Mother-infant Bonding During COVID-19

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531618
• Other study ID #: AAAT0140
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Ginger Atwood, BA
• Phone: 646-400-0988
• Email: ga2608[@]columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Hours to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Country	Name	City	State
United States	Morgan Stanley Children's Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Emotional Synchrony (ES) Scale	The Emotional Synchrony (ES) scale is an observational quantitative tool used to assess interactions between infants and mothers, validated by the research team. Emotional synchrony is defined as a dyadic property that emerges when mother and child function as a unit, rather than as separate individuals. Coders use a 0-100 slider scale where higher scores indicate stronger emotional connections. The 'magnetism' between a mother and child is quantified based on physical and emotional elements observed during their interaction, including mutual eye gaze or aversion, and serve-and-return conversations. ES scores are recorded at baseline and then at 4 and 6-month follow-ups by researchers observing the interactions for 2-5 minutes. Changes in scores from baseline to 6 months are analyzed for each group.	Baseline, 4 months, 6 months
Primary	Change in Maternal Caregiving Behavior Score	The quality of caregiving in the domains of Acceptance versus Rejection, Sensitivity versus Insensitivity, Consideration versus Intrusiveness, Quality of Physical Contact, Quality of Vocal contact, and Effectiveness of Response to Baby's Crying, will be each measured on a scale from 1-9, with 9 indicating higher quality caregiving. These scores will be averaged to produce a composite score (between 1-9) that is the average of all sub-scales. During each Zoom call, following the mother-infant interaction video but prior to intervention for the emotional exchange group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior.	Baseline, 4 months
Primary	Postpartum Bonding Questionnaire (PBQ)	A self-report tool that measures mother-infant bonding in the postpartum period. The PBQ targets maternal feelings, experiences, and attitudes toward her infant. Items are scored on a 6-point Likert scale (0-Always to 5-Never). The PBQ consists of four subscales; general bonding disorders (12 items; 1, 2, 6, 7, 8, 9, 10, 12, 13, 15, 16, 17), severe mother-infant relationship disorders (7 items; 3, 4, 5, 11, 14, 21, 23), infant-focused anxiety (4 items; 19, 20, 22, 25), and risk of abuse (2 items; 18, 24). The total cumulative score, ranging from 0 to 125, is used to screen for general bonding disorders (cut-off score =26), and severe bonding disturbances (cut-off score =40). A lower score indicates better bonding.	Baseline, 4 months
Secondary	Change in Ages and Stages questionnaire (ASQ-3) Score	The ASQ-3 is a validated, widely used, standardized, level 1 screening tool based on parental report that reliably assesses 5 key developmental domains: communication, fine and gross motor, problem solving, and personal-social skills. Each domain is scored between 0-60, where higher scores indicate a better outcome for each subdomain. The ASQ-3 provides cutoff scores to indicate possible delay as follows: communication, 29.65; gross motor, 22.25; fine motor, 25.14; problem solving, 27.72; and personal-social, 25.34. Scores will be assessed between groups to see if intervention group is associated with differences in ASQ-3 score.	6 months
Secondary	Change in Social-Emotional Questionnaire (ASQ-SE) Score	The ASQ-SE is a parent-completed, culturally sensitive questionnaire. It is a screening tool to identify young children who may have social and emotional development trends that warrant further evaluation. It assesses self-regulation, compliance, communication, adaptive behaviors, autonomy, affect, and interaction with people. It takes 10 to 15 minutes to complete. A total score ranging from 0-345 is calculated, where lower scores indicate better socio-emotional outcomes. Scores will be assessed between groups to see if intervention group is associated with differences in ASQ-SE score.	6 months
Secondary	Maternal Anxiety using the State/Trait Anxiety Index (STAI)	The State-Trait Anxiety Inventory-State (STAI) is a 40-item, self-report measure with sub-scales that assess both state and trait anxiety. Responses to the S-anxiety sub scale assess the intensity of their current feelings of anxiety, while responses for the T-anxiety scale assess frequency of feelings of anxiety in general. A total score that can range from 20-80 is computed such that higher scores indicated greater anxiety.	4 months
Secondary	Patient Health Questionnaire (PHQ9)	The PHQ9 is a 9-item self-report measure used to assess the presence and severity of depression. Participants indicate how frequently they experienced each of the 9 items (e.g., "Feeling down, depressed, or hopeless") in the previous two weeks. Response options were 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day). Individual item responses were summed to yield a total score (0-27), with higher scores indicating greater severity depression symptoms.	4 months
Secondary	Perceived Stress Scale (PSS)	The PSS is a 14-item self-report instrument that measures mothers' self-perceived stress. Items include questions such as "In the last month, how often have you felt nervous or "stressed"?" and "In the last month, how often have you found that you could not cope with all the things that you have had to do?" Participants respond to each item on a scale from 0 (Never) to 4 (Very often), indicating the frequency of this symptom in the last month. Items were summed to yield a total score that can range from 0-56,x where higher scores indicate greater stress.	4 months