BackgroundAutistic children can experience mental health, social and emotional difficulties. Carol Gray's Social Stories (TM) are a highly personalised intervention that provide social information in a short individually tailored story.MethodsA multi-site pragmatic cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of Social Stories (TM) alongside care as usual in autistic children aged 4-11 years. The primary outcome was the Social Responsiveness Scale-2 completed by teachers 6 months post-randomisation, analysed on an intention-to-treat basis. Trial Registration: ISRCTN11634810.ResultsEighty-seven schools, including 249 children, were randomised (intervention 44 schools with 129 children, and usual care 43 schools with 120 children). After 6 months, a reduction of 1.61 points was found on the Social Responsiveness Scale-2 in the intervention group (95% CI -4.18 to 0.96, p = .220) and for those who attended at least six sessions a reduction of 3.37 points (CACE 95% CI -6.65 to -0.10, p = .043). Children in the intervention group met their individual socio-emotional goal more frequently than children receiving usual care alone and this was statistically significant. No statistically significant differences were found in other secondary outcomes including anxiety, depression, general health or parental stress.ConclusionsSocial Stories (TM) represent a low-cost, low-burden intervention. Benefits are seen in individual socio-emotional goals but without clinically evident impact on social responsiveness, anxiety, depression, parental stress or general health.
Background Differences in the way autistic children experience the world can contribute to anxiety and stress. Carol Gray’s Social Stories™ are a highly personalised intervention to support children by providing social information about specific situations in an individual story. Objectives This randomised controlled trial aimed to establish whether Social Stories are clinically effective and cost-effective in improving social responsiveness and social and emotional health in children on the autism spectrum in schools. Design A multisite pragmatic cluster randomised controlled trial comparing Social Stories with care as usual. Setting Eighty-seven schools (clusters) across Yorkshire and the Humber. Participants Two hundred and forty-nine children were randomised via a bespoke system hosted at York Trials Unit (129 Social Stories and 120 care as usual). Recruitment was completed in May 2021. Participants were children aged 4–11 years with a diagnosis of autism, alongside teachers, interventionists and caregivers. Recruitment was via schools, NHS trusts, support groups and local publicity. Intervention The intervention included training for educational professionals and caregivers covering psychoeducation and implementation of Social Stories. Stories were written around contextualised goals around the child’s need for social information. Interventionists read the Social Story™ with the child at least six times over 4 weeks during school. Main outcome measure The primary outcome was the Social Responsiveness Scale-2 completed by teachers at 6 months (the primary end point), which measures social awareness, cognition, communication and behaviour. Data were collected from caregivers and educational professionals at 6 weeks and 6 months through questionnaires. Blinding of participants was not possible. Results At 6 months, the estimated difference in expected teacher-reported Social Responsiveness Scale-2 T-score (the primary end point) was −1.61 (95% confidence interval −4.18 to 0.96, p = 0.220), slightly favouring the intervention group. The estimated differences for the parent-reported secondary outcomes at 6 months were small and generally favoured the control group except the measure of children’s quality-adjusted life-year (+ 0.001, 95% confidence interval −0.032 to 0.035) and parental stress (−1.49, 95% confidence interval −5.43 to 2.46, p = 0.460), which favoured the intervention group. Children in the intervention group met their individual goals more frequently than children who received usual care alone (0.97 confidence interval 0.21 to 1.73, p = 0.012). The intervention is likely to save small costs (−£191 per child, 95% confidence interval −767.7 to 337.7) and maintain a similar quality of life compared to usual care. The probability of Social Stories being a preferred option is 75% if the society is willing to pay £20,000 per quality-adjusted life-year gained. Limitations include considerable disruptions during the coronavirus disease 2019 pandemic. Conclusion Social Stories are used in schools and represent a low-cost intervention. There is no clinically evident impact on social responsiveness, anxiety and/or depression, parental stress or general health. Benefits were observed for specific behavioural goals as assessed by the teacher, and Social Stories may serve as a useful tool for facilitating dialogue between children and school staff to address specific behavioural challenges. Usage should be at the school’s discretion. Future work Given the uncertainty of the results in light of coronavirus disease 2019, further work to establish the impact of Social Stories is merited. Trial registration This trial is registered as ISRCTN11634810. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/111/91) and is published in full in Health Technology Assessment ; Vol. 28, No. 39. See the NIHR Funding and Awards website for further award information.
