Group antenatal care: findings from a pilot randomised controlled trial of REACH Pregnancy Circles.

BACKGROUND: Antenatal care has the potential to impact positively on maternal and child outcomes, but traditional models of care in the UK have been shown to have limitations and particularly for those from deprived populations. Group antenatal care is an alternative model to traditional individual care. It combines conventional aspects of antenatal assessment with group discussion and support. Delivery of group antenatal care has been shown to be successful in various countries; there is now a need for a formal trial in the UK. METHOD: An individual randomised controlled trial (RCT) of a model of group care (Pregnancy Circles) delivered in NHS settings serving populations with high levels of deprivation and diversity was conducted in an inner London NHS trust. This was an external pilot study for a potential fully powered RCT with integral economic evaluation. The pilot aimed to explore the feasibility of methods for the full trial. Inclusion criteria included pregnant with a due date in a certain range, 16 + years and living within specified geographic areas. Data were analysed for completeness and usability in a full trial; no hypothesis testing for between-group differences in outcome measures was undertaken. Pre-specified progression criteria corresponding to five feasibility measures were set. Additional aims were to assess the utility of our proposed outcome measures and different data collection routes. A process evaluation utilising interviews and observations was conducted. RESULTS: Seventy-four participants were randomised, two more than the a priori target. Three Pregnancy Circles of eight sessions each were run. Interviews were undertaken with ten pregnant participants, seven midwives and four other stakeholders; two observations of intervention sessions were conducted. Progression criteria were met at sufficient levels for all five measures: available recruitment numbers, recruitment rate, intervention uptake and retention and questionnaire completion rates. Outcome measure assessments showed feasibility and sufficient completion rates; the development of an economic evaluation composite measure of a 'positive healthy birth' was initiated. CONCLUSION: Our pilot findings indicate that a full RCT would be feasible to conduct with a few adjustments related to recruitment processes, language support, accessibility of intervention premises and outcome assessment. TRIAL REGISTRATION: ISRCTN ISRCTN66925258. Retrospectively registered, 03 April 2017.

Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations.

BACKGROUND: Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. METHODS: The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a 'healthy baby' composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born "healthy" in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional 'healthy and positive birth' of the intervention with standard care. Qualitative data will be analysed thematically. DISCUSSION: This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. TRIAL REGISTRATION: Trial registration; ISRCTN, ISRCTN91977441 . Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

Better together: A qualitative exploration of women's perceptions and experiences of group antenatal care.

PROBLEM: Childbearing women from socio-economically disadvantaged communities and minority ethnic groups are less likely to access antenatal care and experience more adverse pregnancy outcomes. BACKGROUND: Group antenatal care aims to facilitate information sharing and social support. It is associated with higher rates of attendance and improved health outcomes. AIMS: To assess the acceptability of a bespoke model of group antenatal care (Pregnancy Circles) in an inner city community in England, understand how the model affects women's experiences of pregnancy and antenatal care, and inform further development and testing of the model. METHODS: A two-stage qualitative study comprising focus groups with twenty six local women, followed by the implementation of four Pregnancy Circles attended by twenty four women, which were evaluated using observations, focus groups and semi-structured interviews with participants. Data were analysed thematically. FINDINGS: Pregnancy Circles offered an appealing alternative to standard antenatal care and functioned as an instrument of empowerment, mediated through increased learning and knowledge sharing, active participation in care and peer and professional relationship building. Multiparous women and women from diverse cultures sharing their experiences during Circle sessions was particularly valued. Participants had mixed views about including partners in the sessions. CONCLUSIONS: Group antenatal care, in the form of Pregnancy Circles, is acceptable to women and appears to enhance their experiences of pregnancy. Further work needs to be done both to test the findings in larger, quantitative studies and to find a model of care that is acceptable to women and their partners.

Testing the effectiveness of REACH Pregnancy Circles group antenatal care: protocol for a randomised controlled pilot trial.

