Rethinking children's right to leisure during school holidays.

Leisure and health are human rights that apply to both children and adults. Leisure can enhance health and enable people to participate fully in leisure activities. One of children's main opportunities for leisure is during school holidays. Little previous research has focused on this time in children's lives. This paper presents a review of the literature surrounding school holidays, providing a critique of educational and public health approaches that focus narrowly on children's future outcomes that may be associated with how they spend their time during these leisure periods. It argues that a more sociological understanding, rooted within child-centred approaches to leisure, provides the opportunity for children's agency, participation and citizenship to be investigated more fully.

The Social and Emotional Education and Development intervention to address wellbeing in primary school age children: the SEED cluster RCT.

Background: Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is little evidence on which programmes are the most effective for improving social and emotional well-being. Objective: The objective was to rigorously evaluate the Social and Emotional Education and Development (SEED) intervention process for improving pupils' social and emotional well-being. Design: This was a stratified cluster randomised controlled trial with embedded process and economic evaluations. Thirty-eight primary schools were randomly assigned to the SEED intervention or to the control group. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in R (statistical package). Setting: The SEED intervention is a whole-school intervention; it involved all school staff and two cohorts of pupils, one starting at 4 or 5 years of age and the second starting at 8 or 9 years of age, across all 38 schools. Participants: A total of 2639 pupils in Scotland. Intervention: The SEED intervention used an iterative process that involved three components to facilitate selection and implementation of school-based actions: (1) questionnaire completion, (2) benchmarked feedback to all staff and (3) reflective discussions (all staff and an educational psychologist). Main outcome measure: The primary outcome was pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score when pupils were 4 years older than at baseline. Results: The primary outcome, pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score at follow-up 3, showed improvements for intervention arm pupils, compared with those in the control arm [relative risk -1.30 (95% confidence interval -1.87 to -0.73), standardised effect size -0.27 (95% confidence interval -0.39 to -0.15)]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. Subgroup analysis showed that all effect sizes were larger for the older cohort, particularly boys [relative risk -2.36 (95% confidence interval -3.62 to -1.11), standardised effect size -0.42 (95% confidence interval -0.64 to -0.20)]. Although there was no statistically significant difference in incremental cost and quality-adjusted life-years, the probability that the intervention is cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year was high, at 88%. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss social and emotional well-being and its contribution to a culture of evaluating practice. Limitations: It was a challenge to retain schools over five waves of data collection. Conclusions: This trial demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older boys and those with greater levels of psychological difficulties. It was beneficial during the transition from primary to secondary school, but this diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other interventions. Future work: Assess whether or not the SEED intervention has a beneficial impact on academic attainment, is transferable to other countries and other organisational settings, would be strengthened by adding core training elements to the intervention process and is transferable to secondary schools. Understand the gender differences illustrated by the outcomes of this trial. Conduct further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration: This trial is registered as ISRCTN51707384. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information.

We studied the Social and Emotional Education and Development (SEED) primary school intervention to see if it could improve the social and emotional well-being of pupils in Scotland. The SEED intervention is a process with several elements. We collected information from school pupils, staff and parents, and assessed if the schools involved were happy, safe and caring environments. We sought to highlight any strengths or weaknesses in how each school approaches social and emotional well-being. The SEED intervention also measures the social and emotional well-being of pupils. This includes pupils' strengths and difficulties, confidence, understanding of emotions and quality of relationships. We gave the information back to each school to help them decide what they can do to improve the social and emotional well-being of their pupils. We gave schools a guide to available resources, reviewed according to how well they are known to work elsewhere. The same social and emotional well-being measurements were repeated every 1 or 2 years, to see if any improvements had been made, and to guide any further adaptions of activities. The study ran in 38 schools over 7 years; half of the schools were randomly selected to receive the SEED intervention and half carried on as normal. Two age groups of pupils were recruited; the younger group was aged 4 or 5 years and the older group was aged 8 or 9 years at the start of the study. We found that the SEED intervention did slightly improve social and emotional well-being. Improvements were greater for older pupils, in particular for boys, and lasted beyond their transition from primary to secondary school. We also found that it was cost-effective for schools to run the SEED intervention. Schools valued the structure and shared ownership associated with the process. We concluded that the SEED intervention is an acceptable way to modestly improve pupil well-being and school ethos.

A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, and topical and oral analgesia (OPPORTUNITY): a two-centre, open-label, randomised controlled feasibility trial.

