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Clinical Trials/NCT00604604
NCT00604604
Completed
N/A

An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression

University of Toronto7 sites in 1 country702 target enrollmentAugust 2004

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postpartum Depression
Sponsor
University of Toronto
Enrollment
702
Locations
7
Primary Endpoint
Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 2004
End Date
April 2007
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)

Time Frame: 12 weeks postpartum

Secondary Outcomes

  • State Anxiety Inventory (STAI); UCLA Loneliness Scale; Maternal Health Service Utilization and Cost of Care Questionnaire; Peer Support Evaluation Inventory; Peer Volunteer Experience Questionnaire; Peer Volunteer Activity Log(12 and 24 weeks postpartum)

Study Sites (7)

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