BACKGROUND: Antenatal care is an important public health priority. Women from socially disadvantaged, and culturally and linguistically diverse groups often have difficulties with accessing antenatal care and report more negative experiences with care. Although group antenatal care has been shown in some settings to be effective for improving women's experiences of care and for improving other maternal as well as newborn health outcomes, these outcomes have not been rigorously assessed in the UK. A pilot trial will be conducted to determine the feasibility of, and optimum methods for, testing the effectiveness of group antenatal care in an NHS setting serving populations with high levels of social deprivation and cultural, linguistic and ethnic diversity. Outcomes will inform the protocol for a future full trial. METHODS: This protocol outlines an individual-level randomised controlled external pilot trial with integrated process and economic evaluations. The two trial arms will be group care and standard antenatal care. The trial will involve the recruitment of 72 pregnant women across three maternity services within one large NHS Acute Trust. Baseline, outcomes and economic data will be collected via questionnaires completed by the participants at three time points, with the final scheduled for 4 months postnatal. Routine maternity service data will also be collected for outcomes assessment and economic evaluation purposes. Stakeholder interviews will provide insights into the acceptability of research and intervention processes, including the use of interpreters to support women who do not speak English. Pre-agreed criteria have been selected to guide the decision about whether or not to progress to a full trial. DISCUSSION: This pilot trial will determine if it is appropriate to proceed to a full trial of group antenatal care in this setting. If progression is supported, the pilot will provide authoritative high-quality evidence to inform the design and conduct of a trial in this important area that holds significant potential to influence maternity care, outcomes and experience. TRIAL REGISTRATION: ISRCTN ISRCTN66925258. Registered 03 April 2017. Retrospectively registered.

Effects of the Learning Together intervention on bullying and aggression in English secondary schools (INCLUSIVE): a cluster randomised controlled trial.

BACKGROUND: Bullying, aggression, and violence among children and young people are some of the most consequential public mental health problems. We tested the Learning Together intervention, which involved students in efforts to modify their school environment using restorative practice and by developing social and emotional skills. METHODS: We did a cluster randomised trial, with economic and process evaluations, of the Learning Together intervention compared with standard practice (controls) over 3 years in secondary schools in south-east England. Learning Together consisted of staff training in restorative practice; convening and facilitating a school action group; and a student social and emotional skills curriculum. Primary outcomes were self-reported experience of bullying victimisation (Gatehouse Bullying Scale; GBS) and perpetration of aggression (Edinburgh Study of Youth Transitions and Crime (ESYTC) school misbehaviour subscale) measured at 36 months. We analysed data using intention-to-treat longitudinal mixed-effects models. This trial was registered with the ISRCTN registry (10751359). FINDINGS: We included 40 schools (20 in each group); no schools withdrew. 6667 (93·6%) of 7121 students participated at baseline and 5960 (83·3%) of 7154 at 36 months. Mean GBS bullying score at 36 months was 0·34 (SE 0·02) in the control group versus 0·29 (SE 0·02) in the intervention group, with a significant adjusted mean difference (-0·03, 95% CI -0·06 to -0·001; adjusted effect size -0·08). Mean ESYTC score at 36 months was 4·33 (SE 0·20) in the control group versus 4·04 (0·21) in the intervention group, with no evidence of a difference between groups (adjusted difference -0·13, 95% CI -0·43 to 0·18; adjusted effect size -0·03). Costs were an additional £58 per pupil in intervention schools than in control schools. INTERPRETATION: Learning Together had small but significant effects on bullying, which could be important for public health, but no effect on aggression. Interventions to promote student health by modifying the whole-school environment are likely to be one of the most feasible and efficient ways of addressing closely related risk and health outcomes in children and young people. FUNDING: National Institute for Health Research, Educational Endowment Foundation.

`It makes sense and it works': Maternity care providers' perspectives on the feasibility of a group antenatal care model (Pregnancy Circles).

