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Background Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is little evidence on which programmes are the most effective for improving social and emotional well-being. Objective The objective was to rigorously evaluate the Social and Emotional Education and Development (SEED) intervention process for improving pupils’ social and emotional well-being. Design This was a stratified cluster randomised controlled trial with embedded process and economic evaluations. Thirty-eight primary schools were randomly assigned to the SEED intervention or to the control group. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in R (statistical package). Setting The SEED intervention is a whole-school intervention; it involved all school staff and two cohorts of pupils, one starting at 4 or 5 years of age and the second starting at 8 or 9 years of age, across all 38 schools. Participants A total of 2639 pupils in Scotland. Intervention The SEED intervention used an iterative process that involved three components to facilitate selection and implementation of school-based actions: (1) questionnaire completion, (2) benchmarked feedback to all staff and (3) reflective discussions (all staff and an educational psychologist). Main outcome measure The primary outcome was pupils’ Strengths and Difficulties Questionnaire-Total Difficulties Score when pupils were 4 years older than at baseline. Results The primary outcome, pupils’ Strengths and Difficulties Questionnaire-Total Difficulties Score at follow-up 3, showed improvements for intervention arm pupils, compared with those in the control arm [relative risk −1.30 (95% confidence interval −1.87 to −0.73), standardised effect size −0.27 (95% confidence interval −0.39 to −0.15)]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. Subgroup analysis showed that all effect sizes were larger for the older cohort, particularly boys [relative risk −2.36 (95% confidence interval −3.62 to −1.11), standardised effect size −0.42 (95% confidence interval −0.64 to −0.20)]. Although there was no statistically significant difference in incremental cost and quality-adjusted life-years, the probability that the intervention is cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year was high, at 88%. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss social and emotional well-being and its contribution to a culture of evaluating practice. Limitations It was a challenge to retain schools over five waves of data collection. Conclusions This trial demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older boys and those with greater levels of psychological difficulties. It was beneficial during the transition from primary to secondary school, but this diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other interventions. Future work Assess whether or not the SEED intervention has a beneficial impact on academic attainment, is transferable to other countries and other organisational settings, would be strengthened by adding core training elements to the intervention process and is transferable to secondary schools. Understand the gender differences illustrated by the outcomes of this trial. Conduct further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration This trial is registered as ISRCTN51707384. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information. Plain language summary We studied the Social and Emotional Education and Development (SEED) primary school intervention to see if it could improve the social and emotional well-being of pupils in Scotland. The SEED intervention is a process with several elements. We collected information from school pupils, staff and parents, and assessed if the schools involved were happy, safe and caring environments. We sought to highlight any strengths or weaknesses in how each school approaches social and emotional well-being. The SEED intervention also measures the social and emotional well-being of pupils. This includes pupils’ strengths and difficulties, confidence, understanding of emotions and quality of relationships. We gave the information back to each school to help them decide what they can do to improve the social and emotional well-being of their pupils. We gave schools a guide to available resources, reviewed according to how well they are known to work elsewhere. The same social and emotional well-being measurements were repeated every 1 or 2 years, to see if any improvements had been made, and to guide any further adaptions of activities. The study ran in 38 schools over 7 years; half of the schools were randomly selected to receive the SEED intervention and half carried on as normal. Two age groups of pupils were recruited; the younger group was aged 4 or 5 years and the older group was aged 8 or 9 years at the start of the study. We found that the SEED intervention did slightly improve social and emotional well-being. Improvements were greater for older pupils, in particular for boys, and lasted beyond their transition from primary to secondary school. We also found that it was cost-effective for schools to run the SEED intervention. Schools valued the structure and shared ownership associated with the process. We concluded that the SEED intervention is an acceptable way to modestly improve pupil well-being and school ethos. Scientific summary Background Improved social and emotional well-being (SEW) during primary school years has been shown to have an impact on health and academic performance and protect against risk behaviours in later years. However, there is little evidence on which school-based programmes are most effective, particularly in the UK. This trial rigorously evaluated one such innovative programme in Scotland. The Social and Emotional Education and Development (SEED) intervention was designed to promote SEW in primary schools in Scotland. Rather than adopting a one-size-fits-all approach whereby SEW packages are delivered in schools to all pupils regardless of need, the SEED intervention was designed to draw on principles of co-production to tailor activities in response to school need. It has three components: (1) an assessment of school needs through staff, pupil and parent questionnaires; (2) feedback of needs assessment data to all school staff and reflective discussion (RD), facilitated by the schools’ educational psychologists (EPs), to select and co-produce school-appropriate, evidence-based actions and initiatives at both class and whole-school levels; and (3) implementation and maintenance of initiatives. Objectives The overarching aim of this study was to rigorously evaluate the impact of the SEED intervention on improving pupils’ SEW via a stratified cluster randomised controlled trial (RCT). The main research questions were addressed by the complementary outcome, process evaluations and economic evaluations. The pupil-related research questions were as follows: Does the SEED intervention improve pupils’ SEW? If so, is the impact different for specific subgroups of pupils (e.g. gender, deprivation)? Is the SEED intervention more effective if started with younger children [SEED trial younger cohort (YC) vs. older cohort (OC)]? What is the duration of the SEED intervention effect? Does the SEED intervention improve the social and emotional experience of transition from primary to secondary school? What is the impact on health behaviours of the SEED intervention during early secondary school years? What are pupils’ experiences of the SEED intervention? The teacher-related research questions were as follows: Are there changes in teachers’ knowledge, attitudes and behaviour relating to developing pupils’ SEW? Were teachers involved, and, if so, how were they involved, in selecting initiatives to respond to the pupils’ needs assessment? What contextual factors facilitate or inhibit the delivery of the SEED intervention? What contextual factors support or hinder the ability