Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial

Background: MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-017-1917-4). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. // Methods: Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. // Discussion: These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design

Young people’s mental health changes, risk and resilience during the Covid-19 pandemic

This is the final version. Available on open access from the American Medical Association via the DOI in this recordData Sharing Statement: Data are available upon reasonable request. The de-identified baseline data and codebook from the MYRIAD trial are available from Prof. Kuyken ([email protected]) upon request (release of data is subject to an approved proposal and a signed data access agreement).Importance As young people’s mental health difficulties increase, understanding risk and resilience factors under challenging circumstances becomes critical. Objective To explore the outcomes of the COVID-19 pandemic on secondary school students’ mental health difficulties, as well as the associations with individual, family, friendship, and school characteristics. Design, Setting, and Participants For this cohort study, follow-up data from the My Resilience in Adolescence (MYRIAD) cluster randomized clinical trial were collected across 2 representative UK cohorts. Mainstream UK secondary schools with a strategy and structure to deliver social-emotional learning, with an appointed head teacher, and that were not rated “inadequate” in their latest official inspection were recruited. A total of 5663 schools were approached, 532 showed interest, and 84 consented. Cohort 1 included 12 schools and 864 students, and cohort 2 included 72 schools and 6386 students. COVID-19 was declared a pandemic after cohort 1 had completed all assessments (September 2018 to January 2020), but cohort 2 had not (September 2019 to June 2021). Exposures Cohort 2 was exposed to the COVID-19 pandemic, including 3 national lockdowns. Associations of individual, family, friendship, and school characteristics with students’ mental health were explored. Main Outcomes and Measures Changes in students’ risk for depression (Center for Epidemiological Studies-Depression scale); social, emotional, and behavioral difficulties (Strengths and Difficulties Questionnaire); and mental well-being (Warwick-Edinburgh Mental Well-Being Scale). Results Of the 7250 participants included, the mean (SD) age was 13.7 (0.6) years, 3947 (55.4%) identified as female, and 5378 (73.1%) self-reported their race as White. Twelve schools and 769 of the 864 students (89.0%) in cohort 1 and 54 schools and 2958 of the 6386 students (46.3%) in cohort 2 provided data and were analyzed. Mental health difficulties increased in both cohorts but to a greater extent among students exposed to the pandemic, including for risk of depression (adjusted mean difference [AMD], 1.91; 95% CI, 1.07-2.76); social, emotional, and behavioral difficulties (AMD, 0.76; 95% CI, 0.33-1.18); and mental well-being (AMD, −2.08; 95% CI, −2.80 to −1.36). Positive school climate, high home connectedness, and having a friend during lockdown were protective factors during the pandemic. Female gender and initial low risk for mental health difficulties were associated with greater mental health deteriorations. Partial school attendance during lockdown was associated with better adjustment than no attendance when returning to school. Conclusions and Relevance This cohort study of secondary school students demonstrated that to promote mental health and adjustment, policy interventions should foster home connectedness, peer friendship, and school climate; avoid full school closures; and consider individual differences.Wellcome TrustNational Institute for Health and Care Research (NIHR)Instituto de Salud Carlos IIIConsortium for Biomedical Research of Epidemiology and Public Healt

Cost-effectiveness of financial incentives to promote adherence to depot antipsychotic medication: economic evaluation of a cluster-randomised controlled trial

