Maternal Psychopathology and Offspring Mental Health (PSI_PER) (PSI_PER)

April 2, 2019 updated by: University of Milano Bicocca

Maternal Mood, Anxiety or Personality Disorders and Their Offspring Mental Outcomes

Pregnant women consecutively referred to the Perinatal Psychiatric Outpatient Department, those in charge of the Psychiatric Outpatient Department and pregnant healthy controls from the general population will be recruited on a voluntary basis. Mothers will be tested with the EPDS, BAI, BDI, WHOQOL, SCID II and CTQ; their children will be tested with the CBCL between 18 months and 5 years.

Study Overview

Status

Completed

Conditions

Detailed Description

in order to attest possible psychic outcomes in offspring of mothers affected by psychiatric disorders due to maternal psychopathology (with an in-depth evaluation about the role of maternal personality disorders), the investigators recruit all the women consecutively referred and admitted to the Perinatal Psychiatric Outpatient Department from January, 2011 to December, 2016, due to the manifestation of psychic suffering during pregnancy.

During their first appointment, patients are routinely administered the Structured Clinical Interview for DSM-IV Axis II Disorders (SCID II), Childhood Trauma Questionnaire (CTQ), World Health Organization Quality of Life Instruments (WHOQOL-BREF), Edinburgh Postnatal Depression Scale (EPDS), Beck Depression Interview (BDI) and Beck Anxiety Interview (BAI). The Mini-International Neuropsychiatric Interview (M.I.N.I.) is used to confirm clinical diagnosis.

As a control samples, the investigators recruited pregnant patients belonging to the Outpatients Psychiatric Department who did not have psychiatric issues linked to their pregnancy or in the relationship with their children and pregnant healthy controls among the general population, with no history of mental health issues. Controls were tested as the clinical sample.

All the patients will be asked to complete a caregiver report form, the Child Behavior Checklist (CBCL), once their children were at least 18 months old.

Study Type

Observational

Enrollment (Actual)

450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

the population is composed by women referred to the Perinatal Psychiatric Outpatient Department, those in charge of the Psychiatric Outpatient Department and pregnant healthy controls from the general population.

Description

Inclusion Criteria:

pregnancy; adequate comprehension; acceptance on a voluntary basis.

Exclusion Criteria:

incapacity; acute psychosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
"PERINATAL"
Pregnant women consecutively referred and admitted to the Perinatal Psychiatric Outpatient Department
"OUTPTS"
Pregnant women belonging to the Outpatients Psychiatric Department who did not have psychiatric issues linked to their pregnancy or in the relationship with their children
Healthy controls
Pregnant women the general population, with no history of mental health issues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
offspring mental outcomes
Time Frame: 18 months-5 years old

Mothers are given the Child Behavior Checklist (CBCL), a widely used caregiver report form identifying problem behavior in children. For the preschool version of the CBCL (CBCL/1½-5), parents or others who interact with the child in regular contexts rate the child's behavior. Respondents rate the child's behavior on a 3-point scale (not true, somewhat or sometimes true, and very true or often true), and are instructed to rate the behavior as it occurs now or within the previous two months. This delineation differs from the instructions on other age-versions, due to the fact that rapid development and behavioral changes in the preschool age range are common. The preschool checklist contains 100 questions about behavior problems.

CBCL scores are divided in: "emotionally reactive", "anxious/depressed", "somatic complaints", "withdrawn", "sleep problems", "attention problems", "aggressive behavior", "externalize", "internalize", "other problems", "total".
18 months-5 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

March 15, 2016

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (ACTUAL)

April 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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