This study will assess whether the promotion of emotional exchange between mother andinfant during the first four months of life improves primarily mother-child earlyrelational health (ERH) and secondarily child neurodevelopmental and maternal mentalhealth outcomes. In prior research on preterm infants, a similar interventiondemonstrated increased quality of maternal caregiving behaviors and significantimprovements in premature infants' neurodevelopment across multiple domains, includingsocial-relatedness and attention problems. The goal of the emotional exchangeintervention is to help mothers provide appropriate stimulation crucial for social,emotional, and neurobehavioral development, by helping the mother and child becomeattuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternalsensitivity, and mother-child emotional connection will be compared between two groups:one receiving newborn parenting education and the other undergoing facilitated emotionalexchange. Assessments will involve videos of mother-infant interactions during eachintervention session and follow-up surveys conducted as part of a linked InstitutionalReview Board-approved study. Data collected in this study will contribute tounderstanding the underlying mechanisms of mother-infant interactions and their role inshaping optimal neurodevelopmental trajectories for infants and maternal mental health.
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.
Upon recruitment, each subject will be assigned a unique study ID to ensure privacy. All
forms and data will use this ID instead of personal names. Information transferred from
Electronic Health Records into our study database will also be linked to the study ID.
The coding information and health record access will be restricted to the study
coordinators and the database manager. Data analysts will receive only coded data, stored
securely on a certified environment and on encrypted, password-protected devices. All
data will be kept in a secure location, accessible only to the research team.
Quality assurance will be upheld by continuous monitoring from the Columbia Institutional
Review Board (IRB). As part of the study protocol, all families will provide consent for
photography, videotaping, and audio recording for use in educational materials,
scientific publications, and professional presentations. This consent is mandatory for
participation in the study. The study includes English-speaking and Spanish-speaking
participants, and all data collected will be securely stored in Redcap, a clinical
research database designed for the safe handling of medical data.
140 dyads will be recruited into each group (EE and NC), totaling a goal of 280 total
enrolled, with a retention goal of n=100 (50 EE, 50 NC) at 6 months.
The study's analysis will employ analyses of covariance to address specific aims:
1. Primary Outcome (Specific Aim 1): Compare mother-infant early relational health,
longitudinally within and between groups over the study's duration. Measures of
emotional connection, maternal bonding, and maternal sensitivity will be considered.
2. Secondary Outcomes (Specific Aim 2): Compare maternal psychopathology and child
development longitudinally within and between groups over the study's duration.
Maternal mental health measures include State / Trait Anxiety Index (STAI),
Perceived Stress Scale (PSS), and Patient Health Questionnaire (PHQ). The Ages and
Stages questionnaires (ASQ:SE; ASQ-3) will be used to assess socioemotional and
physical development.
NOTE:
The investigators have made some major adjustments to the original protocol, which was
developed at the height of the initial first wave of the COVID-19 pandemic. These
necessary adjustments reflect the changing needs of both families and the scientific
questions asked by the RCT. The following is a list of major changes in this modification
(which have been IRB-approved);
- Initial protocol intended to replicate the Family Nurture Intervention (FNI), which
had been designed for mothers and infants in the Neonatal Intensive Care Unit
(NICU). The original FNI included components such as scent-cloth exchange and mutual
calming sessions that were tailored specifically for the NICU setting. We have
updated the protocol to isolate one component of FNI, emotional exchange, to better
suit the environment of the Well Baby Nursery (WBN)
- Rather than comparing to standard care, our control group has been updated to an
active control. Control families receive a structured newborn education curriculum.
This ensures that the time spent by participants with our study staff is consistent
across both intervention and control groups.
- The investigators have removed the EEG and EKG monitoring as primary outcomes, as we
have found it limited our ability to enroll participants.
- Major outcomes 2-7 have been concatenated into one total Maternal Caregiving
Behavior score.
- Secondary outcomes have been added to measure changes in maternal mental health and
child development
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.
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
Morgan Stanley Children's Hospital
New York, New York, United States
Investigator: Dani Dumitriu, MD, PhD
Contact: 646-774-6255
dani.dumitriu@columbia.edu
Ginger Atwood, BA
646-400-0988
ga2608@columbia.edu
Dani Dumitriu, MD, PhD
646-774-6255
dani.dumitriu@columbia.edu
Dani Dumitriu, MD, PhD, Principal Investigator
Columbia University