Danielle Collingridge Moore

Weighted blankets and sleep in autistic children: a randomized controlled trial

OBJECTIVE: To assess the effectiveness of a weighted-blanket intervention in treating severe sleep problems in children with autism spectrum disorder (ASD). METHODS: This phase III trial was a randomized, placebo-controlled crossover design. Participants were aged between 5 years and 16 years 10 months, with a confirmed ASD diagnosis and severe sleep problems, refractory to community-based interventions. The interventions were either a commercially available weighted blanket or otherwise identical usual weight blanket (control), introduced at bedtime; each was used for a 2-week period before crossover to the other blanket. Primary outcome was total sleep time (TST) recorded by actigraphy over each 2-week period. Secondary outcomes included actigraphically recorded sleep-onset latency, sleep efficiency, assessments of child behavior, family functioning, and adverse events. Sleep was also measured by using parent-report diaries. RESULTS: Seventy-three children were randomized and analysis conducted on 67 children who completed the study. Using objective measures, the weighted blanket, compared with the control blanket, did not increase TST as measured by actigraphy and adjusted for baseline TST. There were no group differences in any other objective or subjective measure of sleep, including behavioral outcomes. On subjective preference measures, parents and children favored the weighted blanket. CONCLUSIONS: The use of a weighted blanket did not help children with ASD sleep for a longer period of time, fall asleep significantly faster, or wake less often. However, the weighted blanket was favored by children and parents, and blankets were well tolerated over this period.

Out of sight, out of mind? A review of data available on the health of care home residents in longitudinal and nationally representative cross-sectional studies in the UK and Ireland

BACKGROUND care home residents are aged, many have multiple co-morbidities and low levels of functioning. Yet, the UK has no routinely available, national data on health in care homes. The aim of this study is to identify longitudinal or nationally representative cross-sectional sources of information on the health and wellbeing of older adults residing in care homes in the UK and Ireland. METHODS searches were made of health databases (Medline, Embase), websites of the Economic and Social Data Service and UK Office for National Statistics, and selected journals. On-going longitudinal or repeated cross-sectional studies were sought in the UK and Ireland, that included participants aged over 65 and reported one or more health-related variables. Data were extracted on studies that included older adults in care homes. If necessary, study teams were contacted for information. RESULTS we identified 42 longitudinal cohort or repeated cross-sectional studies in the UK that involved older adults. Of these, 17 studies provided data from care home residents. The time period of data collection ranged from 2 to 40 years. Proxy interviews were used to capture the majority of data in care homes. CONCLUSION in the UK and Ireland, most longitudinal and nationally representative cross-sectional studies do not include or follow-up older adults in care homes. Systematic data collection on the health of older adults in care homes should be a priority, to inform policy development and enable monitoring of care delivery and health outcomes.

Social Stories™ to alleviate challenging behaviour and social difficulties exhibited by children with autism spectrum disorder in mainstream schools: design of a manualised training toolkit and feasibility study for a cluster randomised controlled trial with nested qualitative and cost-effectiveness components.

BACKGROUND A Social Story™ (Carol Gray) is a child-friendly intervention that is used to give children with autism spectrum disorders (ASDs) social information in situations where they have social difficulties. Limited evidence mainly using single-case designs suggests that they can reduce anxiety and challenging behaviour. OBJECTIVES The objectives were to conduct a systematic review, use this to develop a manualised intervention and run a feasibility trial to inform a fully powered randomised controlled trial (RCT) on their clinical effectiveness and cost-effectiveness in schools. DESIGN This is a three-stage study following the Medical Research Council framework for complex interventions. Specifically, it involved a theoretical phase, a qualitative stage and a feasibility trial stage. SETTING Qualitative interviews and focus groups took place in Child and Adolescent Mental Health Service and primary care settings. The feasibility study took place in 37 local mainstream schools. PARTICIPANTS Fifty children (aged 5-15 years) in mainstream school settings with a diagnosis of ASD were entered into the trial. For each child, an associated teacher and parent was also recruited. INTERVENTIONS The intervention was a goal-setting session followed by a manualised toolkit (including a training session) for creating Social Stories™ for use with school-aged children. The comparator treatment was a goal-setting session followed by an attention control. Both arms received treatment as usual. MAIN OUTCOME MEASURES Outcomes tested as part of the feasibility study included child- and proxy-completed questionnaires for mental health, quality of life and goal-based outcome measures. Adults additionally completed behaviour diaries and the parental stress index. RESULTS The review found that the research into social stories is predominantly based in the USA, carried out in under-12-year-olds and using single-case designs. Most studies either did not follow established Social Story criteria or did not report if they did. The assessment of effectiveness presents a largely positive picture but is limited by methodological issues. There were no adequate RCTs and insufficient information to assess a number of important sources of potential bias in most studies. A manualised intervention was produced using an iterative process between user focus groups and a writing team, and assessed in the feasibility study. All 50 participant groups were recruited within the study time frame. Two outcome measures, the Social Responsiveness Scale-2 and the custom-made goal-based measure, showed high levels of completion rates and appeared to be capturing social and behaviour skills targeted by the use of Social Stories. Detailed recommendations for a full trial are provided. LIMITATIONS Blinding of participants was not feasible. Treatment fidelity was not assessed because of low levels of story return rates. CONCLUSIONS The study showed that a fully powered RCT is feasible with an extended geographical footprint. A large amount of data and information has helped to inform the design of this RCT, which will be the subject of a future research grant application. Future work could focus on developing an appropriate blinded outcome measure for this population. STUDY REGISTRATION This study is registered as PROSPERO CRD42011001440. TRIAL REGISTRATION Current Controlled Trials ISRCTN96286707. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.

