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ACTIVE NOT RECRUITING
NCT04531618
NA

Mother-infant Bonding During COVID-19

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

This study will assess whether the promotion of emotional exchange between mother and infant during the first four months of life improves primarily mother-child early relational health (ERH) and secondarily child neurodevelopmental and maternal mental health outcomes. In prior research on preterm infants, a similar intervention demonstrated increased quality of maternal caregiving behaviors and significant improvements in premature infants' neurodevelopment across multiple domains, including social-relatedness and attention problems. The goal of the emotional exchange intervention is to help mothers provide appropriate stimulation crucial for social, emotional, and neurobehavioral development, by helping the mother and child become attuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternal sensitivity, and mother-child emotional connection will be compared between two groups: one receiving newborn parenting education and the other undergoing facilitated emotional exchange. Assessments will involve videos of mother-infant interactions during each intervention session and follow-up surveys conducted as part of a linked Institutional Review Board-approved study. Data collected in this study will contribute to understanding the underlying mechanisms of mother-infant interactions and their role in shaping optimal neurodevelopmental trajectories for infants and maternal mental health.

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

Key Details

Gender

All

Age Range

12 Hours - 72 Hours

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2024-02-14

Completion Date

2028-06-30

Last Updated

2025-05-28

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Emotional Exchange (EE)

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.

OTHER

Newborn Care (NC)

Newborn Care (NC) is a teaching curriculum designed to provide mothers with developmentally appropriate information about newborn care. The curriculum is adapted from previously studied literature that increased maternal knowledge about both medical and developmental concerns.

Locations (1)

Morgan Stanley Children's Hospital

New York, New York, United States