Child DevelopmentNCT04531618
Mother-infant Bonding During COVID-19
A study testing Emotional Exchange (EE) and Newborn Care (NC) in people with Child Development and Mother-Infant Interaction, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Child Development, Mother-Infant Interaction, Relation, Parent-Child
- What is being tested?
- Emotional Exchange (EE) and Newborn Care (NC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 17 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Morgan Stanley Children's Hospital
New York, New York, 10032
About this study
Official title: Randomized Controlled Trial (RCT) of Two Programs Supporting Early Infant Development Beginning in the Well Baby Nursery Through 4 Months of Age
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.
Read the 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:
- 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.
- 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
- Being tested
- Emotional Exchange (EE), Newborn Care (NC)
- Keywords
- Emotional Connection, Emotional Exchange, Early Relational Health, Newborn Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Exchange (EE)Behavioural
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.
Newborn Care (NC)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Exchange (EE) | Experimental | Receives a facilitated emotional exchange session over Zoom in the Well Baby Nursery and up to 7 subsequent Zoom sessions over the next 4 months. Receives: Behavioral: Emotional Exchange (EE) |
| Newborn Care (NC) | Active comparator | Receives didactic newborn parenting education delivering developmentally appropriate content over zoom at the same time points as the emotional exchange group. Receives: Other: Newborn Care (NC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 months, 6 months
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.
Measured: Baseline, 4 months
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.
Measured: Baseline, 4 months
Secondary outcomes (5)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start14 Feb 2024
- Primary completion6 Aug 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dani Dumitriu, Columbia University
- Investigators
- Dani Dumitriu, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531618
- Sponsor's protocol ID
- AAAT0140
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2020
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abidin RR. Parenting stress and the utilization of pediatric services. Child Health Care. 1983 Fall;11(2):70-3. doi: 10.1207/s15326888chc1102_5.
PubMed 10262147Achenbach TM, Rescorla L. Manual for the ASEBA Preschool Forms &Amp; Profiles: an Integrated System of Multi-Informant Assessment. Burlington, VT: ASEBA; 2000.
Als, H. Reading the premature infant. In: Nurturing the Premature Infant: Developmental Interventions in the Neonatal Intensive Care Nursery. New York: Oxford University Press; 1999.
Bailey RC, Kamenga MC, Nsuami MJ, Nieburg P, St Louis ME. Growth of children according to maternal and child HIV, immunological and disease characteristics: a prospective cohort study in Kinshasa, Democratic Republic of Congo. Int J Epidemiol. 1999 Jun;28(3):532-40. doi: 10.1093/ije/28.3.532.
PubMed 10405861Benasich AA, Thomas JJ. Developmental Disorders of Language. Encyclopedia of Cognitive Science Nadel/Cognitive. 2006.
Boivin MJ, Maliwichi-Senganimalunje L, Ogwang LW, Kawalazira R, Sikorskii A, Familiar-Lopez I, Kuteesa A, Nyakato M, Mutebe A, Namukooli JL, Mallewa M, Ruisenor-Escudero H, Aizire J, Taha TE, Fowler MG. Neurodevelopmental effects of ante-partum and post-partum antiretroviral exposure in HIV-exposed and uninfected children versus HIV-unexposed and uninfected children in Uganda and Malawi: a prospective cohort study. Lancet HIV. 2019 Aug;6(8):e518-e530. doi: 10.1016/S2352-3018(19)30083-9. Epub 2019 May 20.
PubMed 31122797Brunelli SA, Curley JP, Gudsnuk K, Champagne FA, Myers MM, Hofer MA, Welch MG. Variations in maternal behavior in rats selected for infant ultrasonic vocalization in isolation. Horm Behav. 2015 Sep;75:78-83. doi: 10.1016/j.yhbeh.2015.08.007. Epub 2015 Aug 22.
PubMed 26306860Cassidy AR, Williams PL, Leidner J, Mayondi G, Ajibola G, Makhema J, Holding PA, Powis KM, Batlang O, Petlo C, Shapiro R, Kammerer B, Lockman S. In Utero Efavirenz Exposure and Neurodevelopmental Outcomes in HIV-exposed Uninfected Children in Botswana. Pediatr Infect Dis J. 2019 Aug;38(8):828-834. doi: 10.1097/INF.0000000000002332.