Social Stories in mainstream schools for children with autism spectrum disorder: a feasibility randomised controlled trial

Objectives To assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial. Design A single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control. Setting 37 primary schools in York, UK. Participants 50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27). Outcome measures Acceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial. Results An assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups. Conclusions Results suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools. Trial registration number ISRCTN96286707; Results.

Autism Spectrum Social Stories In Schools Trial (ASSSIST): study protocol for a feasibility randomised controlled trial analysing clinical and cost-effectiveness of Social Stories in mainstream schools

Introduction Current evidence suggests that Social Stories can be effective in tackling problem behaviours exhibited by children with autism spectrum disorder. Exploring the meaning of behaviour from a childs perspective allows stories to provide social information that is tailored to their needs. Case reports in children with autism have suggested that these stories can lead to a number of benefits including improvements in social interactions and choice making in educational settings. Methods and analysis The feasibility of clinical and cost-effectiveness of a Social Stories toolkit will be assessed using a randomised control framework. Participants (n=50) will be randomised to either the Social Stories intervention or a comparator group where they will be read standard stories for an equivalent amount of time. Statistics will be calculated for recruitment rates, follow-up rates and attrition. Economic analysis will determine appropriate measures of generic health and resource use categories for cost-effectiveness analysis. Qualitative analysis will ascertain information on perceptions about the feasibility and acceptability of the intervention. Ethics and dissemination National Health Service Ethics Approval (NHS; ref 11/YH/0340) for the trial protocol has been obtained along with NHS Research and Development permission from Leeds and York Partnership NHS Foundation Trust. All adverse events will be closely monitored, documented and reported to the study Data Monitoring Ethics Committee. At least one article in a peer reviewed journal will be published and research findings presented at relevant conferences. Trial registration number ISRCTN96286707.

Older Adults’ Social Relationships and Health Care Utilization: A Systematic Review

Background Deficiencies in older people’s social relationships (including loneliness, social isolation, and low social support) have been implicated as a cause of premature mortality and increased morbidity. Whether they affect service use is unclear. Objectives To determine whether social relationships are associated with older adults’ use of health services, independently of health-related needs. Search Methods We searched 8 electronic databases (MEDLINE, Embase, CINAHL, Web of Science, PsycINFO, Scopus, the Cochrane Library, and the Centre for Reviews and Dissemination) for data published between 1983 and 2016. We also identified relevant sources from scanning the reference lists of included studies and review articles, contacting authors to identify additional studies, and searching the tables of contents of key journals. Selection Criteria Studies met inclusion criteria if more than 50% of participants were older than 60 years or mean age was older than 60 years; they included a measure of social networks, received social support, or perceived support; and they reported quantitative data on the association between social relationships and older adults’ health service utilization. Data Collection and Analysis Two researchers independently screened studies for inclusion. They extracted data and appraised study quality by using standardized forms. In a narrative synthesis, we grouped the studies according to the outcome of interest (physician visits, hospital admissions, hospital readmissions, emergency department use, hospital length of stay, utilization of home- and community-based services, contact with general health services, and mental health service use) and the domain of social relationships covered (social networks, received social support, or perceived support). For each service type and social relationship domain, we assessed the strength of the evidence across studies according to the quantity and quality of studies and consistency of findings. Main Results The literature search retrieved 26 077 citations, 126 of which met inclusion criteria. Data were reported across 226 678 participants from 19 countries. We identified strong evidence of an association between weaker social relationships and increased rates of readmission to hospital (75% of high-quality studies reported evidence of an association in the same direction). In evidence of moderate strength, according to 2 high-quality and 3 medium-quality studies, smaller social networks were associated with longer hospital stays. When we considered received and perceived social support separately, they were not linked to health care use. Overall, the evidence did not indicate that older patients with weaker social relationships place greater demands on ambulatory care (including physician visits and community- or home-based services) than warranted by their needs. Authors’ Conclusions Current evidence does not support the view that, independently of health status, older patients with lower levels of social support place greater demands on ambulatory care. Future research on social relationships would benefit from a consensus on clinically relevant concepts to measure. Public Health Implications Our findings are important for public health because they challenge the notion that lonely older adults are a burden on all health and social care services. In high-income countries, interventions aimed at reducing social isolation and loneliness are promoted as a means of preventing inappropriate service use. Our review cautions against assuming that reductions in care utilization can be achieved by intervening to strengthen social relationships.