SummaryBackgroundViolence against children from school staff is widespread in various settings, but few interventions address this. We tested whether the Good School Toolkit—a complex behavioural intervention designed by Ugandan not-for-profit organisation Raising Voices—could reduce physical violence from school staff to Ugandan primary school children.MethodsWe randomly selected 42 primary schools (clusters) from 151 schools in Luwero District, Uganda, with more than 40 primary 5 students and no existing governance interventions. All schools agreed to be enrolled. All students in primary 5, 6, and 7 (approximate ages 11–14 years) and all staff members who spoke either English or Luganda and could provide informed consent were eligible for participation in cross-sectional baseline and endline surveys in June–July 2012 and 2014, respectively. We randomly assigned 21 schools to receive the Good School Toolkit and 21 to a waitlisted control group in September, 2012. The intervention was implemented from September, 2012, to April, 2014. Owing to the nature of the intervention, it was not possible to mask assignment. The primary outcome, assessed in 2014, was past week physical violence from school staff, measured by students' self-reports using the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool—Child Institutional. Analyses were by intention to treat, and are adjusted for clustering within schools and for baseline school-level means of continuous outcomes. The trial is registered at clinicaltrials.gov, NCT01678846.FindingsNo schools left the study. At 18-month follow-up, 3820 (92·4%) of 4138 randomly sampled students participated in a cross-sectional survey. Prevalence of past week physical violence was lower in the intervention schools (595/1921, 31·0%) than in the control schools (924/1899, 48·7%; odds ratio 0·40, 95% CI 0·26–0·64, p<0·0001). No adverse events related to the intervention were detected, but 434 children were referred to child protective services because of what they disclosed in the follow-up survey.InterpretationThe Good School Toolkit is an effective intervention to reduce violence against children from school staff in Ugandan primary schools.FundingMRC, DfID, Wellcome Trust, Hewlett Foundation.

Summary Background Almost a quarter of the world's undernourished people live in India. We tested the effects of three nutrition-sensitive agriculture (NSA) interventions on maternal and child nutrition in India. Methods We did a parallel, four-arm, observer-blind, cluster-randomised trial in Keonjhar district, Odisha, India. A cluster was one or more villages with a combined minimum population of 800 residents. The clusters were allocated 1:1:1:1 to a control group or an intervention group of fortnightly women's groups meetings and household visits over 32 months using: NSA videos (AGRI group); NSA and nutrition-specific videos (AGRI-NUT group); or NSA videos and a nutrition-specific participatory learning and action (PLA) cycle meetings and videos (AGRI-NUT+PLA group). Primary outcomes were the proportion of children aged 6–23 months consuming at least four of seven food groups the previous day and mean maternal body-mass index (BMI). Secondary outcomes were proportion of mothers consuming at least five of ten food groups and child wasting (proportion of children with weight-for-height Z score SD <–2). Outcomes were assessed in children and mothers through cross-sectional surveys at baseline and at endline, 36 months later. Analyses were by intention to treat. Participants and intervention facilitators were not blinded to allocation; the research team were. This trial is registered at ISRCTN, ISRCTN65922679. Findings 148 of 162 clusters assessed for eligibility were enrolled and randomly allocated to trial groups (37 clusters per group). Baseline surveys took place from Nov 24, 2016, to Jan 24, 2017; clusters were randomised from December, 2016, to January, 2017; and interventions were implemented from March 20, 2017, to Oct 31, 2019, and endline surveys done from Nov 19, 2019, to Jan 12, 2020, in an average of 32 households per cluster. All clusters were included in the analyses. There was an increase in the proportion of children consuming at least four of seven food groups in the AGRI-NUT (adjusted relative risk [RR] 1·19, 95% CI 1·03 to 1·37, p=0·02) and AGRI-NUT+PLA (1·27, 1·11 to 1·46, p=0·001) groups, but not AGRI (1·06, 0·91 to 1·23, p=0·44), compared with the control group. We found no effects on mean maternal BMI (adjusted mean differences vs control, AGRI −0·05, −0·34 to 0·24; AGRI-NUT 0·04, −0·26 to 0·33; AGRI-NUT+PLA −0·03, −0·3 to 0·23). An increase in the proportion of mothers consuming at least five of ten food groups was seen in the AGRI (adjusted RR 1·21, 1·01 to 1·45) and AGRI-NUT+PLA (1·30, 1·10 to 1·53) groups compared with the control group, but not in AGRI-NUT (1·16, 0·98 to 1·38). We found no effects on child wasting (adjusted RR vs control, AGRI 0·95, 0·73 to 1·24; AGRI-NUT 0·96, 0·72 to 1·29; AGRI-NUT+PLA 0·96, 0·73 to 1·26). Interpretation Women's groups using combinations of NSA videos, nutrition-specific videos, and...