of the SEED intervention to improve pupils’ SEW? Which teachers engage best with the SEED intervention? What are teachers’ experiences of the SEED intervention? The parent-related research questions were as follows: Do parents report a difference in their child(ren)’s emotional and social development? If applicable, what are parents’ experiences of the SEED intervention? The economic research question was as follows: is SEED cost-effective? Methods A stratified cluster RCT was undertaken across 38 schools in the central Scotland area between 2013 and 2019. We invited state-funded denominational and non-denominational schools from three Scottish local authorities; we did not include independently funded schools. The intervention was delivered in primary schools, but the evaluation took place in primary and secondary schools. Baseline questionnaire data were collected from two cohorts of pupils in primary school, one in year 1 (aged 4–6 years) and the other in year 5 (aged 8–10 years), their parents and school staff. After a 1-year gap, to enable commencement of action plans, three waves of follow-up data were collected annually, then a further final follow-up wave was carried out 2 years after that with the OC of pupils only. Main trial outcomes The primary outcome was the Strengths and Difficulties Questionnaire-Total Difficulties Score (SDQ-TDS) at time 3 (T3) (follow-up 3), when the younger pupils were aged 8–10 years and the older pupils were aged 12–14 years. Secondary outcomes included all five subscales of the Strengths and Difficulties Questionnaire (SDQ); additional measures included pupil and staff well-being, school ethos and relationships. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in the statistical package R (The R Foundation for Statistical Computing, Vienna, Austria). Missing data were handled using repeated measures. Process evaluation The process evaluation design was guided by the UK Medical Research Council framework for the evaluation of complex interventions. Mixed methods included semistructured interviews with head teachers/depute head teachers and EPs, ethnographic notes from RD sessions and focus groups with pupils. An initial analysis was carried out on data collected from case study schools prior to knowing the main trial outcomes using an agreed coding framework. Further thematic analysis was conducted using NVivo (QSR International, Warrington, UK) to interpret trial outcomes and understand mechanisms of change. Economic evaluation The economic evaluation was conducted from a public sector perspective, including the NHS, Personal Social Services and local government. A validated child-specific preference-based measure, the Child Health Utility-9 Dimensions, was used to obtain utility values, which, together with costs, were used to conduct a cost–utility analysis. In addition, a within-trial cost-effectiveness analysis was conducted using the SDQ-TDS, the primary outcome measure for the trial. Data on the costs include costs associated with the provision of the intervention, including staff time, travel and consumables at each stage of the intervention, as well as the resource use cost collected at time 1 (T1) (follow-up 1) and T3 in the public sector, such as general practitioner visits and police visits. Resource use data were collected via the self-completed questionnaires, and the unit costs were obtained from standard UK sources. All analyses were undertaken according to the principle of intention-to-treat and in Stata®/SE 14.0 (StataCorp LP, College Station, TX, USA). Results (research findings) We recruited 38 primary schools with > 2600 pupils. The primary outcome, pupils’ SDQ-TDSs at T3, showed statistically significant improvements for pupils in the intervention arm, compared with those in the control arm [relative risk −1.30, 95% confidence interval (CI) −1.87 to −0.73]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. A subgroup analysis showed that all effect sizes were larger for the OC, particularly older boys (relative risk −2.36, 95% CI −3.62 to −1.11). All five SDQ subscales also showed beneficial and statistically significant results. A secondary analysis showed that the intervention had a range of positive effects on social and emotional skills, and school ethos and relationships. Only boys showed significant results for conduct problems and prosocial behaviour; all the other subscales showed effects for both genders. The intervention effect appeared to be diminished at the longer-term, final follow-up, 6 years post baseline. The economic evaluation concluded that the SEED intervention was likely to be cost-effective, but more so for the OC than the YC. Among the YC, the intervention was associated with a £166 increase in the cost and a 0.19 decrease in the SDQ-TDS, leading to a result of £856 per decrease in SDQ-TDS. Costs were lower in the OC because of the smaller incremental cost and much larger treatment effect, with an incremental cost-effectiveness ratio of £1.22 per 1-unit decrease in the SDQ-TDS. The probability of the SEED intervention being cost-effective at £20,000 per quality-adjusted life-year was > 80%. The process evaluation showed that there was an appreciation for the timing of the SEED intervention in terms of its alignment with the Scottish curriculum. The intervention was perceived as complementary to, rather than competing against, other established initiatives and priorities. Although there was variability in fidelity to the SEED intervention process, the data collection and the process of feeding back data at whole-school staff sessions were the most consistently implemented aspects. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss SEW and its contribution to a culture of evaluating practice. Limitations It was a challenge to retain schools over five waves of data collection. At two waves of data collection (T2 and T4), we lost three schools; however, we did have good school participation at the other three waves of data collection. We caution readers that there is more uncertainty about our results for these two waves. Low parental participation in our survey meant that parent data were unlikely to be a fair basis for influencing school-level decision-making, and this was communicated to schools. Conclusions The SEED cluster RCT provides robust evidence about the effects of the SEED intervention, a school-based intervention to promote SEWamong children. We have demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older pupils and, among the older pupils, particularly for boys and those with greater levels of psychological difficulties of both genders. There is no evidence of the intervention being more beneficial for advantaged pupils, so it should not widen the inequalities gap. It was beneficial during the transition from primary to secondary school, but longer-term analysis suggests that the effect is diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other intervention initiatives. Future work Our recommendations for future implications in relation to action, in numbered order, are to: conduct data linkage to SEED pupils’ external examination results (aggregated linkage rather than individual-pupil level), to assess whether or not the SEED intervention had any beneficial impact on academic attainment explore the transferability of the SEED intervention to other countries within the UK and beyond investigate the impact of adding core training elements (e.g. teacher training on young people’s mental health and well-being) to the intervention process extend the SEED intervention-style process to secondary schools understand the gender differences illustrated by the SEED outcomes develop and evaluate the SEED intervention concept in different settings across the life course further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration This trial is registered as ISRCTN51707384. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information.

