Randomized Controlled Trial (RCT) of Two Programs Supporting Early Infant Development Beginning in the Well Baby Nursery Through 4 Months of Age

In 2021, the American Academy of Pediatrics shifted its focus towards early relational health (ERH) as a buffer against childhood adversity and a promoter of life-course resilience, moving away from the emphasis on childhood toxic stress. Despite recognizing the crucial role of ERH in developmental outcomes, there is a shortage of meaningful, scalable, and longitudinally impactful ERH-based interventions.

Recognizing this gap, it is imperative to develop preventative strategies that safeguard newborns and pave the way for optimal neurodevelopment. Mother-infant nurturing interactions are widely acknowledged as pivotal contributors to optimal neurodevelopmental trajectories. This intervention centers on promoting mother-infant emotional connection during the neonatal period, which is hypothesized to yield long-term benefits in ERH-based and developmental outcomes. The covid-19 pandemic has heightened the urgency of this work, as it has increased maternal stress and led to policy shifts that reduce postpartum contact between families and healthcare providers.

To conduct this study, the research team will identify potential participants among postpartum women delivered at New York-Presbyterian-affiliated Morgan Stanley Children's Hospital. Mother-infant dyads admitted to the well-baby nursery (WBN) will be invited to participate based on chart screening by trained research assistants. WBN attending pediatricians will introduce eligible participants to the study to ensure the mother's interest. If the mother agrees to hear more, a research assistant will visit the mother's room to discuss the study. If the mother agrees to take part, the research assistant will walk through the consent form and answer any questions the mother has about the study.

The study is structured into two participant groups. In the Emotional Exchange (EE) group, mothers will receive sessions focused on facilitated emotional exchanges with their infants. These sessions, conducted by a trained study staff member through Zoom, will involve storytelling and discussing emotional experiences with the baby, with prompts like sharing about the pregnancy or reactions to the baby's smiles. In contrast, the Newborn Care (NC) group will be provided with a parenting curriculum, adapted from a previous study, focusing on essential aspects of newborn care such as sleep practices, infant reflexes, and developmental milestones. These sessions will also be delivered via Zoom by a research assistant.

For both groups, the initial study visit will occur in the postpartum unit before the mothers are discharged. Subsequent sessions will be held weekly for the first four weeks and then approximately monthly until the infant reaches four months of age, all via Zoom in the comfort of the participants' homes. Each session will last between 15 to 30 minutes. Additionally, follow-up visits will involve video recording of mothers engaging in routine care interactions with their infants, such as diaper changes, to capture natural mother-infant interactions.