Stamford Group Family Nurture Intervention
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|ClinicalTrials.gov Identifier: NCT03442439|
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Behavior Problem Developmental Delay Emotional Disturbances Family Conflict||Behavioral: Nutrition and Play Intervention Behavioral: Family Nurture Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Stamford Group Family Nurture Intervention|
|Actual Study Start Date :||January 31, 2018|
|Actual Primary Completion Date :||November 25, 2018|
|Actual Study Completion Date :||November 25, 2018|
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.
Behavioral: Nutrition and Play Intervention
Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.
Other Name: NPI
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.
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 though sustained physical contact; comfort touch, soothing words, and eye contact.
Other Name: FNI
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442439
|United States, Connecticut|
|Stamford Childrens Learning Center|
|Stamford, Connecticut, United States, 06902|
|Principal Investigator:||Martha G Welch, MD||Columbia University|