Background Having a good start in life during pregnancy and infancy has been shown to be important for living both a healthy life and a longer life. Despite the introduction of many policies for the early-years age group, including voucher schemes, with the aim of improving nutrition, there is limited evidence of their impact on health. Objectives To assess the effectiveness of the Healthy Start voucher scheme on infant, child and maternal outcomes, and to capture the lived experiences of the Healthy Start voucher scheme for low-income women. Design This was a natural experiment study using existing data sets, linked to routinely collected health data sets, with a nested qualitative study of low-income women and an assessment of the health economics. Setting Representative sample of Scottish children and UK children. Participants Growing Up in Scotland cohort 2 (n = 2240), respondents to the 2015 Infant Feeding Study (n = 8067) and a sample of 40 participants in the qualitative study. Interventions The Health Start voucher, a means-tested scheme that provides vouchers worth £3.10 per week to spend on liquid milk, formula milk, fruit and vegetables. Main outcome measures Infant and child outcomes – breastfeeding initiation and duration; maternal outcomes – vitamin use pre and during pregnancy. Results The exposed group were women receiving the Healthy Start voucher (R), with two control groups: eligible and not claiming the Healthy Start voucher (E) and nearly eligible. There was no difference in vitamin use during pregnancy for either comparison (receiving the Healthy Start voucher, 82%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.10 vs. receiving the Healthy Start voucher, 87%; nearly eligible, 88%; p = 0.43) in the Growing Up in Scotland cohort. Proportions were similar for the Infant Feeding Study cohort (receiving the Healthy Start voucher, 89%; eligible and not claiming the Healthy Start voucher, 86%; p = 0.01 vs. receiving the Healthy Start voucher, 89%; nearly eligible, 87%; p = 0.01); although results were statistically significantly different, these were small effect sizes. There was no difference for either comparison in breastfeeding initiation or breastfeeding duration in months in Growing Up in Scotland, but there was a negative effect of the Healthy Start voucher in the Infant Feeding Survey. This contrast between data sets indicates that results are inconclusive for breastfeeding. The qualitative study found that despite the low monetary value the women valued the Healthy Start voucher scheme. However, the broader lives of low-income women are crucial to understand the constraints to offer a healthy diet. Limitations Owing to the policy being in place, it was difficult to identify appropriate control groups using existing data sources, especially in the Infant Feeding Study. Conclusions As the Healthy Start voucher scheme attempts to influence health behaviour, this evaluation can inform other policies aiming to change behaviour and use voucher incentives. The null effect of Healthy Start vouchers on the primary outcomes may be due to the value of the vouchers being insufficient to change the broader lives of low-income women to offer a healthy diet. Future work The methods developed to undertake an economic evaluation alongside a natural experiment using existing data can be used to explore the cost-effectiveness of the Healthy Start voucher scheme. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 11. See the NIHR Journals Library website for further project information. Plain language summary What was the problem? United Kingdom governments have introduced many policies to support infants and their families. Most of these policies have not been evaluated in terms of health outcomes. Therefore, there is limited evidence for policy-makers about whether or not the right policies are in place to make a difference to the health of young children and their families. What did we do? We investigated the impact of the Healthy Start voucher scheme (worth £3.10 per week to spend on milk, fruit and vegetables) on the health of low-income mothers, and their infants and young children, in particular vitamin use of mothers and breastfeeding of infants. What did we find? Using survey data, there were high rates of vitamin use during pregnancy, but fewer women taking vitamins before pregnancy. There was no effect of Healthy Start vouchers on taking vitamins before or during pregnancy. There was inconclusive evidence of the effect of Healthy Start vouchers on breastfeeding, indicating that use of the vouchers does not discourage breastfeeding in women with low incomes. From interviews with mothers, we found that they valued the Healthy Start vouchers and understood the aims of the policy. Healthy Start vouchers were not mentioned in decision-making around breastfeeding. Women’s choice to breast or formula feed was based on a range of other factors, such as support to breastfeed. They wanted to provide a healthy diet for their families, but owing to living on low incomes did not always manage it. What does this mean? Policy-makers still need more evidence about the effects of voucher schemes to improve the health of low-income mothers, and their infants and young children. The decision-makers require evidence to determine where to allocate limited resources. There is a need to improve support for low-income families to provide their families with a healthy diet. Scientific summary Background Having a good start in life during pregnancy and infancy has been shown to be important for living both a healthy life and a longer life. Health and well-being during the early years (which starts pre-conception) have a crucial impact on chronic disease and inequalities across the life course and from one generation to the next. There is a willingness of governments to invest in early years, as early investment in the life course has been shown to provide the highest rate of economic return. Despite the introduction of many policies designed to improve the circumstances during pregnancy and early life, there have been few outcome evaluations of these policies. Many of the evaluations are restricted to process evaluations of how the policy is implemented, rather than an evaluation of the outcomes for the mothers and their infants. The Healthy Start voucher (HSV) scheme was introduced in the United Kingdom (UK) in 2005/6. It is a means-tested voucher scheme for pregnant women and mothers with children under 4 years of age. If these women are in receipt of certain means-tested benefits then they are eligible for vouchers to be spent on milk, infant formula milk, fruit and vegetables. They also receive free vitamins. All mothers aged > 18 years are eligible for the scheme. Vouchers worth £3.10 per week are given to eligible women. These can be spent in neighbourhood shops and pharmacies. There are four main aims of the scheme: improve the nutrition of pregnant