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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01640600
First received: July 11, 2012
Last updated: September 8, 2014
Last verified: February 2013
  Purpose

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.

Condition
Behavioral Problems
Cognitive Problems
Motor Development

Study Type: Observational
Study Design: Observational Model: Case Control
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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Externalizing and internalizing behavior [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Cognitive Impairment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Fine & Gross Motor Development [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

We will be collecting saliva from mothers and their children in order to look at certain genes that may be related to developmental outcomes.


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: August 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   4 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640600

Locations
United States, Connecticut
Yale Psychiatry: The PMS, Perinatal, and Postpartum Research Program
New Haven, Connecticut, United States, 06510-2600
Sponsors and Collaborators
Yale University
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Megan V Smith, DrPH Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01640600     History of Changes
Other Study ID Numbers: 1105008516
Study First Received: July 11, 2012
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
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:
Mental Disorders
Nicotine
Antidepressive Agents
Serotonin Uptake Inhibitors
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on September 16, 2014