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Additional file 2: Supplementary Appendix. Sensitivity Analysis. To ensure the addition of the extra 35 low educated families at waves 2 and 3 did not affect the results, we undertook a sensitivity analysis which only included families who had participated since wave 1.

Additional file 1: Supplementary Appendix. Observed Means vs Computed Means. To compare the observed means in the raw data and the predicted means computed using the margins command.

Background There are marked disparities between pre-school children in key skills affecting school readiness, disparities that commonly persist and influence children’s later academic achievements, employment, and adjustment. Much of this disparity is linked to socio-economic disadvantage and its impact on the home learning environment. Children’s Centres are an ideal context in which to implement and evaluate programmes to address this problem. They principally serve the 30% worst areas on the Indices of Deprivation Affecting Children, providing for families from the antenatal period up to age 5 years, aiming to promote parenting skills and provide care for children. Methods We are conducting a randomised controlled trial, based in Children Centres, to evaluate a parenting intervention for caregivers of children between 28 and 45 months of age. The intervention provides training to parents in dialogic book-sharing. The training is run by a facilitator who sees parents in small groups, on a weekly basis over 7 weeks. The study is a cluster randomised controlled trial. Twelve of the Children’s Centres in the town of Reading in the UK have been randomly assigned to an index or control condition. The primary outcome is child cognition (language, attention, and executive function); and secondary outcomes are child social development, behaviour problems, and emotion regulation, parenting during book-sharing and problem solving and parental child behaviour management strategies. Data are collected at baseline, post-intervention and 4–6 months post-intervention. Discussion The Impact of Early-years Provision in Children’s Centres trial (EPICC) aims to evaluate the impact of an early parenting intervention on several key risk factors for compromised child development, including aspects of parenting and child cognition, social development, behaviour problems and emotion regulation. The study is being carried out in Children’s Centres, which largely serve the most disadvantaged families in the UK. Since the intervention is brief and, with modest levels of training, readily deliverable within Children’s Centres and similar early childcare provision centres, demonstration that it is of benefit to child cognition, socio-emotional development and behaviour would be important. Trial registration ISRCTN Registry, ISRCTN28513611. Registered on 28 March 2017. This is version 1 of the protocol for the EPICC trial. Electronic supplementary material The online version of this article (10.1186/s13063-018-2700-x) contains supplementary material, which is available to authorized users.

Importance: Prenatal opioid exposure (POE) is one of the fastest-growing global health problems, but its association with long-term neurologic and physical development remains unknown.\ud \ud Objective: To assess the association between POE and cognitive and motor development in children from age 6 months to 18 years.\ud \ud Data Sources: Key search terms included prenatal opioid exposure, neonatal abstinence syndrome, and neurocognitive development. Studies were searched using PubMed and Embase, with no publication date restriction, through August 20, 2018.\ud \ud Study Selection: Only published cohort studies comparing the results of age-appropriate standardized cognitive and/or motor tests between children with any POE (aged 0-18 years) with drug-free controls were included. Data that were not convertible to means and SDs were excluded.\ud \ud Data Extraction and Synthesis: This study was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines. Data were pooled using a random-effects model.\ud \ud Main Outcomes and Measures: Standardized mean difference of cognitive and motor tests between POE and nonexposed children.\ud \ud Results: Twenty-six peer-reviewed cohort studies were included. Cognitive outcomes were compared for a total of 1455 children with POE and 2982 nonexposed children across 3 age groups (mean [SE] age at cognitive testing was 13 [1.58] months for the toddler group; 4.5 [0.38] years for the preschool group; and 13 [2.36] years for the school-aged group). Motor outcomes were compared for 688 children with POE and 1500 nonexposed children up to age 6 years (mean [SD] age at motor testing, 2 [0.45] years). Standardized mean difference was lower in cognitive tests for children with POE at 0 to 2 years (d = −0.52; 95% CI, −0.74 to −0.31; P

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. (DOCX 63 kb)

Several methods of assessing executive function (EF), self-regulation, language development, and social development in young children have been developed over previous decades. Yet new technologies make available methods of assessment not previously considered. In resolving conceptual and pragmatic limitations of existing tools, the Early Years Toolbox (EYT) offers substantial advantages for early assessment of language, EF, self-regulation, and social development. In the current study, results of our large-scale administration of this toolbox to 1,764 preschool and early primary school students indicated very good reliability, convergent validity with existing measures, and developmental sensitivity. Results were also suggestive of better capture of children’s emerging abilities relative to comparison measures. Preliminary norms are presented, showing a clear developmental trajectory across half-year age groups. The accessibility of the EYT, as well as its advantages over existing measures, offers considerably enhanced opportunities for objective measurement of young children’s abilities to enable research and educational applications.

