Lively Minds: improving health and development through play-a randomised controlled trial evaluation of a comprehensive ECCE programme at scale in Ghana.

INTRODUCTION: Many children in developing countries grow up in environments that lack stimulation, leading to deficiencies in early years of development. Several efficacy trials of early childhood care and education (ECCE) programmes have demonstrated potential to improve child development; evidence on whether these effects can be sustained once programmes are scaled is much more mixed. This study evaluates whether an ECCE programme shown to be effective in an efficacy trial maintains effectiveness when taken to scale by the Government of Ghana (GoG). The findings will provide critical evidence to the GoG on effectiveness of a programme it is investing in, as well as a blueprint for design and scale-up of ECCE programmes in other developing countries, which are expanding their investment in ECCE programmes. METHODS AND ANALYSIS: This study is a cluster randomised controlled trial, in which the order that districts receive the programme is randomised. A minimum sample of 3240 children and 360 schools will be recruited across 72 district school cohort pairs. The primary outcomes are (1) child cognitive and socioemotional development measured using the International Development and Early Learning Assessment tool, the Strengths and Difficulties Questionnaire, and tasks from the Harvard Laboratory for Development Studies; (2) child health (measured using height/weight for age, height-for-weight Z scores). Secondary outcomes include (1) maternal mental health, (using Kessler-10 and Warwick Edinburgh Mental Wellbeing Scale) and knowledge of ECCE practices; (2) teacher knowledge, motivation and teaching quality (measured with classroom observation); (3) parental investment (using the Family Care Index and Home Observation Measurement of the Environment and the Child-Parent Relationship Scale); (4) water, sanitation, and hygiene (WASH) practices; (5) acute malnutrition (using mid-upper arm circumference). We will estimate unadjusted and adjusted intent-to-treat effects. ETHICS AND DISSEMINATION: Study protocols have been approved by ethics boards at the University College London (21361/001), Yale University (2000031549) and Ghanaian Health Service Ethics Review Committee (028/09/21). Results will be made available to participating communities, funders, the wider public and other researchers through peer-reviewed journals, conference presentations, social and print media and various community/stakeholder engagement activities. TRIAL REGISTRATION NUMBER: ISRCTN15360698, AEARCTR-0008500.