Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol.

BACKGROUND: Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component intervention. This trial aims to assess the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying victimisation in English secondary schools. This paper updates the original trial protocol published in 2014 (Trials 15:381, 2014) and presents the changes in the process evaluation protocol and the secondary outcome data collection. METHODS: The methods are summarised as follows. DESIGN: cluster randomised trial. PARTICIPANTS: 40 state secondary schools. Outcomes assessed among the cohort of students at the end of year 7 (n = 6667) at baseline. INTERVENTION: INCLUSIVE is a multi-component school intervention including a social and emotional learning curriculum, changes to school environment (an action group comprising staff and students reviews local data on needs to review rules and policies and determine other local actions) and staff training in restorative practice. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third intervention year involving no external facilitation but all other elements. Comparator: normal practice. OUTCOMES: Primary: Two primary outcomes at student level assessed at baseline and at 36 months: 1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC) 2. Bullying and victimisation: Gatehouse Bullying Scale (GBS) Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. SAMPLE SIZE: 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level. Randomisation: eligible consenting schools were randomised stratified for single-sex versus mixed-sex schools, school-level deprivation and measures of school attainment. DISCUSSION: The trial involves independent research and intervention teams and is supervised by a Trial Steering Committee and a Data Monitoring Committee. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN10751359 . Registered on 11 March 2014

Examining intervention mechanisms of action using mediation analysis within a randomised trial of a whole-school health intervention.

BACKGROUND: Interventions to modify school environments are effective in promoting young people's health across outcomes, but mechanisms are poorly understood. We assessed mediation in a trial of the Learning Together intervention, building on the recent publication of results of effectiveness for reducing bullying and benefits across secondary outcomes and generally good implementation fidelity. METHODS: Within a cluster-randomised trial involving 40 English schools, we examined student-reported and staff-reported school climate and student-reported involvement with delinquent peers at 24-month and 36-month follow-up, assessing the reliability of measures and whether these mediated health outcomes at a final follow-up. RESULTS: Response rates and reliability were good for student-reported but not staff-reported measures. The intervention increased student-reported but not staff-reported-positive school climate but, like effects on student health outcomes, these manifested only at a final follow-up. The intervention reduced student-reported contact with delinquent peers at an interim follow-up. Student-reported potential mediators measured at the interim follow-up were associated with most health outcomes at the final follow-up. Adjustment for student-reported school climate and contact with delinquent peers at the interim follow-up did not reduce the associations between trial arm and our health outcomes. CONCLUSION: Despite being constrained by imperfect measures and by the late manifestation of impacts on student-reported school climate undermining ability to assess mediation, our study for the first time provides tentative evidence that mediation of intervention effects via improved climate and disengagement from delinquent peers is plausible. Our study provides the first evidence from a trial that whole-school interventions may work by modifying school environments and student relationships. TRIAL REGISTRATION NUMBER: ISRCTN10751359

Effects of school environments on student risk-behaviours: evidence from a longitudinal study of secondary schools in England.

BACKGROUND: The theory of human functioning and school organisation proposes that schools with rigid 'boundaries' (weaker relationships), for example, between staff and students, or learning and broader development, engender weaker student school commitment and sense of belonging, particularly among disadvantaged students, leading to greater involvement in risk-behaviours. Existing studies provide some support but rely on a proxy exposure of 'value-added education' and have not explored effects by disadvantage. METHODS: We used longitudinal data from English secondary schools from the control arm of a trial, assessing school-level measures of rigid boundaries, and student commitment and belonging at age 11/12, and student risk-behaviours at age 14/15. RESULTS: Our direct measures were more strongly associated with risk-behaviours than was value-added education. School-level rigid boundaries were associated with increased alcohol use and bullying. Student belonging was more consistently associated with reduced risk-behaviours than was student commitment. Some school effects were greater for students from disadvantaged subgroups defined in terms of poverty, ethnicity and family structure. CONCLUSION: Our results provide direct support for the theory of human functioning and school organisation and suggest a sense of belonging in school might be particularly protective factor among secondary school students. School effects on risk are generally stronger among disadvantaged students as theorised. TRIAL REGISTRATION NUMBER: ISRCTN10751359

Cost-effectiveness of a community-delivered multicomponent intervention compared with enhanced standard care of obese adolescents: cost-utility analysis alongside a randomised controlled trial (the HELP trial)

