Sangath, Porvorim, India.
University of Manchester, Manchester, UK.
Trials. 2023 Oct 12;24(1):667. doi: 10.1186/s13063-023-07621-5.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disability affecting at least 5 million children in South Asia. Majority of these children are without access to evidence-based care. The UK Pre-school Autism Communication Therapy (PACT) is the only intervention to have shown sustained impact on autism symptoms. It was systematically adapted for non-specialist community delivery in South Asia, as the 'Parent-mediated Autism Social Communication Intervention for non-Specialists (PASS)' and extended 'PASS Plus' interventions. RCTs of both showed feasibility, acceptability and positive effect on parent and child dyadic outcomes.
The Communication-centred Parent-mediated treatment for Autism Spectrum Disorder in South Asia (COMPASS) trial is now a scale-up two-centre, two-arm single (rater) blinded random allocation parallel group study of the PASS Plus intervention in addition to treatment as usual (TAU) compared to TAU alone, plus health economic evaluation embedded in the India health system. Two hundred forty children (approximately 120 intervention/120 TAU) with ASD aged 2-9 years will be recruited from two tertiary care government hospitals in New Delhi, India. Accredited Social Health Activists will be one of the intervention delivery agents. Families will undertake up to 12 communication sessions over 8 months and will be offered the Plus modules which address coexisting problems. The trial's primary endpoint is at 9 months from randomisation, with follow-up at 15 months. The primary outcome is autism symptom severity; secondary outcomes include parent-child communication, child adaptation, quality of life and parental wellbeing. Primary analysis will follow intention-to-treat principles using linear mixed model regressions with group allocation and repeated measures as random effects. The cost-effectiveness analysis will use a societal perspective over the 15-month period of intervention and follow-up.
If clinically and cost-effective, this programme will fill an important gap of scalable interventions delivered by non-specialist health workers within the current care pathways for autistic children and their families in low-resource contexts. The programme has been implemented through the COVID-19 pandemic when restrictions were in place; intervention delivery and evaluation processes have been adapted to address these conditions.
ISRCTN; ISRCTN21454676 ; Registered 22 June 2018.
自闭症谱系障碍（ASD）是一种神经发育障碍，影响着南亚至少 500 万儿童。这些儿童中大多数都无法获得基于证据的治疗。英国学前自闭症沟通治疗（PACT）是唯一一种被证明对自闭症症状有持续影响的干预措施。它被系统地改编为非专业人员社区交付，即“非专业人员介导的自闭症社交沟通干预（PASS）”和扩展的“PASS Plus”干预措施。这两项 RCT 都显示了其可行性、可接受性以及对父母和儿童二元结果的积极影响。
目前正在进行的南亚以沟通为中心的自闭症谱系障碍家长介导治疗（COMPASS）试验是一项扩展的、为期两年的、以社区为基础的、单（评估者）盲法随机分组平行组研究，将 PASS Plus 干预与常规治疗（TAU）进行比较，同时进行健康经济学评价，嵌入印度卫生系统。从印度新德里的两家三级政府医院招募 240 名年龄在 2-9 岁的 ASD 儿童（大约 120 名干预组/120 名 TAU 组）。认证的社会健康活动家将是干预提供的一种方式。家庭将在 8 个月内完成多达 12 次沟通课程，并提供解决共存问题的 Plus 模块。试验的主要终点是随机分组后 9 个月，随访时间为 15 个月。主要结局是自闭症症状严重程度；次要结局包括父母-儿童沟通、儿童适应、生活质量和父母幸福感。主要分析将遵循意向治疗原则，使用线性混合模型回归，组分配和重复测量作为随机效应。成本效益分析将在干预和随访的 15 个月期间采用社会视角。
如果在临床和成本效益方面可行，该方案将填补当前资源匮乏环境下自闭症儿童及其家庭的现有照护途径中，由非专业卫生工作者提供的可扩展干预措施的重要空白。该方案是在 COVID-19 大流行期间实施的，当时有各种限制；干预交付和评估过程已经适应了这些情况。
ISRCTN；ISRCTN21454676；注册于 2018 年 6 月 22 日。
