Early Behavioral Intervention for Preterm Infants
Stopped early · Not applicable
Conditions studied: Premature Birth
In brief
The purpose of this study is to determine the effects of Family Nurture Intervention in preschool aged children between 2.5 and 4.5 years of age who were born prematurely and exhibit developmental deficits. The new approach is based on improving aspects of maternal nurturing behaviors as well as mother-child co-regulation, which are important to early development. Since young children with developmental deficits are often easily upset, mothers will be taught how to co-regulate with their child through comfort and calming interactions during 11 clinic visits. Assessments in the follow-up clinic will test the immediate and long-term effects of this new approach to the nurture of children who were born early and demonstrate developmental problems and behavioral problems.
Key facts
- Study ID
- NCT02379130
- Run by
- Columbia University
- People needed
- 36
- Starts
- 2015-02-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2016-07-27
Who can join
Age: 3 and older, up to 3. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Infant is a singleton (matched between groups)
- Mother is 18 years of age or older
- Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent)
- Child demonstrates developmental deficit (language, cognition, motor, emotion)
You may not qualify if…
- The child has severe congenital anomalies including chromosomal anomalies
- The child has severe motor or physical disability
- Mother currently presents with psychosis or is currently taking antipsychotic medication
- Status of enrolled subject changes and subject no longer falls in inclusion criteria
- Mother and/or infant has a medical condition that precludes intervention components
- Mother and/or infant has a contagion that endangers other participants in the study
Where it is running
- Columbia University Medical Center - Nuture Science Center — New York, New York, United States
Full record on ClinicalTrials.gov
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