AIM: To test the feasibility of introducing a group antenatal care initiative (Pregnancy Circles) in an area with high levels of social deprivation and cultural diversity by exploring the views and experiences of midwives and other maternity care providers in the locality before and after the implementation of a test run of the group model. DESIGN: (i) Pre-implementation semi-structured interviews with local stakeholders. (ii) Post-implementation informal and semi-structured interviews and a reflective workshop with facilitating midwives, and semi-structured interviews with maternity managers and commissioners. Data were organised around three core themes of organisational readiness, the acceptability of the model, and its impact on midwifery practice, and analyzed thematically. SETTING: A large inner-city National Health Service Trust in the United Kingdom. PARTICIPANTS: Sixteen stakeholders were interviewed prior to, and ten after, the group model was implemented. Feedback was also obtained from a further nine midwives and one student midwife who facilitated the Pregnancy Circles. INTERVENTION: Four Pregnancy Circles in community settings. Women with pregnancies of similar gestation were brought together for antenatal care incorporating information sharing and peer support. Women undertook their own blood pressure and urine checks, and had brief individual midwifery checks in the group space. FINDINGS: Dissatisfaction with current practice fuelled organisational readiness and the intervention was both possible and acceptable in the host setting. A perceived lack of privacy in a group setting, the ramifications of devolving blood pressure and urine checks to women, and the involvement of partners in sessions were identified as sticking points. Facilitating midwives need to be adequately supported and trained in group facilitation. Midwives derived accomplishment and job satisfaction from working in this way, and considered that it empowered women and enhanced care. KEY CONCLUSIONS: Participants reported widespread dissatisfaction with current care provision. Pregnancy Circles were experienced as a safe environment in which to provide care, and one that enabled midwives to build meaningful relationships with women. IMPLICATIONS FOR PRACTICE: Pre-registration education inadequately prepared midwives for group care. Addressing sticking points and securing management support for Pregnancy Circles is vital to sustain participation in this model of care.

Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations.

BACKGROUND: The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue. METHODS/DESIGN: The study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2-7 and 8-13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority. DISCUSSION: Community REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and delivered by local communities. This pragmatic cluster randomised controlled trial, with integrated process and economic evaluation, aims to rigorously assess the effectiveness of this public health intervention, which is particularly complex due to the required combination of standardisation with local flexibility. It will also answer questions about scalability and generalisability. TRIAL REGISTRATION: ISRCTN registry: registration number 63066975 . Registered on 18 August 2015.

The role of family and school-level factors in bullying and cyberbullying: a cross-sectional study.

BACKGROUND: Bullying and cyberbullying are common phenomena in schools. These negative behaviours can have a significant impact on the health and particularly mental health of those involved in such behaviours, both as victims and as bullies. This UK study aims to investigate student-level and school-level characteristics of those who become involved in bullying and cyberbullying behaviours as victims or perpetrators. METHODS: We used data from 6667 Year 7 students from the baseline survey of a cluster randomized trial in 40 English schools to investigate the associations between individual-level and school-level variables with bullying victimization, cyberbullying perpetration, and cyberbullying victimization. We ran multilevel models to examine associations of bullying outcomes with individual-level variables and school-level variables. RESULTS: In multilevel models, at the school level, school type and school quality measures were associated with bullying risk: students in voluntary-aided schools were less likely to report bullying victimization (0.6 (0.4, 0.9) p = 0.008), and those in community (3.9 (1.5, 10.5) p = 0.007) and foundation (4.0 (1.6, 9.9) p = 0.003) schools were more likely to report being perpetrators of cyberbullying than students in mainstream academies. A school quality rating of "Good" was associated with greater reported bullying victimization (1.3 (1.02, 1.5) p = 0.03) compared to ratings of "Outstanding." CONCLUSIONS: Bullying victimization and cyberbullying prevalence vary across school type and school quality, supporting the hypothesis that organisational/management factors within the school may have an impact on students' behaviour. These findings will inform future longitudinal research investigating which school factors and processes promote or prevent bullying and cyberbullying behaviours. TRIAL REGISTRATION: Trial ID: ISRCTN10751359 Registered: 11/03/2014 (retrospectively registered).

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.

Effectiveness of a structured educational intervention using psychological delivery methods in children and adolescents with poorly controlled type 1 diabetes: a cluster-randomized controlled trial of the CASCADE intervention.

