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Family Nurture Intervention, A Group Model in Connecticut

NCT02970565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-02-15

No results posted yet for this study

Summary

The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.

Conditions

  • Behavior Problem
  • Development Delay
  • Emotional Disturbance
  • Family Conflict

Interventions

BEHAVIORAL

Family Nurture Intervention

The mother-child pair will be asked to talk and play with each other as they customarily do. 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, comfort touch, soothing words, and eye contact.

BEHAVIORAL

Nutrition and Play Intervention

Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.

Sponsors & Collaborators

Principal Investigators

  • Martha G Welch, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02970565 on ClinicalTrials.gov