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Clinical Trials/NCT00298311
NCT00298311CompletedNot Applicable

An RCT to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression

Canadian Research Institute for Social Policy0 sites60 target enrollmentStarted: November 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Primary Endpoint
maternal-infant interaction

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

mci guidance & peer social support

Experimental

home visits to promote maternal-child interaction & social support

Intervention: mci guidance peer support (Behavioral)

peer social support

Sham Comparator

social support

Intervention: mci guidance peer support (Behavioral)

Outcomes

Primary Outcomes

maternal-infant interaction

Time Frame: 12 months

Secondary Outcomes

  • cognitive development(12 months)
  • social development(12 months)
  • salivary cortisol(12 months)
  • depressive symptomatology(12 months)
  • social support(12 months)

Investigators

Sponsor
Canadian Research Institute for Social Policy
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Nicole LeTourneau

Professor

University of Calgary

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