Postpartum Depression Prevention Trial

June 2, 2015 updated by: University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

702

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5R 4B2
        • Peel Health Department
      • Oakville, Ontario, Canada, L6M 3L1
        • Halton Region Health Department
      • Ottawa, Ontario, Canada, K2G 6J8
        • Ottawa Public Health
      • Richmond Hill, Ontario, Canada, L4B 4N7
        • York Region Health Services
      • Sudbury, Ontario, Canada, P3E 3A3
        • Sudbury & District Health Unit
      • Toronto, Ontario, Canada, M2N 5V7
        • Toronto Public Health
      • Windsor, Ontario, Canada, N9J 4J8
        • Windsor Essex County Health Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Control group (usual postpartum care)
Experimental: 2
Experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session)
Behavioral: Peer support
Mothers allocated to the peer support group had access to all of the standard community postpartum services in addition to having received telephone-based support from a peer volunteer (a mother who has previously experienced, and recovered from, postpartum depression and has participated in a 4-hour training session). Telephone contact with a new mother was initiated within 48 to 72 hours of trial enrolment and then as frequently as the dyad deemed necessary; a minimum of four contacts were required.
Other Names:
  • Mother-to-mother support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: 12 weeks postpartum
12 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 and 24 weeks postpartum
12 and 24 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Cindy-Lee Dennis, PhD, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT-66874
  • ISRCTN68337727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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