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Clinical Trials/NCT03897816
NCT03897816
Completed
N/A

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

University of Milano Bicocca0 sites450 target enrollmentJanuary 1, 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Intergenerational Relations
Sponsor
University of Milano Bicocca
Enrollment
450
Primary Endpoint
offspring mental outcomes
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2011
End Date
February 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • pregnancy; adequate comprehension; acceptance on a voluntary basis.

Exclusion Criteria

  • incapacity; acute psychosis.

Outcomes

Primary Outcomes

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".

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