Clinical Interventions to Mitigate Neurodevelopmental Risk

NCT04233489 | Terminated

• 1 other identifier: 7857
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Family Nurture Intervention (FNI) has been shown to facilitate emotional connection and long-term child developmental progress in the NICU population. It has been theorized that FNI also promotes autonomic co-regulation and physiological synchrony between the mother-child dyad. The goal of the pilot study is to assess how a short one-time FNI session between at-risk mother and child dyads in the Well Baby Nursery (WBN) influences physiological synchrony, emotional connection, and developmental changes both short and long-term.

Conditions

Child Development; Mother-Infant Interaction; Diabetes Mellitus, Gestational

Keywords

mother-infant dyad; family nurture intervention; emotional connection; synchrony; mother-infant interaction; child development; Diabetes Mellitus, Gestational

Outcome Measures

Primary Outcomes (5)

• Change in Welch Emotional Connection Score

  The Welch Emotional Connection Screen (WECS) is a validated scale for quantitative assessment of the emotional connection between infant and mother by scoring the interaction of the dyad in four domains: attraction, vocal communication, facial communication and sensitivity/reciprocity. Each domain is scored on a scale from 1.0 to 3.0 in 0.25 point increments, with higher scores indicating stronger emotional connection. The WECS will be measured at baseline for the FNI groups during the intervention, and at 15 months for both FNI and non-FNI groups by a researcher observing the dyadic interaction during a 3 minute period of face-to-face time. Changes in score from baseline to 15 months will be evaluated for FNI groups. Differences in emotional connection will be evaluated in FNI versus non-FNI groups by comparing WECS scores at 15-months.

  Baseline and 15-months of age

• Change in heart rhythm synchrony

  Heart rhythms will be collected through non-invasive EKG monitoring of mother and infant during FNI in order to test the hypothesis that FNI improves emotional connection through autonomic synchrony. To test this, peaks will be extracted from the EKG traces of mother and infant and cross-correlation functions will be used to assess if physiological synchrony between mother-infant heart beats increases throughout the FNI session. Synchrony at the end of the session will also be used to ascertain if autonomic synchrony can be used as a predictor of WECS score or other outcomes at the follow-up sessions.

  Baseline

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

  The ASQ-SE is a 22-item 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 takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-SE scores of FNI and non-FNI participants measuring self-regulation, compliance, communication, adaptive behaviors, autonomy, affect, and interaction with people. This would be assessed

  6 months (over the phone) and 15 months (in person)

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

  The ASQ-3 is a questionnaire aimed to pinpoint developmental progress in children between 1 month to 5.5 years in age. It is parent-centric and is administered through paper and pencil. It takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-3 scores of FNI and non-FNI participants by measuring across five developmental areas: communication, gross motor, fine motor, problem solving, and personal-social.

  6 months (over the phone) and 15 months (in person)

• Change in Brief Infant Toddler Social Emotional Assessment (BITSEA) score

  BITSEA is a short 42-item parent-report screening tool used to identify social-emotional/behavioral problems and delays in competence in 12 to 36 month olds. It takes 10 to 15 minutes to complete. The measure yields two scores: a Problem Total Score and Competence Total Score. It also includes a two separate parental "worry" item for parents to rate their concern about the child's behavior and language on a 5-point scale from 1 being not at all worried to 5 being extremely worried. Change in score will be calculated by comparing BITSEA scores of FNI and non-FNI participants.

  15 months

Secondary Outcomes (5)

• Change in Parenting Stress Index (PSI-4)

  6 months (over the phone) and 15 months (in person)

• Change in Edinburgh Postnatal Depression Scale (EPDS)

  15 months

• Change in Bayley-III Scale

  15 months

• Change in Toddler Sensory Profile-2 score

  15 months

• Change in M/CHAT R/F score

  15 months

Study Arms (2)

Family Nurture Intervention (FNI)

EXPERIMENTAL

This arm contains the combined GDM+FNI and control+FNI cohort.

