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NCT01640600 · ClinicalTrials.gov registry record
Yale Pink and Blue Kids: Effects of Exposure During Pregnancy to Nicotine or Antidepressants in 4-8 Year Old Children
A clinical trial, sponsored by Yale University.
- Completed
- Registry status
- 61
- Enrollment target
NCT01640600: Completed study, sponsored by Yale University.
NCT01640600 is a clinical trial that has completed, run by Yale University. The registered enrollment target is 61 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01640600 has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 61 participants
- Enrollment target
Study Summary
The purpose of this project is to conduct a follow-up study with women that had participated in the Yale Pink and Blue Study of depression in pregnancy and birth outcomes. The Yale Pink and Blue Kids Study is a follow-up study with the mothers and also with the children they were pregnant with in Yale Pink and Blue. These children are now between the ages of 4 and 8 years old, which is a perfect time to look at developmental outcomes in children. This study will look at children with exposure to nicotine or antidepressants during pregnancy, as well as children who were not exposed. The investigators hypothesis is that children who were exposed to either nicotine or antidepressants in pregnancy will have poorer developmental outcomes than children who were not exposed. The investigators are also interested in determining whether nicotine exposure or antidepressant exposure results in poorer outcomes. The investigators specific aims are: 1. To determine whether pre-school and school aged offspring exposed to maternal cigarette smoking or antidepressants during pregnancy are more likely to have social-emotional problems compared to children who were not exposed to cigarettes or antidepressants during pregnancy. 2. To determine whether pre-school and school aged children who were exposed to prenatal maternal cigarette smoking or antidepressants during pregnancy display cognitive impairments as compared to children who were not exposed to either prenatal maternal cigarette smoking or antidepressants. 3. To determine if pre-school and school aged children who were exposed to maternal prenatal cigarette smoking or antidepressants display impaired motor development as compared to children who were not exposed to maternal cigarette smoking or antidepressants in pregnancy.
Primary Outcome
The Revised Child Behavior Checklist (CBCL-2) is one of the most widely-used measures for evaluating maladaptive behavioral and emotional problems in children between the ages of 2 and 18. It assesses internalizing (i.e., anxious, depressive, and overcontrolled) and externalizing (i.e., aggressive, hyperactive, noncompliant, and undercontrolled) behaviors. In addition to the CBCL-2, we will use direct observation of a 2-minute mother-child interaction session to measure externalizing and interna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-07 |
What the finished NCT01640600 record still lists
NCT01640600 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 61 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01640600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01640600 about?
NCT01640600 is a clinical study titled "Yale Pink and Blue Kids: Effects of Exposure During Pregnancy to Nicotine or Antidepressants in 4-8 Year Old Children". The purpose of this project is to conduct a follow-up study with women that had participated in the Yale Pink and Blue Study of depression in pregnancy and birth outcomes. The Yale Pink and Blue Kids Study is a follow-up study with the mothers and also with the children they were pregnant with in Ya...
What is the current status of trial NCT01640600?
This trial is currently completed. The enrollment target is 61 participants. The study started on 2011-10. Estimated completion is 2013-07.
Who is sponsoring clinical trial NCT01640600?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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