Objective To undertake a cost-utility analysis of a motivational multicomponent lifestyle-modification intervention in a community setting (the Healthy Eating Lifestyle Programme (HELP)) compared with enhanced standard care. Design Cost-utility analysis alongside a randomised controlled trial. Setting Community settings in Greater London, England. Participants 174 young people with obesity aged 12–19 years. Interventions Intervention participants received 12 one to-one sessions across 6months, addressing lifestyle behaviours and focusing on motivation to change and self esteem rather than weight change, delivered by trained graduate health workers in community settings. Control participants received a single 1-hour one-to-one nurse delivered session providing didactic weight-management advice. Main outcome measures Mean costs and quality adjusted life years (QALYs) per participant over a 1-year period using resource use data and utility values collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated and non-parametric bootstrapping was conducted to generate a cost-effectiveness acceptability curve (CEAC). Results Mean intervention costs per participant were £918 for HELP and £68 for enhanced standard care. There were no significant differences between the two groups in mean resource use per participant for any type of healthcare contact. Adjusted costs were significantly higher in the intervention group (mean incremental costs for HELP vs enhanced standard care £1003 (95% CI £837 to £1168)). There were no differences in adjusted QALYs between groups (mean QALYs gained 0.008 (95% CI −0.031 to 0.046)). The ICER of the HELP versus enhanced standard care was £120 630 per QALY gained. The CEAC shows that the probability that HELP was cost-effective relative to the enhanced standard care was 0.002 or 0.046, at a threshold of £20 000 or £30 000 per QALY gained. Conclusions We did not find evidence that HELP was more effective than a single educational session in improving quality of life in a sample of adolescents with obesity. HELP was associated with higher costs, mainly due to the extra costs of delivering the intervention and therefore is not cost-effective

Resolving and parameterising the ocean mesoscale in earth system models

Purpose of Review. Assessment of the impact of ocean resolution in Earth System models on the mean state, variability, and future projections and discussion of prospects for improved parameterisations to represent the ocean mesoscale. Recent Findings. The majority of centres participating in CMIP6 employ ocean components with resolutions of about 1 degree in their full Earth Systemmodels (eddy-parameterising models). In contrast, there are alsomodels submitted toCMIP6 (both DECK and HighResMIP) that employ ocean components of approximately 1/4 degree and 1/10 degree (eddy-present and eddy-rich models). Evidence to date suggests that whether the ocean mesoscale is explicitly represented or parameterised affects not only the mean state of the ocean but also the climate variability and the future climate response, particularly in terms of the Atlantic meridional overturning circulation (AMOC) and the Southern Ocean. Recent developments in scale-aware parameterisations of the mesoscale are being developed and will be included in future Earth System models. Summary. Although the choice of ocean resolution in Earth System models will always be limited by computational considerations, for the foreseeable future, this choice is likely to affect projections of climate variability and change as well as other aspects of the Earth System. Future Earth System models will be able to choose increased ocean resolution and/or improved parameterisation of processes to capture physical processes with greater fidelity

A community-based motivational personalised lifestyle intervention to reduce BMI in obese adolescents: results from the Healthy Eating and Lifestyle Programme (HELP) randomised controlled trial.

OBJECTIVE: Approximately 7% of children and young people aged 5-15 years in the UK have obesity at a level likely to be associated with comorbidities. The majority of multicomponent lifestyle programmes have limited applicability and generalisability for British adolescents.The Healthy Eating and Lifestyle Programme (HELP) was a specific adolescent-focused intervention, designed for obese 12 to 18-year-olds seeking help to manage their weight. Participants were randomised to the 12-session HELP intervention or standard care. The primary outcome was difference in mean body mass index (BMI) (kg/m2) between groups at week 26 adjusted for baseline BMI, age and sex. SUBJECTS: 174 subjects were randomised (87 in each arm), of whom 145 (83%) provided primary outcome data at week 26. RESULTS: At week 26 there were no significant effects of the intervention on BMI (mean change in BMI 0.18 kg/m2 for the intervention arm, 0.25 kg/m2 for the control arm; adjusted difference between groups: -0.11 kg/m2 (95% CI -0.62 to 0.40), p=0.7). At weeks 26 and 52 there were no significant differences between groups in any secondary outcomes. CONCLUSION: At minimum this study reinforces the need for higher level, structured interventions to tackle the growing public health burden of obesity in the UK and internationally.The HELP intervention was no more effective than a single educational session for reducing BMI in a community sample of obese adolescents.Further work is needed to understand how weight management programmes can be delivered effectively to young people from diverse and deprived backgrounds in which childhood obesity is common. The study has significant implications in terms of informing public health interventions to tackle childhood obesity. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN99840111

Cost-effectiveness of a community-delivered multicomponent intervention compared with enhanced standard care of obese adolescents: cost-utility analysis alongside a randomised controlled trial (the HELP trial).