INTRODUCTION: Type 1 diabetes (T1D) in children and adolescents is increasing worldwide with a particular increase in children <5 years. Fewer than 1 in 6 children and adolescents achieve recommended glycated hemoglobin (HbA1c) values. METHODS: A pragmatic, cluster-randomized controlled trial assessed the efficacy of a clinic-based structured educational group incorporating psychological approaches to improve long-term glycemic control, quality of life and psychosocial functioning in children and adolescents with T1D. 28 pediatric diabetes services were randomized to deliver the intervention or standard care. 362 children (8-16 years) with HbA1c≥8.5% were recruited. Outcomes were HbA1c at 12 and 24 months, hypoglycemia, admissions, self-management skills, intervention compliance, emotional and behavioral adjustment, and quality of life. A process evaluation collected data from key stakeholder groups in order to evaluate the feasibility of delivering the intervention. RESULTS: 298/362 patients (82.3%) provided HbA1c at 12 months and 284/362 (78.5%) at 24 months. The intervention did not improve HbA1c at 12 months (intervention effect 0.11, 95% CI -0.28 to 0.50, p=0.584), or 24 months (intervention effect 0.03, 95% CI -0.36 to 0.41, p=0.891). There were no significant changes in remaining outcomes. 96/180 (53%) families in the intervention arm attended at least 1 module. The number of modules attended did not affect outcome. Reasons for low uptake included difficulties organizing groups and work and school commitments. Those with highest HbA1cs were less likely to attend. Mean cost of the intervention was £683 per child. CONCLUSIONS: Significant challenges in the delivery of a structured education intervention using psychological techniques to enhance engagement and behavior change delivered by diabetes nurses and dietitians in routine clinical practice were found. The intervention did not improve HbA1c in children and adolescents with poor control. TRIAL REGISTRATION NUMBER: ISRCTN52537669, results.

Timing of the initiation of antenatal care: An exploratory qualitative study of women and service providers in East London.

OBJECTIVE: to explore the factors which influence the timing of the initiation of a package of publically-funded antenatal care for pregnant women living in a diverse urban setting DESIGN: a qualitative study involving thematic analysis of 21 individual interviews and six focus group discussions. SETTING: Newham, a culturally diverse borough in East London, UK PARTICIPANTS: individual interviews were conducted with 21 pregnant and postnatal women and focus group discussions were conducted with a total of 26 health service staff members(midwives and bilingual health advocates) and 32 women from four community groups (Bangladeshi, Somali, Lithuanian and Polish). FINDINGS: initial care-seeking by pregnant women is influenced by the perception that the package of antenatal care offered by the National Health Service is for viable and continuing pregnancies, as well as little perceived urgency in initiating antenatal care. This is particularly true when set against competing responsibilities and commitments in women's lives and for pregnancies with no apparent complications or disconcerting symptoms. Barriers to access to this package of antenatal care include difficulties in navigating the health service and referral system, which are compounded for women unable to speak English, and service provider delays in the processing of referrals. Accessing antenatal care was sometimes equated with relinquishing control, particularly for young women and women for whom language barriers prohibit active engagement with care. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: if women are to be encouraged to seek antenatal care from maternity services early in pregnancy, the purpose and value to all women of doing so need to be made clear across the communities in which they live. As a woman may need time to accept her pregnancy and address other priorities in her life before seeking antenatal care, it is crucial that once she does decide to seek such care, access is quick and easy. Difficulties found in navigating the system of referral for antenatal care point to a need for improved access to primary care and a simple and efficient process of direct referral to antenatal care, alongside the delivery of antenatal care which is woman-centred and experienced as empowering.

Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): a pilot randomised controlled trial.

