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

N/A

Recruiting

Led By Dani Dumitriu, MD, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 months, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trialwill compare mother-infant emotional connection in standard care vs. Family Nurture Intervention, to examine how these interactions affect neurodevelopment. Assessments will include videos & surveys to track progress.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There are no direct medical side effects discussed for this intervention as it focuses on educational and behavioral techniques rather than pharmaceutical treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Emotional Synchrony (ES) Scale

Change in Maternal Caregiving Behavior Score

Postpartum Bonding Questionnaire (PBQ)

Secondary study objectives

Change in Ages and Stages questionnaire (ASQ-3) Score

Change in Social-Emotional Questionnaire (ASQ-SE) Score

Maternal Anxiety using the State/Trait Anxiety Index (STAI)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Emotional Exchange (EE)Experimental Treatment1 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 Control1 Intervention

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

Do I qualify?Apply below to find out