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Family Nurture Intervention (FNI) for Child Development

N/A
Waitlist Available
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 6 months (over the phone) and 15 months (in person)
Awards & highlights

Study Summary

This trial assesses the effects of a single family intervention session on short- and long-term development in at-risk mother-child dyads.

Eligible Conditions
  • Child Development
  • Mother-Infant Interaction
  • Gestational Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months (over the phone) and 15 months (in person)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (over the phone) and 15 months (in person) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Ages and Stages questionnaire (ASQ-3) Score
Change in Brief Infant Toddler Social Emotional Assessment (BITSEA) score
Change in Social-Emotional Questionnaire (ASQ-SE) Score
+2 more
Secondary outcome measures
Change in Bayley-III Scale
Change in Edinburgh Postnatal Depression Scale (EPDS)
Change in M/CHAT R/F score
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Family Nurture Intervention (FNI)Experimental Treatment1 Intervention
This arm contains the combined GDM+FNI and control+FNI cohort.
Group II: Non-FNIActive Control1 Intervention
This arm contains the combined GDM+no FNI and control+no FNI cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Family Nurture Intervention (FNI)
2017
N/A
~240

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteOTHER
475 Previous Clinical Trials
153,903 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,461,011 Total Patients Enrolled
Dani Dumitriu, MD/PhDPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Developmental PsychologyJournal
Family Nurture Intervention for Preterm Infants Facilitates Positive Mother–infant Face-to-face Engagement at 4 Months.
Beebe, Beatrice, Michael M. Myers, Sang Han Lee, Adrianne Lange, Julie Ewing, Nataliya Rubinchik, Howard Andrews, et al.. 2018. “Family Nurture Intervention for Preterm Infants Facilitates Positive Mother–infant Face-to-face Engagement at 4 Months.”. Developmental Psychology. American Psychological Association (APA). doi:10.1037/dev0000557.
BMC PediatricsJournal
Randomized Controlled Trial of Family Nurture Intervention in the NICU: Assessments of Length of Stay, Feasibility and Safety
Welch, Martha G, the FNI Trial Group, Myron A Hofer, Raymond I Stark, Howard F Andrews, Judy Austin, Sara B Glickstein, Robert J Ludwig, and Michael M Myers. 2013. “Randomized Controlled Trial of Family Nurture Intervention in the NICU: Assessments of Length of Stay, Feasibility and Safety”. BMC Pediatrics. Springer Science and Business Media LLC. doi:10.1186/1471-2431-13-148.
Infant Behavior and DevelopmentJournal
Mother and Infant Coordinate Heart Rhythms Through Episodes of Interaction Synchrony
Feldman, Ruth, Romi Magori-Cohen, Giora Galili, Magi Singer, and Yoram Louzoun. 2011. “Mother and Infant Coordinate Heart Rhythms Through Episodes of Interaction Synchrony”. Infant Behavior and Development. Elsevier BV. doi:10.1016/j.infbeh.2011.06.008.
BMC PediatricsJournal
Family Nurture Intervention (FNI): Methods and Treatment Protocol of a Randomized Controlled Trial in the NICU
Welch, Martha G, the Family Nurture Intervention (FNI) Trial Group, Myron A Hofer, Susan A Brunelli, Raymond I Stark, Howard F Andrews, Judy Austin, and Michael M Myers. 2012. “Family Nurture Intervention (FNI): Methods and Treatment Protocol of a Randomized Controlled Trial in the NICU”. BMC Pediatrics. Springer Science and Business Media LLC. doi:10.1186/1471-2431-12-14.
~1 spots leftby Apr 2025
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