Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

Menno Pradhan Sally A Brinkman 0 1 Amanda Beatty Amelia Maika 1 Elan Satriawan Joppe de Ree Amer Hasan 0 Telethon Institute for Child Health Research, Centre for Child Health Research, University of Western Australia , Perth 6907 , Australia 1 School of Population Health, Discipline of Public Health, The University of Adelaide , Adelaide 5005, South Australia Background: This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. Methods/Design: The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. Discussion: This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the execution of the program and the resultant threats to the study, we discuss our analytical plan and intentions for endline data collection. Trials registration: Current Controlled Trials ISRCTN76061874 - Background Early childhood is a very active period of brain development that lays the foundation for later learning. Research shows that a childs early life has consequences for their adult years [1]. It is similarly recognized that many of the problems arising in early childhood have associated social and financial costs that cumulatively represent a considerable drain on a countrys resources [2]. A countrys future productivity may be undermined if children are not protected and afforded the opportunities to thrive. In addition, the deleterious effects of poor outcomes in early childhood can be long-lasting, affecting school attainment, employment, wages, criminality and social integration. It is more cost-effective to institute preventive measures and support for children early on than to compensate for disadvantage as they grow older [3]. Strong foundations including good health, nutrition and a nurturing environment during childhood can help ensure a smooth transition to primary school, a better chance of completing basic education, and a route out of poverty and disadvantage [4]. School readiness leads to school success; however, the characteristics of school readiness are multidimensional. Early predictors of school success point to the contribution of positive peer relationships, and sensitive and stimulating family processes [5]. The literature suggests a link between childrens learning-related social skills and academic performance. For example, a childs social adjustment to kindergarten has been linked to the childs performance and involvement in the school [6,7], and childrens work-related skills (for example, the degree to which children show compliance with instructions) are closely related to school success as well as their selfregulation [8]. Although many of these skills increase with age, there is enough variation in how children develop during their first 5 years of life to suggest that chronological age is not an effective indicator of school readiness in itself [9]. School outcomes, especially achievement, remain remarkably stable after the first years of school [10,11], once again indicating the importance of health and holistic child development prior to school entry. Early childhood development and education in developing countries The Strong Foundations Education for All Global Monitoring Report [4] conducted by UNESCO states that there are large disparities in educational attainment within countries. Developing countries with a rapidly increasing divide between rich and poor are particularly vulnerable to creating a generation of poor and uneducated children that will eventually undermine the countries increasing prosperity [12]. Children from poorer and rural households and those socially excluded have significantly less access to early childhood care and education than those from richer and urban households [13]. Although there is a wealth of data in the medical, sociological and economic academic literature on the health and nutritional status of young children in developing countries, there is comparatively little data on early childhood development and school readiness (for example, physical development, language and cognitive development, communications skills, and socio-emotional development). It is generally believed that low parental education levels play a causal role in explaining poor child health status in developing countries, but it is not clear if this also applies to other dimensions of skill formation in early childhood [3]. Inadequate knowledge by parents about the importance of early childhood and the long-term impact of early parenting practices may all contribute to low levels of parental investment in their childrens early skill formation [3]. The Lancet has published two series [13,14] of journal articles on child development in developing countries. The articles pull together the available literature on early child development in developing countries and note that the primary causes of poor development include: malnutrition, iodine and iron deficiency, inadequate stimulation, malaria, violence, maternal depression, exposure to heavy metals, diarrhea, and HIV/AIDS [15]. The second paper [14] assesses strategies to promote child development and prevent the loss of developmental potential. The authors findings suggest that the most effective interventions are th (...truncated)