Baseline information and results of additional analyses. Baseline values for questionnaires. Sensitivity analyses of primary and secondary outcomes with all participants, details of economic costs of service use for cases with complete data by trial allocation, cost-effectiveness results based upon the QALY and maltreatment outcomes by societal perspective and by NHS and PSS perspectives, economic sensitivity analysis that varied gFNP session attendance and group size, and economic subgroup analyses by phase of recruitment. (DOCX 59 kb)

Background:\ud \ud Family Nurse Partnership (FNP) is a home-based nurse home-visiting programme to support vulnerable parents. Group Family Nurse Partnership (gFNP) has similar aims and materials and was demonstrated to be feasible in implementation evaluations.\ud Objectives:\ud \ud To determine whether or not gFNP, compared with usual care, could reduce risk factors for maltreatment in a vulnerable group and be cost-effective.\ud Design:\ud \ud A multisite randomised controlled parallel-group trial and prospective economic evaluation, with eligible women allocated (minimised by site and maternal age group) to gFNP or usual care.\ud Setting:\ud \ud Community locations in the UK.\ud Participants:\ud \ud Expectant mothers aged

This study investigated whether the amount and timing of group-based childcare between birth and 51 months were predictive of cognitive development at 51 months, taking into account: other non-parental childcare; demographic characteristics; cognitive development at 18 months, sensitive parenting and a stimulating home environment. Children’s (N=978) cognitive development was assessed at 51 months with four subscales of the British Ability Scales, two verbal and two non-verbal. Mothers were interviewed and observed at 3, 10, 18, and 36 months and the quality of group care was assessed at 10, 18 and 36 months (N=239) if it was used for ≥12 hours per week. Age of starting in group care and amount were highly associated (r=-.75). Multiple regressions indicated that, controlling for other factors, higher cognitive development and particularly non-verbal ability was associated with more hours per week in group care from 0 to 51 months, or an earlier start, or group care before age 2. Nevertheless, the majority of variance was explained by other predictors: sex (girl), higher cognitive development at 18 months, older mother, first language English, mother of white ethnic background, with more qualifications, higher family social class, more maternal responsivity at 10 months and a more stimulating home learning environment (HLE) at 36 months. Hours per week in relative care or home-based care were not significant predictors of cognitive scores. For the smaller relatively advantaged sample who had group care quality information (N=239), quality was a marginal predictor of better cognitive development but age of starting group care was not. Most variance was explained by 18 month cognitive development, maternal education and family social class.

Childcare systems involve labour market, parental leave and childcare policies. It is clear\ud that some countries, including the Czech Republic, fall far behind recommended targets for\ud childcare provision. Early Childhood Education and Care (ECEC) has two major functions:\ud to help parents’ participation in the labour market, and to foster children’s development.\ud Governments frequently make the mistake of focussing on one only of these functions, and\ud it is negligent for a government to ignore that ECEC will inevitably influence both parental\ud employment and children’s development.\ud Societies are changing, and the demand for skills will increase, and required skills will\ud change so an adaptable workforce is important. A country’s future depends on how it treats\ud children. It is almost always cheaper, more effective, and more sustainable to prevent\ud problems rather than to try and cure them later, and preschool experience is critical for\ud adult skills.\ud The most effective approach to ECEC is high-quality universal services, with additional\ud individual support for those in need. Good quality, affordable ECEC helps the reconciliation\ud of work and family life and thus fosters parental labour market participation and gender\ud equality. Improving childcare may also improve declining fertility rates, by lowering the\ud cost of childbearing in terms of employment and career opportunities. The use of childcare\ud will be affected by parental leave and the availability, cost, and quality of care. Very long\ud parental leave appears to lead to lower use of childcare in a number of countries.\ud Children’s daily experiences drive child development, and these daily experiences constitute\ud the quality of care. Overall, high-quality childcare has been associated with benefits\ud for children’s development, with the strongest effects for children from disadvantaged\ud backgrounds. The evidence on preschool years (over three years) is fairly consistent, but\ud the evidence for birth to three years is equivocal with some studies finding negative effects,\ud some no effects and some positive effects associated with childcare. Discrepant results\ud relate partly to age of starting and partly to quality of childcare. Also childcare effects vary\ud by family background and negative, neutral and positive effects may occur depending on\ud the relative balance of quality of care at home and in childcare. Effects may relate to both\ud quantity and quality of childcare, but effect sizes for childcare are about half that for family\ud factors. Stable care with staff that has good training contributes substantially to good\ud quality care.\ud As indicated in the EU (2013) recommendation on investing in children, investing in highquality\ud ECEC is an effective evidence-based policy tool, although it is not a panacea.\ud However, the level of ECEC provision is very unequal across the EU, and to be effective, it\ud needs to be of high quality. The Czech Republic is planning policy changes to expand its childcare system. As early child development is the foundation for later educational, social and occupational success, there are likely to be longer-term consequences. Such changes may well affect longer-term EU-2020 goals through improving children’s outcomes including reducing early school-leaving and improving access to higher education, which in turn may lead to overall poverty reduction, and enhanced social inclusion, resulting from improved employment amongst the population.

SPIRIT Checklist. (DOC 121 kb)