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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201806003389716 Date of Registration: 16/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Capital Mãe
Official scientific title Capital Mãe: an ecological and integrated approach to save the brains of the children of Maputo
Brief summary describing the background and objectives of the trial Capital Mãe is an action research project led by the NGO ATIA Mozambique, and supported by Grand Challenges Canada's "Saving Brains" program. The action will consist in providing women entrepreneurs in poor neighborhoods of Maputo with integrated services acting on different levels of the environment of their children under 3 years of age to promote their cognitive and socio-emotional development, by reducing exposure to toxic stress and by implementing early stimulation activities and strengthening maternal skills. The activities of the integrated program are as follows: a center for early stimulation and reinforcement of maternal skills dedicated to children from 6 to 36 months and their mothers (Capital Mãe centers), support services for the economic project of entrepreneurial mothers and support and social integration services for their families. Over the 2 years of implementation, the project wants to demonstrate that: - Children benefiting from the project's EDC services over a period of 9 months, compared to the control group, see their score on the Bayley-III scale increase by a minimum of 0.30SD - Mothers involved in mother-child workshops and ECD visits over a period of 9 months, compared to the control group, see their score on the HOME scale increase by a minimum of 0.30SD - Women receiving economic support over 9 months, compared to the control group, see their score on the Severity Measure of depression-Adults scale and on Cohen's Perceived Stress Scale decrease by at least 0.25SD - Women receiving economic support over 9 months, compared to the control group, see their household income increase by at least 0.5SD - Children and their family members receiving a minimum of 6 months of social support, compared to the control group, see their access to basic services and their family environment improve: rate of resolution of social difficulties in the test group >0.25SD to the rate of resolution of social difficulties in the control group
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied early childhood development,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 02/07/2018
Actual trial start date
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 446
Actual target sample size (number of participants)
Recruitment status Not yet 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Exposure to ecological/integrated program Children: everyday / mothers: weekly (mother and child workshops) and monthly (economic support) 9 months center for early stimulation and reinforcement of maternal skills dedicated to children from 6 to 36 months and their mothers (Capital Mãe centers), support services for the economic project of entrepreneurial mothers and support and social integration services for their families 221
Control Group Historical follow up of a similar group in non-intervention zone No intervention 9 months Base line assessment, after 9 months assessment 225 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Living in a vulnerable neighborhood in Maputo Living in one of ATIA's intervention zone Accessing ATIA's integrated services and productive loans Being a woman Being between 6 and 36 months old Living outside ATIA's intervention zone Being a man Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 6 Month(s) 50 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
No 30/07/2018 CNBS
Ethics Committee Address
Street address City Postal code Country
Avenida Eduardo Mondlane, Nº 1008 Maputo 1106 Mozambique
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement of the child's score on Bayley-III Pre-test Post-test (= pre-test + 9 months)
Primary Outcome Improvement of the mother's score on the HOME inventory (0-3) Pre-test Post-test (= pre-test + 9 months)
Secondary Outcome Improvement of the mother's score on Severity Measure of depression - Adult Pre-test Post-test (= pre-test + 9 months)
Secondary Outcome Improvement of the mother's score on Cohen's Perceived Stress Scale Pre-test Post-test (= pre-test + 9 months)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ATIA Mozambique Q41, n° 870, Rua Marcelino dos Santos - Xipamanine Maputo 1110 Mozambique
ATIA Mozambique Maxaquene B Maputo 1107 Mozambique
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada MaRS Centre, West Tower 661 University Avenue, Suite 1720 Toronto ON M5G 1M1 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ATIA Mozambique Q41, n° 870, Rua Marcelino dos Santos - Xipamanine Maputo 1110 Mozambique Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Laurent Foubert 285A, Avenida Ahmed Sekou Toure - Polana Cimento A Maputo 1101 Mozambique
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Laurent Foubert laurent.foubert@atia-ong.org +258846043566 285A, Avenida Ahmed Sekou Toure - Polana Cimento B
City Postal code Country Position/Affiliation
Maputo 1101 Mozambique Country Coordinator ATIA Mozambique
Role Name Email Phone Street address
Public Enquiries Valentina Foubert Tabares valentina.foubert@atia-ong.org +258842494822 285A, Avenida Ahmed Sekou Toure - Polana Cimento B
City Postal code Country Position/Affiliation
Maputo 1101 Mozambique ECD Technical support ATIA Mozambique
Role Name Email Phone Street address
Scientific Enquiries Laurent Foubert laurent.foubert@atia-ong.org +258846043566 285A, Avenida Ahmed Sekou Toure - Polana Cimento B
City Postal code Country Position/Affiliation
Maputo 1101 Mozambique Country Coordinator ATIA Mozambique
REPORTING
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