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Completed
NCT04531618
Mother-infant Bonding During COVID-19
Conditions: Child Development, Mother-Infant Interaction, Relation, Parent-Child
Sex: All
Ages: 12 Hours – 72 Hours
Healthy volunteers: Yes
Phase: NA
Enrollment: 132
Sponsor: Columbia University
Location: Morgan Stanley Children's Hospital New York New York
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.
Eligibility Criteria
Inclusion Criteria:
* Mother agrees to participate in a linked study involving additional surveys and assessments
* Newborn born between 35 weeks and 40 weeks and 6 days gestational age
* Newborn is a singleton
* Mother can speak English or Spanish
Exclusion Criteria:
* Newborn born at less than 35 weeks and 0 days gestational age
* Newborn born at more than 40 weeks and 6 days gestational age
* Infant's attending physician does not recommend enrollment in the study based on newborn health concerns or diagnoses, or based on concern regarding maternal history of maternal substance abuse, severe psychiatric illness or psychosis
* Mother and/or infant has a medical condition that precludes intervention components
* Newborn is a twin or other multiple at birth
* Mother is unwilling to be video recorded
Source: ClinicalTrials.gov (NCT04531618). StuddyBuddy aggregates publicly available trial information.