Background Bullying, aggression and violence among children and young people are some of the most consequential public mental health problems. Objectives The 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. Design INCLUSIVE was a cluster randomised trial with integral economic and process evaluations. Setting Forty 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). Participants A 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. Intervention Schools 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 measures Self-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. Results Primary 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. Limitations Our 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. Conclusions Learning Together is effective across a very broad range of key public health targets for adolescents. Future work Further studies are required to assess refined versions of this intervention in other settings. Trial registration Current Controlled Trials ISRCTN10751359. 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. 18. See the NIHR Journals Library website for further project information. Additional funding was provided by the Educational Endowment Foundation.

IntroductionImproving complementary feeding in Ethiopia requires special focus on dietary diversity. The Sustainable Undernutrition Reduction in Ethiopia (SURE) programme is a government-led multisectoral intervention that aims to integrate the work of the health and agriculture sectors to deliver a complex multicomponent intervention to improve child feeding and reduce stunting. The Federal Ministries of Health and Agriculture and Natural Resources implement the intervention. The evaluation aims to assess a range of processes, outcomes and impacts.Methods and analysisThe SURE evaluation study is a theory-based, mixed methods study comprising impact and process evaluations. We hypothesise that the package of SURE interventions, including integrated health and agriculture behaviour change communication for nutrition, systems strengthening and multisectoral coordination, will result in detectable differences in minimum acceptable diet in children 6–23 months and stunting in children 24–47 months between intervention and comparison groups. Repeated cross-sectional household surveys will be conducted at baseline and endline to assess impact. The process will be assessed using observations, key informant interviews and focus group discussions to investigate the fidelity and dose of programme implementation, behavioural pathways of impact and contextual factors interacting with the intervention. Pathways of impact will also be explored through statistical analyses.Ethics and disseminationThe study has received ethics approval from the scientific and ethical review committees at the Ethiopian Public Health Institute and the London School of Hygiene and Tropical Medicine. The findings will be disseminated collaboratively with stakeholders at specified time points and through peer-reviewed publications and presentations.

BackgroundChild maltreatment is a significant public health problem. Group Family Nurse Partnership (gFNP) is a new intervention for young, expectant mothers implemented successfully in pilot studies. This study was designed to determine the effectiveness and cost-effectiveness of gFNP in reducing risk factors for maltreatment with a potentially vulnerable population.MethodsA multi-site, randomized controlled, parallel-arm trial and prospective economic evaluation was conducted, with allocation via remote randomization (minimization by site, maternal age group) to gFNP or usual care. Participants were expectant mothers aged below 20 years with at least one live birth, or aged 20–24 years with no live births and with low educational qualifications. Data from maternal interviews at baseline and when infants were 2, 6 and 12 months, and video-recording at 12 months, were collected by researchers blind to allocation. Cost information came from weekly logs completed by gFNP family nurses and other service delivery data reported by participants. Primary outcomes measured at 12 months were parenting attitudes (Adult-Adolescent Parenting Index, AAPI-2) and maternal sensitivity (CARE Index). The economic evaluation was conducted from a UK NHS and personal social services perspective with cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The main analyses were intention-to-treat with additional complier average causal effects (CACE) analyses.ResultsBetween August 2013 and September 2014, 492 names of potential participants were received of whom 319 were eligible and 166 agreed to take part, 99 randomly assigned to receive gFNP and 67 to usual care. There were no between-arm differences in AAPI-2 total (7 · 5/10 in both, SE 0.1), difference adjusted for baseline, site and maternal age group 0 · 06 (95% CI − 0 · 15 to 0 · 28, p = 0 · 59) or CARE Index (intervention 4 · 0 (SE 0 · 3); control 4 · 7 (SE 0 · 4); difference adjusted for site and maternal age group − 0 · 68 (95% CI − 1 · 62 to 0 · 16, p = 0 · 25) scores. The probability that gFNP is cost-effective based on the QALY measure did not exceed 3%.ConclusionsThe trial did not support gFNP as a means of reducing the risk of child maltreatment in this population but slow recruitment adversely affected group size and consequently delivery of the intervention.Trial registration ISRCTN78814904. Registered on 17 May 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2259-y) contains supplementary material, which is available to authorized users.

