Family Nurture Intervention (FNI) for Mother-infant Bonding during COVID-19

Not currently recruiting at 1 trial location

Overseen By Ginger Atwood, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Preterm birth, Post-term birth, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if enhancing emotional exchanges between mothers and their newborns during the first four months can improve their relationship and support the baby's development. It compares two groups: one receives basic newborn care education, while the other participates in guided emotional bonding sessions, known as Family Nurture Intervention (FNI). Mothers with newborns between 35 and 40 weeks, who are single births and speak English or Spanish, might be a good fit. Video recordings of the bonding sessions and follow-up surveys will help researchers understand how these interactions affect the baby's growth and the mother's mental well-being. As an unphased trial, this study offers a unique opportunity to contribute to understanding early mother-infant bonding and its impact on development.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mother-infant interactions rather than medication use.

What prior data suggests that this intervention is safe for mother-infant bonding?

Research has shown that the Family Nurture Intervention (FNI) is safe for both mothers and babies. A previous study found it to be safe and easy to implement, with no harm or serious side effects. This study, which involved mothers and their babies in a neonatal intensive care unit, demonstrated positive results.

The FNI strengthens the bond between mothers and their babies through guided emotional exchange sessions. These sessions support the baby's development and improve the mother's mental health. Participants in earlier studies reported better bonding and attachment, which are crucial for a child's brain development and emotional well-being.

Overall, evidence indicates that FNI is well-tolerated and does not pose significant safety concerns for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Nurture Intervention (FNI) for mother-infant bonding because it offers a unique approach during a critical time affected by COVID-19. Unlike traditional methods that focus on didactic newborn parenting education, the Emotional Exchange (EE) arm of FNI emphasizes facilitated emotional bonding sessions conducted over Zoom. This method aims to strengthen emotional connections between mothers and infants right from the Well Baby Nursery, with ongoing support through additional sessions over four months. By prioritizing emotional exchange, this intervention could significantly enhance early bonding experiences, which are crucial for both maternal and infant well-being.

What evidence suggests that the Family Nurture Intervention (FNI) could be effective for mother-infant bonding during COVID-19?

Research has shown that the Family Nurture Intervention (FNI) can significantly enhance the bond between mothers and their babies. In studies with premature infants, FNI improved interactions, with mothers providing more attentive care. Babies in these studies also demonstrated better social skills and focus. In this trial, participants in the Emotional Exchange (EE) arm will receive facilitated emotional exchange sessions, a component of the FNI approach, to strengthen the mother-baby connection. This connection is crucial for the child's social and emotional development, suggesting FNI could positively impact early relationship health and brain development. ^{1 6 7 8 9}

Who Is on the Research Team?

Dani Dumitriu, MD, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for mothers with newborns born between 37 and 40 weeks +6 days, who speak English or Spanish, and agree to participate in linked studies. Excluded are infants needing special care due to anomalies, those advised against by physicians due to health concerns or maternal history of substance abuse/psychosis, multiples like twins, and mothers unwilling to be recorded.

Inclusion Criteria

Newborn born between 37 weeks and 40 weeks and 6 days gestational age

Mother agrees to participate in a linked study involving additional surveys and assessments

The baby is the only one born during delivery.

Exclusion Criteria

Your baby has a medical condition that requires specialized care beyond what is typically needed for newborns.

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

Newborn born at more than 40 weeks and 6 days gestational age

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Initial Session

Initial study visit occurs in the postpartum unit before discharge, introducing the intervention

1 day

1 visit (in-person)

Intervention

Weekly sessions for the first four weeks, then monthly until the infant is four months old, focusing on emotional exchange or newborn care

16 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including video recordings of mother-infant interactions

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Family Nurture Intervention (FNI)

Trial Overview The study tests if promoting emotional exchange (EE) between mother-infant pairs improves relational health and child development compared to standard newborn care education (NC). It involves observing interactions through videos during sessions and follow-up surveys from a related study.

How Is the Trial Designed?

Group I: Emotional Exchange (EE) Experimental Treatment 1 Intervention

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.

Group II: Newborn Care (NC) Active Control 1 Intervention

Receives didactic newborn parenting education delivering developmentally appropriate content over zoom at the same time points as the emotional exchange group.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

The Family Nurture Intervention (FNI) significantly improved the quality of maternal caregiving behavior in mothers of premature infants in the NICU, as shown in a study with 65 participants.

