Children's Learning Centers Group FNI

Columbia University

Status: Completed

Conditions: Behavior Problem; Development Delay; Emotional Disturbances; Relation, Mother-Child; Family Conflict

Treatments: Behavioral: Family Nurture Intervention (FNI); Behavioral: Standard Children's Learning Center (CLC) Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03908268

AAAS1630

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 24 to 57 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

CLC Program

Active Comparator group

Description:

Half of the mother-child dyads who are enrolled in the study will be randomly assigned to the Standard Children's Learning Center Program group.

Treatment:

Behavioral: Standard Children's Learning Center (CLC) Program

FNI plus CLC Program

Experimental group

Description:

Half of the mother-child dyads who are enrolled in the study will be randomly assigned to the Family Nurture Intervention plus Standard CLC Program group.

Treatment:

Behavioral: Family Nurture Intervention (FNI)