Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901917619299 Date of Registration: 24/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Community Singing-Based Intervention for Perinatal Mental Health in The Gambia
Official scientific title Testing the feasibility of a Community Singing-Based Intervention for Perinatal Mental Health in The Gambia
Brief summary describing the background and objectives of the trial Perinatal mental health problems affect up to 1 in 5 women worldwide. Mental health problems in the perinatal period are a particular challenge in low and middle-income countries (LMICs) where they can be at least twice as frequent as in higher income countries. It is thus of high priority to develop new low-cost, low-resource, non-stigmatising and culturally appropriate approaches to reduce symptoms of anxiety and depression perinatally, for the benefit of both mother and child. Music-centered approaches may be particularly useful in The Gambia since a range of musical practices that specifically engage pregnant women and new mothers already exist. This study a stepped wedge feasibility trial that will examine how the creative arts - in particular, group singing - could show special promise in alleviating perinatal mental distress in The Gambia. There are two arms to the study with 60 pregnant women in the intervention arm and 60 in the control arm. Women in the intervention will participate in weekly singing groups session, led by local Kanyeleng groups, for six weeks. The control group will receive standard care. We will collect mental health symptoms using the EPDS and SRQ-20 as well as recruitment rate, retention and attrition rates of participants, clinic’s adherence to stepped wedge schedule, completeness of data by site and over time, qualitative interviews and video and audio recordings. This feasibility trial will build the foundation of a large trial that will be able to ascertain the efficacy of this approach to alleviate symptoms of anxiety and depression during pregnancy in the Gambia.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Music Intervention
Anticipated trial start date 05/11/2018
Actual trial start date
Anticipated date of last follow up 06/05/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control 6 weeks Participants receive standard care 60 Active-Treatment of Control Group
Experimental Group Community Singing Group Once a week for 90 minutes 6 weeks The singing group will take place in the morning as this is the time deemed to best suit the majority of women and was best for the clinic. Local Kanyeleng groups who specialize in musical practices to support women’s health will lead the sessions. The topic of each of the 6 sessions will be co-designed with the Kanyeleng groups via an extended workshop with the research team. This workshop will provide some level of standardization in terms of guiding principles and content for the sessions. The nature of the intervention will necessarily vary somewhat across the four settings, especially as one of these settings includes a Wolof speaking group with distinct cultural beliefs, practices, and language. By using the Kanyeleng groups local to each of the four clinics involved, the sessions will be contextually appropriate, while the workshop with all four Kanyeleng groups before the intervention begins will ensure that the overarching goals, content, and approach to session delivery is broadly standardized. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant (14-24 weeks gestation) Speak Wollof or Mandinka fluently At least one previous late-term miscarriage Current psychosis or history of psychosis Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/06/2018 Goldsmiths Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Goldsmiths, University of London New Cross London 0146 United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/05/2018 Gambia Government MRC Gambia joint ethics committee
Ethics Committee Address
Street address City Postal code Country
MRC Unit The Gambia at LSHTM Atlantic Boulevard Fajara 00000 Gambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/07/2018 The Australian National University Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Level 2, Birch Building 36, Science Road, The Australian National University Canberra 2601 Australia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anxiety and Depression Symptoms using the Edinburgh Postnatal Depression Scale and the Self Report Questionnaire. Baseline, Post intervention, One month follow up
Secondary Outcome 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 Baseline, during the singing group intervention, and post Intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ministry of Health and Social Welfare Senegambia Highway Kotu Gambia
FUNDING SOURCES
Name of source Street address City Postal code Country
AHRC MRC Global Health Partnership Grant 2nd floor David Phillips Building, Polaris House, North Star Ave Swindon United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Goldsmiths University of London Goldsmiths, University of London New Cross London 0146 United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
National Centre for Arts and Culture Marina Parade Banjul Gambia
Ministry of Health and Social Welfare Quadrangle Banjul Gambia
Bonnie McConnell Australian National University Canberra Australia
Vivette Glover Imperial College, London London United Kingdom
Ian Cross Cambridge University Cambridge United Kingdom
Paul Ramchandani Cambridge University Cambridge United Kingdom
Victoria Cornelius Imperial College London United Kingdom
Buba Darboe Ministry of Health and Social Welfare Banjul Gambia
Malick Gaye Ministry of Health and Social Welfare Banjul Gambia
Hassoum Ceesay National Centre for Arts and Culture Banjul Gambia
Hajara Huma National Centre for Arts and Culture Banjul Gambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lauren Stewart l.stewart@gold.ac.uk +442079197195 Goldsmiths, University of London, New Cross
City Postal code Country Position/Affiliation
Lodnon United Kingdom Professor in Psychology
Role Name Email Phone Street address
Public Enquiries Jane Offerman j.offerman@gold.ac.uk +442079197870 Goldsmiths, University of London, New Cross
City Postal code Country Position/Affiliation
Lodnon United Kingdom Research Administrator
Role Name Email Phone Street address
Scientific Enquiries Victoria Cornelius v.cornelius@imperial.ac.uk +442075941218 111 Stadium House White City Campus
City Postal code Country Position/Affiliation
London United Kingdom Senior Lecturer in Clinical Trial Statistics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified participant data including demographic data and EPDS and SRQ-20 raw scores. Statistical Analysis Plan,Study Protocol Data will be available for 10 years post the publication of the results. Deidentified participant data that underline the results reported in the results article will be available upon reasonable request to the first author, Dr Sanfilippo.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information