Background The UK has seen a recent shift towards children’s mental health being supported and treated in school settings. Several current school-based interventions focus on autism and social skills, with education professional involvement in their delivery increasing. The study of these interventions poses specific implementation challenges. This paper discusses implementation successes and learnings from the I-SOCIALISE research study which delivered and evaluated efficacy of LEGO® based therapy (now Play Brick Therapy) for autistic children and young people delivered in schools. Detailed Methods and results of the trial are reported elsewhere. Methods The I-SOCIALISE study was a pragmatic large-scale NIHR-funded cluster randomised controlled trial. Children and young people, their parents/guardians, and schoolteachers or teaching assistants were recruited from mainstream schools in the UK. They completed outcome measures and were randomised to receive either 12-week of LEGO® based therapy and usual support or usual support only. Various methods to achieve successful recruitment and retention were used and learnings were documented. Results The study recruited to time and target with successful delivery of this complex intervention in schools. Several lessons were learnt about recruitment methods, data collection, participant burden and retention, blinding, and the importance of relationships with key school contacts. Main recommendations based on these learnings are provided. Conclusions This study demonstrated that it is possible to undertake large scale, robust evaluation of pragmatically delivered complex school-based interventions. Recommendations are made to address the logistical challenges of undertaking research in this setting which are intended to facilitate future research.

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.

Preventative inhaled treatments preserve lung function and reduce exacerbations in cystic fibrosis (CF). Self-reported adherence to these treatments is over-estimated. An online platform (CFHealthHub) has been developed with patients and clinicians to display real-time objective adherence data from dose-counting nebulisers, so that clinical teams can offer informed treatment support. In this paper, we identify pre-implementation barriers to healthcare practitioners performing two key behaviours: accessing objective adherence data through the website CFHealthHub and discussing medication adherence with patients. We aimed to understand barriers during the pre-implementation phase, so that appropriate strategy could be developed for the scale up of implementing objective adherence data in 19 CF centres. Thirteen semi-structured interviews were conducted with healthcare practitioners working in three UK CF centres. Qualitative data were coded using the theoretical domains framework (TDF), which describes 14 validated domains to implementation behaviour change. Analysis indicated that an implementation strategy should address all 14 domains of the TDF to successfully support implementation. Participants did not report routines or habits for using objective adherence data in clinical care. Examples of salient barriers included skills, beliefs in consequences, and social influence and professional roles. The results also affirmed a requirement to address organisational barriers. Relevant behaviour change techniques were selected to develop implementation strategy modules using the behaviour change wheel approach to intervention development. This paper demonstrates the value of applying the TDF at pre-implementation, to understand context and to support the development of a situationally relevant implementation strategy.

This paper systematically reviewed the literature reporting the validity and reliability of hyperpolarised gas MRI as a marker of lung health in cystic fibrosis (CF). MEDLINE, EMBASE and grey literature were searched for studies assessing the measurement properties of hyperpolarised helium-3 or xenon-129 MRI. The COSMIN risk of bias tool was used to critically appraise eligible studies. Findings show hyperpolarised gas MRI was able to detect structural and functional abnormalities in the lungs, detect response to treatments, and is more sensitive than FEV1 in detecting ventilation defects in CF patients. There was moderately robust evidence for construct validity of hyperpolarised gas MRI, although evidence for other types of validity is currently low. Nonetheless, high quality studies concluded that hyperpolarised gas MRI is a reliable tool and test results are reproducible in CF patients. Hyperpolarised gas MRI is a promising tool for detecting early CF pulmonary disease and for longitudinal monitoring of CF.