Social learning through friendships is important in child development. Autistic children often initiate and engage in social interactions differently than neurotypical peers. LEGO ® based therapy is a group intervention which facilitates social interactions with peers using collaborative LEGO ® play. A 1:1 cluster randomised controlled trial with autistic children aged 7–15 comparing 12 weeks’ LEGO ® based therapy and usual support to usual support alone in 98 mainstream schools (2017–2019) was carried out. The primary outcome was social skills (Social Skills Improvement System) completed by unblinded teachers (not intervention deliverers) at 20 weeks. Analysis used intention-to-treat. Fifty intervention schools (127 participants) and 48 control schools (123 participants) were allocated. Primary analysis included 45 intervention schools (116 participants) and 42 control schools (101 participants). The between-arms difference was 3.74 (p = 0.06, 95% confidence interval: −0.16, 7.63) and 1.68 (p = 0.43, 95% confidence interval: −2.51, 5.87) at 20 and 52 weeks (0.18 and 0.08 standardised effect sizes). Twenty-week outcomes for those receiving per protocol intervention were 4.23 (95% confidence interval 0.27, 8.19) with a standardised effect size of 0.21. Sensitivity estimates were between 3.10 and 4.37 (0.15–0.21 standardised effect sizes). Three unrelated serious adverse events were reported. LEGO ® based therapy has a small positive non-significant benefit for social skills at 20 weeks but not 52 weeks. Lay abstract Autism is characterised by keen interests and differences in social interactions and communication. Activities that help autistic children and young people with social skills are commonly used in UK schools. LEGO ® based therapy is a new activity that provides interesting and fun social opportunities for children and young people and involves building LEGO ® models together. This study looked at LEGO ® based therapy for the social skills of autistic children and young people in schools. It was a randomised controlled trial, meaning each school was randomly chosen (like flipping a coin) to either run LEGO ® based therapy groups in school over 12 weeks and have usual support from school or other professionals, or only have usual support from school or other professionals. The effect of the LEGO ® based therapy groups was measured by asking children and young people, their parents/guardians, and a teacher at school in both arms of the study to complete some questionnaires. The main objective was to see if the teacher’s questionnaire answers about the children and young people’s social skills changed between their first and second completions. The social skills of participants in the LEGO ® based therapy groups were found to have improved in a small way when compared to usual support only. The study also found that LEGO ® based therapy was not very costly for schools to run and parents/guardians and teachers said they thought it was good for their children and young people. We suggest further research into different potential benefits of LEGO ® based therapy. Keywords ASD , autism , child mental health , LEGO , based therapy , school-based
LAY ABSTRACT:Autism is characterised by keen interests and differences in social interactions and communication. Activities that help autistic children and young people with social skills are commonly used in UK schools. LEGO® based therapy is a new activity that provides interesting and fun social opportunities for children and young people and involves building LEGO® models together. This study looked at LEGO® based therapy for the social skills of autistic children and young people in schools. It was a randomised controlled trial, meaning each school was randomly chosen (like flipping a coin) to either run LEGO® based therapy groups in school over 12 weeks and have usual support from school or other professionals, or only have usual support from school or other professionals. The effect of the LEGO® based therapy groups was measured by asking children and young people, their parents/guardians, and a teacher at school in both arms of the study to complete some questionnaires. The main objective was to see if the teacher's questionnaire answers about the children and young people's social skills changed between their first and second completions. The social skills of participants in the LEGO® based therapy groups were found to have improved in a small way when compared to usual support only. The study also found that LEGO® based therapy was not very costly for schools to run and parents/guardians and teachers said they thought it was good for their children and young people. We suggest further research into different potential benefits of LEGO® based therapy.
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.
ObjectivesThis 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.DesignJLA PSP method. The PSP termed these symptoms MNYES.MethodsThe 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.ResultsOver 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.InterpretationThe top 10 unanswered research questions are expected to generate much needed, relevant and impactful research into MNYES.
Objective: To date, there have been no reviews bringing together evidence on the clinical management of functional neurological disorder (FND) and patients', caregivers', and healthcare workers' experiences. This review provides an overview of the literature focused on the clinical management of FND.Methods: Four databases were searched, and a consultation exercise was conducted to retrieve relevant records dated from September 2010 to September 2020. Articles documenting diagnostic methods, treatments or in-terventions, or the experiences and perspectives of patients and healthcare workers in the clinical management of FND were included.Results: In total, 2756 records were retrieved, with 162 included in this review. The diagnostic methods reported predominantly included positive clinical signs, v-EEG and EEG. Psychological treatments and medication were the most reported treatments. Mixed findings of the effectiveness of CBT were found. Haloperidol, physiotherapy and scripted diagnosis were found to be effective in reducing FND symptoms. Several facilitators and barriers for patients accessing treatment for FND were reported.Conclusion: The literature describing the clinical management for FND has increased considerably in recent times. A wide variety of diagnostic tools and treatments and interventions were found, with more focus being placed on tests that confirm a diagnosis than 'rule-out' tests. The main treatment type found in this review was medication. This review revealed that there is a lack of high-quality evidence and reflects the need for official clinical guidelines for FND, providing healthcare workers and patients the support needed to navigate the process to diagnose and manage FND.
