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.: PACTR201909733644315 Date of Registration: 26/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of the First Steps "Intera za Mbere" Program
Official scientific title Evaluation of the First Steps "Intera za Mbere" Program
Brief summary describing the background and objectives of the trial The cluster-randomized trial is to evaluate the impact on early childhood development by offering holistic parenting education to parents of 0-3 year olds in Rwanda. The program has two treatment arms: light touch which includes parenting sessions and radio programs; and full touch which, in addition to light touch activities, has family take-home activity cards/leaflets, village book banks, book gifting, and targeted home visits as program components.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Early Childhood Development
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Evaluation of Early Childhood Developmen Parenting Intervention
Anticipated trial start date 01/09/2019
Actual trial start date
Anticipated date of last follow up 31/08/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 1188
Actual target sample size (number of participants)
Recruitment status Active, not 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 Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Group - - Control Group 396 Dose Comparison
Experimental Group Light Touch Intervention. Parenting sessions - 75 minutes each. Radio programs - 15 to 20 minutes each. 17 parenting sessions, once per week. 17 radio programs played during parenting sessions. Parents are given educational sessions related to early childhood development in parental training sessions delivered by local volunteers. 396
Experimental Group Full touch intervention. Parenting sessions 75 minutes each. Radio programs 15-20 minutes each. Village book banks. Book gifting to each family at the end of parenting sessions. Family take-home activity cards/leaflets At least 2 home visits to every family by a trained community volunteer (more visits for at risk families). 17 parenting sessions, once per week. 17 radio programs played during parenting sessions. The full touch has all the components of the light-touch intervention. But it also has targeted home visits, book gifting, and village book banks as additional aspects. 396
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Households that have children 6-23 months at baseline. Households are situated in the geographic area of the study. - Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
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 16/08/2019 Rwanda National Ethics Committee
Ethics Committee Address
Street address City Postal code Country
KG 1 Roundabout, Kigali Kigali 999999 Rwanda
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 08/07/2019 National Institute of Statistics of Rwanda
Ethics Committee Address
Street address City Postal code Country
KN 2 Av 36, INGENZI, KABEZA, Muhima, Nyarugenge Kigali 6139 Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child development assessment scores in the following domains - gross motor, fine motor, social-emotional, expressive language. Scored using the Malawi Developmental Assessment Test, MDAT At baseline, September 2019. At endline of the trial, September 2020
Secondary Outcome ECD-related parenting practices, assessed using questions from the MICS At baseline, September 2019. At endline of the trial, September 2020
Secondary Outcome Infant and young child feeding practices - breastfeeding and introduction of complementary foods At baseline, September 2019. At endline of the trial, September 2020
Secondary Outcome Child care of illness, assessed using questions from the MICS At baseline, September 2019. At endline of the trial, September 2020
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Laterite Ltd. Plot 1563, KG 12 Avenue, Gaculiro, Kinyinya, Kigali Kigali Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada Sandra Rotman Centre, University Health Network Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Save the Children Rwanda Nyarutarama, Plot 204, KG 9 AV, House No.23 Kigali Rwanda Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Professor Pasco Fearon 26 Bedford Way, Bloomsbury London WC1H 0AP United Kingdom
Monique Abimpaye KG 9 Ave Kigali Rwanda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Magdalena Vinyard mvinyard@laterite.com +250782994553 Plot 1563, KG 12 Avenue, Gaculiro, Kinyinya Kigali
City Postal code Country Position/Affiliation
Kigali Rwanda Research Manager
Role Name Email Phone Street address
Public Enquiries Magdalena Vinyard mvinyard@laterite.com +250782994553 Plot 1563, KG 12 Avenue, Gaculiro, Kinyinya Kigali
City Postal code Country Position/Affiliation
Kigali Rwanda Research Manager
Role Name Email Phone Street address
Scientific Enquiries Magdalena Vinyard mvinyard@laterite.com +250782994553 Plot 1563, KG 12 Avenue, Gaculiro, Kinyinya Kigali
City Postal code Country Position/Affiliation
Kigali Rwanda Research Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A link to the summary of results will be shared in the trial registration record, within 12 months of study completion. Informed Consent Form,Statistical Analysis Plan,Study Protocol The summary results will be available upon completion of analysis Open Access
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