Maternal Psychopathology and Offspring Mental Health (PSI_PER) (PSI_PER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03897816|
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 4, 2019
|Condition or disease|
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|
|Actual Enrollment :||450 participants|
|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|
Pregnant women consecutively referred and admitted to the Perinatal Psychiatric Outpatient Department
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
Pregnant women the general population, with no history of mental health issues
- 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".