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Stamford Group Family Nurture Intervention

NCT03442439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-04-08

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
  • Developmental Delay
  • Emotional Disturbances
  • Family Conflict

Interventions

BEHAVIORAL

Nutrition and Play Intervention

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

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 though sustained physical contact; comfort touch, soothing words, and eye contact.

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
2018-01-31
Primary Completion
2018-11-25
Completion
2018-11-25

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 NCT03442439 on ClinicalTrials.gov