COMIC, Leeds and York Partnership NHS Foundation Trust, York, UK.
Department of Health Sciences, University of York, York, UK.
BMJ Open. 2019 Jun 1;9(5):e030471. doi: 10.1136/bmjopen-2019-030471.
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.
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 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.
ISRCTN64852382; Pre-results.
针对自闭症谱系障碍（ASD）儿童的社交技能训练干预措施通常侧重于技能缺陷模型，而不是建立在现有技能的基础上，也不鼓励儿童寻求自己的解决方案。基于乐高的治疗是一种以儿童为中心的干预措施，旨在帮助提高社交互动技能并减少孤立感。该疗法专为学龄期 ASD 儿童设计，在学校环境中采用基于小组的游戏，鼓励同伴关系和社交学习。尽管先前的随机对照试验（RCT）报告了基于乐高的治疗有潜在益处，并且许多学校都采用了该疗法，但支持其对 ASD 儿童社交和情感福祉有效性的证据有限，并且没有评估成本效益。
这项多中心、实用、集群 RCT 将随机分配 240 名（年龄 7-15 岁）有 ASD 临床诊断的参与者接受常规护理或基于乐高的治疗加常规护理。将在学校层面进行集群随机化，对每所学校进行随机化，而不是对学校内的每个孩子进行随机化。所有潜在参与者都将在同意参与研究之前进行资格筛选（父母代表其孩子给予知情同意）。所有参与者将在随机分组后 20 周和 52 周进行随访，以评估社交、情感和行为变化。主要结局测量是由与参与儿童相关的教师或助教在 20 周随访时间点完成的社会技能改善系统的社交技能子量表。
约克大学研究伦理委员会已批准伦理。试验结果将提交给同行评议的期刊发表，并将传播给参与家庭、教育从业者以及第三部门，包括志愿和社区组织。
ISRCTN64852382；预结果。
