Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04531618
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2020-08-19
Brief Title:
Mother-infant Bonding During COVID-19
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Randomized Controlled Trial RCT of Two Programs Supporting Early Infant Development Beginning in the Well Baby Nursery Through 4 Months of Age
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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 mothers interest If the mother agrees to hear more a research assistant will visit the mothers 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 babys 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 n100 50 EE 50 NC at 6 months
The studys 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 studys 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 studys 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 ASQSE 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
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 Childrens 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 mothers interest If the mother agrees to hear more a research assistant will visit the mothers 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 babys 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 n100 50 EE 50 NC at 6 months
The studys 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 studys 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 studys 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 ASQSE 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None