Back to resultsStamford Group Family Nurture Intervention
Primary Purpose
Behavior Problem, Developmental Delay, Emotional Disturbances
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition and Play Intervention
Family Nurture Intervention
Sponsored by
About this trial
This is an interventional other trial for Behavior Problem focused on measuring Family Nurture Intervention, Martha G. Welch MD, Randomized Controlled Trial, Preschool Intervention, Pre-school Intervention, Multiple Family Group Intervention, Emotional Connection, Co-regulation
Eligibility Criteria
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
Sites / Locations
- Stamford Childrens Learning Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nutrition and Play Intervention (NPI)
Family Nurture Intervention (FNI)
Arm Description
Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.
Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03442439
Brief Title
Stamford Group Family Nurture Intervention
Official Title
Stamford Group Family Nurture Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
November 25, 2018 (Actual)
Study Completion Date
November 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problem, Developmental Delay, Emotional Disturbances, Family Conflict
Keywords
Family Nurture Intervention, Martha G. Welch MD, Randomized Controlled Trial, Preschool Intervention, Pre-school Intervention, Multiple Family Group Intervention, Emotional Connection, Co-regulation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition and Play Intervention (NPI)
Arm Type
Active Comparator
Arm Description
Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.
Arm Title
Family Nurture Intervention (FNI)
Arm Type
Experimental
Arm Description
Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and Play Intervention
Other Intervention Name(s)
NPI
Intervention Description
Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.
Intervention Type
Behavioral
Intervention Name(s)
Family Nurture Intervention
Other Intervention Name(s)
FNI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Welch Emotional Connection Scale (WECS) Score
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha G Welch, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stamford Childrens Learning Center
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
12. IPD Sharing Statement
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Stamford Group Family Nurture Intervention
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