Children's Learning Centers Group FNI
Condition: Relation, Mother-Child; Family Conflict; Emotional Disturbances; Behavior Problem; Development Delay
MeSH terms: Problem Behavior; Affective Symptoms
Study type: Interventional

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.
    

Intervention name(s): Family Nurture Intervention (FNI); Standard Children's Learning Center (CLC) Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The mother-child pair will be asked to talk and play with each other as the pair customarily does. If the child becomes restless and dysregulated, the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comforting touch, soothing words and eye contact. Each dyad will attend eight group FNI sessions within sixteen weeks.; Typical, age-tailored CLC curriculum taught by CLC teachers. Children attend CLC as usual and parents do not take part in group sessions.
Other intervention name(s): FNI; CLC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Co-regulation; Emotional Connection; Family Nurture Intervention; Preschool Intervention; Martha G. Welch MD; Multiple Family Group Intervention; Randomized Controlled Trial