Background: Offering a modest financial incentive to people with psychosis can promote adherence to depot antipsychotic medication, but the cost-effectiveness of this approach has not been examined. Methods: Economic evaluation within a pragmatic cluster-randomised controlled trial. 141 patients under the care of 73 teams (clusters) were randomised to intervention or control; 138 patients with diagnoses of schizophrenia, schizo-affective disorder or bipolar disorder participated. Intervention participants received £15 per depot injection over 12 months, additional to usual acute, mental and community primary health services. The control group received usual health services. Main outcome measures: incremental cost per 20% increase in adherence to depot antipsychotic medication; incremental cost of ‘good’ adherence (defined as taking at least 95% of the prescribed number of depot medications over the intervention period). Findings: Economic and outcome data for baseline and 12-month follow-up were available for 117 participants. The adjusted difference in adherence between groups was 12.2% (73.4% control vs. 85.6% intervention); the adjusted costs difference was £598 (95% CI -£4 533, £5 730). The extra cost per patient to increase adherence to depot medications by 20% was £982 (95% CI -£8 020, £14 000). The extra cost per patient of achieving 'good' adherence was £2 950 (CI -£19 400, £27 800). Probability of cost-effectiveness exceeded 97.5%at willingness-to-pay values of £14 000 for a 20% increase in adherence and £27 800 for good adherence. Interpretation: Offering a modest financial incentive to people with psychosis is cost-effective in promoting adherence to depot antipsychotic medication. Direct healthcare costs (including costs of the financial incentive) are unlikely to be increased by this intervention. Trial Registration: ISRCTN.com 7776928

We are ready to sock it to ‘em! The ‘STOPCUTS’ pilot study. It is possible to do a full trial of protective socks for skin tears.

Conference poster presented at Clinical Trials Symposium, RD&E 5/11/15This poster summarises independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit Programme (Grant Reference Number PB-PG-0711-25129). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health

Glue ear, hearing loss and IQ:an association moderated by the child's home environment

BACKGROUND: Glue ear or otitis media with effusion (OME) is common in children and may be associated with hearing loss (HL). For most children it has no long lasting effects on cognitive development but it is unclear whether there are subgroups at higher risk of sequelae. OBJECTIVES: To examine the association between a score comprising the number of times a child had OME and HL (OME/HL score) in the first four/five years of life and IQ at age 4 and 8. To examine whether any association between OME/HL and IQ is moderated by socioeconomic, child or family factors. METHODS: Prospective, longitudinal cohort study: the Avon Longitudinal Study of Parents and Children (ALSPAC). 1155 children tested using tympanometry on up to nine occasions and hearing for speech (word recognition) on up to three occasions between age 8 months and 5 years. An OME/HL score was created and associations with IQ at ages 4 and 8 were examined. Potential moderators included a measure of the child's cognitive stimulation at home (HOME score). RESULTS: For the whole sample at age 4 the group with the highest 10% OME/HL scores had performance IQ 5 points lower [95% CI -9, -1] and verbal IQ 6 points lower [95% CI -10, -3] than the unaffected group. By age 8 the evidence for group differences was weak. There were significant interactions between OME/HL and the HOME score: those with high OME/HL scores and low 18 month HOME scores had lower IQ at age 4 and 8 than those with high OME/HL scores and high HOME scores. Adjusted mean differences ranged from 5 to 8 IQ points at age 4 and 8. CONCLUSIONS: The cognitive development of children from homes with lower levels of cognitive stimulation is susceptible to the effects of glue ear and hearing loss

Cost and disease burden of Dengue in Cambodia

<p>Abstract</p> <p>Background</p> <p>Dengue is endemic in Cambodia (pop. estimates 14.4 million), a country with poor health and economic indicators. Disease burden estimates help decision makers in setting priorities. Using recent estimates of dengue incidence in Cambodia, we estimated the cost of dengue and its burden using disability adjusted life years (DALYs).</p> <p>Methods</p> <p>Recent population-based cohort data were used to calculate direct and productive costs, and DALYs. Health seeking behaviors were taken into account in cost estimates. Specific age group incidence estimates were used in DALYs calculation.</p> <p>Results</p> <p>The mean cost per dengue case varied from US$36 -$75 over 2006-2008 respectively, resulting in an overall annual cost from US$3,327,284 in 2008 to US$14,429,513 during a large epidemic in 2007. Patients sustain the highest share of costs by paying an average of 78% of total costs and 63% of direct medical costs. DALY rates per 100,000 individuals ranged from 24.3 to 100.6 in 2007-2008 with 80% on average due to premature mortality.</p> <p>Conclusion</p> <p>Our analysis confirmed the high societal and individual family burden of dengue. Total costs represented between 0.03 and 0.17% of Gross Domestic Product. Health seeking behavior has a major impact on costs. The more accurate estimate used in this study will better allow decision makers to account for dengue costs particularly among the poor when balancing the benefits of introducing a potentially effective dengue vaccine.</p

