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

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
Dr. Nicole LeTourneau, University of Calgary
ClinicalTrials.gov Identifier:
NCT00298311
First received: March 1, 2006
Last updated: August 3, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Postpartum Depression Behavioral: mci guidance peer support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: An RCT to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression

Resource links provided by NLM:


Further study details as provided by Dr. Nicole LeTourneau, University of Calgary:

Primary Outcome Measures:
  • maternal-infant interaction [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • cognitive development [ Time Frame: 12 months ]
  • social development [ Time Frame: 12 months ]
  • salivary cortisol [ Time Frame: 12 months ]
  • depressive symptomatology [ Time Frame: 12 months ]
  • social support [ Time Frame: 12 months ]

Enrollment: 60
Study Start Date: November 2005
Study Completion Date: July 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mci guidance & peer social support
home visits to promote maternal-child interaction & social support
Behavioral: mci guidance peer 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
Behavioral: mci guidance peer support
12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00298311

Sponsors and Collaborators
Canadian Research Institute for Social Policy
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
Investigators
Principal Investigator: Nicole Letourneau, PhD University of Calgary
  More Information

Responsible Party: Dr. Nicole LeTourneau, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00298311     History of Changes
Other Study ID Numbers: PPD MOD
Study First Received: March 1, 2006
Last Updated: August 3, 2017

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 18, 2017