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

This study is currently recruiting participants.

Verified by Canadian Research Institute for Social Policy, February 2006

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
Information provided by:	Canadian Research Institute for Social Policy
ClinicalTrials.gov Identifier:	NCT00298311

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	Phase
Postpartum Depression	Procedure: Peer Support	Phase II

MedlinePlus related topics: Depression Postpartum Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety Study
Official Title:	An RCT to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression

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

Primary Outcome Measures:

maternal-infant interaction

Secondary Outcome Measures:

cognitive development
social development
salivary cortisol
depressive symptomatology
social support

Estimated Enrollment:	104
Study Start Date:	November 2005
Estimated Study Completion Date:	September 2008

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: Jody Macdonald, M.Sc. (780) 492-8029 jody.macdonald@ualberta.ca
Contact: Ann O'Neill, M.A. (780) 492-9046 ann.oneill@nurs.ualberta.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

Study ID Numbers:	PPD MOD
Study First Received:	March 1, 2006
Last Updated:	March 1, 2006
ClinicalTrials.gov Identifier:	NCT00298311
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum

Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009