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Trial to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression (PPD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Canadian Research Institute for Social Policy.
Recruitment status was  Recruiting
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:
Canadian Research Institute for Social Policy
ClinicalTrials.gov Identifier:
NCT00298311
First received: March 1, 2006
Last updated: February 6, 2009
Last verified: February 2009
History of Changes
  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
 Procedure: Peer Support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Canadian Research Institute for Social Policy:

Primary Outcome Measures:
  • maternal-infant interaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cognitive development [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • social development [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • salivary cortisol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • depressive symptomatology [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • social support [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: November 2005
Estimated Study Completion Date: July 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298311

Contacts
Contact: Linda Duffet-Leger (506) 452-6160 lindadl@rogers.com

Locations
Canada, Alberta
Women's Health Research Unit Recruiting
Edmonton, Alberta, Canada
Contact: Nicole L Letourneau, PhD     506-458-7647     nicolel@unb.ca    
Contact: Katie Young, MA     506-447-3204     kyoung@unb.ca    
Canada, New Brunswick
Linda Duffet-Leger Recruiting
Fredericton, New Brunswick, Canada, E3B 5A4
Contact: Linda Duffet-Leger, MN     (506) 452-6160     lindadl@rogers.com    
Principal Investigator: Nicole Letourneau, PhD            
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 New Brunswick
  More Information

No publications provided

Responsible Party: Nicole Letourneau, University of New Brunswick
ClinicalTrials.gov Identifier: NCT00298311     History of Changes
Other Study ID Numbers: PPD MOD
Study First Received: March 1, 2006
Last Updated: February 6, 2009
Health Authority: Canada: Ethics Review Committee

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 June 18, 2013