NCT03897816

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2016

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

5.2 years

First QC Date

March 29, 2019

Last Update Submit

April 2, 2019

Conditions

Keywords

personality disordersanxiety disordersmood disorders

Outcome Measures

Primary Outcomes (1)

  • offspring mental outcomes

    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".

    18 months-5 years old

Study Arms (3)

"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

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • pregnancy; adequate comprehension; acceptance on a voluntary basis.

You may not qualify if:

  • incapacity; acute psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (23)

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    PMID: 10831472BACKGROUND
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    PMID: 24495551BACKGROUND
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  • 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.

    PMID: 29522959BACKGROUND
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    PMID: 25455250BACKGROUND
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    PMID: 25553403BACKGROUND
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    PMID: 23060622BACKGROUND
  • 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.

    PMID: 23487258BACKGROUND
  • 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.

    PMID: 19464141BACKGROUND
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    PMID: 23126640BACKGROUND
  • 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.

    PMID: 20547016BACKGROUND
  • 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.

    PMID: 12662254BACKGROUND
  • 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.

    PMID: 26544906BACKGROUND
  • 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.

    PMID: 15760246BACKGROUND
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    PMID: 17148723BACKGROUND
  • 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.

    PMID: 20483973BACKGROUND
  • 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.

    PMID: 15883651BACKGROUND
  • 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.

    PMID: 20974776BACKGROUND
  • 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.

    PMID: 26656018BACKGROUND
  • 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.

    PMID: 12124409BACKGROUND
  • 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.

    PMID: 15346666BACKGROUND
  • 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.

    PMID: 26444130BACKGROUND

MeSH Terms

Conditions

Personality DisordersAnxiety DisordersMood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 1, 2019

Study Start

January 1, 2011

Primary Completion

March 15, 2016

Study Completion

February 1, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04