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NCT03908268 · ClinicalTrials.gov registry record · NA
Children's Learning Centers Group FNI
A NA study of Behavior Problem and Development Delay, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT03908268: Completed NA study of Behavior Problem and Development Delay, sponsored by Columbia University.
NCT03908268 is a NA study of Behavior Problem and Development Delay that has completed, run by Columbia University. The registered enrollment target is 90 participants, below the 217-participant average among 7 other Behavior Problem trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03908268, a NA study of Behavior Problem and Development Delay, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the effects of Family Nurture Intervention in a mother-child group setting with a Standard Children's Learning Center (CLC) Program for preschool-aged children (ages 2-4.5). This approach is based on creating emotional connection and establishing mother-child two-way regulation, which the investigators hypothesize affects early child development. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to regulate each other physically-leading to an automatic calming response to contact with each other.
Primary Outcome
Mother-child interactions will be assessed for social engagement and emotional connection via the Welch Emotional Connection Screen (WECS). The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which the investigators 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 i
Conditions Studied
Interventions
- BEHAVIORAL Family Nurture Intervention (FNI)
- BEHAVIORAL Standard Children's Learning Center (CLC) Program
Study Locations (1)
Connecticut
- Children's Learning Centers of Fairfield County - Cos Cob
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2020-06-11 |
| Phase | NA |
What the finished NCT03908268 record still lists
NCT03908268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 217-participant average among 7 other Behavior Problem trials with a reported enrollment target (59% lower).
The record links to 5 conditions, with Behavior Problem appearing as the primary indexed condition, and to 2 interventions - of which Family Nurture Intervention (FNI) is the first listed.
NCT03908268 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT03908268 about?
NCT03908268 is a clinical study titled "Children's Learning Centers Group FNI". The purpose of this study is to compare the effects of Family Nurture Intervention in a mother-child group setting with a Standard Children's Learning Center (CLC) Program for preschool-aged children (ages 2-4.5). This approach is based on creating emotional connection and establishing mother-child ...
What is the current status of trial NCT03908268?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2019-01-29. Estimated completion is 2020-06-11.
What conditions does trial NCT03908268 study?
This clinical trial studies the following conditions: Behavior Problem, Development Delay, Emotional Disturbances, Family Conflict, Relation, Mother-Child.
What interventions are being tested in trial NCT03908268?
The interventions under investigation include: Family Nurture Intervention (FNI) (BEHAVIORAL), Standard Children's Learning Center (CLC) Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT03908268?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03908268 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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