- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00298311
Effect of Home-Based Peer Support on Maternal-Infant Interaction and Postpartum Depression
August 3, 2017 updated by: Dr. Nicole LeTourneau, Canadian Research Institute for Social Policy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mci guidance & peer social support
home visits to promote maternal-child interaction & social support
|
12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program
|
Sham Comparator: peer social support
social support
|
12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
maternal-infant interaction
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cognitive development
Time Frame: 12 months
|
12 months
|
social development
Time Frame: 12 months
|
12 months
|
salivary cortisol
Time Frame: 12 months
|
12 months
|
depressive symptomatology
Time Frame: 12 months
|
12 months
|
social support
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nicole Letourneau, PhD, University of Calgary
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
March 1, 2006
First Submitted That Met QC Criteria
March 1, 2006
First Posted (Estimate)
March 2, 2006
Study Record Updates
Last Update Posted (Actual)
August 7, 2017
Last Update Submitted That Met QC Criteria
August 3, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPD MOD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
British Columbia Children's HospitalActive, not recruiting
-
University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
-
Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
Clinical Trials on mci guidance peer support
-
Universitätsklinikum Hamburg-EppendorfCompletedQuality of Life | Depressive Symptoms | Self EsteemGermany
-
Northwestern UniversityCompletedDepressionUnited States
-
University of Eastern FinlandSocial Insurance Institution, Finland; Finnish Cultural FoundationRecruiting
-
Lighthouse TrustUniversity of North Carolina, Chapel Hill; World Health Organization; Kamuzu... and other collaboratorsUnknown
-
Makerere UniversityUniversity of Bergen; Centre MurazUnknownMalnutrition | Neurologic Deficits | Poor Performance Status | Infections, Hospital | Mixed Behavior and Emotional DisorderUganda
-
Indiana UniversityPatient-Centered Outcomes Research InstituteEnrolling by invitationGeneralized Anxiety Disorder | Chest Pain | PanicUnited States
-
Universitätsklinikum Hamburg-EppendorfUniversity of UlmActive, not recruitingSevere Mental Health Condition With Indication of Hospital AdmissionGermany
-
MRC/UVRI and LSHTM Uganda Research UnitKarolinska Institutet; University of California, San Francisco; European and... and other collaboratorsRecruitingHIV-1-infectionUganda
-
Hospices Civils de LyonRecruiting
-
Ohio State UniversityCambia Health FoundationEnrolling by invitationDementia | Family Caregiver | Peer SupportUnited States