ObjectivesTo assess the cost-effectiveness of LEGO-based therapy compared with usual support.DesignCost-utility analysis alongside randomised control trial.SettingMainstream primary and secondary schools in the UK.Participants248 children and young people (CYP) with autism spectrum disorder (ASD) aged 7–15 years.InterventionLEGO-based therapy is a group social skills intervention designed specifically for CYP with ASD. Through play, CYP learn to use the skills such as joint attention, sharing, communication and group problem-solving. CYP randomised to the intervention arm received 12 weekly sessions of LEGO-based therapy and usual support, while CYP allocated to control arm received usual support only.Main outcome measuresAverage costs based on National Health Service (NHS) and personal social services perspective and quality-adjusted life years (QALYs) measured by EQ-5D-Y over time horizon of 1 year were collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated, and non-parametric bootstrapping was conducted. The uncertainty around the ICER estimates was presented using cost-effectiveness acceptability curve (CEAC). A set of sensitivity analyses were conducted to assess the robustness of the primary findings.ResultsAfter adjustment and bootstrapping, on average, CYP in LEGO-based therapy group incurred less costs (incremental cost was −£251 (95% CI −£752 to £268)) and gained marginal improvement in QALYs (QALYs gained 0.009 (95% CI −0.008 to 0.028)). The CEAC shows that the probability of LEGO-based therapy being cost-effective was 94% at the willingness-to-pay threshold of £20 000 per QALY gained. Results of sensitivity analyses were consistent with the primary outcomes.ConclusionCompared with usual support, LEGO-based therapy produced marginal reduction in costs and improvement in QALYs. Results from both primary and sensitivity analyses suggested that LEGO-based therapy was likely to be cost-effective.Trial registration numberISRCTN64852382.
Background: In recent years, the rates of young people presenting with self-harming have increased dramatically, with self-harm being a predictor of suicide. Despite evidence suggesting that self-harm is common in young people and that hospital admissions are increasing, research exploring the reasons behind young people’s motivations is not easily accessed. Systematic reviews have explored this from a range of perspectives, but none have drawn all this literature together. Methods: A systematic review of systematic reviews was conducted in accordance with PRISMA guidelines. Seven databases were searched using a peer reviewed search strategy, with a focus on the factors of child and adolescent self-harming. All English language articles, published between 2008 and 2021, were considered, and screened against inclusion criteria. References of included articles were also searched for eligible articles. Results: Twenty-two systematic reviews were included after screening against eligibility criteria. Narrative synthesis identified eight themes for motivation or reasons for self-harming: identity and subcultures, peer influences, educational stressors, mental ill health, cognitive and neuropsychological factors, trauma and attachment, internet influences and social media. Conclusion: Reasons for self-harming in adolescents are complex and multifactorial. Many studies focus on single causes or associations with self-harm rather than open-mindedly exploring a range of factors or the interactions between them. This leaves gaps in the research where hypothetical reasons for self-harm have not been systematically explored. The themes identified here could help in the clinical assessment process and guide future research in this area, including the development of potential differentiated prevention and treatment approaches.
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.
Background: Non-attendance at initial appointments is a widespread problem which affects mental health services and patients. Methods: This mixed methods systematic review identified and synthesised the available literature on factors, which could be modified either by patients or by services, that can influence early attrition to services offering psychological support for common mental health problems. Searches were conducted January 2017, updated Oct 2019, in MEDLINE, CINAHL Plus, EMBASE, Cochrane Library and PsycINFO. Screening, data extraction and quality appraisal were completed independently by two reviewers. Quality appraisals used Joanna Briggs Institute tools. Results: Of the 31,758 references identified (21,123 unique), 34 studies were selected for inclusion. Studies used cohort (14), cross-sectional (10) and qualitative (9) designs. An additional study reported both quantitative and qualitative components. Findings from observational studies related to the presenting problem, beliefs about symptoms and treatment, contact with services, practical challenges and social support. Themes from qualitative studies centred around individual perceptions of symptoms and support, social and cultural influences, experiences with services and practical issues. Similarities and differences between quantitative and qualitative syntheses are discussed in a combined synthesis. Limitations: This review did not attempt to measure the effect of factors affecting attendance, or the effectiveness of interventions to reduce non-attendance to initial treatment appointments. Conclusions: Ensuring treatments offered matched patient perceptions of problems, reducing patient concerns around engagement, and offering prompt responses with flexibility to accommodate patient circumstances consistently influenced initial attendance. More work is needed to improve perceptions of mental health services in the community.