OBJECTIVE: To undertake a cost-utility analysis of a motivational multicomponent lifestyle-modification intervention in a community setting (the Healthy Eating Lifestyle Programme (HELP)) compared with enhanced standard care. DESIGN: Cost-utility analysis alongside a randomised controlled trial. SETTING: Community settings in Greater London, England. PARTICIPANTS: 174 young people with obesity aged 12-19 years. INTERVENTIONS: Intervention participants received 12 one-to-one sessions across 6 months, addressing lifestyle behaviours and focusing on motivation to change and self-esteem rather than weight change, delivered by trained graduate health workers in community settings. Control participants received a single 1-hour one-to-one nurse-delivered session providing didactic weight-management advice. MAIN OUTCOME MEASURES: Mean costs and quality-adjusted life years (QALYs) per participant over a 1-year period using resource use data and utility values collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated and non-parametric bootstrapping was conducted to generate a cost-effectiveness acceptability curve (CEAC). RESULTS: Mean intervention costs per participant were £918 for HELP and £68 for enhanced standard care. There were no significant differences between the two groups in mean resource use per participant for any type of healthcare contact. Adjusted costs were significantly higher in the intervention group (mean incremental costs for HELP vs enhanced standard care £1003 (95% CI £837 to £1168)). There were no differences in adjusted QALYs between groups (mean QALYs gained 0.008 (95% CI -0.031 to 0.046)). The ICER of the HELP versus enhanced standard care was £120 630 per QALY gained. The CEAC shows that the probability that HELP was cost-effective relative to the enhanced standard care was 0.002 or 0.046, at a threshold of £20 000 or £30 000 per QALY gained. CONCLUSIONS: We did not find evidence that HELP was more effective than a single educational session in improving quality of life in a sample of adolescents with obesity. HELP was associated with higher costs, mainly due to the extra costs of delivering the intervention and therefore is not cost-effective. TRIAL REGISTRATION NUMBER: ISRCTN9984011.This work was supported by the NIHR under its Programme Grants for Applied Research programme (Grant Reference Number RP-PG-0608-10035)—the Paediatric Research in Obesity Multi-model Intervention and Service Evaluation (PROMISE) programme). The HELP research team acknowledges the support of the NIHR through the Primary Care Research Network. TJC was funded by MRC grant MR/M012069/1

Assessing the efficacy of the healthy eating and lifestyle programme (HELP) compared with enhanced standard care of the obese adolescent in the community: study protocol for a randomized controlled trial

Background: The childhood obesity epidemic is one of the foremost UK health priorities. Childhood obesity tracks into adult life and places individuals at considerable risk for diabetes, cardiovascular disease, liver disease and other morbidities. There is widespread need for paediatric lifestyle programmes as change may be easier to accomplish in childhood than later in life. Study Design/Method: The study will evaluate the management of adolescent obesity by conducting a Medical Research Council complex intervention phase III efficacy randomised clinical trial of the Healthy Eating Lifestyle Programme within primary care. The study tests a community delivered multi-component intervention designed for adolescents developed from best practice as identified by National Institute for Health and Clinical Excellence. The hospital based pilot reduced body mass index and improved health-related quality of life. Subjects will be individually randomised to receiving either the Healthy Eating Lifestyle Programme (12 fortnightly family sessions) or enhanced standard care. Baseline and follow up assessments will be undertaken blind to allocation status. A health economic evaluation is also being conducted. 200 obese young people (13-17 years, body mass index > 98th centile for age and sex) will be recruited from primary care within the greater London area. The primary hypothesis is that a motivational and solution-focused family-based weight management programme delivered over 6 months is more efficacious in reducing body mass index in obese adolescents identified in the community than enhanced standard care. The primary outcome will be body mass index at the end of the intervention, adjusted for baseline body mass index, age and sex. The secondary hypothesis is that the Healthy Eating Lifestyle Programme is more efficacious in improving quality of life and psychological function and reducing waist circumference and cardiovascular risk factors in obese adolescents than enhanced standard care assessed at 6 and 12 months post baseline assessment. Improvement in quality of life predicts on-going lifestyle change and maximises the chances of long-term weight reduction. We will explore whether improvement in QOL may be intermediate on the pathway between the intervention and body mass index change

