Status:
COMPLETED
Norwalk Feasibility Study
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Norwalk Housing Authority (NHA)
Conditions:
Behavior Problem
Development Delay
Eligibility:
All Genders
24-78 years
Phase:
NA
Brief Summary
The purpose of this study is two-fold: 1) to examine the feasibility of the Drop-In model of Family Nurture Intervention (FNI); and 2) to collect pilot data concerning the mother's response to the Dro...
Detailed Description
Family Nurture Intervention (FNI) is a novel family-based program that facilitates mother-child emotional connection and co-regulation. Many current interventions aim at helping the child to self-regu...
Eligibility Criteria
Inclusion
- Mother is fluent in English or Spanish
- Mother is 18 years of age or older at the time of consent
- Mother-child pair does not demonstrate emotional connection as measured by the WECS
- Child is between the ages of 2 to 4½ years at date of enrollment (child must be younger than 4 years and 9 months at baseline assessment) or between 2 to 4½ at date of enrollment in study AAAQ9547
- Child resides with mother
Exclusion
- The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
- The child has a diagnosis of Autism Spectrum Disorder
- The child has severe motor or physical disability
- Mother currently presents with psychosis or is currently taking antipsychotic medication
- Current maternal drug and/or alcohol abuse
- Mother is more than four months pregnant
- Mother and/or infant has a medical condition or contagion that precludes intervention components
- Mother is unable to commit to study schedule
Key Trial Info
Start Date :
July 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04048720
Start Date
July 5 2019
End Date
October 1 2019
Last Update
November 9 2020
Active Locations (1)
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1
Norwalk Housing Authority
Norwalk, Connecticut, United States, 06854