women, increase fruit and vegetable intake, initiate and maintain breastfeeding, and introduce foods in addition to milk as part of a progressively varied diet when infants are 6 months old. The effectiveness and cost-effectiveness of the HSV scheme have not yet been shown. Previous evaluations of outcomes comparing the HSV scheme with the Welfare Food Scheme (WFS) found that mothers eligible for the HSV scheme had higher daily intakes of iron, calcium, folate and vitamin C than mothers eligible for WFS. A mixed-methods study of practitioners and low-income mothers found that recipients valued the vouchers but that there were substantial barriers to access, including low levels of awareness of the HSV scheme among both mothers and practitioners, and uncertainty about the eligibility criteria among health professionals. A report on the operational aspects of the HSV scheme concluded that a comparative study is needed that extends previous analyses to the examination of outcomes and assessing the cost-effectiveness of the HSV scheme. There remains a need to determine the effectiveness on health outcomes and cost-effectiveness of the HSV scheme, using larger studies and investigating a wide range of outcomes with longer-term follow-up. Unless such schemes are rigorously evaluated there is a risk that resources will be wasted on ineffective interventions, or that opportunities to improve the design and administration of potentially valuable interventions are missed. Objectives The overall aim was to evaluate the HSV scheme in relation to the extent to which it improves the nutrition of pregnant women and the health outcomes of their infants. There were five objectives to investigate: the effectiveness of the HSV scheme in relation to vitamin use in pregnancy and breastfeeding initiation and duration the effectiveness of the HSV scheme in relation to infant and child weight and body size, child morbidity, infant and child feeding, and maternal health how findings differ between different populations (Scotland and England) to establish actual voucher usage and determine the reasons for uptake and non-uptake of the HSV to establish the cost-effectiveness of the HSV. Methods This evaluation of the HSV scheme had a focus on outcomes in pregnancy, early infancy and late infancy, with the potential to follow infants into adulthood through routinely collected data. It was a mixed-methods study, taking a natural experiment approach. It combined a quantitative evaluation with an integrated qualitative study to understand the lived experiences of low-income women. In addition to evaluating the health outcomes, we developed a framework to undertake an economic evaluation alongside a natural experiment using observational data. Exposure, controls and comparison groups The exposed group were those women eligible and claiming HSV, namely recipients (R). One reason the HSV scheme has not been evaluated on a large scale is the difficulty of identifying an appropriate comparison group. As the HSV is means tested it is not clear what an appropriate comparison group is; it is not appropriate to compare those who are eligible for HSV with those who do not meet the eligibility criteria as they are a very different group in terms of socioeconomic characteristics, with very different health behaviours and outcomes. We identified two comparison groups, the first being women who are eligible for HSV but do not claim the vouchers, namely eligible (E). The second comparison group was low-income women who just miss out on eligibility for HSV owing to not being eligible for the means-tested benefits owing to slightly increased income levels, namely nearly eligible (NE). With these exposure and control groups, there are three ways to compare these groups: recipients versus eligible but not claiming (group 1 vs. group 2) recipients versus nearly eligible (group 1 vs. group 3) all eligible versus nearly eligible (group 1 and 2 combined vs. group 3). Design The design used a multiple analytical approach in line with Medical Research Council guidance for the evaluation of natural experiments (NEs). There are three parts to this evaluation: secondary analysis of two existing data sets, including linking one to routinely collected health data (objectives 1, 2 and 3) qualitative interview study of mothers including a descriptive analysis of voucher usage (objective 4) establishing methods for cost-effectiveness analysis and conducting preliminary analysis (objective 5). Quantitative data sources and analysis For the quantitative analysis, we used two high-quality surveys representative of the Scottish population [Growing Up in Scotland (GUS); n = 2240] and the UK population [Infant Feeding Survey (IFS) 2010; n = 8067] to evaluate the HSV scheme. We examined potential improvement in vitamin use in pregnancy and breastfeeding initiation and duration, and other related health outcomes for low-income mothers and their children. We linked the GUS data to NHS routinely collected data to examine further health outcomes. We used propensity score matching on key characteristics to allow for the exposed and control groups to be more balanced on covariates. This method tries to mimic the characteristics of a randomised controlled trial. The propensity score is a balancing score, which means that it is conditional on the propensity score; the distribution of observed baseline covariates will be similar between treated and untreated subjects. This matching technique minimises selection bias and is better at getting to the causal effect than simple covariate adjustment in models. Qualitative interview study We carried out 40 in-depth, semistructured, face-to-face interviews, spread across each of the exposed and control groups. Key foci of the analysis were the processes involved in the take-up, non-take-up or discontinuation of the HSV scheme; the experience of using HSVs and how the vouchers are used. Framework for the cost-effectiveness analysis We developed and proposed methods and guidance for conducting economic evaluations in population health using observation data from NEs. Such evaluations are subject to the inherent biases that affect observational data. We reviewed and adapted current economic methods guidance and incorporated evidence from economic evaluations carried out in similar early years contexts. In addition, we used methods from previous studies that incorporated economics into NEs in education and microeconomics as well as health economic evaluations using observational data. Ethics Ethics approval was not required for the secondary analysis of existing data as there was no primary data collection. The linkage and release of the GUS data with the routinely collected data for research purposes was approved subject to Public Benefit and Privacy Panel for Health and Social Care project number 1516-0614. The qualitative study was reviewed and fully approved by the University of Glasgow, College