Choosing and using methodological search filters : searchers' views

© 2014 The authors. Health Information and Libraries Journal © 2014 Health Libraries Group.Peer reviewedPostprin

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

Workplace Stress, Presenteeism, Absenteeism, and Resilience Amongst University Staff and Students in the COVID-19 Lockdown

Background: This study explored how the COVID-19 outbreak and arrangements such as remote working and furlough affect work or study stress levels and functioning in staff and students at the University of York, UK. Methods: An invitation to participate in an online survey was sent to all University of York staff and students in May-June 2020. We measured stress levels [VAS-scale, Perceived Stress Questionnaire (PSQ)], mental health [anxiety (GAD-7), depression (PHQ-9)], physical health (PHQ-15, chronic medical conditions checklist), presenteeism, and absenteeism levels (iPCQ). We explored demographic and other characteristics as factors which may contribute to resilience and vulnerability for the impact of COVID-19 on stress. Results: One thousand and fifty five staff and nine hundred and twenty five students completed the survey. Ninety-eight per cent of staff and seventy-eight per cent of students worked or studied remotely. 7% of staff and 10% of students reported sickness absence. 26% of staff and 40% of the students experienced presenteeism. 22-24% of staff reported clinical-level anxiety and depression scores, and 37.2 and 46.5% of students. Staff experienced high stress levels due to COVID-19 (66.2%, labeled vulnerable) and 33.8% experienced low stress levels (labeled resilient). Students were 71.7% resilient vs. 28.3% non-resilient. Predictors of vulnerability in staff were having children [OR = 2.23; CI (95) = 1.63-3.04] and social isolation [OR = 1.97; CI (95) = 1.39-2.79] and in students, being female [OR = 1.62; CI (95) = 1.14-2.28], having children [OR = 2.04; CI (95) = 1.11-3.72], and social isolation [OR = 1.78; CI (95) = 1.25-2.52]. Resilience was predicted by exercise in staff [OR = 0.83; CI (95) = 0.73-0.94] and in students [OR = 0.85; CI (95) = 0.75-0.97]. Discussion: University staff and students reported high psychological distress, presenteeism and absenteeism. However, 33.8% of staff and 71.7% of the students were resilient. Amongst others, female gender, having children, and having to self-isolate contributed to vulnerability. Exercise contributed to resilience. Conclusion: Resilience occurred much more often in students than in staff, although psychological distress was much higher in students. This suggests that predictors of resilience may differ from psychological distress per se. Hence, interventions to improve resilience should not only address psychological distress but may also address other factors

Assessment of Cytokines, microRNA and patient related outcome measures in Conversion Disorder/Functional Neurological Disorder (CD/FND) : the CANDO clinical feasibility study

Background: Conversion disorder/functional neurological disorder (CD/FND) occurs often in neurological settings and can lead to long-term distress, disability and demand on health care services. Systemic low-grade inflammation might play a role, however, the pathogenic mechanism is still unknown. Aim: 1) To explore the feasibility to establish and assess a cohort of CD/FND with motor symptoms, involving persons with lived experience (PPI). 2) To generate proof of concept regarding a possible role for cytokines, microRNA, cortisol levels and neurocognitive symptoms in patients with motor CD/FND. Method: Feasibility study. Results: The study showed active involvement of patients despite high clinical illness burden and disability, neurocognitive symptoms, childhood adverse experiences (ACE) and current life events. The study provided valuable knowledge regarding the feasibility of conducting a study in these patients that will inform future study phases. In the sample there were elevated levels of IL6, IL12, IL17A, IFNg, TNFa and VEGF-a, suggesting systemic low-grade inflammation. Also, microRNAs involved in inflammation and vascular inflammation were correlated with TNFa and VEGFa respectively, suggesting proof of concept for an epigenetic mechanism. Owing to the COVID-19 outbreak, the patient sample was limited to 15 patients. Conclusion: It is a novelty that this study is conducted in the clinical setting. This innovative, translational study explores stress-related SLI in CD/FND patients and the feasibility of a larger project aiming to develop new treatments for this vulnerable population. Given the positive findings, there is scope to conduct further research into the mechanism of disease in CD/FND

Identifying the top research priorities in medically not yet explained symptoms (MNYES) : a James Lind Alliance priority setting partnership

OBJECTIVES: This study establishes research priorities for medically not yet explained symptoms (MNYES), also known as persistent physical symptoms or medically unexplained symptoms, from the perspective of patients, caregivers and clinicians, in a priority setting partnership (PSP) following the James Lind Alliance (JLA) approach. Research into such symptoms in general has been poorly funded over the years and so far has been primarily researcher-led with minimal input from patients, caregivers and clinicians; and sometimes has been controversial. DESIGN: JLA PSP method. The PSP termed these symptoms MNYES. METHODS: The study was conducted according to the JLA’s detailed methodology for conducting priority setting exercises. It involved five key stages: defining the appropriate term for the conditions under study by the PSP Steering Group; gathering questions on MNYES from patients, caregivers and clinicians in a publicly accessible survey; checking these research questions against existing evidence; interim prioritisation in a second survey; and a final multi-stakeholder consensus meeting to determine the top 10 unanswered research questions using the modified nominal group methodology. RESULTS: Over 700 responses from UK patients, caregivers and clinicians were identified in the two surveys and charities contributed from a broad range of medical specialties and primary care. The final top 10 unanswered research questions cover, among others: treatment strategies, personalisation of treatment, collaborative care pathways, training for clinicians and outcomes that matter to patients. INTERPRETATION: The top 10 unanswered research questions are expected to generate much needed, relevant and impactful research into MNYES

Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments (I-SOCIALISE) : study protocol

INTRODUCTION: Social skills training interventions for children with autism spectrum disorder (ASD) typically focus on a skills deficit model rather than building on existing skills or encouraging the child to seek their own solutions. LEGO-based therapy is a child-oriented intervention to help improve social interactional skills and reduce isolation. The therapy is designed for school-age children with ASD and uses group-based play in a school setting to encourage peer relationships and social learning. Despite the reported potential benefits of LEGO-based therapy in a prior randomised controlled trial (RCT) and its adoption by many schools, the evidence to support its effectiveness on the social and emotional well-being of children with ASD is limited and includes no assessment of cost-effectiveness. METHODS AND ANALYSIS: This multicentre, pragmatic, cluster RCT will randomise 240 participants (aged 7-15 years) with a clinical diagnosis of ASD to receive usual care or LEGO-based therapy with usual care. Cluster randomisation will be conducted on a school level, randomising each school as opposed to each individual child within a school. All prospective participants will be screened for eligibility before assenting to the study (with parents giving informed consent on behalf of their child). All participants will be followed up at 20 and 52 weeks after randomisation to assess for social, emotional and behavioural changes. The primary outcome measure is the social skills subscale of the Social Skills Improvement System completed by a teacher or teaching assistant associated with participating children at the 20-week follow-up time point. ETHICS AND DISSEMINATION: Ethics approval has been obtained via the University of York Research Ethics Committee. The results of the trial will be submitted for publication in a peer-reviewed journal and will be disseminated to participating families, education practitioners and the third sector including voluntary and community organisations. TRIAL REGISTRATION NUMBER: ISRCTN64852382; Pre-results

Play brick therapy to aid the social skills of children and young people with autism spectrum disorder : the I-SOCIALISE cluster RCT

BACKGROUND: Social skills interventions are commonly recommended to help children and young people with autism spectrum disorder develop social skills, but some struggle to engage in these interventions. LEGO ® (LEGO System A/S, Billund, Denmark) based therapy, a group social skills intervention, aims to be more interesting and engaging. OBJECTIVE: To evaluate the clinical effectiveness of LEGO ® based therapy on the social and emotional skills of children and young people with autism spectrum disorder in school settings compared with usual support. Secondary objectives included evaluations of cost-effectiveness, acceptability and treatment fidelity. DESIGN: A cluster randomised controlled trial randomly allocating participating schools to either LEGO ® based therapy and usual support or usual support only. SETTING: Mainstream schools in the north of England. PARTICIPANTS: Children and young people (aged 7-15 years) with autism spectrum disorder, their parent/guardian, an associated teacher/teaching assistant and a facilitator teacher/teaching assistant (intervention schools only). INTERVENTION: Schools randomised to the intervention arm delivered 12 weekly sessions of LEGO ® based therapy, which promotes collaborative play and encourages social problem-solving in groups of three children and young people with a facilitator (trained teacher or teaching assistant). Participants received usual support from school and community services. Participants in the control arm received usual support only. Research assistants and statisticians were blind to treatment allocation. MAIN OUTCOME MEASURE: The social skills subscale of the Social Skills Improvement System (SSIS), completed by the children and young people's unblinded teacher pre randomisation and 20 weeks post randomisation. The SSIS social skills subscale measures social skills including social communication, co-operation, empathy, assertion, responsibility and self-control. Participants completed a number of other pre- and post-randomisation measures of emotional health, quality of life, loneliness, problem behaviours, academic competence, service resource utilisation and adverse events. RESULTS: A total of 250 children and young people from 98 schools were randomised: 127 to the intervention arm and 123 to the control arm. Intention-to-treat analysis of the main outcome measure showed a modest positive difference of 3.74 points (95% confidence interval -0.16 to 7.63 points, standardised effect size 0.18; p  = 0.06) in favour of the intervention arm. Statistical significance increased in per-protocol analysis, with a modest positive difference (standardised effect size 0.21; p  = 0.036). Cost-effectiveness of the intervention was found in reduced service use costs and a small increase in quality-adjusted life-years. Intervention fidelity and acceptability were positive. No intervention-related adverse events or effects were reported. CONCLUSIONS: The primary and pre-planned sensitivity analysis of the primary outcome consistently showed a positive clinical difference, with modest standardised effect sizes of between 0.15 and 0.21. There were positive health economics and qualitative findings, corroborated by the difference between arms for the majority of secondary outcomes, which were not statistically significant but favoured the intervention arm. Post hoc additional analysis was exploratory and was not used in drawing this conclusion. Given the small positive change, LEGO ® based therapy for children and young people with autism spectrum disorder in schools should be considered. LIMITATIONS: The primary outcome measure was completed by an unblinded teacher (rather than by the facilitator). FUTURE WORK: The study team recommends future research into LEGO ® based therapy, particularly in school environments. TRIAL REGISTRATION: This trial is registered as ISRCTN64852382. FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 15/49/32) and is published in full in Public Health Research; Vol. 11, No. 12. See the NIHR Funding and Awards website for further award information