BACKGROUND: Youth bullying and other aggressive behaviours are a major public health concern owing to their impact on adolescent physical and mental health and well-being. Whole-school restorative approaches have been identified as a promising method of addressing aggressive behaviour but there have been no randomised trials undertaken to examine their effects. AIM: To examine the feasibility and acceptability of implementing and trialling the INCLUSIVE (initiating change locally in bullying and aggression through the school environment) intervention in English secondary schools. DESIGN: Cluster randomised controlled pilot trial in eight schools (1 : 1 computer-generated random allocation post baseline by a statistician blind to the identity of clusters) and process evaluation. SETTING: Secondary schools in England (purposively sampled to ensure diversity). PARTICIPANTS: Year 8 students (aged 12-13 years), teachers, other school staff and intervention providers. INTERVENTION: Whole-school restorative approach to address bullying and aggression, involving the following standard processes: school action group formation and external facilitation to review needs assessment data, identify priorities, and plan and monitor school-level actions; staff training in restorative practices; and a new social and emotional skills curriculum. COMPARISON GROUP: Standard practice. MAIN OUTCOME MEASURES: (1) The primary outcome of interest was the feasibility and acceptability of delivering and trialling the intervention according to prespecified criteria; (2) process data were analysed to explore participants' experiences of implementing and trialling the intervention and how these varied according to school context; and (3) indicative primary outcomes (aggressive behaviour measures), secondary outcomes, intermediate outcomes and economic evaluation methods were piloted. DATA SOURCES: Students (n = 1144 baseline; n = 1114 follow-up) and teachers (n = 387 baseline; n = 336 follow-up) were surveyed at the start and end of the 2011-12 academic year (baseline September 2011; follow-up June-July 2012). A total of 1017 students surveyed at baseline remained in the study at follow-up (89%). Other quantitative data were collected via intervention provider checklists (n = 4) and action group surveys (n = 44); qualitative data were collected via interviews (n = 34), focus groups (n = 20) and observations of action group meetings (n = 16). RESULTS: (1) All prespecified feasibility and acceptability criteria were met. (2) Qualitative data indicated that all intervention components and the trial design were feasible and acceptable to students and staff, including in more disadvantaged school contexts. Qualitative data also suggested that student participation may be a core component in improving relationships and engagement across the school. The later-than-planned project start (July) and the timing of the baseline surveys (September), which needed to be completed pre allocation, caused delays in launching the intervention, staff training and other intervention outputs. (3) Three pilot primary outcomes were examined (completion rate at follow-up range: 91.7-94.2%) and the Gatehouse Bullying Scale and the Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale were acceptable, discriminating and reliable measures of bullying and aggression in this context. Our pilot economic analyses support the use of the Child Health Utility 9D scale with this population and the feasibility of cost-utility analysis, although this should be supplemented with a cost-consequence analysis. There was no evidence of harm. CONCLUSIONS: It is feasible and acceptable to implement and trial the INCLUSIVE intervention in English secondary schools, although a longer lead-in time is required to enable timely intervention outputs to occur. A Phase III cluster randomised controlled trial is required to examine the effectiveness and cost-effectiveness over a 3-year period of implementation for reducing aggressive behaviours, promoting mental health and well-being, and reducing health inequalities. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88527078. FUNDING: The National Institute for Health Research Health Technology Assessment programme (research), the Paul Hamlyn Foundation, the Big Lottery Fund and the Coutts Charitable Trust (intervention). The report will be published in full in Health Technology Assessment; Vol. 19, No. 53. See the NIHR Journals Library website for further project information.

Implementing a structured education program for children with diabetes: lessons learnt from an integrated process evaluation.

BACKGROUND: There is recognition of an urgent need for clinic-based interventions for young people with type 1 diabetes mellitus that improve glycemic control and quality of life. The Child and Adolescent Structured Competencies Approach to Diabetes Education (CASCADE) is a structured educational group program, using psychological techniques, delivered primarily by diabetes nurses. Composed of four modules, it is designed for children with poor diabetic control and their parents. A mixed methods process evaluation, embedded within a cluster randomized control trial, aimed to assess the feasibility, acceptability, fidelity, and perceived impact of CASCADE. METHODS: 28 pediatric diabetes clinics across England participated and 362 children aged 8-16 years, with type 1 diabetes and a mean glycosylated hemoglobin (HbA1c) of 8.5 or above, took part. The process evaluation used a wide range of research methods. RESULTS: Of the 180 families in the intervention group, only 55 (30%) received the full program with 53% attending at least one module. Only 68% of possible groups were run. Staff found organizing the groups burdensome in terms of arranging suitable dates/times and satisfactory group composition. Some staff also reported difficulties in mastering the psychological techniques. Uptake, by families, was influenced by the number of groups run and by school, work and other commitments. Attendees described improved: family relationships; knowledge and understanding; confidence; motivation to manage the disease. The results of the trial showed that the intervention did not significantly improve HbA1c at 12 or 24 months. CONCLUSIONS: Clinic-based structured group education delivered by staff using psychological techniques had perceived benefits for parents and young people. Staff and families considered it a valuable intervention, yet uptake was poor and the burden on staff was high. Recommendations are made to inform issues related to organization, design, and delivery in order to potentially enhance the impact of CASCADE and future programs. CURRENT CONTROLLED TRIALS: ISRCTN52537669.

