Maternal Psychopathology and Offspring Mental Health (PSI_PER)
NCT ID: NCT03897816
Last Updated: 2019-04-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
450 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-01-01
Study Completion Date
2019-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Maternal Well-being in the Perinatal Period
NCT06473935
Perinatal Depression
Anxiety
Loneliness
+1 more
RECRUITING
Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health
NCT06379074
Postpartum Depression
Insomnia
Stress
NOT_YET_RECRUITING
NA
Cohort Study on the Outcome and Influencing Factors of Perinatal Depression
NCT04517981
Perinatal Depression
Prognosis
UNKNOWN
Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population
NCT06297252
Pregnancy
RECRUITING
NA
Description of the Psychiatric Care Pathway of Pregnant Women After the Early Prenatal Interview
NCT04574986
Psychiatric Disorder
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Intergenerational Relations
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
"PERINATAL"
Pregnant women consecutively referred and admitted to the Perinatal Psychiatric Outpatient Department
No interventions assigned to this group
"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
No interventions assigned to this group
Healthy controls
Pregnant women the general population, with no history of mental health issues
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
pregnancy; adequate comprehension; acceptance on a voluntary basis.
Exclusion Criteria
incapacity; acute psychosis.
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Milano Bicocca
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
References
Explore related publications, articles, or registry entries linked to this study.
Bloch M, Schmidt PJ, Danaceau M, Murphy J, Nieman L, Rubinow DR. Effects of gonadal steroids in women with a history of postpartum depression. Am J Psychiatry. 2000 Jun;157(6):924-30. doi: 10.1176/appi.ajp.157.6.924.
Reference Type
BACKGROUND
Mehta D, Newport DJ, Frishman G, Kraus L, Rex-Haffner M, Ritchie JC, Lori A, Knight BT, Stagnaro E, Ruepp A, Stowe ZN, Binder EB. Early predictive biomarkers for postpartum depression point to a role for estrogen receptor signaling. Psychol Med. 2014 Aug;44(11):2309-22. doi: 10.1017/S0033291713003231. Epub 2014 Feb 5.
Reference Type
BACKGROUND
Couto TC, Brancaglion MY, Alvim-Soares A, Moreira L, Garcia FD, Nicolato R, Aguiar RA, Leite HV, Correa H. Postpartum depression: A systematic review of the genetics involved. World J Psychiatry. 2015 Mar 22;5(1):103-11. doi: 10.5498/wjp.v5.i1.103.
Reference Type
BACKGROUND
Guintivano J, Arad M, Gould TD, Payne JL, Kaminsky ZA. Antenatal prediction of postpartum depression with blood DNA methylation biomarkers. Mol Psychiatry. 2014 May;19(5):560-7. doi: 10.1038/mp.2013.62. Epub 2013 May 21.
Reference Type
BACKGROUND
Ruiz SK, Harris SJ, Martinez P, Gold PM, Klimes-Dougan B. Young adult's attachment style as a partial mediator between maternal functioning and young adult offsprings' functioning. J Affect Disord. 2018 May;232:393-399. doi: 10.1016/j.jad.2017.12.034. Epub 2018 Jan 9.
Reference Type
BACKGROUND
Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, Howard LM, Pariante CM. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014 Nov 15;384(9956):1800-19. doi: 10.1016/S0140-6736(14)61277-0. Epub 2014 Nov 14.
Reference Type
BACKGROUND
Matijasevich A, Murray J, Cooper PJ, Anselmi L, Barros AJ, Barros FC, Santos IS. Trajectories of maternal depression and offspring psychopathology at 6 years: 2004 Pelotas cohort study. J Affect Disord. 2015 Mar 15;174:424-31. doi: 10.1016/j.jad.2014.12.012. Epub 2014 Dec 13.
Reference Type
BACKGROUND
Sellers R, Collishaw S, Rice F, Thapar AK, Potter R, Mars B, Harold GT, Smith DJ, Owen MJ, Craddock N, Thapar A. Risk of psychopathology in adolescent offspring of mothers with psychopathology and recurrent depression. Br J Psychiatry. 2013 Feb;202:108-14. doi: 10.1192/bjp.bp.111.104984. Epub 2012 Oct 11.
Reference Type
BACKGROUND
Wisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.
Reference Type
BACKGROUND
Challacombe F, Salkovskis P. A preliminary investigation of the impact of maternal obsessive-compulsive disorder and panic disorder on parenting and children. J Anxiety Disord. 2009 Oct;23(7):848-57. doi: 10.1016/j.janxdis.2009.04.002. Epub 2009 Apr 23.
Reference Type
BACKGROUND
Low NC, Dugas E, Constantin E, Karp I, Rodriguez D, O'Loughlin J. The association between parental history of diagnosed mood/anxiety disorders and psychiatric symptoms and disorders in young adult offspring. BMC Psychiatry. 2012 Nov 5;12:188. doi: 10.1186/1471-244X-12-188.
Reference Type
BACKGROUND
Martini J, Knappe S, Beesdo-Baum K, Lieb R, Wittchen HU. Anxiety disorders before birth and self-perceived distress during pregnancy: associations with maternal depression and obstetric, neonatal and early childhood outcomes. Early Hum Dev. 2010 May;86(5):305-10. doi: 10.1016/j.earlhumdev.2010.04.004. Epub 2010 May 23.
Reference Type
BACKGROUND
Black DW, Gaffney GR, Schlosser S, Gabel J. Children of parents with obsessive-compulsive disorder -- a 2-year follow-up study. Acta Psychiatr Scand. 2003 Apr;107(4):305-13. doi: 10.1034/j.1600-0447.2003.02182.x.