Modifying the secondary school environment to reduce bullying and aggression: the INCLUSIVE cluster RCT

BackgroundBullying, aggression and violence among children and young people are some of the most consequential public mental health problems.ObjectivesThe INCLUSIVE (initiating change locally in bullying and aggression through the school environment) trial evaluated the Learning Together intervention, which involved students in efforts to modify their school environment using restorative approaches and to develop social and emotional skills. We hypothesised that in schools receiving Learning Together there would be lower rates of self-reported bullying and perpetration of aggression and improved student biopsychosocial health at follow-up than in control schools.DesignINCLUSIVE was a cluster randomised trial with integral economic and process evaluations.SettingForty secondary schools in south-east England took part. Schools were randomly assigned to implement the Learning Together intervention over 3 years or to continue standard practice (controls).ParticipantsA total of 6667 (93.6%) students participated at baseline and 5960 (83.3%) students participated at final follow-up. No schools withdrew from the study.InterventionSchools were provided with (1) a social and emotional curriculum, (2) all-staff training in restorative approaches, (3) an external facilitator to help convene an action group to revise rules and policies and to oversee intervention delivery and (4) information on local needs to inform decisions.Main outcome measuresSelf-reported experience of bullying victimisation (Gatehouse Bullying Scale) and perpetration of aggression (Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale) measured at 36 months. Intention-to-treat analysis using longitudinal mixed-effects models.ResultsPrimary outcomes – Gatehouse Bullying Scale scores were significantly lower among intervention schools than among control schools at 36 months (adjusted mean difference –0.03, 95% confidence interval –0.06 to 0.00). There was no evidence of a difference in Edinburgh Study of Youth Transitions and Crime scores. Secondary outcomes – students in intervention schools had higher quality of life (adjusted mean difference 1.44, 95% confidence interval 0.07 to 2.17) and psychological well-being scores (adjusted mean difference 0.33, 95% confidence interval 0.00 to 0.66), lower psychological total difficulties (Strengths and Difficulties Questionnaire) score (adjusted mean difference –0.54, 95% confidence interval –0.83 to –0.25), and lower odds of having smoked (odds ratio 0.58, 95% confidence interval 0.43 to 0.80), drunk alcohol (odds ratio 0.72, 95% confidence interval 0.56 to 0.92), been offered or tried illicit drugs (odds ratio 0.51, 95% confidence interval 0.36 to 0.73) and been in contact with police in the previous 12 months (odds ratio 0.74, 95% confidence interval 0.56 to 0.97). The total numbers of reported serious adverse events were similar in each arm. There were no changes for staff outcomes. Process evaluation – fidelity was variable, with a reduction in year 3. Over half of the staff were aware that the school was taking steps to reduce bullying and aggression. Economic evaluation – mean (standard deviation) total education sector-related costs were £116 (£47) per pupil in the control arm compared with £163 (£69) in the intervention arm over the first two facilitated years, and £63 (£33) and £74 (£37) per pupil, respectively, in the final, unfacilitated, year. Overall, the intervention was associated with higher costs, but the mean gain in students’ health-related quality of life was slightly higher in the intervention arm. The incremental cost per quality-adjusted life year was £13,284 (95% confidence interval –£32,175 to £58,743) and £1875 (95% confidence interval –£12,945 to £16,695) at 2 and 3 years, respectively.LimitationsOur trial was carried out in urban and periurban settings in the counties around London. The large number of secondary outcomes investigated necessitated multiple statistical testing. Fidelity of implementation of Learning Together was variable.ConclusionsLearning Together is effective across a very broad range of key public health targets for adolescents.Future workFurther studies are required to assess refined versions of this intervention in other settings.Trial registrationCurrent Controlled Trials ISRCTN10751359.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 7, No. 18. See the NIHR Journals Library website for further project information. Additional funding was provided by the Educational Endowment Foundation.</jats:sec