PubMed 30985518Cesari M, Penninx BW, Newman AB, Kritchevsky SB, Nicklas BJ, Sutton-Tyrrell K, Rubin SM, Ding J, Simonsick EM, Harris TB, Pahor M. Inflammatory markers and onset of cardiovascular events: results from the Health ABC study. Circulation. 2003 Nov 11;108(19):2317-22. doi: 10.1161/01.CIR.0000097109.90783.FC. Epub 2003 Oct 20.
PubMed 14568895Chapieski ML, Evankovich KD. Behavioral effects of prematurity. Semin Perinatol. 1997 Jun;21(3):221-39. doi: 10.1016/s0146-0005(97)80065-1.
PubMed 9205977D'Anna-Hernandez KL, Ross RG, Natvig CL, Laudenslager ML. Hair cortisol levels as a retrospective marker of hypothalamic-pituitary axis activity throughout pregnancy: comparison to salivary cortisol. Physiol Behav. 2011 Aug 3;104(2):348-53. doi: 10.1016/j.physbeh.2011.02.041. Epub 2011 Mar 21.
PubMed 21397617Dowlati Y, Herrmann N, Swardfager W, Liu H, Sham L, Reim EK, Lanctot KL. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010 Mar 1;67(5):446-57. doi: 10.1016/j.biopsych.2009.09.033. Epub 2009 Dec 16.
PubMed 20015486Dumitriu D, Emeruwa UN, Hanft E, Liao GV, Ludwig E, Walzer L, Arditi B, Saslaw M, Andrikopoulou M, Scripps T, Baptiste C, Khan A, Breslin N, Rubenstein D, Simpson LL, Kyle MH, Friedman AM, Hirsch DS, Miller RS, Fernandez CR, Fuchs KM, Keown MK, Glassman ME, Stephens A, Gupta A, Sultan S, Sibblies C, Whittier S, Abreu W, Akita F, Penn A, D'Alton ME, Orange JS, Goffman D, Saiman L, Stockwell MS, Gyamfi-Bannerman C. Outcomes of Neonates Born to Mothers With Severe Acute Respiratory Syndrome Coronavirus 2 Infection at a Large Medical Center in New York City. JAMA Pediatr. 2021 Feb 1;175(2):157-167. doi: 10.1001/jamapediatrics.2020.4298.
PubMed 33044493Gabay C, Kushner I. Acute-phase proteins and other systemic responses to inflammation. N Engl J Med. 1999 Feb 11;340(6):448-54. doi: 10.1056/NEJM199902113400607. No abstract available.
PubMed 9971870Evans C, Jones CE, Prendergast AJ. HIV-exposed, uninfected infants: new global challenges in the era of paediatric HIV elimination. Lancet Infect Dis. 2016 Jun;16(6):e92-e107. doi: 10.1016/S1473-3099(16)00055-4. Epub 2016 Mar 31.
PubMed 27049574
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial (RCT) of Two Programs Supporting Early Infant Development Beginning in the Well Baby Nursery Through 4 Months of Age
- ClinicalTrials.gov ID
- NCT04531618
- Acronym / sponsor ID
- AAAT0140
- Keywords
- Emotional Connection, Emotional Exchange, Early Relational Health, Newborn Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional Exchange (EE) | Experimental | Behavioral: Emotional Exchange (EE)Receives a facilitated emotional exchange session over Zoom in the Well Baby Nursery and up to 7 subsequent Zoom sessions over the next 4 months. |
| Newborn Care (NC) | Active comparator | Other: Newborn Care (NC)Receives didactic newborn parenting education delivering developmentally appropriate content over zoom at the same time points as the emotional exchange group. |
Who may qualify
- Ages
- 12 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Emotional Exchange (EE) |
| 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. | Other | Newborn Care (NC) |
Primary outcome
Change in Emotional Synchrony (ES) Scale
Time frame: Baseline, 4 months, 6 months
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.
Change in Maternal Caregiving Behavior Score
Time frame: Baseline, 4 months
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.
Postpartum Bonding Questionnaire (PBQ)
Time frame: Baseline, 4 months
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.
