Postpartum DepressionNCT00298311
Effect of Home-Based Peer Support on Maternal-Infant Interaction and Postpartum Depression
A study testing mci guidance peer support in people with Postpartum Depression, run by Canadian Research Institute for Social Policy.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- mci guidance peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Infants who have been admitted to the NICU
- Infants will be excluded if medicated with corticosteroids
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- mci guidance peer support
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mci guidance peer supportBehavioural
12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program
| Study group | Role | What they receive |
|---|---|---|
| mci guidance & peer social support | Experimental | home visits to promote maternal-child interaction \& social support Receives: Behavioral: mci guidance peer support |
| peer social support | Sham comparator | social support Receives: Behavioral: mci guidance peer support |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal-infant interaction
Measured: 12 months
Secondary outcomes (5)
cognitive development
Measured: 12 months
social development
Measured: 12 months
salivary cortisol
Measured: 12 months
depressive symptomatology
Measured: 12 months
social support
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startNov 2005
- Primary completionFeb 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Research Institute for Social Policy
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Dr. Nicole LeTourneau, University of Calgary
- Investigators
- Nicole Letourneau, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298311
- Sponsor's protocol ID
- PPD MOD
- Status last verified
- Aug 2017
- First submitted
- 1 Mar 2006
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34286512
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT to Evaluate the Effect of Home-Based Peer Support on Maternal-Infant Interaction, Infant Health Outcomes, and Postpartum Depression
- ClinicalTrials.gov ID
- NCT00298311
- Acronym / sponsor ID
- PPD MOD
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Canadian Research Institute for Social PolicyUniversity, hospital or other
- 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
- Study start
- Nov 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mci guidance & peer social support | Experimental | Behavioral: mci guidance peer supporthome visits to promote maternal-child interaction \& social support |
| peer social support | Sham comparator | Behavioral: mci guidance peer supportsocial support |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Infants who have been admitted to the NICU
- Infants will be excluded if medicated with corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mci guidance peer support12 weeks of home visits by peer mentor recovered from PPD and Keys to Caregiving (NCAST, 1990) program | Behavioural | mci guidance & peer social support, peer social support |
Primary outcome
maternal-infant interaction
Time frame: 12 months
5 secondary outcomes
cognitive development
Time frame: 12 months
social development
Time frame: 12 months
salivary cortisol
Time frame: 12 months
depressive symptomatology
Time frame: 12 months
social support
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Derived from this study: PubMed 34286512Yonemoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Letourneau, PhD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing mci guidance peer support in people with Postpartum Depression, run by Canadian Research Institute for Social Policy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal-infant interaction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.