of Social Science Ethics Committee in October 2015. This Committee complies with the Economic and Social Research Council’s research ethics framework. Results Impacts on child health For nearly all the outcomes across both GUS and IFS, apart from ever breastfeeding and breastfeeding duration in IFS, the results indicated there is no effect of HSV on the outcomes. For ever breastfed and duration of breastfeeding there are differences between propensity score results from GUS and IFS, with the IFS indicating a negative effect of HSV on breastfeeding. Ever breastfed: R 49%, E 53%, p = 0.255; R 58%, NE 62%, p = 0.189; all eligible (AE) 58%, NE 62%, p = 0.168, in GUS; R 57%, E 69%, p < 0.0001; R 53%, NE 70%, p < 0.0001; AE 60%, NE 74%, p < 0.0001, in IFS. Duration of breastfeeding in months (standard deviation): R 1.32 (2.1), E 1.46 (2.2), p = 0.374; R 1.73 (2.3), NE 1.88 (2.3), p = 0.315; AE 1.84 (2.4), NE 1.88 (2.3), p = 0.803, in GUS; R 1.37 (2.6), E 1.94 (3.0), p < 0.0001; R 1.23 (2.4), NE 2.09 (3.1), p < 0.0001; AE 1.53 (2.7), NE 2.51 (3.3), p < 0.0001, in IFS. For birthweight and low birthweight, the effect sizes and significance vary across the data sets and methods, indicating less confidence in the results of the HSV scheme on birthweight. For premature births and age at introduction of solid foods, there is more consistency across the data sets and evaluation methods, indicating some confidence in the results. Impacts on maternal health There was no difference in vitamin use during pregnancy for either comparison: R 82%, E 86%, p = 0.10; R 87%, NE 88%, p = 0.43; AE 87%, NE 88%, p = 0.43, in GUS. Proportions were similar for IFS: R 89%, E 86%, p = 0.01; R 89%, NE 87%, p = 0.01; AE 88%, NE 86%, p = 0.43. Although results were statistically significantly different, indicating increased vitamin use in the HSV groups, these are small effect sizes. We were able to examine further health outcomes, health behaviours and financial difficulties of the mothers in the GUS data set. For health during pregnancy, alcohol use and household managing financially, there was no effect of the HSV scheme across all the comparison groups. There were slight differences in mother’s current health as assessed by the Short Form questionnaire-12 items when the NE comparison group was used as the control. Short Form questionnaire-12 items physical health mean (standard deviation) R 52.26 (7.45), E 52.43 (6.84), p = 0.734; R 51.28 (8.36), NE 53.09 (6.87), p = 0.0002; AE 51.52 (8.13), NE 53.09 (6.87), p = 0.001. Short Form questionnaire-12 items mental health mean (standard deviation): R 51.11 (9.12), E 51.36 (8.74), p = 0.693; R 50.69 (9.23), NE 52.28 (8.36), p = 0.0045; AE 50.81 (9.19), NE 52.28 (8.3), p = 0.0083. There were large differences in smoking when the NE comparison group was used as the control: R 43%, E 34%, p = 0.419; R 37%, NE 24%, p < 0.0001; AE 35%, NE 24%, p < 0.0001 for current smoking status, and R 10.6, E 11.14, p = 0.581; R 10.9, NE 8.6, p = 0.00014; AE 10.9, NE 8.6, p = 0.0001 for numbers of cigarettes smoked per day. Understanding mother’s experiences The rich accounts given by the participants gave rise to four key themes: knowledge, awareness, take up and use of the HSV scheme; opinions of the HSV scheme; the effect of the HSV scheme on diet and feeding choices for their babies and children; and the broader lives of low-income women. The HSV scheme aims were well understood and the scheme was valued by participants. They thought that the eligibility criteria should be widened as they had had positive experiences and appreciated the scheme and the impact that the vouchers had on their lives. For some mothers, it supported them to provide a healthy diet and the opportunity to give their children a range of fruit and vegetables. For many other mothers, despite appropriate nutrition for children being important to them, there was evidence that some children still had poor diets. The HSVs were not mentioned in their decision-making around breastfeeding. Women’s choice to breast or formula feed was based on a range of other factors, such as support to breastfeed and assumptions and expectations of health professionals. The HSVs were incorporated into budgeting strategies and were seen as a good support in the context of the lives of low-income women. Methods for conducting a health economic analysis alongside a natural experiment Current guidance for economic evaluations focusses on randomised controlled trial designs and therefore does not address the specific challenges for natural experiment designs. Using such guidance can lead to suboptimal design, data collection and data analysis for NEs, leading to a bias in the estimated effectiveness and cost-effectiveness of the intervention or policy. We produced a framework to use when conducting an economic evaluation alongside a natural experiment. Conclusions Despite inconclusive findings of the impact of the HSV scheme on health, the HSV scheme attempts to influence health behaviour, and this evaluation can inform other policies aiming to change behaviours or use voucher incentives. There was a high use of vitamins during pregnancy in all groups, with indications of a small increase in vitamin use in the IFS group. Breastfeeding behaviour was similar in both recipients and nearly eligible groups, offering reassurance that the HSV scheme does not disincentivise breastfeeding, but results differed across GUS and IFS. The null effect of HSV on the primary outcomes may be due to the value of the vouchers being insufficient to make a large impact on the income for these women and children. There is a need to provide additional support for smoking cessation to the women eligible for HSVs. Implications for future research Future research should use the methods developed to undertake an economic evaluation alongside a natural experiment using existing data to explore the cost-effectiveness of the HSV scheme. We would also recommend further work to explore and identify other data sources or control groups to improve triangulation and strengthen the causal effects of this policy evaluation. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 13/164/10) and is published in full in Public Health Research; Vol. 11, No. 11. See the NIHR Funding and Awards website for further award information.

Background: The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. Methods: There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. Results: Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six ‘core elements’ that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. Limitations: The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. Conclusions: This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as ‘events in systems’ that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. Future work: We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. Funding: This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).