BACKGROUND: Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the preoperative period. Therefore, we aimed to assess feasibility, acceptability, and recruitment and retention rates of a preoperative package of non-operative care in patients awaiting knee replacement surgery. METHODS: We did an open-label, randomised controlled, feasibility trial in two secondary care centres in the UK. Eligible participants were aged 15-85 years, on the waiting list for a knee arthroplasty for osteoarthritis, and met at least one of the thresholds for one of the four components of the preoperative package of non-operative care intervention (ie, weight loss, exercise therapy, use of insoles, and analgesia adjustment). Participants were randomly assigned (2:1) to either the intervention group or the standard of care (ie, control) group. All four aspects of the intervention were delivered weekly over 12 weeks. Participants in the intervention group were reviewed regularly to assess adherence. The primary outcome was acceptability and feasibility of delivering the intervention, as measured by recruitment rate, retention rate at follow-up review after planned surgery, health-related quality of life, joint-specific scores, and adherence (weight change and qualitative interviews). This study is registered with ISRCTN, ISRCTN96684272. FINDINGS: Between Sept 3 2018, and Aug 30, 2019, we screened 233 patients, of whom 163 (73%) were excluded and 60 (27%) were randomly assigned to either the intervention group (n=40) or the control group (n=20). 34 (57%) of 60 participants were women, 26 (43%) were men, and the mean age was 66·8 years (SD 8·6). Uptake of the specific intervention components varied: 31 (78%) of 40 had exercise therapy, 28 (70%) weight loss, 22 (55%) analgesia adjustment, and insoles (18 [45%]). Overall median adherence was 94% (IQR 79·5-100). At the final review, the intervention group lost a mean of 11·2 kg (SD 5·6) compared with 1·3 kg (3·8) in the control group (estimated difference -9·8 kg [95% CI -13·4 to -6·3]). A clinically significant improvement in health-related quality o life (mean change 0·078 [SD 0·195]) were reported, and joint-specific scores showed greater improvement in the intervention group than in the control group. No adverse events attributable to the intervention occurred. INTERPRETATION: Participants adhered well to the non-operative interventions and their health-related quality of life improved. Participant and health professional feedback were extremely positive. These findings support progression to a full-scale effectiveness trial. FUNDING: Versus Arthritis.

Social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease.

BACKGROUND: Globally, cardiovascular diseases (CVD, that is, coronary heart (CHD) and circulatory diseases combined) contribute to 31% of all deaths, more than any other cause. In line with guidance in the UK and globally, cardiac rehabilitation programmes are widely offered to people with heart disease, and include psychosocial, educational, health behaviour change, and risk management components. Social support and social network interventions have potential to improve outcomes of these programmes, but whether and how these interventions work is poorly understood.  OBJECTIVES: To assess the effectiveness of social network and social support interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease. The comparator was usual care with no element of social support (i.e. secondary prevention alone or with cardiac rehabilitation).  SEARCH METHODS: We undertook a systematic search of the following databases on 9 August 2022: CENTRAL, MEDLINE, Embase, and the Web of Science. We also searched ClinicalTrials.gov and the WHO ICTRP. We reviewed the reference lists of relevant systematic reviews and included primary studies, and we contacted experts to identify additional studies.  SELECTION CRITERIA: We included randomised controlled trials (RCTs) of social network or social support interventions for people with heart disease. We included studies regardless of their duration of follow-up, and included those reported as full text, published as abstract only, and unpublished data. DATA COLLECTION AND ANALYSIS: Using Covidence, two review authors independently screened all identified titles. We retrieved full-text study reports and publications marked 'included', and two review authors independently screened these, and conducted data extraction. Two authors independently assessed risk of bias, and assessed the certainty of the evidence using GRADE. Primary outcomes were all-cause mortality, cardiovascular-related mortality, all-cause hospital admission, cardiovascular-related hospital admission, and health-related quality of life (HRQoL) measured at > 12 months follow-up.  MAIN RESULTS: We included 54 RCTs (126 publications) reporting data for a total of 11,445 people with heart disease. The median follow-up was seven months and median sample size was 96 participants. Of included study participants, 6414 (56%) were male, and the mean age ranged from 48.6 to 76.3 years. Studies included heart failure (41%), mixed cardiac disease (31%), post-myocardial infarction (13%), post-revascularisation (7%), CHD (7%), and cardiac X syndrome (1%) patients. The median intervention duration was 12 weeks. We identified notable diversity in social network and social support interventions, across what was delivered, how, and by whom.  We assessed risk of bias (RoB) in primary outcomes at > 12 months follow-up as either 'low' (2/15 studies), 'some concerns' (11/15), or 'high' (2/15). 'Some concerns' or 'high' RoB resulted from insufficient detail on blinding of outcome assessors, data missingness, and absence of pre-agreed statistical analysis plans. In particular, HRQoL outcomes were at high RoB. Using the GRADE method, we assessed the certainty of evidence as low or very low across outcomes. Social network or social support interventions had no clear effect on all-cause mortality (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.49 to 1.13, I2 = 40%) or cardiovascular-related mortality (RR 0.85, 95% CI 0.66 to 1.10, I2 = 0%) at > 12 months follow-up. The evidence suggests that social network or social support interventions for heart disease may result in little to no difference in all-cause hospital admission (RR 1.03, 95% CI 0.86 to 1.22, I2 = 0%), or cardiovascular-related hospital admission (RR 0.92, 95% CI 0.77 to 1.10, I2 = 16%), with a low level of certainty. The evidence was very uncertain regarding the impact of social network interventions on HRQoL at > 12 months follow-up (SF-36 physical component score: mean difference (MD) 31.53, 95% CI -28.65 to 91.71, I2 = 100%, 2 trials/comparisons, 166 participants; mental component score MD 30.62, 95% CI -33.88 to 95.13, I2 = 100%, 2 trials/comparisons, 166 participants).  Regarding secondary outcomes, there may be a decrease in both systolic and diastolic blood pressure with social network or social support interventions. There was no evidence of impact found on psychological well-being, smoking, cholesterol, myocardial infarction, revascularisation, return to work/education, social isolation or connectedness, patient satisfaction, or adverse events.  Results of meta-regression did not suggest that the intervention effect was related to risk of bias, intervention type, duration, setting, and delivery mode, population type, study location, participant age, or percentage of male participants.  AUTHORS' CONCLUSIONS: We found no strong evidence for the effectiveness of such interventions, although modest effects were identified in relation to blood pressure. While the data presented in this review are indicative of potential for positive effects, the review also highlights the lack of sufficient evidence to conclusively support such interventions for people with heart disease. Further high-quality, well-reported RCTs are required to fully explore the potential of social support interventions in this context. Future reporting of social network and social support interventions for people with heart disease needs to be significantly clearer, and more effectively theorised, in order to ascertain causal pathways and effect on outcomes.

