Clinical trial NCT03908268: Children's Learning Centers Group FNI
Official title: Group Family Nurture Intervention: Short and Long Term Effects on Preschool Aged Children and Their Mothers at Children's Learning Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relation, Mother-Child
Family Conflict
Emotional Disturbances
Behavior Problem
Development Delay
Keywords: Co-regulation
Emotional Connection
Family Nurture Intervention
Preschool Intervention
Martha G. Welch MD
Multiple Family Group Intervention
Randomized Controlled Trial
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Children's Learning Centers of Fairfield County
First posted: 2019-04-09
Enrollment: 90
Sex: ALL
Minimum age (years): 24
Maximum age (years): 57
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the effects of Family Nurture Intervention in a mother-child group setting with a Standard Children's Learning Center (CLC) Program for preschool-aged children (ages 2-4.5). This approach is based on creating emotional connection and establishing mother-child two-way regulation, which the investigators hypothesize affects early child development. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to regulate each other physically-leading to an automatic calming response to contact with each other.

Detailed description: This study tests a group model of Family Nurture Intervention (FNI), a novel family-based intervention that facilitates mother-child emotional connectedness and co-regulation. Many current interventions aim at helping the child to self-regulate with or without the mother's help. However, according to the investigators' Calming Cycle Theory, the ability of the mother-child dyad to promote optimal development is dependent on the dyad's ability to co-regulate. The interactive co-regulation between the mother and the child shapes the behavior of both. This study aims to investigate the short and long term effects of FNI in a multiple family group setting for preschool aged children to prevent and/or treat developmental/behavioral problems.

Previously, FNI implemented in the Neonatal Intensive Care Unit (NICU) for premature infants and their mothers at Columbia University Medical Center demonstrated that FNI positively alters neurodevelopment of premature infants. Infants who received FNI in the NICU demonstrated increased brain activity in the prefrontal cortex at term age, improved cognitive and language development at 18 months as measured by the Bayley Scales of Infant Development, improved behavior on the Child Behavior Checklist (CBCL) and reduced risk for autism as indicated by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months. The pilot study of FNI with preschool aged children and their mothers shows a 40% reduction in behavioral problems on the CBCL. Accordingly, the investigators hypothesize that the Family Nurture Intervention will alter physiological regulatory capacities and will result in improved indices of mother-child emotional connection and other outcomes in the preschool population similar to the results in the preterm population.

Eligibility criteria: Inclusion Criteria:

* Mother is able to consent in English or Spanish
* Mother is 18 years of age or older at the time of consent
* Child is between the ages of 2 to 4 years and 9 months at date of enrollment
* Child resides with mother

Exclusion Criteria:

* The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
* The child has a diagnosis of Autism Spectrum Disorder
* The child has severe motor or physical disability
* Mother currently presents with psychosis or is currently taking antipsychotic medication
* Current maternal drug and/or alcohol abuse
* Mother is more than four months pregnant
* Mother and/or infant has a medical condition or contagion that precludes intervention components
* Mother is unable to commit to study schedule
* Mother is currently involved with the Department of Children and Families (DCF)

Primary outcomes:
measure: Change in Videotaped Interrupted Welch Lap Test
timeFrame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Secondary outcomes:
measure: Respiration
timeFrame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
measure: ECG
timeFrame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
measure: Change in Maternal Symptoms of Anxiety and Depression
timeFrame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
measure: Change in Maternal Symptoms of Anxiety and Depression
timeFrame: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Other outcomes:
Locations:
city: Cos Cob
country: United States
facility: Children's Learning Centers of Fairfield County
state: Connecticut
Study officials:
affiliation: Columbia University
name: Martha Welch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Welch MG, Myers MM, Grieve PG, Isler JR, Fifer WP, Sahni R, Hofer MA, Austin J, Ludwig RJ, Stark RI; FNI Trial Group. Electroencephalographic activity of preterm infants is increased by Family Nurture Intervention: a randomized controlled trial in the NICU. Clin Neurophysiol. 2014 Apr;125(4):675-684. doi: 10.1016/j.clinph.2013.08.021. Epub 2013 Oct 17.
citation: 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.
citation: Myers MM, Grieve PG, Stark RI, Isler JR, Hofer MA, Yang J, Ludwig RJ, Welch MG. Family Nurture Intervention in preterm infants alters frontal cortical functional connectivity assessed by EEG coherence. Acta Paediatr. 2015 Jul;104(7):670-7. doi: 10.1111/apa.13007. Epub 2015 Apr 13.