Stamford Group Family Nurture Intervention

Developmental Delay Clinical Trial

Official title:

Stamford Group Family Nurture Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442439
• Other study ID #: AAAR5518
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: November 25, 2018

Study information

• Verified date: April 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 25, 2018
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 54 Months

Eligibility

Inclusion Criteria:

• Child is a singleton

• Mother can speak, read and write in English or Spanish

• Child is between the ages of 2-4 1/2 years at date of enrollment

• Mother is 18 years of age or older at the time of consent

• Child resides with mother

• Child demonstrates developmental deficit as measured by the Strengths and Difficulties Questionnaire (13 or higher on behavioral questions or 4 or less on prosocial questions)

• Mother and child deemed "emotionally unconnected" using the Welch Emotional Connection Scale (WECS) to score their five minute Welch Lap Test video

• Mother is able to commit to study schedule

Exclusion Criteria:

• The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral palsy

• Child has a motor disability

• Mother sees or hears things that other people do not seem to see or hear

• Mother has trouble distinguishing whether something is real or part of imagination or dreams

• Mother is currently taking antipsychotic medications

• Mother or child have any medical conditions that might prevent them from participating in block play, mother holding child, or child sitting on mother's lap

• Mother has any current drug and/or alcohol abuse

• Mother is more than 4 months pregnant

• Mother is currently involved with Department of Children and Families

• The child has a diagnosis of Autism

Related Conditions & MeSH terms

• Affective Symptoms
• Behavior Problem
• Developmental Delay
• Emotional Disturbances
• Family Conflict
• Problem Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Stamford Childrens Learning Center	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Welch Emotional Connection Scale (WECS) Score	This is designed to measure emotional connection. Children will be asked to sit on their mother's lap for five minutes. This interaction will be video taped, and will be behaviorally coded using the Welch Emotional Connection Scale (WECS) and using a paradigm evaluated in Noldus coding software.; The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which we hypothesize predicts optimal development. There are four items on the WECS: Mutual Attraction, Mutual Vocal Exchange, Mutual Facial Engagement, and Mutual Sensitivity/Reciprocity. Each item is rated on a scale from 1 to 3 in 0.25 increments with a score of 3 considered optimal. At or below 2.25 on any individual item, or a total score below 9 means that the mother-child pair is not emotionally connected. There is also a binary question to the rater asking if the pair is emotionally connected - yes or no. The mother and child are scored as a pair, not individually.	12 months