Background: There is a need to develop weight management interventions that fit seamlessly into the busy lives of women during the postpartum period. Objective: The objective was to develop and pilot-test an evidence- and theory-based intervention, delivered by short message service, which supported weight loss and weight loss maintenance in the postpartum period. Design: Stage 1 involved the development of a library of short message service messages to support weight loss and weight loss maintenance, with personal and public involvement, focusing on diet and physical activity with embedded behaviour change techniques, and the programming of a short message service platform to allow fully automated intervention delivery. Stage 2 comprised a 12-month, single-centre, two-arm, pilot, randomised controlled trial with an active control. Setting: This study was set in Northern Ireland; women were recruited via community-based approaches. Participants: A total of 100 women with overweight or obesity who had given birth in the previous 24 months were recruited. Interventions: The intervention group received an automated short message service intervention about weight loss and weight loss maintenance for 12 months. The active control group received automated short message service messages about child health and development for 12 months. Main outcome measures: The main outcomes measured were the feasibility of recruitment and retention, acceptability of the intervention and trial procedures, and evidence of positive indicative effects on weight. Weight, waist circumference and blood pressure were measured by the researchers; participants completed a questionnaire booklet and wore a sealed pedometer for 7 days at baseline, 3, 6, 9 and 12 months. Outcome assessments were collected during home visits and women received a voucher on completion of each of the assessments. Qualitative interviews were conducted with women at 3 and 12 months, to gather feedback on the intervention and active control and the study procedures. Quantitative and qualitative data were used to inform the process evaluation and to assess fidelity, acceptability, dose, reach, recruitment, retention, contamination and context. Results: The recruitment target of 100 participants was achieved (intervention, n = 51; control, n = 49); the mean age was 32.5 years (standard deviation 4.3 years); 28 (28%) participants had a household income of

Background: Finding solutions to rising levels of obesity continues to be a major public health focus. Social support has an important role in successful weight loss, and digital interventions can reach a large proportion of the population at low cost. Objective: To develop and assess the feasibility and acceptability of an application (app), web- and social support-based intervention in supporting adults with obesity to achieve weight loss goals. Design: Stage 1 – intervention development phase involved three focus groups (n = 10) with users, and think-aloud interviews and field testing with another group (n = 28). Stage 2 – the intervention and evaluation methods were explored in a feasibility randomised controlled trial with economic and process evaluation. Setting: Greater Glasgow and Clyde, UK. Participants: Adults with a body mass index of ≥ 30kg/m2 who owned a smartphone and were interested in losing weight were randomised 2 : 1 (intervention : control) and followed up at 12 months. Recruitment took place in April–October 2016. Interventions: The intervention group had access to HelpMeDoIt! for 12 months. This encouraged them to (1) set goals, (2) monitor progress and (3) harness social support by inviting ‘helpers’ from their existing social network. The control group received a healthy lifestyle leaflet. Main outcome measures: Data from stage 1 informed the intervention design. Key measures in stage 2 assessed the feasibility and acceptability of the intervention and trial methods against prespecified progression criteria. Three primary outcomes were explored: body mass index, diet and physical activity. Secondary outcomes included weight, waist and hip circumference, social support, self-efficacy, motivation, mental health, health-related quality of life, NHS resource use, participant-borne costs and intervention costs. Qualitative interviews with participants (n = 26) and helpers (n = 9) explored the feasibility and acceptability of the trial methods and intervention. Results: Stage 1 produced (1) a website that provided evidence-based information for lifestyle change and harnessing social support, and (2) an app that facilitated goal-setting, self-monitoring and supportive interaction between participants and their helper(s). Progression criteria were met, demonstrating that the intervention and trial methods were feasible and acceptable. A total of 109 participants (intervention, n = 73; control, n = 36) were recruited, with 84 participants (77%: intervention, 71%; control, 89%) followed up at 12 months. Data were successfully collected for most outcome measures (≥ 82% completion). Participants and helpers were generally positive, although helper engagement with the app was low. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it twice or more, 28 helpers enrolled via the app, and 19 (36%) participants interacted with their helper(s) via the app. Interview data indicated that HelpMeDoIt! prompted support from helpers that often occurred without the helpers using the app. Limitations: Early technical problems meant that some participants and helpers had difficulty accessing the app. Ethical constraints meant that we were unable to contact helpers directly for interview. Conclusions: The HelpMeDoIt! study demonstrated that a weight loss intervention delivered via an app and a website is feasible and acceptable. Progression criteria were met, supporting further evaluation of the intervention. Future work: To further explore (1) the motivation and engagement of helpers, (2) the programme theory and (3) the effectiveness and cost-effectiveness of the intervention. Trial registration: Current Controlled Trials ISRCTN85615983. 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. 8, No. 3. See the NIHR Journals Library website for further project information.

Background: Increasing physical activity in the workplace can provide physical and mental health benefits for employees and economic benefits for the employer through reduced absenteeism and increased productivity. However, there is limited evidence on effective behaviour change interventions in workplace settings that led to maintained physical activity. This study aimed to address this gap and contribute to the evidence base for effective and cost-effective workplace interventions. Objectives: To determine the effectiveness and cost-effectiveness of the Physical Activity Loyalty scheme, a multicomponent intervention based on concepts similar to those that underpin a high-street loyalty card, which was aimed at encouraging habitual physical activity behaviour and maintaining increases in mean number of steps per day. Design: A cluster randomised controlled trial with an embedded economic evaluation, behavioural economic experiments, mediation analyses and process evaluation. Setting: Office-based employees from public sector organisations in Belfast and Lisburn city centres in Northern Ireland. Participants: A total of 853 participants [mean age 43.6 years (standard deviation 9.6 years); 71% of participants were female] were randomly allocated by cluster to either the intervention group or the (waiting list) control group. Intervention: The 6-month intervention consisted of financial incentives (retail vouchers), feedback and other evidence-based behaviour change techniques. Sensors situated in the vicinity of the workplaces allowed participants to monitor their accumulated minutes of physical activity. Main outcome measures: The primary outcome was mean number of steps per day recorded using a sealed pedometer (Yamax Digiwalker CW-701; Yamax, Tasley, UK) worn on the waist for 7 consecutive days and at 6 and 12 months post intervention. Secondary outcomes included health, mental well-being, quality of life, work absenteeism and presenteeism, and the use of health-care resources. Results: The mean number of steps per day were significantly lower for the intervention group than the control group [6990 mean number of steps per day (standard deviation 3078) vs. 7576 mean number of steps per day (standard deviation 3345), respectively], with an adjusted mean difference of –336 steps (95% confidence interval –612 to –60 steps; p = 0.02) at 6 months post baseline, but not significantly lower at 12 months post baseline. There was a small but significant enhancement of mental well-being in the intervention group (difference between groups for the Warwick–Edinburgh Mental Wellbeing Scale of 1.34 points, 95% confidence interval 0.48 to 2.20 points), but not for the other secondary outcomes. An economic evaluation suggested that, overall, the scheme was not cost-effective compared with no intervention. The intervention was £25.85 (95% confidence interval –£29.89 to £81.60) more costly per participant than no intervention and had no effect on quality-adjusted life-years (incremental quality-adjusted life-years –0.0000891, 95% confidence interval –0.008 to 0.008). Limitations: Significant restructuring of participating organisations during the study resulted in lower than anticipated recruitment and retention rates. Technical issues affected intervention fidelity. Conclusions: Overall, assignment to the intervention group resulted in a small but significant decline in the mean pedometer-measured steps per day at 6 months relative to baseline, compared with the waiting list control group. The Physical Activity Loyalty scheme was deemed not to be cost-effective compared with no intervention, primarily because no additional quality-adjusted life-years were gained through the intervention. Research to better understand the mechanisms of physical activity behaviour change maintenance will help the design of future interventions. Trial registration: Current Controlled Trials ISRCTN17975376. 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. 7, No. 15. See the NIHR Journals Library website for further project information.

