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Children's Learning Centers Group FNI

NCT03908268 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-02-15

No results posted yet for this study

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.

Conditions

  • Relation, Mother-Child
  • Family Conflict
  • Emotional Disturbances
  • Behavior Problem
  • Development Delay

Interventions

BEHAVIORAL

Family Nurture Intervention (FNI)

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.

BEHAVIORAL

Standard Children's Learning Center (CLC) Program

Typical, age-tailored CLC curriculum taught by CLC teachers. Children attend CLC as usual and parents do not take part in group sessions.

Sponsors & Collaborators

  • Children's Learning Centers of Fairfield County

    collaborator UNKNOWN

  • Columbia University

    lead OTHER

Principal Investigators

  • Martha Welch, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
57 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2020-06-11
Completion
2020-06-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03908268 on ClinicalTrials.gov