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

BACKGROUND: Systematic reviews suggest that interventions that address school organisation are effective in reducing victimisation and bullying. We successfully piloted a school environment intervention modified from international studies to incorporate 'restorative justice' approaches. This trial aims to establish the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying in English secondary schools. DESIGN: cluster randomised trial. PARTICIPANTS: 40 state-supported secondary schools. OUTCOMES assessed among the cohort of students in year 8 (n = approximately 6,000) in intervention year 1. INTERVENTION: INCLUSIVE is a school-led intervention which combines changes to the school environment with the promotion of social and emotional skills and restorative practices through: the formation of a school action group involving students and staff supported by an external facilitator to review local data on needs, determine priorities, and develop and implement an action plan for revising relevant school policies/rules and other actions to improve relationships at school and reduce aggression; staff training in restorative practices; and a new social and emotional skills curriculum. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third locally facilitated intervention year.Comparator: normal practice. OUTCOMES: primary: 2 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 will be randomised stratified for single sex versus mixed sex schools, school-level deprivation and measures of school attainment. DISCUSSION: The trial will be run by independent research and intervention teams and supervised by a Trial Steering Committee and a Data Monitoring Committee (DMC). TRIAL REGISTRATION: Current Controlled Trials ISRCTN10751359 (Registered 11 March 2014).

Do family factors protect against sexual risk behaviour and teenage pregnancy among multiply disadvantaged young people? Findings from an English longitudinal study.

UNLABELLED: Background Structure and parenting within family of origin have been found to be determinants of sexual risk and teenage pregnancy in the general youth population. Few studies have examined determinants of sexual risk among disadvantaged young people; those that do have not examined teenage pregnancy outcomes. METHODS: Longitudinal data from a cohort of multiply disadvantaged at-risk young people aged 13-15 years living in deprived neighbourhoods in England (n=1285) were analysed to examine how family structure, communication with parents and parental interest in education were associated with heterosexual debut, contraception use, expectation of teenage pregnancy and teenage pregnancy. RESULTS: At follow-up, young women living with both biological parents were less likely than other young women to become pregnant (odds ratio (OR)=0.21, 95% confidence interval (CI): 0.04-0.97). Young women who could talk to their mothers about private things were less likely to expect to become a teenage parent (OR=0.61, 95% CI: 0.37-0.99). Those whose parents cared very much how they did at school were less likely to report contraception nonuse (OR=0.44, 95% CI: 0.21-0.93). After adjustment, no associations between any family factors and sexual health outcomes were found for young men. CONCLUSIONS: We found limited evidence for family-related effects on sexual health risk or teenage pregnancy among disadvantaged young women in England and no evidence of risk factors within the home environment for young men's outcomes. This suggests that targeted family-based interventions may not be appropriate for addressing these outcomes.

Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study.

