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Domiciliary Care Workers (DCWs) are employed in both public and private sectors to support adults at home. The support they provide varies but often includes personal care, which demands close contact between care worker and the person being supported. Since the start of the COVID-19 pandemic, people working across the care sectors in England and Wales have experienced higher rates of death involving COVID-19 infection. Social care workers, in both residential and domiciliary care settings, have been particularly badly affected, with rates of death involving COVID-19 approximately double that for health care workers. We aim to generate rapid high-quality evidence based on the views of care workers and by data formed from linking care workers' registration data to routine electronic heath record (EHR) data. We can use this information to inform public health interventions for safer working practice and additional support for care workers.

Protocol extended files

Domiciliary Care Workers (DCWs) are employed in both public and private sectors to support adults at home. The support they provide varies but often includes personal care, which demands close contact between care worker and the person being supported. Since the start of the COVID-19 pandemic, people working across the care sectors in England and Wales have experienced higher rates of death involving COVID-19 infection. Social care workers, in both residential and domiciliary care settings, have been particularly badly affected, with rates of death involving COVID-19 approximately double that for health care workers. We aim to generate rapid high-quality evidence based on the views of care workers and by data formed from linking care workers' registration data to routine electronic heath record (EHR) data. We can use this information to inform public health interventions for safer working practice and additional support for care workers.

Background Reducing bullying is a public health priority. KiVa, a school-based anti-bullying programme, is effective in reducing bullying in Finland and requires rigorous testing in other countries, including the UK. This trial aims to test the effectiveness and cost-effectiveness of KiVa in reducing child reported bullying in UK schools compared to usual practice. The trial is currently on-going. Recruitment commenced in October 2019, however due to COVID-19 pandemic and resulting school closures was re-started in October 2020. Methods Design: Two-arm pragmatic multicentre cluster randomised controlled trial with an embedded process and cost-effectiveness evaluation. Participants: 116 primary schools from four areas; North Wales, West Midlands, South East and South West England. Outcomes will be assessed at student level (ages 7–11 years; n = approximately 13,000 students). Intervention: KiVa is a whole school programme with universal actions that places a strong emphasis on changing bystander behaviour alongside indicated actions that provide consistent strategies for dealing with incidents of bullying. KiVa will be implemented over one academic year. Comparator: Usual practice. Primary outcome: Student-level bullying-victimisation assessed through self-report using the extensively used and validated Olweus Bully/Victim questionnaire at baseline and 12-month follow-up. Secondary outcomes: student-level bullying-perpetration; student mental health and emotional well-being; student level of, and roles in, bullying; school related well-being; school attendance and academic attainment; and teachers’ self-efficacy in dealing with bullying, mental well-being, and burnout. Sample size: 116 schools (58 per arm) with an assumed ICC of 0.02 will provide 90% power to identify a relative reduction of 22% with a 5% significance level. Randomisation: recruited schools will be randomised on 1:1 basis stratified by Key-Stage 2 size and free school meal status. Process evaluation: assess implementation fidelity, identify influences on KiVa implementation, and examine intervention mechanisms. Economic evaluation: Self-reported victimisation, Child Health Utility 9D, Client Service Receipt Inventory, frequency of services used, and intervention costs. The health economic analysis will be conducted from a schools and societal perspective. Discussion This two-arm pragmatic multicentre cluster randomised controlled trial will evaluate the KiVa anti-bullying intervention to generate evidence of the effectiveness, cost-effectiveness and scalability of the programme in the UK. Our integrated process evaluation will assess implementation fidelity, identify influences on KiVa implementation across England and Wales and examine intervention mechanisms. The integrated health economic analysis will be conducted from a schools and societal perspective. Our trial will also provide evidence regarding the programme impact on inequalities by testing whether KiVa is effective across the socio-economic gradient. Trial registration Trials ISRCTN 12300853 Date assigned 11/02/2020.

Additional file 5. Defining the groups based on LARC use, events related to planning a pregnancy andcontrary events, and conception.

Additional file 1. Supplementary Table S1. Baseline sociodemographic characteristics of BABBLE sample and non-BABBLE sample. Supplementary Table S2. Bivariate analyses of family environment, maternal and child predictors of maternal MLU. Supplementary Table S3. Bivariate analyses of family environment, maternal, and child predictors of children’s MLU.

Additional file 1. Defining LARC events using (a) read codes and (b) BNF prescription codes.

Additional file 3. Assumptions agreed by the Plan-it study team in advance.

Additional file 2. Clinical codes.

BackgroundThe short-term effectiveness (to 24 months post partum) of a preventative home-visiting intervention, the Family Nurse Partnership, was previously assessed in the Building Blocks trial (BB:0–2).ObjectivesThe objectives were to establish the medium-term effectiveness of the Family Nurse Partnership in reducing maltreatment and improving maternal health (second pregnancies) and child health, developmental and educational outcomes (e.g. early educational attendance, school readiness); to explore effect moderators and mediators; and to describe the costs of enhancing usually provided health and social care with the Family Nurse Partnership.DesignChildren and their mothers from an existing trial cohort were followed up using routine data until the child was 7 years of age.SettingThis study was set in 18 partnerships between local authorities and health-care organisations in England.ParticipantsThe participants were mothers [and their firstborn child(ren)] recruited as pregnant women aged ≤ 19 years, in local authority Family Nurse Partnership catchment areas, at InterventionsThe intervention comprised up to a maximum of 64 home visits by specially trained family nurses from early pregnancy until the firstborn child was 2 years of age, plus usually provided health and social care support. The comparator was usual care alone.Main outcome measuresThe primary outcome measure was child-in-need status recorded at any time during follow-up. The secondary outcomes were as follows: (1) referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions at any time during follow-up; (2) early child care and educational attendance, school readiness (Early Years Foundation Stage Profile score) and attainment at Key Stage 1; and (3) health-care costs.Data sourcesThe following data sources were used: maternally reported baseline and follow-up data (BB:0–2), Hospital Episode Statistics data (NHS Digital), social care and educational data (National Pupil Database) and abortions data (Department of Health and Social Care).ResultsThere were no differences between study arms in the rates of referral to social services, being registered as a child in need, receiving child protection plans, entering care or timing of first referral for children subsequently assessed as in need. There were no differences between study arms in rates of hospital emergency attendance, admission for injuries or ingestions, or in duration of stay for admitted children. Children in the Family Nurse Partnership arm were more likely to achieve a good level of development at reception age (school readiness), an effect strengthened when adjusting for birth month. Differences at Key Stage 1 were not statistically different, but, after adjusting for birth month, children in the Family Nurse Partnership arm were more likely to reach the expected standard in reading. Programme effects were greater for boys (Key Stage 1: writing); children of younger mothers (Key Stage 1: writing, Key Stage 1: mathematics); and children of mothers not in employment, education or training at study baseline (Key Stage 1: writing). There were no differences between families who were part of the Family Nurse Partnership and those who were not for any other outcome. The differences between study arms in resource use and costs were negligible.LimitationsThe outcomes are constrained to those available from routine sources.ConclusionsThere is no observable benefit of the programme for maltreatment or maternal outcomes, but it does generate advantages in school readiness and attainment at Key Stage 1.Future workThe trajectory of longer-term programme benefits should be mapped using routine and participant-reported measures.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. 9, No. 2. See the NIHR Journals Library website for further project information.

Additional file 1. SPIRIT Checklist