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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00298311
Other study ID # PPD MOD
Secondary ID
Status Completed
Phase N/A
First received March 1, 2006
Last updated August 3, 2017
Start date November 2005
Est. completion date July 2010

Study information

Verified date August 2017
Source Canadian Research Institute for Social Policy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2010
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (8)

Lead Sponsor Collaborator
Canadian Research Institute for Social Policy Canadian Mental Health Association, Department of Health and Wellness, NB, Edmonton Mental Health Services, Pediatric Rehabilitation Services, Social Support Research Program, University Health Network, Toronto, Women's Health Research Unit

Outcome

Type Measure Description Time frame Safety issue
Primary maternal-infant interaction 12 months
Secondary cognitive development 12 months
Secondary social development 12 months
Secondary salivary cortisol 12 months
Secondary depressive symptomatology 12 months
Secondary social support 12 months
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