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.: PACTR202205571729412 Date of Approval: 23/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Strengthening the capacity for play-based learning: Evidence from Kenya; Study Protocol
Official scientific title Strengthening the capacity for play-based learning: Evidence from Kenya; Study Protocol
Brief summary describing the background and objectives of the trial Abstract Background: Quality early childhood education (ECE) can improve school readiness, positively influence learning outcomes, and increase primary and secondary school completion rates, particularly for marginalized children. Play is a valued and ever-present aspect of culture and is believed to promote enjoyable learning if fully utilized. While governments have committed to implementing learning through play in national policies and ECE standard guidelines, challenges exist on how best to support teachers and other stakeholders to facilitate this approach. Objectives: The proposed research will test and adapt innovations to support capacity building for teachers, parents, and other key stakeholders in how to implement Learning through Play (LTP) approaches by building on existing positive and playful practices in pre-primary schools. The research will be anchored on the “Tayari Pre-school Program”. Methods: The research will use a mixed-methods approach and take an integrated approach to scale up. The integrated approach will involve holistic thinking by bringing together different parts, contexts, and stakeholders to co-create and better understand how LTP can improve school readiness. Thus, the design is informed by stakeholder involvement and takes account of the global pandemic to ensure that research can continue regardless of any disruptions. Expected outcomes: The research will illustrate promising approaches that promote LTP, smooth transition to primary school and inclusive ECE that addresses inequalities related to gender, disability, and other factors of disadvantage. The research findings will be disseminated through national, regional, continental, and global platforms to add to the national, regional, and global knowledge base.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 31/05/2022
Actual trial start date
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 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
Experimental Group Learning through play 12 months We propose to use a combination of approaches to collect the data. In the first phase, we will conduct a systematic review (26) which will support the knowledge synthesis of models, mechanisms, and frameworks to understand the conditions under which they have worked. The review will uncover evidence gaps, key parameters to be strengthened and map relevant stakeholders and organizations and their levels of involvement in the implementation of LTP approaches. The review will be iterative and will be structured around the theory of change, allowing for the identification of other emerging tenets. We will examine ongoing LTP initiatives in Africa to document best practices, understand emerging impacts, and examine their integration into existing early learning models. The rapid review will provide a matrix of key information necessary for adapting the identified models in Kenya and for cross-context learning. In the second phase, we shall adopt the models identified in the first phase using Group Model Building (GMB), a participatory approach that facilitates shared learning and understanding of structures within a system and their relationship to the outcomes of interest (22). The use of the GMB approach will allow for an iterative process involving stakeholders on how the early learning systems operate advancing workforce development. Thus, the approach helps us advance ongoing work in building sustainable ECE systems to support access, quality, and inclusion in the long term. Building on the findings of the rapid review, we will adapt the GMB approach to understanding various elements of identified frameworks, how they are connected, and how they promote or can integrate LTP approaches. The research will engage diverse stakeholders such as practitioners, parents, communities, technocrats, policymakers, and program implementers drawn from the existing early learning programs. Deliberate efforts will be made to ensure adequate gender and special needs representation. Through di 30
Control Group Government services 12 Government standard services 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Public pre-primary schools within the study site Private pre-primary schools within the study site Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 6 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 22/04/2022 Amref ESRC
Ethics Committee Address
Street address City Postal code Country
PO Box 30125-00100-Nairobi Nairobi 30125 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adoption of learning through play in pre-school 2
Secondary Outcome Improved teachers' knowledge on learning through play 2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
African Population and Health APHRC Campus, Kitisuru,Nairobi, Kenya. Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
IDRC Canada K1G 3H9 Ontario 8500 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor African Population and Health Research Center APHRC Campus, Kitisuru,Nairobi, Kenya Nairobi 10787 Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Africa Early Childhood Network Hemingways Block Nairobi 00502 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maurice Mutisya mmutisya@aphrc.org +254722205933 APHRC Campus, Manga Cl, Nairobi
City Postal code Country Position/Affiliation
Nairobi 10787 Kenya Research Scientist
Role Name Email Phone Street address
Public Enquiries Kenneth Okelo kokelo@aphrc.org +254722205933 APHRC Campus, Manga Cl, Nairobi
City Postal code Country Position/Affiliation
Nairobi 10787 Kenya Research Officer
Role Name Email Phone Street address
Scientific Enquiries Patricia Wekulo pwekulo@aphrc.org +254722205933 APHRC Campus, Manga Cl, Nairobi
City Postal code Country Position/Affiliation
Nairobi 10787 Kenya Sinior Research Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participant data collected during the trial, after deidentification will be available. This data will be available to investigators who propose to use this data and has been approved by an independent review committee (“learned intermediary”) identified for this purpose. Informed Consent Form,Study Protocol 24 months Controlled, through email.
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