Clinical trial NCT03897816: Maternal Psychopathology and Offspring Mental Health (PSI_PER)
Official title: Maternal Mood, Anxiety or Personality Disorders and Their Offspring Mental Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intergenerational Relations
Keywords: personality disorders
anxiety disorders
mood disorders
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 450
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

pregnancy; adequate comprehension; acceptance on a voluntary basis.

Exclusion Criteria:

incapacity; acute psychosis.

Primary outcomes:
measure: offspring mental outcomes
timeFrame: 18 months-5 years old
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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