An interventional study of Nutrition and Play Intervention and Family Nurture Intervention in Behavior Problem, Developmental Delay and Emotional Disturbances, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 24 Months to 54 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-08.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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.
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.
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Exclusion Criteria:
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
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
Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.
Also known as: NPI
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.
Also known as: FNI
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.
Time frame: 12 months
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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