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

Yale Pink and Blue Kids: Effects of in Utero Exposure to Nicotine and Selective Serotonin Reuptake Inhibitors 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 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.

Study Overview

• Status: Completed
• Conditions: Behavioral Problems; Cognitive Problems; Motor Development

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510-2600
      • Yale Psychiatry: The PMS, Perinatal, and Postpartum Research Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Each subject is a previous study participant known to this research team who has agreed to be contacted about future studies. We will review only their research records and not medical records in order to determine eligibility. There are no subjects for whom the ability to give informed consent can be questioned. All of the subjects were at least the age of 18 at the time of their initial PAB participation between 2005-2008, and thus are at least age 20 at the present time. All subjects are English speaking.

These are women who participated in the PAB Study (HIC #12394) and delivered a singleton birth (no twins or triplets) between 2005-2008. We are inviting them and their children (now aged 4-8) to participate.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Children exposed to SSRIs in utero; This group are comprised of children whose mothers used antidepressants during pregnancy and who were therefore exposed to antidepressants in utero.
Children exposed to nicotine in utero; This group is comprised of children whose mothers smoked cigarettes during pregnancy and who were therefore exposed to nicotine in utero.
Children exposed to neither nicotine nor SSRIs; This group is comprised of children who were exposed to neither nicotine nor SSRIs in utero.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); National Alliance for Research on Schizophrenia and Depression
• Investigators: Principal Investigator: Megan V Smith, DrPH, Yale University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: To determine whether 4-8 year-old children exposed to nicotine or antidepressants in utero have more behavioral problems.; To determine whether 4-8 year-old children exposed to nicotine or antidepressants in utero have more cognitive problems.; To determine whether 4-8 year-old children exposed to nicotine or antidepressants in utero have poorer motor development.
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: 1105008516