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.

Autism spectrum disorder is characterised by difficulties with social relationships and communication, which can make it difficult to make friends. Social skills training is commonly used to help children and young people learn different social skills, but some children and young people do not enjoy these therapies. LEGO^® (LEGO System A/S, Billund, Denmark) based therapy takes a new approach by focusing on making the process interesting and fun. This research investigated the effect of LEGO^® based therapy groups in schools on the social and emotional abilities of children and young people with autism spectrum disorder. It was a randomised controlled trial, so each school that was taking part was randomly chosen to provide either usual support (from the school or NHS services) or 12 sessions of LEGO^® based therapy with a trained school staff member as well as usual support. Children and young people played one of three roles ­ the 'engineer' (gives instructions), the 'supplier' (finds the pieces) or the 'builder' (builds the model) ­ and worked together. Questionnaires completed by children and young people, their parents/guardians and teachers were used to look at the intervention's effects. The main objective was to see if there was a change in social skills measured by a teacher-completed questionnaire. Results showed that the social skills of children and young people in the LEGO^® based therapy groups did improve a little. We found that the intervention is not very costly for schools to run. Many parents/guardians and teachers thought that the intervention was beneficial and that the children and young people enjoyed it.

I-SOCIALISE: Results from a cluster randomised controlled trial investigating the social competence and isolation of children with autism taking part in LEGO® based therapy ('Play Brick Therapy') clubs in school environments.

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.

Scoping review: Alternatives to self-harm recommended on mental health self-help websites.

Less than half of all young people with mental health difficulties will seek professional treatment. Due to the private nature of self-harm it is estimated that only 1:28 young males and 1:18 young females who self-harm ever present to hospital. Self-help supports improved coping strategies and life changes without reliance on a clinical intervention which could be used to reduce self-harming behaviours. The study objective is to review self-help alternatives to self-harm on mental health websites that can be accessed by young people. Google, Bing, and Yahoo search engines were used to search for appropriate websites. Eighty-two unique websites on mental health were identified, of which 55 met the inclusion criteria. A total of 1177 self-help suggestions were found for those struggling with self-harm urges. The average number of suggestions per site was 42 (Range 3-252). The main techniques suggested were: seeking social contact/help, physical activity, displacement/mimicking techniques, relaxing/comforting techniques, sensory techniques, fun/diverting techniques, aggressive techniques, creative/reflective techniques. This review found not all strategies were suitable for young people and that the large number of possible strategies could be challenging for a young person to navigate. However, mental health self-help websites were generally of high quality and gave a range of potentially helpful strategies. The categories created from this review could be used as a guide to consider with the young person when making an individualized self-help plan to manage self-harm urges. Further research is required to assess if and how these techniques could be used individually or in combination to reduce self-harm.

Co-production of a nature-based intervention for children with ADHD study (CONIFAS): Protocol for co-production phases.

Children with Attention Deficit Hyperactivity Disorder can face difficulties with inattention, hyperactivity, and impulsivity, which can impact many areas of their lives, including their educational attainment and social and emotional wellbeing. Involvement in nature-based activities can reduce these difficulties and improve wellbeing, but there are limited resources for supporting children with this diagnosis to access these approaches and no nature-based interventions designed with and for this group. This protocol describes a co-production study in which children diagnosed with Attention Deficit Hyperactivity Disorder aged 5-11 years old, their parents/guardians, and professionals will attend a series of workshops to share their knowledge to co-produce a new nature-based intervention for this population of children. We aim to understand how the children's' experiences of Attention Deficit Hyperactivity Disorder may affect their interactions with nature, identify how activity in and with nature may help with symptom reduction and general wellbeing, and co-produce an intervention for families which applies our learning. The result of this study will be the designed intervention and insights into how children and young people with Attention Deficit Hyperactivity Disorder interact with nature. The prototype intervention will then undergo feasibility testing in a future study. Trail registration: NIHR203043; ISRCTN11763460.

A mixed methods evaluation of the acceptability of therapy using LEGO® bricks (LEGO® based therapy) in mainstream primary and secondary education.

Many autistic children and young people need extra support with social skills. Social skills programmes, such as LEGO® based therapy (LBT), are commonly used to help with these difficulties. The aim of this study was to examine the acceptability of LBT using qualitative interviews and questionnaires with facilitators and parents/guardians on behalf of autistic children and young people. Acceptability was measured in line with constructs of the Theoretical Framework of Acceptability. Questionnaires were analyzed descriptively and between group comparisons were undertaken using the Mann-Whitney U Test. Telephone interviews were undertaken with a sub-sample of facilitators. All interviews were recorded, transcribed verbatim, and framework analysis was performed by two researchers supported by NVivo. The questionnaire response rate was 80% for facilitators and 77% for parents/guardians. Overall acceptability, measured on a 1-5 (minimum-maximum) scale, was high for both facilitators and parents/guardians with a median (range) of 5 (4-5) and 4 (3-5), respectively. Facilitators rated the acceptability of the programme significantly higher overall than parents (p < 0.001). Facilitators reported that participants and wider school staff viewed the programme positively. They observed improvements in communication and social skills during the sessions. Potential barriers to programme delivery, such as resources and staff schedules, were identified but facilitators reported that these challenges did not outweigh the benefits. There is increasing emphasis on the role of schools in seeking to improve social outcomes for autistic children therefore this high degree of acceptability makes this an attractive school-based programme for schools, autistic children and their families. LAY SUMMARY: Social skills programmes, such as LEGO® based therapy (LBT), are often used to help autistic children and young people with their social skills. The acceptability of LBT with school staff and parents/guardians on behalf of children and young people was explored using interviews and questionnaires. Our results show that LBT is viewed as a highly acceptable programme that can help autistic children and young people improve their communication and social skills.

Cost-utility analysis of LEGO based therapy for school children and young people with autism spectrum disorder: results from a randomised controlled trial.

OBJECTIVES: To assess the cost-effectiveness of LEGO-based therapy compared with usual support. DESIGN: Cost-utility analysis alongside randomised control trial. SETTING: Mainstream primary and secondary schools in the UK. PARTICIPANTS: 248 children and young people (CYP) with autism spectrum disorder (ASD) aged 7-15 years. INTERVENTION: LEGO-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 MEASURES: Average 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. RESULTS: After 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. CONCLUSION: Compared 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 NUMBER: ISRCTN64852382.

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.