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

Tracking Information

First Received Date ^ICMJE

March 1, 2006

Last Updated Date

February 6, 2009

Start Date ^ICMJE

November 2005

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

maternal-infant interaction

Change History

Complete list of historical versions of study NCT00298311 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

cognitive development
social development
salivary cortisol
depressive symptomatology
social support

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Postpartum Depression

Intervention ^ICMJE

Procedure: Peer Support

12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

104

Estimated Completion Date

July 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Linda Duffet-Leger

(506) 452-6160

lindadl@rogers.com

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00298311

Other Study ID Numbers ^ICMJE

PPD MOD

Has Data Monitoring Committee

Responsible Party

Nicole Letourneau, University of New Brunswick

Study Sponsor ^ICMJE

Canadian Research Institute for Social Policy

Collaborators ^ICMJE

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 ^ICMJE

Principal Investigator:

Nicole Letourneau, PhD

University of New Brunswick

Information Provided By

Canadian Research Institute for Social Policy

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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