BackgroundWe have previously reported benefits for reduced bullying, smoking, alcohol and other drug use and mental health from a trial of ‘Learning Together’, an intervention that aimed to modify school environments and implement restorative practice and a social and emotional skill curriculum.ObjectivesTo conduct post hoc theory-driven analyses of broader impacts.DesignCluster randomised trial.Settings40 state secondary schools in southern England.ParticipantsStudents aged 11/12 years at baseline.OutcomesStudent self-reported measures at 24 and 36 months of: cyberbullying victimisation and perpetration; observations of other students perpetrating aggressive behaviours at school; own perpetration of aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use.ResultsWe found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.ConclusionThese analyses suggested that the intervention was effective in bringing about a broader range of beneficial outcomes, adding to the evidence that the intervention is a promising approach to promote adolescent health via an intervention that is attractive to schools.Trial registration numberISRCTN10751359.

BackgroundMicronutrient deficiencies including selenium (Se) are widespread in Malawi and potentially underlie a substantial disease burden, particularly among poorer and marginalised populations. Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers – a process known as agronomic biofortification (agro-biofortification) – and this may contribute to alleviating deficiencies. The Addressing Hidden Hunger with Agronomy (AHHA) trial aims to establish the efficacy of this approach for improving Se status in rural Malawi.MethodsA double-blind, randomised, controlled trial will be conducted in a rural community in Kasungu District, Central Region, Malawi. The hypothesis is that consumption of maize flour agro-biofortified with Se will increase serum Se concentration. We will recruit 180 women of reproductive age (WRA) (20–45 years) and 180 school-age children (SAC) (5–10 years) randomly assigned in a 1:1 ratio to receive either maize flour enriched through agro-biofortification with Se or a control flour not enriched with Se. Households will receive flour (330 g per capita per day) for 12 weeks. The primary outcome is Se concentration in serum (μg/L). Serum will be extracted from venous blood samples drawn at baseline (prior to flour distribution) and end-line. Selenium concentration will be measured by using inductively coupled plasma mass spectrometry.DiscussionFindings will be communicated to policy stakeholders and participating communities and reported in peer-reviewed journals.Trial registrationThe Addressing Hidden Hunger with Agronomy (Malawi) trial is registered (5th March 2019; ISCRTN85899451).

BackgroundThe Good School Toolkit, a complex behavioural intervention designed by Raising Voices a Ugandan NGO, reduced past week physical violence from school staff to primary students by an average of 42% in a recent randomised controlled trial. This process evaluation quantitatively examines what was implemented across the twenty-one intervention schools, variations in school prevalence of violence after the intervention, factors that influence exposure to the intervention and factors associated with students’ experience of physical violence from staff at study endline.MethodsImplementation measures were captured prospectively in the twenty-one intervention schools over four school terms from 2012 to 2014 and Toolkit exposure captured in the student (n = 1921) and staff (n = 286) endline cross-sectional surveys in 2014. Implementation measures and the prevalence of violence are summarised across schools and are assessed for correlation using Spearman’s Rank Correlation Coefficient. Regression models are used to explore individual factors associated with Toolkit exposure and with physical violence at endline.ResultsSchool prevalence of past week physical violence from staff against students ranged from 7% to 65% across schools at endline. Schools with higher mean levels of teacher Toolkit exposure had larger decreases in violence during the study. Students in schools categorised as implementing a ‘low’ number of program school-led activities reported less exposure to the Toolkit. Higher student Toolkit exposure was associated with decreased odds of experiencing physical violence from staff (OR: 0.76, 95%CI: 0.67-0.86, p-value< 0.001). Girls, students reporting poorer mental health and students in a lower grade were less exposed to the toolkit. After the intervention, and when adjusting for individual Toolkit exposure, some students remained at increased risk of experiencing violence from staff, including, girls, students reporting poorer mental health, students who experienced other violence and those reporting difficulty with self-care.ConclusionsOur results suggest that increasing students and teachers exposure to the Good School Toolkit within schools has the potential to bring about further reductions in violence. Effectiveness of the Toolkit may be increased by further targeting and supporting teachers’ engagement with girls and students with mental health difficulties.Trial registrationThe trial is registered at clinicaltrials.gov, NCT01678846, August 24th 2012.Electronic supplementary materialThe online version of this article (10.1186/s12889-018-5462-1) contains supplementary material, which is available to authorized users.