Stamford Group Family Nurture Intervention
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2018
CompletedFirst Submitted
Initial submission to the registry
February 2, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2018
CompletedApril 8, 2019
April 1, 2019
10 months
February 2, 2018
April 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Nutrition and Play Intervention (NPI)
ACTIVE COMPARATORHalf of the mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.
Family Nurture Intervention (FNI)
EXPERIMENTALHalf of the mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.
Interventions
Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stamford Childrens Learning Center
Stamford, Connecticut, 06902, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martha G Welch, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
Study Record Dates
First Submitted
February 2, 2018
First Posted
February 22, 2018
Study Start
January 31, 2018
Primary Completion
November 25, 2018
Study Completion
November 25, 2018
Last Updated
April 8, 2019
Record last verified: 2019-04