Background: People with Parkinson’s disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life. Objective: To estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson’s disease. Design: A multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses. Setting: Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions. Participants: A total of 474 people with Parkinson’s disease (i.e. Hoehn and Yahr scale stages 1–4) were recruited: 238 were assigned to a physiotherapy programme and 236 were assigned to usual care. Random allocation was 50 : 50. Interventions: All participants received routine care; the usual-care group received an information digital versatile disc (DVD) and a single advice session at trial completion. The intervention group had an individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE. Main outcome measures: The primary outcome was the risk of repeat falling, collected by self-report monthly diaries between 0 and 6 months after randomisation. Secondary outcomes included near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson’s Disease Questionnaire. Results: PDSAFE is the largest RCT of falls management among people with Parkinson’s disease: 541 patients were screened for eligibility. The average age was 72 years, and 266 out of 474 (56%) participants were men. Of the 474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group. No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR) 1.21, 95% confidence interval (CI) 0.74 to 1.98; p = 0.447]. An analysis of secondary outcomes demonstrated better balance (Mini-BESTest: mean difference 0.95, 95% CI 0.24 to 1.67; p = 0.009), functional strength (CST: p = 0.041) and falls efficacy (Falls Efficacy Scale – International: mean difference 1.6, 95% CI –3.0 to –0.19; p = 0.026) with near-falling significantly reduced with PDSAFE (OR 0.67, 95% CI 0.53 to 0.86; p = 0.001) at 6 months. Prespecified subgroup analysis (i.e. disease severity and FoG) revealed a PDSAFE differing effect; the intervention may be of benefit for people with moderate disease but may increase falling for those in the more severe category, especially those with FoG. Limitations: All participants were assessed at primary outcome; only 73% were assessed at 12 months owing to restricted funding. Conclusions: PDSAFE was not effective in reducing repeat falling across the range of people with Parkinson’s disease in the trial. Secondary analysis demonstrated that other functional tasks and self-efficacy improved and demonstrated differential patterns of intervention impact in accordance with disease severity and FoG, which supports previous secondary research findings and merits further primary evaluation. Future work: Further trials of falls prevention on targeted groups of people with Parkinson’s disease are recommended. Trial registration: Current Controlled Trials ISRCTN48152791. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 36. See the NIHR Journals Library website for further project information. Sarah E Lamb is funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust, the NIHR Oxford Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust and CLAHRC Oxford. Victoria A Goodwin is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care in the South West Peninsula (PenCLAHRC). Lynn Rochester is supported by the NIHR Newcastle Biomedical Research Centre based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The research was also supported by the NIHR Newcastle Clinical Research Facility Infrastructure funding. Helen C Roberts is supported by CLAHRC Wessex and the NIHR Southampton Biomedical Research Centre.

Background: It is widely recognised that drink driving is a leading cause of road traffic accidents (RTAs). There is evidence that changing the drink-drive limit from a blood alcohol concentration of 0.08 to 0.05 g/dl is effective in reducing RTAs. Scotland changed the blood alcohol concentration limit to 0.05 g/dl on 5 December 2014. Aims: To assess whether or not the numbers and rates of RTAs and per capita alcohol consumption in Scotland were reduced because of the 2014 drink-drive legislation. To assess whether or not the 2014 change in legislation provided good value for money. Design: A natural experimental, quantitative study. The control group was England and Wales, that is, the other countries in Great Britain, where the drink-drive legislation remained unchanged. Setting: Great Britain. Participants: The entire population of Scotland, England and Wales for the period of January 2013–December 2016. Intervention: The change to drink-drive legislation in Scotland. Outcome measures: The counts and rates of RTAs; and per capita alcohol consumption. Methods: For the numbers and rates of RTAs (both traffic flow and population denominators were used), and separately for the intervention and control trial groups, negative binomial regression models were fitted to panel data sets to test for a change in outcome level after the new 2014 legislation was in place. To obtain a ‘difference-in-differences’ (DiD)-type measure of effect, an interaction term between the intervention group indicator and the binary covariate for indicating pre and post change in legislation (‘pseudo’-change for the control group) was assessed. For off- and on-trade per capita alcohol sales, and separately for the intervention and control trial group, seasonal autoregressive integrated moving average error models were fitted to the relevant time series. Results: The change to drink-drive legislation was associated with a 2% relative decrease in RTAs in Scotland [relative risk (RR) 0.98, 95% CI 0.91 to 1.04; p = 0.53]. However, the pseudo-change in legislation was associated with a 5% decrease in RTAs in England and Wales (RR 0.95, 95% CI 0.90 to 1.00; p = 0.05). For RTA rates, with traffic flow as the denominator, the DiD-type estimate indicated a 7% increase in rates for Scotland relative to England and Wales (unadjusted RR 1.07, 95% CI 0.98 to 1.17; p = 0.1). The change to drink-drive legislation was associated with a 0.3% relative decrease in per capita off-trade sales (–0.3%, 95% CI –1.7% to 1.1%; p = 0.71) and a 0.7% decrease in per capita on-trade sales (–0.7%, 95% CI –0.8% to –0.5%; p

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.