BACKGROUND: Type 1 diabetes (T1D) in children and young people is increasing worldwide with a particular increase in children under the age of 5 years. Fewer than one in six children and young people achieve glycosylated fraction of haemoglobin (HbA1c) values in the range identified as providing best future outcomes. There is an urgent need for clinic-based pragmatic, feasible and effective interventions that improve both glycaemic control and quality of life (QoL). The intervention offers both structured education, to ensure young people know what they need to know, and a delivery model designed to motivate self-management. OBJECTIVE: To assess the feasibility of providing a clinic-based structured educational group programme incorporating psychological approaches to improve long-term glycaemic control, QoL and psychosocial functioning in a diverse range of young people. DESIGN: The study was a pragmatic, cluster randomised control trial with integral process and economic evaluation. SETTING: Twenty-eight paediatric diabetes services across London, south-east England and the Midlands. RANDOMISATION: Minimised by clinic size, age (paediatric or adolescent) and specialisation (district general hospital clinic or teaching hospital/tertiary clinic). ALLOCATION: Half of the sites were randomised to the intervention arm and half to the control arm. Allocation was concealed until after clinics had consented and the first participant was recruited. Where possible, families were blind to allocation until recruitment finished. PARTICIPANTS: Forty-three health-care practitioners (14 teams) were trained in the intervention. The study recruited 362 children aged 8-16 years, diagnosed with T1D for > 12 months, with a mean 12-month HbA1c level of ≥ 8.5%. INTERVENTION: Two 1-day workshops taught intervention delivery. A detailed manual and resources were provided. The intervention consists of four group education sessions led by a paediatric diabetes specialist nurse with another team member. OUTCOMES: The primary outcome was glycaemic control, assessed at the individual level using venous HbA1c values, measured at baseline, 12 and 24 months. Secondary outcomes were directly and indirectly related to diabetes management, including hypoglycaemic episodes, hospital admissions, diabetes regimen, knowledge, skills and responsibility for diabetes management, intervention compliance, clinic utilisation, emotional and behavioural adjustment, and general and diabetes-specific QoL. PROCESS EVALUATION: Questionnaires, semistructured interviews, informal discussion following observation sessions, fieldwork notes and case note review were used to collect qualitative and quantitative data from key stakeholder groups at specific time points in the trial. STATISTICAL ANALYSES: Primary and secondary analyses were intention-to-treat comparisons of outcomes at 12 and 24 months, using analysis of covariance with a random effect for clinic. Prespecified subgroup analyses based on age, gender, initial HbA1c value and socioeconomic status were estimated from models that included an interaction term. The economic analysis compared long-term costs and predicted quality-adjusted life-years (QALYs). RESULTS: The intervention did not improve HbA1c at 12 months [intervention effect 0.11; 95% confidence interval (CI) -0.28 to 0.50; p = 0.584] or 24 months (intervention effect 0.03; 95% CI -0.36 to 0.41; p = 0.891). A total of 298/362 patients (82.3%) provided blood samples at 12-month follow-up, and 284/362 (78.5%) provided blood samples at 24-month follow-up. Follow-up questionnaires were completed by 307 patients (85.3%) at 12 months and by 295 patients (81.5%) at 24 months. Intervention group parents at 12 months (95% CI 0.74; 0.03 to 1.52) and young people at 24 months (0.85; 95% CI 0.03 to 1.61) had higher scores on the diabetes family responsibility questionnaire. Young people reported reduced happiness with body weight at 12 months (-0.56; 95% CI -1.03 to -0.06). Only 68% of groups were run. Of the 180 families recruited, 96 (53%) attended at least one module. Reasons for low uptake included difficulties organising groups, and work and school commitments. Young people with higher HbA1c levels were less likely to attend. Parents and young people who attended groups described improved family relationships, improved knowledge and understanding, greater confidence and increased motivation to manage diabetes. Twenty-four months after the intervention, nearly half of the young people reported that the groups had made them want to try harder and that they had carried on trying. A high-quality, complex, pragmatic trial of structured education can be delivered alongside standard care in NHS diabetes clinics. Health-care providers benefited from behaviour change skill training and can deliver pragmatic aspects of a National Institute for Health and Care Excellence (NICE)-compliant structured education programme after relatively brief training. The process evaluation provides insight into aspects of the model, and highlights strengths and aspects that may have contributed to the failure to influence primary and secondary outcomes. Current NHS practice dominates CASCADE (Child and Adolescent Structured Competencies Approach to Diabetes Education) in that it achieves the same number of QALYs at a lower cost. The mean cost of providing the intervention was £5098 per site or £683 per child. Members of paediatric diabetes services trained to deliver the CASCADE structured education package using behaviour change techniques did not improve glycaemic control in patients compared with control subjects 1 and 2 years after the intervention. The training workshops for practitioners were well evaluated; however, more intensive training was needed. The intervention cost £683 per patient but was not cost-effective because it did not improve metabolic control. CONCLUSIONS: A high-quality, complex, pragmatic trial of structured education can be successfully conducted alongside standard care in NHS diabetes clinics. Pragmatic components of a NICE-compliant structured education programme can be successfully delivered following a relatively brief 2-day training while paediatric health-care professionals benefit from training in behaviour change skills. The study provides invaluable information on barriers and opportunities regarding future, similar interventions. A low dropout rate and good attendance for the subgroup that attended the intervention suggests there might be improved uptake if offered to young people with lower HbA1c. Testing whether this approach can be more successful with a robust ongoing supervisory element should be a target of further research. TRIAL REGISTRATION: Current Controlled Trials ISRCTN52537669. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 20. See the NIHR Journals Library website for further project information.