SAFETEL: a pilot randomised controlled trial to assess the feasibility and acceptability of a safety planning and telephone follow-up intervention to reduce suicidal behaviour.

BACKGROUND: A previous suicide attempt is an important predictor of future suicide. However, there are no evidence-based interventions administered in UK general hospital contexts to reduce suicidal behaviour in patients admitted following a suicide attempt. Consequently, the objective of this pilot randomised controlled trial was to explore whether a safety planning and telephone follow-up intervention (SAFETEL) was feasible and acceptable for individuals treated in hospital following a suicide attempt. METHODS: In this three-phase study with an embedded process evaluation, a safety planning intervention was tailored to the UK context (Phase I), piloted (Phase II, n = 32), and tested in a feasibility randomised controlled trial (Phase III). In Phase III, participants were allocated to either the intervention (n = 80) or control group (n = 40) using telephone randomisation with a 2:1 ratio. The acceptability and feasibility of the trial and intervention procedures were evaluated using both qualitative (interviews and focus groups) and quantitative data. The number of hospital representations of suicidal behaviour was also collected 6 months after study recruitment based on electronic patient records. RESULTS: Findings indicated that SAFETEL was both acceptable and feasible. Hospital staff reported the intervention fitted and complemented existing services, and patients reported that they favoured the simplicity and person-centred approach of the safety planning intervention. CONCLUSIONS: All progression criteria were met supporting further evaluation of the intervention in a full-scale clinical effectiveness trial. TRIAL REGISTRATION: ISRCT, ISRCTN62181241 , 5/5/2017.

Effectiveness of social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effectiveness of social network and social support interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease. As a secondary output of this review, and to assist in conceptualising future research focused on social network and social support interventions, we aim to develop a logic model theorising the relationship between social networks or social support and heart disease outcomes. We will draw on existing models of social support for health (e.g. Berkman 2000), as well as established approaches to theorising and implementing behaviour change (e.g. Michie 2011).

SAFETEL randomised controlled feasibility trial of a safety planning intervention with follow-up telephone contact to reduce suicidal behaviour: study protocol.

INTRODUCTION: There are no evidence-based interventions that can be administered in hospital settings following a general hospital admission after a suicide attempt. AIM: To determine whether a safety planning intervention (SPI) with follow-up telephone support (SAFETEL) is feasible and acceptable to patients admitted to UK hospitals following a suicide attempt. METHODS AND ANALYSIS: Three-phase development and feasibility study with embedded process evaluation. Phase I comprises tailoring an SPI with telephone follow-up originally designed for veterans in the USA, for use in the UK. Phase II involves piloting the intervention with patients (n=30) who have been hospitalised following a suicide attempt. Phase III is a feasibility randomised controlled trial of 120 patients who have been hospitalised following a suicide attempt with a 6-month follow-up. Phase III participants will be recruited from across four National Health Service hospitals in Scotland and randomised to receive either the SPI with telephone follow-up and treatment as usual (n=80) or treatment as usual only (n=40). The primary outcomes are feasibility outcomes and include the acceptability of the intervention to participants and intervention staff, the feasibility of delivery in this setting, recruitment, retention and intervention adherence as well as the feasibility of collecting the self-harm re-admission to hospital outcome data. Statistical analyses will include description of recruitment rates, intervention adherence/use, response rates and estimates of the primary outcome event rates, and intervention effect size (Phase III). Thematic analyses will be conducted on interview and focus group data. ETHICS AND DISSEMINATION: The East of Scotland Research Ethics Service (EoSRES) approved this study in March 2017 (GN17MH101 Ref: 17/ES/0036). The study results will be disseminated via peer-reviewed publication and conference presentations. A participant summary paper will also be disseminated to patients, service providers and policy makers alongside the main publication. TRIAL REGISTRATION NUMBER: ISRCTN62181241.