Back to resultsEffect of Home-Based Peer Support on Maternal-Infant Interaction and Postpartum Depression
Primary Purpose
Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mci guidance peer support
Sponsored by
About this trial
This is an interventional health services research trial for Postpartum Depression
Eligibility Criteria
Inclusion Criteria: Eligible mothers will be identified as experiencing symptoms of PPD and scores >12 on the Edinburgh Postnatal Depression Scale. Mothers must speak English or French. Mothers will not be excluded for taking anti-depressant or anti-psychotic medication, using other interventions for PPD, or reporting a history of mental illness; The infant must be full-term, in the care of the mother and between 3 to 6 months of age at initial enrollment. Exclusion Criteria: Infants who have been admitted to the NICU Infants will be excluded if medicated with corticosteroids
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
mci guidance & peer social support
peer social support
Arm Description
home visits to promote maternal-child interaction & social support
social support
Outcomes
Primary Outcome Measures
maternal-infant interaction
Secondary Outcome Measures
cognitive development
social development
salivary cortisol
depressive symptomatology
social support
Full Information
NCT ID
NCT00298311
First Posted
March 1, 2006
Last Updated
August 3, 2017
Sponsor
Canadian Research Institute for Social Policy
Collaborators
Women's Health Research Unit, Social Support Research Program, University Health Network, Toronto, Edmonton Mental Health Services, Canadian Mental Health Association, Pediatric Rehabilitation Services, Department of Health and Wellness, NB
1. Study Identification
Unique Protocol Identification Number
NCT00298311
Brief Title
Effect of Home-Based Peer Support on Maternal-Infant Interaction and Postpartum Depression
Official Title
An RCT to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canadian Research Institute for Social Policy
Collaborators
Women's Health Research Unit, Social Support Research Program, University Health Network, Toronto, Edmonton Mental Health Services, Canadian Mental Health Association, Pediatric Rehabilitation Services, Department of Health and Wellness, NB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to examine the impact of a home-based peer support intervention for mothers affected by postpartum depression (PPD) and for their infants.
Detailed Description
This controlled study will help establish the link between support for maternal caregiving, maternal-infant interaction, infant neuroendocrinology and infant cognitive and social development. The primary hypothesis predicts that home-based peer support will improve maternal-infant interactions. Secondary hypotheses predict that home-based peer support will: improve infants' cognitive development; improve infants' social development; decrease average daily salivary cortisol levels in infants; reduce maternal depressive symptomatology; and improve maternal perceptions of social support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mci guidance & peer social support
Arm Type
Experimental
Arm Description
home visits to promote maternal-child interaction & social support
Arm Title
peer social support
Arm Type
Sham Comparator
Arm Description
social support
Intervention Type
Behavioral
Intervention Name(s)
mci guidance peer support
Intervention Description
12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program
Primary Outcome Measure Information:
Title
maternal-infant interaction
Time Frame
12 months
Secondary Outcome Measure Information:
Title
cognitive development
Time Frame
12 months
Title
social development
Time Frame
12 months
Title
salivary cortisol
Time Frame
12 months
Title
depressive symptomatology
Time Frame
12 months
Title
social support
Time Frame
12 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eligible mothers will be identified as experiencing symptoms of PPD and scores >12 on the Edinburgh Postnatal Depression Scale.
Mothers must speak English or French.
Mothers will not be excluded for taking anti-depressant or anti-psychotic medication, using other interventions for PPD, or reporting a history of mental illness;
The infant must be full-term, in the care of the mother and between 3 to 6 months of age at initial enrollment.
Exclusion Criteria:
Infants who have been admitted to the NICU
Infants will be excluded if medicated with corticosteroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Letourneau, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34286512
Citation
Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.
Results Reference
derived
Learn more about this trial
Effect of Home-Based Peer Support on Maternal-Infant Interaction and Postpartum Depression
We'll reach out to this number within 24 hrs