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.
Background Interventions designed to support children with a diagnosis of Autism Spectrum Conditions (ASC) can be time consuming, needing involvement of outside experts. Social Stories™ are a highly personalised intervention aiming to give children with ASC social information or describing an otherwise difficult situation or skill. This can be delivered daily by staff in education settings. Studies examining Social Story™ use have yielded mostly positive results but have largely been single case studies with a lack of randomised controlled trials (RCTs). Despite this numerous schools are utilising Social Stories™, and a fully powered RCT is timely. Methods A multi-site pragmatic cluster RCT comparing care as usual with Social Stories™ and care as usual. This study will recruit 278 participants (aged 4–11) with a clinical diagnosis of ASC, currently attending primary school in the North of England. Approximately 278 school based staff will be recruited to provide school based information about participating children with approximately 140 recruited to deliver the intervention. The study will be cluster randomised by school. Potential participants will be screened for eligibility prior to giving informed consent. Follow up data will be collected at 6 weeks and 6 months post randomisation and will assess changes in participants’ social responsiveness, goal based outcomes, social and emotional health. The primary outcome measure is the Social Responsiveness Scale Second Edition (SRS-2) completed by school based staff at 6 months. Approvals have been obtained from the University of York’s Research Governance Committee, Research Ethics Committee and the Health Research Authority. Study results will be submitted for publication in peer-reviewed journals and disseminated to participating families, educational staff, local authority representatives, community groups and Patient and Participant Involvement representatives. Suggestions will be made to NICE about treatment evidence dependent on findings. Discussion This study addresses a much used but currently under researched intervention and results will inform school based support for primary school children with a diagnosis of ASC. Trial registration The trial is registered on the ISRCTN registry (registration number: ISRCTN11634810 ). The trial was retrospectively registered on 23rd April 2019.
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.
A new model for a community mental health service for children and young people aged 0-18 years is described. This has been formulated after multi-level consultation including extensive user/carer involvement. The proposed model is multidisciplinary and integrated with multiagency provision, with smooth access onto and through care pathways. This model brings voluntary and statutory agencies into an integrated collaboration. It reinforces that social and emotional development and psychological functioning is everybody’s business and creates conditions where a child’s needs can be addressed on a day-to-day basis rather than through a “clinic-based model”.
Purpose The purpose of this paper is to focus upon the challenges faced by a research team when conducting a computerised cognitive behaviour therapy (CCBT) trial for adolescents with low mood/depression and how solutions were sought to eliminate these difficulties in future child and adolescent mental health clinical research. Design/methodology/approach The authors have presented a number of problems faced by the research team when conducting a randomised controlled trial (RCT) concerning adolescents with low mood/depression. Findings From examining the problems faced by the research team, the authors have provided key pieces of advice for prospective adolescent mental health RCTs. This advice includes developing clear project plans, setting strategies to encourage and maintain study information in the community and support recruitment, and keeping your organisation appraised of study needs and network and involve governance departments, IT and finance departments in these discussions early. Originality/value RCTs, particularly those focusing on child and adolescent mental health, can face a number of difficulties throughout its stages of completion (from protocol development to follow-up analysis). Studies involving the use of technologies add a layer of complexity to this. This review will be of value to researchers aiming to run a high-quality RCT concerning child and adolescent mental health.
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.
Background and aims Key information summary is one of the first national shared electronic patient records enabling GPs to share clinical information with unscheduled care providers, including out-of-hours. Implemented during 2013, over 90,000 patient records have been created. This evaluation identified the impact of key information summary on healthcare services. Methods Evidence was collected using online questionnaires and structured telephone interviews. Opinions providing a numerical estimate of value were analysed using statistical methods, while qualitative responses were synthesised using thematic analysis. Results The vast majority of respondents from 441 GP practices and 33 out-of-hours clinicians show that key information summary enhances patient safety, improves clinical management, reduces hospital admissions, empowers clinicians, aids communication across services and enables decisions to be responsive to patients’ wishes. Conclusions Patients willingly consent to share data with unscheduled care clinicians. Patients benefitting include those with palliative, complex or multiple conditions, at high risk of using emergency services. Out-of-hours clinicians would welcome more key information summaries, all well-completed and including social care information. Improvements include software enhancements and wider sharing of information with all unscheduled care services.