Behavioral: Family Nurture Intervention (FNI)

Non-FNI

NO INTERVENTION

This arm contains the combined GDM+no FNI and control+no FNI cohort.

Interventions

Family Nurture Intervention (FNI) BEHAVIORAL

FNI is a family based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a physician. The mother is asked to sit with her baby in her arms so that they are face-to-face, and when the baby becomes restless, the physician will coach the mom to bring the baby back to a calm state. The mother will also be encouraged to verbalize her feelings to her baby. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants in the neonatal intensive care unit (NICU).

Family Nurture Intervention (FNI)

Eligibility Criteria

• Age: 12 Hours - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Medically healthy mothers with and without diabetes (type 1, type 2, or gestational) and their infants
• Infants with gestational age between 37 0/7 and 40 6/7
• APGAR score above 7 five minutes after birth
• Infants between 12-72 hours of life at time of the study
• Mothers between 18-50 years old

You may not qualify if:

• Infants with gestational age below 37 0/7 or above 40 6/7
• Infant requiring resuscitation at birth
• Infant admitted to NICU
• Prenatal exposures to psychiatric medications, alcohol, recreational drug use, or smoking
• HIV-positive mother
• Mother with psychiatric diagnosis
• Infant with genetic disorder

Sponsors & Collaborators

• Columbia University: lead
• New York State Psychiatric Institute: collaborator

Study Sites (1)

Morgan Stanley Children's Hospital of New York

New York, New York, 10032, United States

Location

Related Publications (6)

• Beebe B, Myers MM, Lee SH, Lange A, Ewing J, Rubinchik N, Andrews H, Austin J, Hane A, Margolis AE, Hofer M, Ludwig RJ, Welch MG. Family nurture intervention for preterm infants facilitates positive mother-infant face-to-face engagement at 4 months. Dev Psychol. 2018 Nov;54(11):2016-2031. doi: 10.1037/dev0000557. Epub 2018 Oct 4.

  PMID: 30284883 BACKGROUND

• Isler JR, Stark RI, Grieve PG, Welch MG, Myers MM. Integrated information in the EEG of preterm infants increases with family nurture intervention, age, and conscious state. PLoS One. 2018 Oct 24;13(10):e0206237. doi: 10.1371/journal.pone.0206237. eCollection 2018.

  PMID: 30356312 BACKGROUND

• Welch MG, Hofer MA, Brunelli SA, Stark RI, Andrews HF, Austin J, Myers MM; Family Nurture Intervention (FNI) Trial Group. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU. BMC Pediatr. 2012 Feb 7;12:14. doi: 10.1186/1471-2431-12-14. Erratum In: BMC Pediatr. 2012;12:107.

  PMID: 22314029 BACKGROUND

• Welch MG, Hofer MA, Stark RI, Andrews HF, Austin J, Glickstein SB, Ludwig RJ, Myers MM; FNI Trial Group. Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. BMC Pediatr. 2013 Sep 24;13:148. doi: 10.1186/1471-2431-13-148.

  PMID: 24063360 BACKGROUND

• Welch MG, Firestein MR, Austin J, Hane AA, Stark RI, Hofer MA, Garland M, Glickstein SB, Brunelli SA, Ludwig RJ, Myers MM. 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. J Child Psychol Psychiatry. 2015 Nov;56(11):1202-11. doi: 10.1111/jcpp.12405. Epub 2015 Mar 11.

  PMID: 25763525 BACKGROUND

• Feldman R, Magori-Cohen R, Galili G, Singer M, Louzoun Y. Mother and infant coordinate heart rhythms through episodes of interaction synchrony. Infant Behav Dev. 2011 Dec;34(4):569-77. doi: 10.1016/j.infbeh.2011.06.008. Epub 2011 Jul 20.

  PMID: 21767879 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dani Dumitriu, MD/PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: January 3, 2020
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)