Postpartum Depression Prevention Trial
An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression
2 other identifiers
interventional
702
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2004
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 17, 2008
CompletedFirst Posted
Study publicly available on registry
January 30, 2008
CompletedJune 3, 2015
January 1, 2008
2.7 years
January 17, 2008
June 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)
12 weeks postpartum
Secondary Outcomes (1)
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 Arms (2)
1
NO INTERVENTIONControl group (usual postpartum care)
2
EXPERIMENTALExperimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- infant not discharged home with mother
- current use of anti-depressant or anti-psychotic medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Sudbury & District Health Unit
Greater Sudbury, Ontario, P3E 3A3, Canada
Peel Health Department
Mississauga, Ontario, L5R 4B2, Canada
Halton Region Health Department
Oakville, Ontario, L6M 3L1, Canada
Ottawa Public Health
Ottawa, Ontario, K2G 6J8, Canada
York Region Health Services
Richmond Hill, Ontario, L4B 4N7, Canada
Toronto Public Health
Toronto, Ontario, M2N 5V7, Canada
Windsor Essex County Health Unit
Windsor, Ontario, N9J 4J8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cindy-Lee Dennis, PhD
Lawrence S. Bloomberg Faculty of Nursing, University of Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 17, 2008
First Posted
January 30, 2008
Study Start
August 1, 2004
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
June 3, 2015
Record last verified: 2008-01