Postpartum Depression Prevention Trial

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00604604
First received: January 17, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Postpartum Depression
Behavioral: Peer support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 12 weeks postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 702
Study Start Date: August 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control group (usual postpartum care)
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 Name: Mother-to-mother support
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 Name: Mother-to-mother support

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604604

Locations
Canada, Ontario
Peel Health Department
Mississauga, Ontario, Canada, L5R 4B2
Halton Region Health Department
Oakville, Ontario, Canada, L6M 3L1
Ottawa Public Health
Ottawa, Ontario, Canada, K2G 6J8
York Region Health Services
Richmond Hill, Ontario, Canada, L4B 4N7
Sudbury & District Health Unit
Sudbury, Ontario, Canada, P3E 3A3
Toronto Public Health
Toronto, Ontario, Canada, M2N 5V7
Windsor Essex County Health Unit
Windsor, Ontario, Canada, N9J 4J8
Sponsors and Collaborators
University of Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Cindy-Lee Dennis, PhD Lawrence S. Bloomberg Faculty of Nursing, University of Toronto
  More Information

No publications provided

Responsible Party: Dr. Cindy-Lee Dennis, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto
ClinicalTrials.gov Identifier: NCT00604604     History of Changes
Other Study ID Numbers: MCT-66874, ISRCTN68337727
Study First Received: January 17, 2008
Last Updated: January 17, 2008
Health Authority: Canada: University of Toronto

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on August 26, 2014