Behavioral ProblemsPABKidsNCT01640600
Yale Pink and Blue Kids: Effects of Exposure During Pregnancy to Nicotine or Antidepressants in 4-8 Year Old Children
An observational study of Behavioral Problems and Cognitive Problems, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 65 years
- Conditions the study is for
- Behavioral Problems, Cognitive Problems, Motor Development
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Psychiatry: The PMS, Perinatal, and Postpartum Research Program
New Haven, Connecticut, 06510-2600
About this study
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
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:
- 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.
- 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.
- 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.
- Conditions
- Behavioral Problems, Cognitive Problems, Motor Development
- 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.
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral ProblemsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Megan V Smith, DrPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640600
- Sponsor's protocol ID
- 1105008516
- Acronym
- PABKids
- Status last verified
- Dec 2016
- First submitted
- 11 Jul 2012
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01640600
- Acronym / sponsor ID
- PABKids / 1105008516
- Conditions
- Behavioral Problems, Cognitive Problems, Motor Development
- 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.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression, National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Externalizing and internalizing behavior
Time frame: 1 year
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan V Smith, DrPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral Problems and Cognitive Problems, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Externalizing and internalizing behavior (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.