Reference Type
BACKGROUND
Castelli RD, Quevedo Lde A, Coelho FM, Lopez MA, da Silva RA, Bohm DM, Souza LD, de Matos MB, Pinheiro KA, Pinheiro RT. Cognitive and language performance in children is associated with maternal social anxiety disorder: A study of young mothers in southern Brazil. Early Hum Dev. 2015 Dec;91(12):707-11. doi: 10.1016/j.earlhumdev.2015.10.002. Epub 2015 Nov 16.
Reference Type
BACKGROUND
Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available.
Reference Type
BACKGROUND
Munk-Olsen T, Laursen TM, Pedersen CB, Mors O, Mortensen PB. New parents and mental disorders: a population-based register study. JAMA. 2006 Dec 6;296(21):2582-9. doi: 10.1001/jama.296.21.2582.
Reference Type
BACKGROUND
Paulson JF, Bazemore SD. Prenatal and postpartum depression in fathers and its association with maternal depression: a meta-analysis. JAMA. 2010 May 19;303(19):1961-9. doi: 10.1001/jama.2010.605.
Reference Type
BACKGROUND
Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.
Reference Type
BACKGROUND
Earls MF; Committee on Psychosocial Aspects of Child and Family Health American Academy of Pediatrics. Incorporating recognition and management of perinatal and postpartum depression into pediatric practice. Pediatrics. 2010 Nov;126(5):1032-9. doi: 10.1542/peds.2010-2348. Epub 2010 Oct 25.
Reference Type
BACKGROUND
Bosanquet K, Bailey D, Gilbody S, Harden M, Manea L, Nutbrown S, McMillan D. Diagnostic accuracy of the Whooley questions for the identification of depression: a diagnostic meta-analysis. BMJ Open. 2015 Dec 9;5(12):e008913. doi: 10.1136/bmjopen-2015-008913.
Reference Type
BACKGROUND
Wisner KL, Parry BL, Piontek CM. Clinical practice. Postpartum depression. N Engl J Med. 2002 Jul 18;347(3):194-9. doi: 10.1056/NEJMcp011542. No abstract available.
Reference Type
BACKGROUND
Goodman JH. Postpartum depression beyond the early postpartum period. J Obstet Gynecol Neonatal Nurs. 2004 Jul-Aug;33(4):410-20. doi: 10.1177/0884217504266915.
Reference Type
BACKGROUND
Byatt N, Levin LL, Ziedonis D, Moore Simas TA, Allison J. Enhancing Participation in Depression Care in Outpatient Perinatal Care Settings: A Systematic Review. Obstet Gynecol. 2015 Nov;126(5):1048-1058. doi: 10.1097/AOG.0000000000001067.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
981
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies
NCT05951738
UNKNOWN
NA
Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum
NCT05766007
RECRUITING
Clinical and Cost-effectiveness of an Online Self-help Intervention and a Face-to-face Intervention Versus Usual Care in Mothers at Moderate Risk for Perinatal Depression
NCT07027761
NOT_YET_RECRUITING
NA
Perinatal Mental Health Care in Switzerland
NCT04185896
UNKNOWN
MAMA NO STRESS Project. The Effects of the "HAPPY MAMA" Intervention
NCT04093791
UNKNOWN
NA
Global Mental Health of Urban Mothers
NCT04363177
UNKNOWN
NA
Diagnostic Accuracy of the Stepped Screening Protocol and Its Screening Tools in the Perinatal Period.
NCT05961306
RECRUITING
Maternal Mental Health in the Hospital Setting
NCT03777046
COMPLETED
NA
Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women
NCT05175755
UNKNOWN
NA
Psychiatry Research and Motherhood at 6 to 8 (PRAM-P@6to8)
NCT06162689
ENROLLING_BY_INVITATION
Post-natal Depression and Chronic Stress
NCT03088319
COMPLETED
Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic
NCT04377412
UNKNOWN
Pathways to Perinatal Mental Health Equity
NCT06790641
RECRUITING
NA
PREVENTION OF PERINATAL DEPRESSION BY EPDS DURING THE FIRST PRENATAL CONSULTATION AT MATERNITY DEPARTMENT
NCT05632510
UNKNOWN
NA
Screening for Depression and Anxiety in Pregnant and Postpartum Women: Evaluating Prevalence, Risk Factors, and the Stepped Screening Protocol in a Care Pathway
NCT06664593
COMPLETED
Psychological Impact of the Lockdown on Patients Giving Birth During the COVID-19 Epidemic Short Title : Isolement and Childbirth: Psychological Impact
NCT04366817
COMPLETED
NA
Psychological Screening and Nursing of Twin Pregnancy
NCT05182541
RECRUITING
NA
Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
NCT00380419
COMPLETED
NA
Optimizing Clinical Screening and Management of Maternal Mental Health: Predicting Women at Risk for Perinatal Depression
NCT03144752
COMPLETED
Estimating the Prevalence of Postpartum Anxiety and Depression in the Context of the Coronavirus Disease (COVID-19) Pandemic
NCT04852757
COMPLETED
Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic
NCT04487171
UNKNOWN
NA
DECIDE to Improve Maternal Mental Health Care Delivery
NCT07098260
RECRUITING
NA
Online Training for Addressing Perinatal Depression
NCT04919967
COMPLETED
NA
Pregnancy Without Psychosocial Stress
NCT04853693
UNKNOWN
NA
A Study of Pregnant and Postpartum Women With and Without Mood Disorders
NCT03615794
COMPLETED