Title: A cluster randomised controlled trial evaluation and cost-effectiveness analysis of the Roots of Empathy schools-based programme for improving social and emotional wellbeing outcomes among 8-9 year olds in Northern Ireland
Funder: Health and Social Care Research and Development Division (HSC R&D) of Public Health Agency, Northern Ireland

Abstract: DESIGN: Cluster randomised controlled trial.SETTING: Primary schools in the Belfast Health and Social Care (HSC) Trust South Eastern HSC Trust Southern HSC Trust and Western HSC Trust areas in Northern Ireland.TARGET POPULATION: All primary schools (in the four HSC Trust areas) not already implementing the Roots ofEmpathy (ROE) programme will be eligible to take part with the exception of Special Schools and schools with less than 10 children in Year 5 (aged 8-9 years). All children who are entering Year 5 in 2011/12 in eligible schools at baseline will be eligible to participate in the trial. RANDOM ALLOCATION: 70 schools will be recruited for the trial (20 in Belfast HSC Trust; 20 in South Eastern HSC Trust; 30 in Southern and Western HSC Trusts combined) and will be randomly assigned to either the intervention (n=35) or control group (n=35). Where there are parallel classes one Year 5 class will be randomly selected within each school. The intervention group will receive the ROE programme in their selected Year 5 class for one academic year (2011/12). The control group will not receive the ROE programme but will continue with usual classroom activity. The control group will be placed on a waiting list to receive the programme the following year but on the understanding that it is not delivered to their current Year 5 cohort as they progress through Years 6 and 7.INTERVENTION: The ROE programme is a universal classroom-based social and emotional competencepromotion programme for primary age pupils. It is a 27 lesson programme that runs for one school year and is based around a monthly classroom visit by an infant and parent whom the class adopts at the start of the school year. During these monthly visits children learn about the baby’s growth and development via interactions and observations with the baby. Each month a trained ROE instructor who is not the class teacher visits the classroom 3 times for: a pre-family visit; the visit of the parent and infant; and a post-family visit. Each ROE lesson provides opportunities to discuss and learn about the different dimensions of empathy namely: emotion identification and explanation; perspective-taking; and emotional sensitivity. The parent-infant visit thus serves as a springboard for these discussions about understanding feelings and infant development and effective parenting practices. The total cost to implement the programme in 35 schools (including start up and in-kind costs) is approx. £105000. These costs for 2011/12 will be underwritten by the NI Public Health Agency (see accompanying letter).CHILD OUTCOMES: PRIMARY: 1) increased prosocial behaviour; 2) reduced behavioural difficulties. SECONDARY: 3) increased understanding of infant crying; 4) increased ability to recognise emotions; 5) increased empathy; 6) increased ability to regulate emotions; 7) improved educational outcomes; and 8) improved quality of life.DATA COLLECTION: Parental and pupil consent will be sought prior to participation in the trial. Pupils in both the intervention and control groups will be tested on the outcome measures at baseline (pre-test) at the end of the intervention and then annually for the next three years using the same measures and until children are at the end of their first year in secondary school. Data will also be collected on programme delivery and fidelity across all 35 intervention schools as well as data on activities undertaken across the 35 control schools. In addition qualitative case studies will be conducted in 6 schools to track the experiences and perspectives of the children parents and teachers and to study the actual implementation of the programme.SAMPLE SIZE: Existing meta-analyses suggest typical effect sizes for programmes like ROE of a magnitude in the range of d=.22 to .57. Childrens behaviour (Outcomes 5 and 6 above) represent the primary outcomes for this trial. Typical ICCs for the behavioural measure to be used (SDQ) have been found typically to range from .05 to .15. With the inclusion of pre-test covariates it is reasonable to assume that the multilevel models to be used in the analysis will account for at least 20% of the variation in post-test outcome scores. With these assumptions it is estimated that a total sample size of 1260 children will be required to detect the lower bound anticipated effect size (.22) with 85% power (for ICC=.05) and 60% power (for ICC=.15). The average class size for the schools in the proposed trial is estimated to be 33. With an anticipated recruitment rate of 75% and an 8% attrition rate per year this will result in a final sample at the final data sweep of 18 children per school on average. With 70 classes in the trial this meets the total sample size of 1260 children.ANALYSIS: Baseline characteristics will be summarised by school and described by group allocation. The difference in outcomes will be described at each follow up point. Data will be analysed by intention to treat using multilevel modelling with pupils (level 1) clustered within classrooms/schools (level 3). As there is only one classroom per school then it is not possible to distinguish the effects of classrooms and schools. The introduction of interaction effects into the models will enable the exploration of potential subgroup effects by gender and socio-economic status. An economic evaluation in the form of a cost-effectiveness analysis will be undertaken alongside the trial. The costs and outcomes of ROE and usual education will be compared to assess the cost-effectiveness of ROE in preventing cases of aggressive behaviour and increasing prosocial behaviour among school aged children. A broad societal perspective will be adopted capturing resource use data related to each child’s contact with the National Health Service Personal Social Services educational services and judicial service directly as a result of their aggressive behaviour. Additional data on out-of-pocket costs incurred by the child’s family because of the child’s antisocial behaviour will also be collected. Uncertainty surrounding the estimate will be summarised in a cost effectiveness acceptability curve.PROJECT TIMETABLE: Project set up (Aug 11); Pretests (Sep 11); Intervention implementation (Oct 11 - Jun 12); Qualitative case studies (Oct 11 - Jun 12); Post tests (Jun 12); Analysis and write up of trial and case study data (Jul - Nov 12); Submission of first interim report of findings (Dec 12); 12 mth follow-up (Jun 13); second interim report (Sep 13); 24 mth follow-up (Jun 14); third interim report (Sep 14); 36 month follow-up (Jun 2015); final analysis and write up (Jul - Dec 2015); Final report (Dec 2015).


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH