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Based Intervention to Improve Developmental Status Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-037156 on 19 October 2020. Downloaded from Group- based intervention to improve developmental status among children age 6–18 months in rural Shanxi province, China: a study protocol for a cluster randomised controlled trial Mengxue Xu,1 Aihua Liu,1 Chunxia Zhao,2 Hai Fang,3 Xiaona Huang,2 Stephen Berman,4 Hongyan Guan 1,5 To cite: Xu M, Liu A, Zhao C, ABSTRACT Strengths and limitations of this study et al. Group- based intervention Introduction Early childhood development (ECD) is a to improve developmental critical component for building the foundation of future ► This study fills a gap in the evidence regarding small status among children age physical and emotional health and subsequent academic 6–18 months in rural Shanxi group- based early childhood development (ECD) in- success. The quality of the home environment to promote province, China: a study protocol terventions for at risk rural Chinese children aged development is an important factor in ECD. Since large for a cluster randomised 6–18 months. rural–urban disparities in the home environment exist controlled trial. BMJ Open ► Documenting cost- effectiveness will provide a solid 2020;10:e037156. doi:10.1136/ in China, there is a critical need to develop and evaluate evidence- based foundation for the implementation bmjopen-2020-037156 interventions to promote ECD in rural areas. Individual of future national official recommendations and pol- center- based or home- based interventions dominate ► Prepublication history and icies for ECD in rural China. the current ECD programmes in rural China. However, additional material for this ► This study will explore the feasibility of extending paper are available online. To group- based interventions offer potential advantages in current essential child healthcare service within the view these files, please visit terms of both effectiveness and cost. Thus, we aim to: (1) rural public health system. the journal online (http:// dx. doi. evaluate the effectiveness of an integrated group-based ► The limitations of this project are the possible loss org/ 10. 1136/ bmjopen- 2020- intervention, the Care Group Intervention, in enhancing to follow- up and limited operational capacity of 037156). ECD among children age 6–18 months and (2) conduct a facilitators. cost- effectiveness analysis. http://bmjopen.bmj.com/ Received 04 February 2020 Methods and analysis The Care Group Intervention Revised 20 August 2020 Accepted 17 September 2020 uses a cluster (by township) randomised controlled trial conducted in Fenxi county, Shanxi province, China, INTRODUCTION from July 2019, for 1 year. The intervention focuses on There are 250 million children (43% of whom five key components of nurturing care including good are under aged 5 years) in low- income and health, adequate nutrition, responsive caregiving, security middle- income counties who are at risk of and safety, and opportunities for early learning. The having a compromised development trajec- intervention comprises small groups of 3–10 children tory. Inadequate home stimulation as well as within a certain age range and their primary caregivers other health and environmental factors may on October 1, 2021 by guest. Protected copyright. that are led by well- trained local facilitators. Outcomes lead to developmental delay. It is estimated includes infants’ developmental quotient (Bayley Scales that as many as 15 million children under age of Infant Development III, Ages & Stages Questionnaire: Social–Emotional, second edition); anaemia (HemoCue 5 years in China are unable to fully realise Hb 301+); nurturing environment (Infant/Toddler Home their developmental potential. China ranks Observation for Measurement of the Environment), parent- as having the third highest number of chil- 1 child interaction (Teaching Scale) and caregiver depression dren with poor development in the world. © Author(s) (or their (Center for Epidemiological Studies Depression). Cost data In rural areas, only 57.4% of children have employer(s)) 2020. Re- use are collected throughout the entire study to carry out a two or more toys and only 21.5% have three permitted under CC BY-NC. No 2 commercial re- use. See rights cost- effectiveness analysis. or more books. Children with a persistent and permissions. Published by Ethics and dissemination This study was approved by developmental delay in early life will limit BMJ. the Ethical Committee of Capital Institute of Pediatrics, their developmental trajectory leading to a For numbered affiliations see Beijing, China on 10 July 2018 (SHERLL2018014). Findings decline in health status, work income and end of article. and results from this project will be disseminated