Clinical Trials Directory

Trials / Completed

CompletedNCT03897816

Maternal Psychopathology and Offspring Mental Health (PSI_PER)

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

Status
Completed
Phase
Study type
Observational
Enrollment
450 (actual)
Sponsor
University of Milano Bicocca · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2011-01-01
Primary completion
2016-03-15
Completion
2019-02-01
First posted
2019-04-01
Last updated
2019-04-04

Source: ClinicalTrials.gov record NCT03897816. Inclusion in this directory is not an endorsement.