this supplement is to comprehensively evaluate the effect of COVID-19 related stress in pregnant and postpartum women enrolled in the ENRICH-2 cohort. We will evaluate this by adding state-of-the-art self- reported measures integrated with real-time physiological data that are not currently part of the funded parent study. The rationale for this supplement is driven by the gap in knowledge about the effect of the COVID-19 pandemic on psychosocial outcomes, alcohol use, and stress-related physical outcomes in pregnant and postpartum women, a vulnerable population disproportionately affected. We will address this gap in knowledge by pursuing two specific aims which evaluate the effect of COVID-19 on adverse maternal and infant outcomes in the ENRICH-2 cohort: 1) psychosocial outcomes and alcohol use, assessed as COVID-19 stress related to exposures and symptoms, COVID-19 pandemic adjustment, emotion regulation, mother-infant attachment, and alcohol consumption and 2) physiologic outcomes assessed as heart rate variability and sleep patterns, evaluated by wearable electronics – an approach particularly novel in the current social distancing environment. This approach is highly innovative, and will allow for the objective, real-time data collection in the climate of prolonged social distancing and challenges associated with face-to-face research visits in vulnerable populations. A detailed characterization of COVID-19 related outcomes in pregnant and postpartum women, effect of COVID-related social isolation and other hardships on mental health and alcohol use, as well as the cumulative effect on pediatric neurodevelopmental outcomes are highly significant in order to lay out the foundation for early effective interventions to mitigate the effects in these vulnerable populations.