Implementing an early childhood development intervention with routine immunization visits in India: a feasibility trial.

Integrating an early childhood development (ECD) intervention within routine healthcare visits offers an important opportunity for a population-level approach to support ECD in low- and middle-income countries (LMICs) where 250 million children under the age of 5 years fail to reach their full developmental potential. This paper reports on the feasibility of integrating an adapted healthcare-based ECD intervention (Sit Down and Play) in primary health centers (PHCs) serving low-income rural communities in Karnataka, India, and its potential to support research-informed components needed to improve ECD (e.g., opportunities for learning). Using a prospective cluster nonrandomized pilot and feasibility trial, caregivers with infants 6-10 weeks of age were recruited from 2 PHCs: one which delivered the intervention at two subsequent immunization visits (n = 25) and the other as care as usual (n = 28). Feasibility was assessed using the following indicators: implementation, practicality, acceptability, demand, and limited efficacy. Quality of home stimulation and opportunities for learning were explored with key items from the UNICEF Multiple Cluster Index Surveys with generalized estimating equation models. While outcome measures were to be obtained from all participants 3-month post-enrollment, due to COVID19 restrictions, there was variability in timing of follow-up interviews; however, outcome data from all participants were obtained and no significant group differences existed in contact time. Results suggest the feasibility of delivery of SDP during routine immunization visits, high satisfaction with adapted content, and utility of developed training and fidelity measures. Though not powered for hypothesis testing, our exploratory analyses reveal the intervention group demonstrated greater improvements on quality of home stimulation over time than the control group.

conclusionOur findings suggest integrating an ECD intervention with routine healthcare visits is a feasible and promising strategy for supporting ECD in India. Further studies are needed to determine the effectiveness of SDP on children's development.

trial registrationClinicalTrials.gov Identifier: NCT04167254. WHAT IS KNOWN: • Interventions are increasingly being developed to target responsive caregiving and opportunities for learning because of their potential to support early childhood development (ECD) in low- and middle-income countries where 250 million children under the age of 5 years fail to reach their full developmental potential. • A critical issue in ECD intervention research is the gap between what is known to be effective treatment to protect healthy brain development and what is provided to millions of caregivers during routine care who live in low-income communities. WHAT IS NEW: • We adapted a brief, ECD intervention for use with routine healthcare visits in India as a population-level strategy to support ECD in LMICs. • Our results demonstrate feasibility, acceptability, and improvements in key parenting behaviors that promote ECD.