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

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ClinicalTrials.gov Identifier: NCT03897816
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

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.

Condition or disease
Intergenerational Relations

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.


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Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Mood, Anxiety or Personality Disorders and Their Offspring Mental Outcomes
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : March 15, 2016
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

pregnancy; adequate comprehension; acceptance on a voluntary basis.

Exclusion Criteria:

incapacity; acute psychosis.


Publications:

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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT03897816     History of Changes
Other Study ID Numbers: 981
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Milano Bicocca:
personality disorders
anxiety disorders
mood disorders
Additional relevant MeSH terms:
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Personality Disorders
Mental Disorders