Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 1, 2006
February 6, 2009
November 2005
February 2009   (final data collection date for primary outcome measure)
maternal-infant interaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
maternal-infant interaction
Complete list of historical versions of study NCT00298311 on ClinicalTrials.gov Archive Site
  • 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 ]
  • cognitive development
  • social development
  • salivary cortisol
  • depressive symptomatology
  • social support
Not Provided
Not Provided
 
Trial to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression (PPD)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Postpartum Depression
Procedure: Peer Support
12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
104
July 2009
February 2009   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact: Linda Duffet-Leger (506) 452-6160 lindadl@rogers.com
Canada
 
NCT00298311
PPD MOD
No
Nicole Letourneau, University of New Brunswick
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
Principal Investigator: Nicole Letourneau, PhD University of New Brunswick
Canadian Research Institute for Social Policy
February 2009

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