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

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

280 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Family Nurture Intervention (FNI) for mother-infant bonding during COVID-19?

Research shows that Family Nurture Intervention (FNI) in the NICU helps improve maternal caregiving, reduces infant heart rate, and enhances social and neurodevelopmental outcomes for preterm infants, suggesting it may also support mother-infant bonding during COVID-19. ^{1 2 3 4 5}

Is Family Nurture Intervention (FNI) safe for use in humans?

Research on Family Nurture Intervention (FNI) in neonatal intensive care units (NICUs) has shown that it is safe to implement, with studies focusing on its feasibility and safety in high-acuity settings. ^{1 2 3 4 6}

How is the Family Nurture Intervention (FNI) treatment different from other treatments for mother-infant bonding during COVID-19?

Family Nurture Intervention (FNI) is unique because it focuses on creating an emotional connection between mothers and their infants in the NICU through calming sessions that include scent cloth exchange, vocal soothing, and skin-to-skin contact. This approach is novel as it addresses both maternal and infant needs simultaneously, aiming to improve neurodevelopmental outcomes and reduce the risk of long-term behavioral issues. ^{1 2 3 4 6}

Research Team

Dani Dumitriu, MD, PhD

Principal Investigator

Columbia University

Eligibility Criteria

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

Mother can speak English or Spanish

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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 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]

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 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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Preterm infant heart rate is lowered after Family Nurture Intervention in the NICU: Evidence in support of autonomic conditioning. [2022]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Advances in family-based interventions in the neonatal ICU. [2016]

6. Norway pubmed.ncbi.nlm.nih.gov

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