Communication-centered Parent-mediated treatment for Autism Spectrum Disorder in South Asia (COMPASS).

世界上80%患有自闭症谱系障碍的儿童生活在资源匮乏的环境中。来自高收入国家的最新证据支持父母介导的有针对性的干预措施对自闭症儿童早期治疗的有效性。通过父母提供的干预措施还有其他好处，可以提高父母的知识和士气，可能促进母亲的社会赋权，推广到改善儿童的家庭环境，从而可能对社会环境、儿童环境和功能结果产生长期影响。在英国进行的学前自闭症交流治疗（PACT）试验是此类试验中规模最大的。它的目的是让父母认识到孩子的社交困难，并创造一个环境，让孩子有空间和时间按照自己的节奏进行交流。这种干预使用视频反馈技术与父母一起工作，以提高他们对自闭症儿童的非典型交流的理解和反应。试验表明，接受这种治疗的自闭症儿童受益于父母能够创造的丰富的交流环境；这反过来又对孩子们发起的社会互动产生了积极的影响。更重要的是，这些变化，在亲子互动和孩子的独立交流方面，在六年后的随访研究中持续存在，表明接受干预的孩子的自闭症症状有所减轻。目前，该干预措施已成功地适用于南亚地区，包括相关的文化适应，以提高家长的接受程度，制定监督和培训梯级，使干预措施能够由社区非专业工作人员提供，并在家中实施。随后在一项试点试验中对南亚自闭症谱系障碍（PASS）的父母介导干预进行了评估，证明了其可接受性、可行性和有效性。随后，印度的团队开发并试行了一套互补的合并症方案，为2-9岁年龄组的ASD儿童（PASS Plus）提供了全面的干预措施。在这两项试点研究中，也对评价方法进行了调整和检验。在印度和其他低资源环境中，大多数ASD儿童没有得到基于证据的护理，建议的研究人员已经表明，这种护理可以减轻ASD的症状，并且在建议的研究环境中分娩是可行和可接受的。拟议的试验将以印度已经开展的这项试点工作为基础，并将对该干预措施进行最大规模、最确定的试验，涉及240名参与者，这些参与者是通过首都新德里的两家三级政府医院招募的，这两家医院为城市贫困人口提供服务。干预措施将通过现有的卫生系统一线工作人员提供。该试验将评估干预ASD症状和亲子互动的有效性和成本效益，以及对儿童功能、父母福祉和社会赋权的更普遍影响。COMPASS将是在任何低资源环境中针对自闭症谱系障碍进行的同类试验中规模最大的一次，所产生的证据不仅将影响印度（拥有500多万自闭症谱系障碍儿童）的卫生政策和实践，还将影响该地区其他低资源环境的卫生政策和实践。

Eighty percent of the world's children with Autism Spectrum Disorders (ASD) live in low resource settings. Recent evidence from high-income countries supports the effectiveness of targeted parent-mediated interventions for the early treatment of children with ASD. Interventions that are delivered through parents have the additional advantages of improving parental knowledge and morale, potentially promoting the social empowerment of mothers, generalising into improvements in the family environment for the child and thus potentially conferring long-term impacts on the social context, the child's environment and functional outcomes. The Pre-school Autism Communication Therapy (PACT) trial conducted in the UK is the largest yet trial of this kind. It is targeted at getting parents to recognize their child's social communication difficulties and create an environment which gives the child a space and time to communicate at their own pace. This intervention uses video feedback techniques to work with parents to enhance their understanding and responsiveness to the atypical communications of young children with autism. The trial showed that children with ASD who received this treatment benefited from the enriched communication environment that their parents were able to create; this in turn had a positive impact on the social interactions the children initiated. More importantly these changes, in the parent child interaction and independent communication from the child, were sustained in a follow up study after six years which demonstrated a decrease in autism symptoms in children who received the intervention. The intervention has now been successfully adapted for use in South Asia, including relevant cultural adaptation to enhance parental acceptability, developing a supervision and training cascade to allow the intervention to be delivered by community based non-specialist workers, and delivery of the intervention at home. The resulting Parent mediated intervention for Autism Spectrum Disorders in South Asia (PASS) was subsequently evaluated in a pilot trial which demonstrated its acceptability, feasibility and efficacy. Subsequently, the team in India have developed and piloted a complementary comorbidity package creating a comprehensive intervention for children with ASD in the 2-9 year age group (PASS Plus). Evaluation methods have also been adapted and tested in both of these pilot studies. Most children with ASD in India and other low resource settings do not receive evidence based care which the proposal investigators have shown can reduce the symptoms of ASD and is feasible and acceptable for delivery in the proposed study setting. The proposed trial will build on this pilot work already carried out in India, and will carry out the largest, definitive, trial of the intervention, involving 240 participants recruited through two tertiary government hospitals in the capital city of New Delhi, which cater to an urban poor population. The intervention will be delivered through existing health system frontline workers. The trial will evaluate the effectiveness and cost effectiveness of the intervention on symptoms of ASD and parent-child interaction as well as more general impacts on child functioning, parental well-being and social empowerment. COMPASS will be the largest trial of its kind for ASD in any low resource setting and the evidence generated will have an impact not only health policy and practice in India, home to over 5 million children with ASD, but also other low resource settings in the region.