via life satisfaction in adulthood.3–5 High- quality publications and presentations. early childhood development (ECD) proj- Correspondence to Trial registration number Chinese Clinical Trials Registry: ects can return as much as US$6–17 for every Dr Hongyan Guan; ChiCTR1900022894. Registered on 30 April 2019. cip_ ghy@ yeah. net US$1 invested.6 Therefore, interventions to Xu M, et al. BMJ Open 2020;10:e037156. doi:10.1136/bmjopen-2020-037156 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-037156 on 19 October 2020. Downloaded from support and improve ECD are positioned as fundamental intervention towards child development conducted by approaches to break intergenerational poverty; one of the same research team found that the micronutrient the major sustainable development goals.7 powder improved haemoglobin levels for children aged Unequal resource allocation negatively contributes to 6–11 months.19 the observed rural–urban disparity in ECD in China.8 Evidences have showed that group-based intervention Cognitive scores among infants in rural areas of Shaanxi has the advantage of being less costly.20 21 However, current province has been demonstrated to be significantly lower group- based interventions whose participants are usually than those of infants in urban areas.9 As many as 13.4% unfixed and of large age interval, which may weaken the of infants in rural Shaanxi have a severe risk of cognitive effectiveness. Small group-based intervention with fixed delay based on the Bayley Scales of Infant Development population might solve this concern. A fixed group can III (BSID- III).10 According to a survey conducted in six foster a stronger sense of community and help caregivers poverty- stricken counties of Guizhou and Shanxi prov- to reduce feeling of isolation and depression. In addition, inces during 2013, 37% of children aged 0–3 years had it is conducive to modelling a positive parenting envi- suspected developmental delay based on Ages & Stages ronment through promoting mutual learning and peer Questionnaires (ASQs, third edition) and 59.8% had at support among caregivers, while giving caregivers tools least one problem of nutrition, disease or physical devel- and skills of nurturing care. Experiences in Pakistan and opment.2 As a predictive factor of cognitive development, Bangladesh have shown that small group- based interven- anaemia is another prevalent concern for rural chil- tions on nurturing care and child development contribute dren. One study reported that 54.3% of infants in poor to children’s language, cognitive, motor and social devel- rural China were anaemic, while 24.3% of whom had opment, as well as improved caregivers’ nurturing knowl- moderate/severe anaemia.11 edge and maternal depression.22 23 However, there is no Considering the large numbers of children with poor evidence regarding small group-based ECD interventions development in China, the Chinese government has made for at risk rural young children in China yet. a series of efforts aimed at promoting ECD. The Outline In this project, we will apply a small group-based inter- of the Program for Chinese Children’s Development vention, the Care Group Intervention, in Fenxi county, (2011–2020) explicitly sets out main goals and coping Shanxi province for 1 year, to explore its effect on the strategies for promoting child development through four outcome of child development and nurturing care ability aspects, namely health, education, legal protection and and depression among primary caregivers. Meanwhile, we environment, covering both urban and rural children.12 will conduct a cost- effectiveness analysis to examine both The Plan for the Development of Children in Poor the costs and outcomes of the intervention. This project Areas (2014–2020) concentrates on improving nutrition, will fill the gap of lacking evidence of small group-based disease prevention, protection and education for young intervention on ECD for rural Chinese children aged 6–18 rural children in all of the 680 national-level poverty- months. In addition, documenting cost-effectiveness will stricken counties.13 Recently, the Guidelines of the State provide a solid evidence-based foundation for implemen- http://bmjopen.bmj.com/ Council on Promoting the Development of Nurturing tation of future official recommendations and policies for Care Services for Children Under 3 clearly states that ECD in rural China. the responsibility of nurturing for children aged 0–3 years should be family oriented, and the development of service should emphasise providing professional guid- STUDY HYPOTHESIS ance for families.14 Children’s ECD as measured by BSID- III Score (language, To our knowledge, previous ECD interventions in China cognition and motors skill) will be significantly improved
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