This study is the first to demonstrate that a structured, nurture-based intervention can enhance maternal caregiving in a hospital setting, suggesting that such programs should be integrated into standard NICU care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family nurture intervention improves the quality of maternal caregiving in the neonatal intensive care unit: evidence from a randomized controlled trial. Hane, AA., Myers, MM., Hofer, MA., et al.[2022]

The Family Nurture Intervention (FNI) significantly improved maternal behaviors and infant neurodevelopment over 18 months, including a reduced risk of autism, based on a randomized controlled trial.

Preliminary results from a pilot study indicated that FNI also led to significant reductions in adverse behaviors in preschool children, suggesting its potential long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calming cycle theory: the role of visceral/autonomic learning in early mother and infant/child behaviour and development. Welch, MG.[2017]

The Family Nurture Intervention (FNI) was safely and feasibly implemented in a high-acuity NICU, involving 150 infants and their families, but did not significantly affect the length of stay in the NICU, which was the primary outcome measure.

Despite the lack of impact on the primary outcome, the study suggests that FNI can be integrated into NICU care without increasing medical complications, indicating its potential for future research on long-term neurodevelopmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. Welch, MG., Hofer, MA., Stark, RI., et al.[2021]

The Family Nurture Intervention (FNI) significantly improved cognitive and language development in preterm infants, as measured by the Bayley Scales of Infant Development III, with notable differences in scores compared to standard care.

FNI also led to fewer attention problems and better social-relatedness outcomes, with only 27% of FNI infants failing M-CHAT items compared to 76% of those receiving standard care, indicating its effectiveness in enhancing neurobehavioral outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Nurture Intervention in the Neonatal Intensive Care Unit improves social-relatedness, attention, and neurodevelopment of preterm infants at 18 months in a randomized controlled trial. Welch, MG., Firestein, MR., Austin, J., et al.[2023]

Recent family-related interventions in the NICU have shown positive effects, including reduced parenting stress and improved maternal mental health, which are crucial for the well-being of preterm infants.

The Family Nurture Intervention (FNI) not only enhances the emotional connection between mother and infant but also leads to better neurobehavioral outcomes for infants at term and at 18 months, highlighting the importance of nonmedical approaches in improving long-term health for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in family-based interventions in the neonatal ICU. Welch, MG., Myers, MM.[2016]

The Family Nurture Intervention (FNI) significantly reduced heart rate in preterm infants during their stay in the NICU, indicating a calming effect that may benefit their cardiac health.

The study involved 37 infants receiving FNI and a matched control group of 32 infants, with heart rate data analyzed over a 6-week period, showing a dose-response relationship where more FNI sessions correlated with lower heart rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preterm infant heart rate is lowered after Family Nurture Intervention in the NICU: Evidence in support of autonomic conditioning. Ludwig, RJ., Grunau, RE., Chafkin, JE., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01439269

Study Details | NCT01439269 | Family Nurture Intervention ... The purpose of this study is to test the efficacy of a family nurture intervention in the neonatal intensive care unit (NICU).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30284883/

Family nurture intervention for preterm infants facilitates ... Family nurture intervention for preterm infants facilitates positive mother-infant face-to-face engagement at 4 months.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1355184125000560

Intervention strategies to enhance early mother-infant ... Family centered care and kangaroo mother care practices have significantly improved mother-infant interaction and bonding at the neonatal intensive care unit ( ...

4. researchgate.net researchgate.net/publication/292526336_Family_Nurture_Intervention_Improves_the_Quality_of_Maternal_Caregiving_in_the_Neonatal_Intensive_Care_Unit_Evidence_from_a_Randomized_Controlled_Trial

(PDF) Family Nurture Intervention Improves the Quality of ... Results: Relative to mothers in the SC condition, those in the FNI group showed significantly higher quality MCB, which remained significant ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6202224/

Family Nurture Intervention for Preterm Infants Facilitates ... Comparing FNI to SC dyads, FNI mothers showed more touch and calmer touch patterns, and FNI infants showed more angry-protest but less cry. In ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6606523/

maternal engagement in the neonatal intensive care unit ... Findings from a randomized control trial of the Family Nurture Intervention confirmed the intervention was safe and feasible, as evidenced by ...

7. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-12-14

Family nurture intervention (FNI) - BMC Pediatrics This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI).

8. mdpi.com mdpi.com/1660-4601/19/3/1126

Attachment- and Relationship-Based Interventions during ... The attachment- or relationship-based intervention was effective in relieving maternal traumatic stress, maternal depression, infant weight ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0899588523001016

Bonding and Attachment with Baby in the Womb or ... Bonding and attachment are critically important for the well-being of infants and children and positively impact fetal and infant brain development.