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Trial NCT00604604

Resource URI: http://static.linkedct.org/resource/trials/NCT00604604
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/16877>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/3258>
linkedct:brief_title Postpartum Depression Prevention Trial
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/10473>
linkedct:criteria Inclusion Criteria: - live birth - discharged from hospital - <2 weeks postpartum - scored >9 on the EPDS - availability of a peer volunteer who speaks the potential participant's language Exclusion Criteria: - infant not discharged home with mother - current use of anti-depressant or anti-psychotic medication - prior self-reported mental illness, including prior PPD, will NOT be an exclusion criterion
linkedct:description Many new mothers from diverse cultures experience postpartum depression (PPD), a serious form of maternal morbidity with well documented health consequences for the mother, child, and family. While the cause of PPD remains unclear, research consistently demonstrates the importance of psychosocial variables. The purpose of this randomized controlled trial is to evaluate the effect of peer (mother-to-mother) support on the prevention of PPD among mothers identified as high-risk. Public health nurses using the Edinburgh Postnatal Depression Scale (EPDS) screened mothers who were less than 2 weeks postpartum in the regions of Toronto, Peel, Halton, York, Windsor, Sudbury, and Ottawa. Eligible and consenting mothers were randomized to either a control group (usual postpartum care) or experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session). Diverse study outcomes, including depressive symptomatology and health service utilization, were assessed at 12 and 24 weeks postpartum. The results from this trial will make substantive contributions in six areas: (1) develop the body of knowledge concerning the effectiveness of peer support in the prevention of PPD among at-risk mothers; (2) advance our understanding of the advantages and disadvantages of using peer volunteers as a complementary form of health care; (3) provide an economic evaluation of a peer support intervention; (4) offer a detailed analysis of peer support interactions including supportive functions provided, types of relationships developed, and health benefits perceived; (5) investigate the utility of screening at-risk mothers using the EPDS in general public health nursing practice; and (6) present valuable information regarding PPD among a multicultural Canadian population.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age N/A
linkedct:end_date April 2007
linkedct:enrollment 702 (xsd:int)
linkedct:firstreceived_date January 17, 2008
linkedct:has_dmc Yes
linkedct:id NCT00604604
linkedct:intervention <http://static.linkedct.org/resource/intervention/43156>
rdfs:label Trial NCT00604604
linkedct:lastchanged_date January 17, 2008
linkedct:lead_sponsor_agency University of Toronto
linkedct:location <http://static.linkedct.org/resource/location/18859>
linkedct:location <http://static.linkedct.org/resource/location/19257>
linkedct:location <http://static.linkedct.org/resource/location/19458>
linkedct:location <http://static.linkedct.org/resource/location/19519>
linkedct:location <http://static.linkedct.org/resource/location/20032>
linkedct:location <http://static.linkedct.org/resource/location/21404>
linkedct:location <http://static.linkedct.org/resource/location/21480>
linkedct:nct_id NCT00604604
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression
linkedct:org_study_id MCT-66874
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10002>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/487>
foaf:page <http://clinicaltrials.gov/show/NCT00604604>
linkedct:phase N/A
linkedct:primary_completion_date April 2007
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/32543>
linkedct:secondary_id ISRCTN68337727
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/106937>
linkedct:source University of Toronto
linkedct:start_date August 2004
linkedct:study_design Prevention, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary The primary objective of this study is to evaluate the effect of peer (mother-to-mother) support on the prevention of postpartum depression among mothers identified as high-risk.
rdf:type linkedct:trials
linkedct:verification_date January 2008