Effect of Home-Based Peer Support on Maternal-Infant Interaction and Postpartum Depression

August 3, 2017 updated by: Dr. Nicole LeTourneau, Canadian Research Institute for Social Policy

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

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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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:

  • 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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mci guidance & peer social support
home visits to promote maternal-child interaction & social support
12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program
Sham Comparator: peer social support
social support
12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maternal-infant interaction
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
cognitive development
Time Frame: 12 months
12 months
social development
Time Frame: 12 months
12 months
salivary cortisol
Time Frame: 12 months
12 months
depressive symptomatology
Time Frame: 12 months
12 months
social support
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

November 1, 2005

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

March 1, 2006

First Submitted That Met QC Criteria

March 1, 2006

First Posted (Estimate)

March 2, 2006

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

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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