Training school teachers to deliver a mindfulness program: exploring scalability, acceptability, effectiveness and cost-effectiveness

This is the final version. Available on open access from SAGE Publications via the DOI in this recordBackground: There is growing research support for the use of mindfulness training (MT) in schools, but almost no high-quality evidence about different training models for people wishing to teach mindfulness in this setting. Effective dissemination of MT relies on the development of scalable training routes. Objective: To compare four training routes for school teachers wishing to deliver MT differing in intensity and potential scalability, considering teaching competency, training acceptability and cost-effectiveness. Methods: Schools were randomised to an existing route comprising an eight-session instructor-led personal mindfulness course, combined with four-day MT program training, or one of three more scalable, lower-intensity, alternatives: an instructor-led personal mindfulness course combined with one-day MT program training; a selftaught personal mindfulness course (delivered through a course book) combined with four-day MT program training and a self-taught personal mindfulness course combined with one-day MT program training. Results: Attrition from training was substantial across all routes. The instructor-led course was more effective than the self-taught course in increasing teachers’ personal mindfulness skills. Even the most intensive (existing) training route brought only 29% of the teachers commencing training, and 56% of those completing the study protocol, to the required minimum competency threshold (an advanced beginner rating on an adapted version of the MBI-TAC). The differences in levels of competency achieved by existing training compared with the more scalable alternatives were modest, with economic evaluation suggesting that the existing route was both more expensive and more effective than lower intensity alternatives, but with no statistically significant differences between routes. Conclusions: This research questions the move towards abbreviating teacher training to increase scalability and suggests instead that many teachers require additional support to ensure competency from first delivery of MT in the classroom.Wellcome Trus

Societal Burden of Clinically Anxious Youth Referred for Treatment: A Cost-of-illness Study

A prevalence-based cost-of-illness study using a societal perspective was conducted to investigate the cost-of-illness in clinically anxious youth aged 8–18 in The Netherlands. Discriminant validity of the cost diary used was obtained by comparing costs of families with an anxious child (n = 118) to costs of families from the general population (n = 41). To examine the convergent validity, bottom-up acquired costs derived from cost diaries were compared to top-down acquired costs obtained from national registrations. Bottom-up acquired costs measured by means of cost diaries amounted to €2,748 per family of a clinically referred anxious child per annum. Societal costs of families with clinically anxious children were almost 21 times as high compared to families from the general population. With respect to convergent validity, total health care costs using the bottom-up approach from clinically anxious children were quite comparable to those of top-down data of anxious children, although costs within the subcategories differed considerably. Clinical anxiety disorders in childhood cost the Dutch society more than 20 million euros a year. Based on results of discriminate and convergent validity, the cost diary seems a valid method in establishing cost-of-illness in childhood anxiety disorders

Revisiting the Yorkshire Ripper Murders: Interrogating Gender Violence, Sex Work, and Justice

Between 1975 and 1980, 13 women, 7 of whom were sex workers, were murdered in the North of England. Aside from the femicide itself, the case was infamous for police failings, misogyny, and victim blaming. The article begins with a discussion of the serial murder of women as a gendered structural phenomenon within the wider context of violence, gender, and arbitrary justice. In support of this, the article revisits the above case to interrogate police reform in England and Wales in the wake of the murders, arguing that despite procedural reform, gendered cultural practices continue to shape justice outcomes for victims of gender violence. In addition, changes to prostitution policy are assessed to highlight how the historical and ongoing Othering and criminalization of street sex workers perpetuates the victimization of this marginalized group of women