Background: There are no randomised trials of peripheral capillary oxygen saturation (SpO2) targets in acute respiratory infection. Two national guidelines recommended different targets for the management of acute viral bronchiolitis. Objectives: To compare the American Academy of Pediatrics guideline target of SpO2 ≥ 90% with the Scottish Intercollegiate Guidelines Network target of SpO2 ≥ 94%. Design: A multicentre, parallel-group, double-blind, randomised controlled, equivalence trial with economic evaluation. Setting: Eight paediatric hospital departments in the UK. Participants: Infants > 6 weeks and ≤ 12 months of age (corrected for prematurity) with physician-diagnosed bronchiolitis admitted to hospital from a paediatric emergency assessment area. Follow-up for 6 months by standardised telephone contacts. Intervention: Infants were randomised to a target oxygen saturation of ≥ 94% (standard care) or ≥ 90% (modified care) displayed by a pulse saturation oximeter (Masimo Corporation Limited, CA, USA). Routine care: All infants received routine care in addition to the study intervention. Infants were eligible for discharge when they exhibited a SpO2 of ≥ 94% in room air for 4 hours including a period of sleep and were also feeding adequately (≥ 75% usual volume). Primary outcome: A total of 615 infants were recruited, of whom 308 were allocated to the standard care group and 307 to the modified care group. The primary outcome was time to cough resolution. There was equivalence at the prespecified variance of ± 2 days [time to cough resolution: standard care group, 15 days; modified care group, 15 days; median difference 1 day (benefit modified), 95% confidence interval (CI) –1 to 2 days]. Secondary results: Return to adequate feeding occurred sooner in infants in the modified care group than in those in the standard care group (19.5 vs. 24.1 hours). This difference was non-equivalent [median difference 2.7 hours (95% CI –0.3 to 7.0 hours) versus prespecified ± 4 hours; post-hoc hazard ratio 1.22 (95% CI 1.04 to 1.44 (p-value = 0.015)]. Parent perspective of the time taken to return to normal was not equivalent, being 12 days in the standard care group compared with 11 days in the modified care group [median difference 1.0 day (95% CI 0.0 to 3.0 days) versus prespecified ± 2 days; post-hoc hazard ratio 1.19 (95% CI 1.00 to 1.41); p-value = 0.043]. At 28 days, SpO2 was equivalent [mean difference 0.11% (95% CI –0.35% to 0.57%), within the 1% prespecified]. The modified care group (55.6%) required oxygen less than the standard care group (73.1%), and for a shorter period (5.7 hours vs. 27.6 hours). Infants in the modified care group were fit for discharge (30.2 hours vs. 44.2 hours, hazard ratio 1.46, 95% CI 1.23 to 1.73; p-value

Background: Cognitive–behavioural therapy (CBT) for childhood anxiety disorders is associated with modest outcomes in the context of parental anxiety disorder. Objectives: This study evaluated whether or not the outcome of CBT for children with anxiety disorders in the context of maternal anxiety disorders is improved by the addition of (i) treatment of maternal anxiety disorders, or (ii) treatment focused on maternal responses. The incremental cost-effectiveness of the additional treatments was also evaluated. Design: Participants were randomised to receive (i) child cognitive–behavioural therapy (CCBT); (ii) CCBT with CBT to target maternal anxiety disorders [CCBT + maternal cognitive–behavioural therapy (MCBT)]; or (iii) CCBT with an intervention to target mother–child interactions (MCIs) (CCBT + MCI). Setting: A NHS university clinic in Berkshire, UK. Participants: Two hundred and eleven children with a primary anxiety disorder, whose mothers also had an anxiety disorder. Interventions: All families received eight sessions of individual CCBT. Mothers in the CCBT + MCBT arm also received eight sessions of CBT targeting their own anxiety disorders. Mothers in the MCI arm received 10 sessions targeting maternal parenting cognitions and behaviours. Non-specific interventions were delivered to balance groups for therapist contact. Main outcome measures: Primary clinical outcomes were the child’s primary anxiety disorder status and degree of improvement at the end of treatment. Follow-up assessments were conducted at 6 and 12 months. Outcomes in the economic analyses were identified and measured using estimated quality-adjusted life-years (QALYs). QALYS were combined with treatment, health and social care costs and presented within an incremental cost–utility analysis framework with associated uncertainty. Results: MCBT was associated with significant short-term improvement in maternal anxiety; however, after children had received CCBT, group differences were no longer apparent. CCBT + MCI was associated with a reduction in maternal overinvolvement and more confident expectations of the child. However, neither CCBT + MCBT nor CCBT + MCI conferred a significant post-treatment benefit over CCBT in terms of child anxiety disorder diagnoses [adjusted risk ratio (RR) 1.18, 95% confidence interval (CI) 0.87 to 1.62, p = 0.29; adjusted RR CCBT + MCI vs. control: adjusted RR 1.22, 95% CI 0.90 to 1.67, p = 0.20, respectively] or global improvement ratings (adjusted RR 1.25, 95% CI 1.00 to 1.59, p = 0.05; adjusted RR 1.20, 95% CI 0.95 to 1.53, p = 0.13). CCBT + MCI outperformed CCBT on some secondary outcome measures. Furthermore, primary economic analyses suggested that, at commonly accepted thresholds of cost-effectiveness, the probability that CCBT + MCI will be cost-effective in comparison with CCBT (plus non-specific interventions) is about 75%. Conclusions: Good outcomes were achieved for children and their mothers across treatment conditions. There was no evidence of a benefit to child outcome of supplementing CCBT with either intervention focusing on maternal anxiety disorder or maternal cognitions and behaviours. However, supplementing CCBT with treatment that targeted maternal cognitions and behaviours represented a cost-effective use of resources, although the high percentage of missing data on some economic variables is a shortcoming. Future work should consider whether or not effects of the adjunct interventions are enhanced in particular contexts. The economic findings highlight the utility of considering the use of a broad range of services when evaluating interventions with this client group. Trial registration: Current Controlled Trials ISRCTN19762288. Funding: This trial was funded by the Medical Research Council (MRC) and Berkshire Healthcare Foundation Trust and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR partnership (09/800/17) and will be published in full in Health Technology Assessment; Vol. 19, No. 38.