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Background: There is growing consensus regarding the importance of attending to children’s social and emotional well-being. There is now a substantial evidence base demonstrating the links between a child’s early social and emotional development and a range of key longer-term education, social and health outcomes. Universal school-based interventions provide a significant opportunity for early intervention in this area and yet the existing evidence base, particularly in relation to their long-term effects, is limited.  Objectives and main outcomes: To determine the effectiveness and cost-effectiveness of Roots of Empathy (ROE), a universal school-based programme that, through attempting to enhance children’s empathy, seeks to achieve the following two main outcomes: improvement in prosocial behaviour and reduction in difficult behaviour.  Design: A cluster randomised controlled trial and an economic evaluation. A total of 74 primary schools were randomly assigned to deliver ROE or to join a waiting list control group. Seven schools withdrew post randomisation and a further two withdrew before the immediate post-test time point. Children (n = 1278) were measured pre test and immediately post test, and then for 3 years following the end of the programme. Data were also collected from teachers and parents.  Setting and participants: The intervention schools delivered ROE to their Year 5 children (aged 8–9 years) as a whole class.  Intervention: ROE is delivered on a whole-class basis for one academic year (October–June). It consists of 27 lessons based around the monthly visit from a baby and parent who are usually recruited from the local community. Children learn about the baby’s growth and development and are encouraged to generalise from this to develop empathy towards others.  Results: Although it was developed in Canada, the programme was very well received by schools, parents and children, and it was delivered effectively with high fidelity. ROE was also found to be effective in achieving small improvements in children’s prosocial behaviour (Hedges’ g = 0.20; p = 0.045) and reductions in their difficult behaviour (Hedges’ g = –0.16; p = 0.060) immediately post test. Although the gains in prosocial behaviour were not sustained after the immediately post-test time point, there was some tentative evidence that the effects associated with reductions in difficult behaviour may have remained up to 36 months from the end of the programme. These positive effects of ROE on children’s behaviour were not found to be associated with improvements in empathy or other social and emotional skills (such as emotional recognition and emotional regulation), on which the trial found no evidence of ROE having an effect. The study also found that ROE was likely to be cost-effective in line with national guidelines.  Conclusions: These findings are consistent with those of other evaluations of ROE and suggest that it is an effective and cost-effective programme that can be delivered appropriately and effectively in regions such as Northern Ireland. A number of issues for further consideration are raised regarding opportunities to enhance the role of parents; how a time-limited programme such as ROE can form part of a wider and progressive curriculum in schools to build on and sustain children’s social and emotional development; and the need to develop a better theory of change for how ROE works.  Trial registration: Current Controlled Trials ISRCTN07540423.  Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 6, No. 4. See the NIHR Journals Library website for further project information.

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A cluster randomised controlled trial and evaluation and cost-effectiveness analysis of the Roots of Empathy schools-based programme for improving social and emotional well-being outcomes among 8- to 9-year-olds in Northern Ireland