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

全球80%患有自闭症谱系障碍(ASD)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对患有自闭症儿童的早期治疗采取有针对性的父母干预措施的有效性。通过父母提供的干预措施还有额外的好处，即提高父母的知识和士气，潜在地促进母亲的社会赋权，概括为改善儿童的家庭环境，从而可能对社会背景、儿童的环境和功能结果产生长期影响。在英国进行的学龄前自闭症沟通疗法(PACT)试验是此类试验中规模最大的。它的目标是让父母认识到他们孩子的社交困难，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。这项干预使用视频反馈技术与父母合作，增强他们对自闭症幼儿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他们的父母能够创造的丰富的交流环境；这反过来又对儿童发起的社会互动产生了积极影响。更重要的是，在亲子互动和与孩子的独立交流方面，这些变化在六年后的一项跟踪研究中得到了持续，该研究表明，接受干预的儿童的自闭症症状有所减少。现已成功地将干预措施用于南亚，包括相关的文化适应以提高父母的接受度，制定监督和培训级联以允许社区非专业工作人员提供干预措施，以及在家中提供干预措施。随后在一项试点试验中评估了由此产生的针对南亚自闭症谱系障碍(PASS)的家长中介干预(PASS)，证明了其可接受性、可行性和有效性。随后，印度的研究小组开发并试行了一套补充的共病方案，为2-9岁年龄组的自闭症儿童创建了全面的干预措施(PASS Plus)。评估方法也在这两项试点研究中进行了调整和测试。在印度和其他低资源环境中，大多数患有自闭症的儿童没有得到循证护理，提案调查人员已经证明，这种护理可以减少自闭症的症状，并且在拟议的研究环境中是可行和可以接受的。拟议中的试验将建立在印度已经开展的这项试点工作的基础上，并将进行规模最大的、最终的干预试验，涉及首都新德里的两家三级政府医院招募的240名参与者，这两家医院为城市贫困人口提供服务。干预将通过现有的卫生系统前线工作人员进行。该试验将评估针对自闭症症状和亲子互动的干预措施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广泛影响。COMPASS将是ASD在任何低资源环境下进行的同类试验中规模最大的，所产生的证据不仅将影响印度的卫生政策和实践，而且还将影响该地区其他低资源环境下的卫生政策和实践。

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.