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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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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201901917619299 |
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Date of registration:
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24/01/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Community Singing-Based Intervention for Perinatal Mental Health in The Gambia
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Scientific title:
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Testing the feasibility of a Community Singing-Based Intervention for Perinatal Mental Health in The Gambia |
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Date of first enrolment:
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05/11/2018 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5878 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Non-randomised,Allocation was determined by the holder of the sequence who is situated off site
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Phase:
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Not Applicable
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Countries of recruitment
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Gambia
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Contacts
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Name:
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Victoria
Cornelius |
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Address:
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111 Stadium House White City Campus
London
United Kingdom |
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Telephone:
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+442075941218 |
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Email:
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v.cornelius@imperial.ac.uk |
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Affiliation:
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Senior Lecturer in Clinical Trial Statistics |
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Name:
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Jane
Offerman |
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Address:
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Goldsmiths, University of London, New Cross
Lodnon
United Kingdom |
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Telephone:
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+442079197870 |
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Email:
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j.offerman@gold.ac.uk |
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Affiliation:
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Research Administrator |
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Key inclusion & exclusion criteria
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Inclusion criteria: Pregnant (14-24 weeks gestation)
Speak Wollof or Mandinka fluently
Exclusion criteria: At least one previous late-term miscarriage
Current psychosis or history of psychosis
Age minimum:
19 Year(s)
Age maximum:
44 Year(s)
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy and Childbirth
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Pregnancy and Childbirth
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Intervention(s)
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Community Singing Group
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Control
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Primary Outcome(s)
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Anxiety and Depression Symptoms using the Edinburgh Postnatal Depression Scale and the Self Report Questionnaire.
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Secondary Outcome(s)
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Feasibility outcomes include Recruitment rate, Retention and attrition rates of participants, Clinic’s adherence to step-wedge schedule, Completeness of data by site and over time, Qualitative interviews of participants perceptions of the intervention, Video and audio recording of sessions to evaluate whether sessions conformed to outlined guidelines
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Source(s) of Monetary Support
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AHRC MRC Global Health Partnership Grant
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Ethics review
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Status: Approved
Approval date: 24/05/2018
Contact:
information@mrc.gm
Gambia Government MRC Gambia joint ethics committee
+2204495442
information@mrc.gm
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Status: Approved
Approval date: 29/06/2018
Contact:
s.mcveigh@gold.ac.uk
Goldsmiths Ethics Committee
+442079197171
s.mcveigh@gold.ac.uk
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Status: Approved
Approval date: 24/07/2018
Contact:
human.ethics.officer@anu.edu.au
The Australian National University Human Research Ethics Committee
+6161256782
human.ethics.officer@anu.edu.au
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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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