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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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6 July 2015 |
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Main ID: |
ISRCTN56529202 |
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Date of registration:
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02/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluating collaborative care for postpartum depression in pediatric primary care settings (EPDS) trial
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Scientific title:
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Evaluating collaborative care for Postpartum Depression in pediatric primary care Settings (EPDS) trial: a multi-centre randomised controlled trial |
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Date of first enrolment:
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05/01/2015 |
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Target sample size:
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360 |
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Recruitment status: |
Recruiting |
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URL:
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http://isrctn.com/ISRCTN56529202 |
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Study type:
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Interventional |
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Study design:
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Multi-centre randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Cindy-Lee
Dennis |
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Address:
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University of Toronto
Lawrence S. Bloomberg Faculty of Nursing
155 College Street
Suite 130
M5T 1P8
Toronto
Canada |
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Telephone:
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+1 (0) 416 946 8608 |
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Email:
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cindylee.dennis@utoronto.ca |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Mothers who meet the following criteria:
1. Has a healthy child participating in the TARGet Kids! study
2. Is between 0 to 6 months postpartum
3. Edinburgh Postnatal Depression Scale (EPDS) score >9 at TARGet Kids! baseline and trial recruitment (2-stage assessment)
4. Understands spoken English
Exclusion criteria: 1. Current use of antidepressant medication
2. Current receipt of any form of psychotherapy administered by a trained professional
3. Active suicidal or self-harm thoughts
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postpartum depression
Mental and Behavioural Disorders
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
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Intervention(s)
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Mothers randomly assigned to the treatment group will have access to usual postpartum care in addition to the treatment provided by the study, which will include the four standard criteria for collaborative care: (1) a multi-professional approach to care; (2) a structured management plan; (3) scheduled participant follow-ups; and (4) enhanced inter-professional communication.
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Primary Outcome(s)
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Depressive symptoms as identified by the EPDS and Structured Clinical Interview for DSM-V (SCID-V) at 6 months post-randomization (immediately post-treatment)
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Secondary Outcome(s)
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What is the effect of the collaborative care treatment on:
The mother?s
1. Depressive symptoms at 9 and 12 months post-randomization?
2. Anxiety at 6, 9, and 12 months post-randomization?
3. Quality of life at 6, 9, and 12 months post-randomization?
4. Health service use at 12 months randomization?
The child?s
5. Cognitive development at 24 months of age?
6. Temperament at 12 and 24 months of age?
7. Language development at 18 months of age?
Other questions:
1. What is the nature and intensity of the collaborative care treatment activities?
2. What are mothers? evaluations of their collaborative care experience?
3. Cost implications?
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Secondary ID(s)
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MOP-133601
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Source(s) of Monetary Support
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Canadian Institutes of Health - CIHR (MOP-133601) (Canada)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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