NCT00298311

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

March 1, 2006

Last Update Submit

August 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • maternal-infant interaction

    12 months

Secondary Outcomes (5)

  • cognitive development

    12 months

  • social development

    12 months

  • salivary cortisol

    12 months

  • depressive symptomatology

    12 months

  • social support

    12 months

Study Arms (2)

mci guidance & peer social support

EXPERIMENTAL

home visits to promote maternal-child interaction \& social support

Behavioral: mci guidance peer support

peer social support

SHAM COMPARATOR

social support

Behavioral: mci guidance peer support

Interventions

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

mci guidance & peer social supportpeer social support

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Infants who have been admitted to the NICU
  • Infants will be excluded if medicated with corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Nicole Letourneau, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 2, 2006

Study Start

November 1, 2005

Primary Completion

February 1, 2009

Study Completion

July 1, 2010

Last Updated

August 7, 2017

Record last verified: 2017-08