NCT02970565

Family Nurture Intervention, A Group Model in Connecticut

Family Nurture Intervention, A Group Model: Short and Long Term Effects on Behavior and Development of Preschool Aged Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 24 Months – 54 Months
• Healthy volunteers: Accepted

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.

Detailed description

There are several early intervention programs that are available for children with emotional, behavioral and developmental disorders, ranging from behavioral treatment and sensory exposure therapy to pharmaceutical treatments. Although improvements in behavior have resulted from these interventions, they are limited in numerous ways. They are usually time-consuming, both for the child and the teacher or clinician providing the intervention. In order to see an effect of the intervention, most children must engage in the intervention procedure for several years. Moreover, the effects of most current intervention procedures are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable side effects that may modulate behavior, emotion, and physiological functions. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2016-11-22
• Last updated: 2023-02-15

Locations

1 site across 1 country: United States