Clinical trial NCT04531618: Mother-infant Bonding During COVID-19
Official title: Randomized Controlled Trial (RCT) of Two Programs Supporting Early Infant Development Beginning in the Well Baby Nursery Through 4 Months of Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Development
Mother-Infant Interaction
Relation, Parent-Child
Keywords: Emotional Connection
Emotional Exchange
Early Relational Health
Newborn Care
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 132
Sex: ALL
Minimum age (years): 12
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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

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

Primary outcomes:
measure: Change in Emotional Synchrony (ES) Scale
timeFrame: Baseline, 4 months, 6 months
measure: Change in Maternal Caregiving Behavior Score
timeFrame: Baseline, 4 months
measure: Postpartum Bonding Questionnaire (PBQ)
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Change in Ages and Stages questionnaire (ASQ-3) Score
timeFrame: 6 months
measure: Change in Social-Emotional Questionnaire (ASQ-SE) Score
timeFrame: 6 months
measure: Maternal Anxiety using the State/Trait Anxiety Index (STAI)
timeFrame: 4 months
measure: Patient Health Questionnaire (PHQ9)
timeFrame: 4 months
measure: Perceived Stress Scale (PSS)
timeFrame: 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Morgan Stanley Children's Hospital
state: New York
Study officials:
affiliation: Columbia University
name: Dani Dumitriu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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