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Mother-infant Bonding During COVID-19

NCT04531618 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-05-28

No results posted yet for this study

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.

Conditions

  • Child Development
  • Mother-Infant Interaction
  • Relation, Parent-Child

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.

Sponsors & Collaborators

Principal Investigators

  • Dani Dumitriu, MD, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2026-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531618 on ClinicalTrials.gov