Yale Pink and Blue Kids: Effects of Exposure During Pregnancy to Nicotine or Antidepressants in 4-8 Year Old Children

Motor Development Clinical Trial

— PABKids  

Official title:

Yale Pink and Blue Kids: Effects of in Utero Exposure to Nicotine and Selective Serotonin Reuptake Inhibitors in 4-8 Year Old Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640600
• Other study ID #: 1105008516
• Status: Completed
• Phase: N/A
• First received: July 11, 2012
• Last updated: June 2, 2017
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: December 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

Inclusion Criteria:

• Women who participated in the Yale Pink and Blue Study and had children born between 2005 and 2008.

• Exposure to SSRIs during pregnancy will be defined as those women with no exposure in pregnancy and continuous use of SSRIs (defined as taking at least one SSRI during every trimester).

• Exposure to nicotine will be defined as no exposure (no cigarettes during pregnancy), light exposure (an average of less than one cigarette a day over pregnancy duration), and heavy exposure (an average of one cigarette a day over the duration of pregnancy.

Exclusion Criteria:

• Spanish-Speaking women and women who live over a one hour driving distance from Yale will be considered ineligible.

• Children are not eligible if their mother had gestational exposure to prescription drugs in the FDA-defined category of D or X, since this can confound our assessment.

• Women with discontinuous use of SSRIs (defined as using SSRIs during pregnancy, but not every trimester) will also be excluded.

Related Conditions & MeSH terms

• Behavioral Problems
• Cognitive Problems
• Motor Development
• Problem Behavior

Locations

Country	Name	City	State
United States	Yale Psychiatry: The PMS, Perinatal, and Postpartum Research Program	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Alliance for Research on Schizophrenia and Depression, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Externalizing and internalizing behavior	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 internalizing symptoms, as parent report on the CBCL-2 may be biased by maternal psychopathology.	1 year
Primary	Cognitive Impairment	Cognitive impairment is measured using the Kaufman Brief Intelligence Test (KBIT-2), which measures both verbal and nonverbal intelligence through questions , riddles, and pictures. A computer test, CogState, will also assess cognitive functioning, specifically executive functioning through card-related tasks that will ask a child to respond in different ways.	1 year
Primary	Fine & Gross Motor Development	Fine and Gross Motor Skills will be measured using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (10), the most widely administered test of fine and gross motor skills in children ages 4 to 21. Administration time is approximately 60 minutes. Subtests include: Fine Motor Precision, Fine Motor Integration, Manual Dexterity, and Bilateral Coordination.	1 Year