A qualitative study of uptake of free vitamins in England.

OBJECTIVE: To identify reasons why eligible families are not accessing free 'Healthy Start' vitamin supplementation (providing vitamins A, C and D) in England. DESIGN: Qualitative study using in-depth interviews. SETTING: 13 primary care trusts in England. PARTICIPANTS: Purposive sample of 15 Healthy Start coordinators, 50 frontline health and children's professionals and 107 parents. RESULTS: Vitamin take-up was low across all research sites, reported as below 10% of eligible beneficiaries for free vitamins. Reasons identified by both parents and professionals included (1) poor accessibility of vitamins, (2) low promotion of the scheme by health professionals, (3) a lack of awareness among eligible families, and (4) low motivation among mothers to take vitamins for themselves during pregnancy or for children under 4 years old. CONCLUSIONS: Low uptake rates can be explained by poor accessibility of vitamins and lack of awareness and motivation to take vitamin supplements among eligible families. Universal provision (at least for pregnant women) and better training for health professionals are identified as potential solutions worthy of further research and evaluation.

Pilot multimethod trial of a school-ethos intervention to reduce substance use: building hypotheses about upstream pathways to prevention.

PURPOSE: Interventions to improve school ethos can reduce substance use but "upstream" causal pathways relating to implementation and school-level changes are uncertain. We use qualitative and quantitative data from a pilot trial to build hypotheses regarding these. METHODS: The Healthy School Ethos intervention involved two schools being provided with facilitation, training, and funding to plan and implement actions (some mandatory and some locally determined) to improve school ethos over one year. The evaluation involved a pilot-trial with two intervention and two comparison schools; semi-structured interviews with facilitators, staff, and students; and baseline and follow-up surveys with students aged 11 to 12 years. RESULTS: Student accounts linked participation in planning or delivering intervention activities with improved self-regard and relationships with staff and other students. Some activities such as re-writing school rules involved broad participation. Students in receipt of actions such as peer-mediation or motivational sessions reported benefits such as improved safety and relationships. Some student accounts linked improved self-regard and relationships with increased engagement and aspirations, and reduced substance use. At 9-month follow-up, students in intervention schools reported less hurting and teasing of others and feeling unsafe at school. Other outcomes suggested intervention benefits but were not significant. CONCLUSIONS: School-ethos interventions may reduce substance use through upstream pathways involving the aforementioned factors. Future phase-III trials should quantitatively model the extent to which these mediate intervention effects.

Health outcomes of youth development programme in England: prospective matched comparison study.

OBJECTIVE: To evaluate the effectiveness of youth development in reducing teenage pregnancy, substance use, and other outcomes. DESIGN: Prospective matched comparison study. SETTING: 54 youth service sites in England. PARTICIPANTS: Young people (n=2724) aged 13-15 years at baseline deemed by professionals as at risk of teenage pregnancy, substance misuse, or school exclusion or to be vulnerable. INTERVENTION: Intensive, multicomponent youth development programme including sex and drugs education (Young People's Development Programme) versus standard youth provision. MAIN OUTCOME MEASURES: Various, including pregnancy, weekly cannabis use, and monthly drunkenness at 18 months. RESULTS: Young women in the intervention group more commonly reported pregnancy than did those in the comparison group (16% v 6%; adjusted odds ratio 3.55, 95% confidence interval 1.32 to 9.50). Young women in the intervention group also more commonly reported early heterosexual experience (58% v 33%; adjusted odds ratio 2.53, 1.09 to 5.92) and expectation of teenage parenthood (34% v 24%; 1.61, 1.07 to 2.43). CONCLUSIONS: No evidence was found that the intervention was effective in delaying heterosexual experience or reducing pregnancies, drunkenness, or cannabis use. Some results suggested an adverse effect. Although methodological limitations may at least partly explain these findings, any further implementation of such interventions in the UK should be only within randomised trials.