A sustainable organizational structure to integrate psycho-social stimulation programme into primary health care services in Bangladesh: protocol for a pragmatic cluster randomized controlled trial on scaling up early childhood development activities

Background Early childhood development (ECD) in low to middle-income nations has been a pressing concern for the last two to three decades. It is estimated that approximately 250 million children under the age of five are not reaching their full developmental potential due to factors such as poverty, malnutrition, and insufficient home stimulation. It is estimated that in Bangladesh, 44% of the children under 5 years live in poverty and 31% are stunted, and both factors are risks for poor childhood development. We aim to develop a sustainable, scaled ECD programme using an evidence-based curriculum of psychosocial stimulation for disadvantaged Bangladeshi children.Methods Approximately 10,000 malnourished children aged 6-24 months will be identified by mid-upper arm circumference (MUAC) < 13.5 cm, assessed by government health staff in over 500 community clinics (CCs) in 21 sub-districts of Hobiganj, Brahmanbaria, Laxmipur and Narsingdi districts. The children and their mothers will participate in the psychosocial stimulation programme that will be delivered fortnightly for one year to small groups at the CCs by health workers. We will train approximately 1,500 health staff in rural CCs to deliver the ECD sessions. We will follow a cascade training model to train personnel at all levels of the primary health care system. A subsample will be evaluated using a cluster randomized controlled trial in 48 CCs (24 intervention and 24 control). From each CC, 10 children aged 6-24 months will be tested before and after the programme. The primary outcome is children's cognitive development and we will also measure language composite scores on the Bayley Scales of Infant and Toddler Development. Secondary outcomes are children's growth, maternal knowledge and depressive symptoms, and stimulation in the home. Intention-to-treat analysis will be used to assess intervention effects.Discussion There are no existing ECD services for the children under three years delivered by the health care system in Bangladesh. This study will help policy makers to consider incorporating ECD activities into the treatment of malnourished children in rural CCs, under the government's primary health care system, thereby developing a sustainable structure for improving disadvantaged children's development. The findings will also provide information to facilitate scaling ECD in the primary health care systems in other low and middle-income countries.Trial registration ClinicalTrials.gov Identifier: NCT04093934 (Date: 13 April 2022).