Cluster Randomised Controlled Trial of the effectiveness of comprehensive early childhood development (CECD) services in rural areas, China

Author(s):  
Renfu Luo
BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e023539 ◽  
Author(s):  
Jane Fisher ◽  
Tuan Tran ◽  
Stanley Luchters ◽  
Thach D Tran ◽  
David B Hipgrave ◽  
...  

IntroductionOptimal early childhood development is an international priority. Risks during pregnancy and early childhood have lasting effects because growth is rapid. We will test whether a complex intervention addressing multiple modifiable risks: maternal nutrition, mental health, parenting capabilities, infant health and development and gender-based violence, is effective in reducing deficient cognitive development among children aged two in rural Vietnam.Methods and analysisThe Learning Clubs intervention is a structured programme combining perinatal stage-specific information, learning activities and social support. It comprises 20 modules, in 19 accessible, facilitated groups for women at a community centre and one home visit. Evidence-informed content is from interventions to address each risk tested in randomised controlled trials in other resource-constrained settings. Content has been translated and culturally adapted for Vietnam and acceptability and feasibility established in pilot testing.We will conduct a two-arm parallel-group cluster-randomised controlled trial, with the commune as clustering unit. An independent statistician will select 84/112 communes in Ha Nam Province and randomly assign 42 to the control arm providing usual care and 42 to the intervention arm. In total, 1008 pregnant women (12 per commune) from 84 clusters are needed to detect a difference in the primary outcome (Bayley Scales of Infant and Toddler Development Cognitive Score <1 SD below standardised norm for 2 years of age) of 15% in the control and 8% in the intervention arms, with 80% power, significance 0.05 and intracluster correlation coefficient 0.03.Ethics and disseminationMonash University Human Research Ethics Committee (Certificate Number 20160683), Melbourne, Victoria, Australia and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-377IDD- YTCC), Hanoi, Vietnam have approved the trial. Results will be disseminated through a comprehensive multistranded dissemination strategy including peer-reviewed publications, national and international conference presentations, seminars and technical and lay language reports.Trial registration numberACTRN12617000442303; Pre-results.


Author(s):  
Tessa Delaney ◽  
Jacklyn K. Jackson ◽  
Jannah Jones ◽  
Alix Hall ◽  
Ashleigh Dives ◽  
...  

The use of ‘Energisers,’ short bouts of moderate-to-vigorous physical activity (MVPA), have been shown to significantly increase children’s physical activity within the school setting but not within Early Childhood Education and Care (ECEC) centres. The aim of this study is to assess the efficacy of an intervention involving the provision of educator-led daily Energisers to increase the time children spend in MVPA while attending ECEC. Fourteen ECEC centres in the Hunter region of New South Wales, Australia, will be randomised to either an intervention or control group. The intervention group will be supported by the research team to implement three brief (5-min) educator-led Energisers each day for children aged three to six years between the hours of 9:00 a.m. to 3.00 p.m. Control ECEC centres will continue to provide ‘normal practice’ to children. The primary trial outcome is child minutes of MVPA whilst in ECEC, assessed objectively via accelerometery over three days. Outcome assessment will occur at baseline and 6 months post-baseline. Linear mixed models under an intention-to-treat framework will be used to compare differences between groups in MVPA at follow-up. This will be the first cluster randomised controlled trial to test the efficacy of Energisers in isolation on increasing the time children spend in MVPA.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Zvezdana Petrovic ◽  
Olivia Clayton ◽  
Jan Matthews ◽  
Catherine Wade ◽  
Lina Tan ◽  
...  

Abstract Background In the early years of life, the benefits of parental engagement in children’s learning are well documented. Early childhood educators are a potentially effective source of support, having opportunity to engage with parents on key issues related to children’s learning and development. Educators report a need for more practical strategies for building positive partnerships with the parents of children in their care. To address this need, we have developed a practice support system, Partnering with Parents, to guide educators in Early Childhood Education and Care (ECEC) through practical strategies for working with parents. Partnering with Parents is designed to be embedded in everyday service delivery. Methods Using a cluster randomised controlled trial (cRCT) with intervention and wait-list control groups, we aim to evaluate the effectiveness of the Partnering with Parents practice support system under normal service conditions. The intervention is being trialled in ECEC services across Victoria, Australia. Services in the intervention group implemented the 10-week intervention before the control group commenced the intervention. Educators and parents of children attending the participating services are taking part in evaluating the intervention by completing questionnaires online at three time points (before, immediately after, and 3 months after the intervention group received the intervention). Results One hundred eighteen educators and 302 parents recruited from 19 participating ECEC services have consented to take part in the trial. Conclusions There is considerable potential for ECEC services to improve everyday interactions with parents and potentially child outcomes, by implementing this practice support model. Future research in this field can examine long-term effects of improving the parent-educator relationship. The intervention has potential to be widely embedded in educator training or professional development. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000488101. Prospectively registered 25 March 2019.


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