- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03442439
Stamford Group Family Nurture Intervention
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Stamford, Connecticut, United States, 06902
- Stamford Childrens Learning Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nutrition and Play Intervention (NPI)
Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.
|
Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.
Other Names:
|
Experimental: Family Nurture Intervention (FNI)
Half of the mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Welch Emotional Connection Scale (WECS) Score
Time Frame: 12 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAR5518
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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