5 secondary outcomes
Change in Ages and Stages questionnaire (ASQ-3) Score
Time frame: 6 months
Change in Social-Emotional Questionnaire (ASQ-SE) Score
Time frame: 6 months
Maternal Anxiety using the State/Trait Anxiety Index (STAI)
Time frame: 4 months
Patient Health Questionnaire (PHQ9)
Time frame: 4 months
Perceived Stress Scale (PSS)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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- BackgroundAchenbach TM, Rescorla L. Manual for the ASEBA Preschool Forms &Amp; Profiles: an Integrated System of Multi-Informant Assessment. Burlington, VT: ASEBA; 2000.
- BackgroundAls, H. Reading the premature infant. In: Nurturing the Premature Infant: Developmental Interventions in the Neonatal Intensive Care Nursery. New York: Oxford University Press; 1999.
- Background: PubMed 10405861Bailey RC, Kamenga MC, Nsuami MJ, Nieburg P, St Louis ME. Growth of children according to maternal and child HIV, immunological and disease characteristics: a prospective cohort study in Kinshasa, Democratic Republic of Congo. Int J Epidemiol. 1999 Jun;28(3):532-40. doi: 10.1093/ije/28.3.532.
- BackgroundBenasich AA, Thomas JJ. Developmental Disorders of Language. Encyclopedia of Cognitive Science Nadel/Cognitive. 2006.
- Background: PubMed 31122797Boivin MJ, Maliwichi-Senganimalunje L, Ogwang LW, Kawalazira R, Sikorskii A, Familiar-Lopez I, Kuteesa A, Nyakato M, Mutebe A, Namukooli JL, Mallewa M, Ruisenor-Escudero H, Aizire J, Taha TE, Fowler MG. Neurodevelopmental effects of ante-partum and post-partum antiretroviral exposure in HIV-exposed and uninfected children versus HIV-unexposed and uninfected children in Uganda and Malawi: a prospective cohort study. Lancet HIV. 2019 Aug;6(8):e518-e530. doi: 10.1016/S2352-3018(19)30083-9. Epub 2019 May 20.
- Background: PubMed 26306860Brunelli SA, Curley JP, Gudsnuk K, Champagne FA, Myers MM, Hofer MA, Welch MG. Variations in maternal behavior in rats selected for infant ultrasonic vocalization in isolation. Horm Behav. 2015 Sep;75:78-83. doi: 10.1016/j.yhbeh.2015.08.007. Epub 2015 Aug 22.
- Background: PubMed 30985518Cassidy AR, Williams PL, Leidner J, Mayondi G, Ajibola G, Makhema J, Holding PA, Powis KM, Batlang O, Petlo C, Shapiro R, Kammerer B, Lockman S. In Utero Efavirenz Exposure and Neurodevelopmental Outcomes in HIV-exposed Uninfected Children in Botswana. Pediatr Infect Dis J. 2019 Aug;38(8):828-834. doi: 10.1097/INF.0000000000002332.
- Background: PubMed 14568895Cesari M, Penninx BW, Newman AB, Kritchevsky SB, Nicklas BJ, Sutton-Tyrrell K, Rubin SM, Ding J, Simonsick EM, Harris TB, Pahor M. Inflammatory markers and onset of cardiovascular events: results from the Health ABC study. Circulation. 2003 Nov 11;108(19):2317-22. doi: 10.1161/01.CIR.0000097109.90783.FC. Epub 2003 Oct 20.
- Background: PubMed 9205977Chapieski ML, Evankovich KD. Behavioral effects of prematurity. Semin Perinatol. 1997 Jun;21(3):221-39. doi: 10.1016/s0146-0005(97)80065-1.
- Background: PubMed 21397617D'Anna-Hernandez KL, Ross RG, Natvig CL, Laudenslager ML. Hair cortisol levels as a retrospective marker of hypothalamic-pituitary axis activity throughout pregnancy: comparison to salivary cortisol. Physiol Behav. 2011 Aug 3;104(2):348-53. doi: 10.1016/j.physbeh.2011.02.041. Epub 2011 Mar 21.
- Background: PubMed 20015486Dowlati Y, Herrmann N, Swardfager W, Liu H, Sham L, Reim EK, Lanctot KL. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010 Mar 1;67(5):446-57. doi: 10.1016/j.biopsych.2009.09.033. Epub 2009 Dec 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dani Dumitriu, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Exchange (EE) and Newborn Care (NC) in people with Child Development and Mother-Infant Interaction, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotional Synchrony (ES) Scale (time frame: Baseline, 4 months, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04531618, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.