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

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.

Objectives: Phase 3 trial of the clinical and cost-effectiveness of the 'Parent-mediated intervention for Autism Spectrum Disorders in South Asia-Plus' (PASS+) intervention in addition to treatment as usual (TAU) compared to treatment as usual (TAU) alone in India. The study will take the already successfully piloted PASS+ intervention to scale.

Design: Two centre, two arm single (rater) blinded random allocation parallel group study of experimental treatment plus TAU against TAU alone. Primary endpoint 9 months, follow-up 15 months. Primary outcome: autism symptom severity (blind-rated Brief Observation of Social Communication Change). Secondary outcomes: include parent-child communication, child adaptation and QoL, parental wellbeing. Primary analysis intention to treat; planned secondary analysis of proposed mediators of treatment effect. Health Economic evaluation will estimate the cost-effectiveness of the intervention from a societal perspective using a QoL index valued to allow calculation of QALYs.

Participants: 240 children aged 2 to 9 years with ASD, recruited from Autism clinics in two tertiary government hospitals in New Delhi, India.

Treatments: PASS+ is a manualised and piloted adaptation of the UK Pre-school Autism Communication Therapy (PACT), that uses video-feedback with parents to help them enhance social communication in their autistic child. It will be delivered by existing health system frontline workers, in 12 home-based sessions. TAU in the two recruitment centres is delivered through weekly autism clinics, an eclectic mix of behavioural therapy approaches which are delivered once a month delivered by specialists. The duration of therapy is based on the families' ability to follow up, adherence is under 50%.

Outcome: Generalizability and policy impact will be maximized through embedding the trial in routine facilities with embedded primary health-care workers, and using our policy influence to disseminate the findings.

The primary stakeholders impacted by this work will be young people affected by ASD and their families and the wider communities where these individuals live.
Recent epidemiological evidence has shown that about 1% of children are affected by Autism Spectrum Disorders (ASD), translating to at least five million affected families in India alone. The vast majority, approaching nearly 100% of these children, do not receive community based interventions. COMPASS will represent the first definitive trial of the effectiveness and cost-effectiveness of such an intervention, which has been piloted to ensure contextual acceptability to parents and feasibility for delivery by low-cost frontline workers, in the region. The intervention has been carefully adapted to address social and cultural barriers through four years of systematic formative and piloting research.

Young people and their families will therefore benefit from improved social communication skills and thus improved social integration both with their families and within their communities, enhancing their wellbeing for all of these groups. Young people, families and communities will benefit from better understanding of ASD and the increased social acceptance of neurodevelopmental disability. A successful outcome from the trial will bring economic benefits to families (reducing costs associated with loss of wages for parents, changing residences to seek care, changing schools) and national healthcare systems (direct medical expenses born by the health system for autism care).

Healthcare workers and national health systems will benefit from the outcomes of this study along with the scientific community. Health workers will benefit from a defined programme of training and supervision, upskilling them and providing a resource which will be able to perpetuate these skills into the future. The team in India has developed and evaluated an enhancement of the core communication component with modules to address comorbidities to increase acceptability of the intervention by parents and the potential effectiveness of the intervention. We will also use a digital platform to embed self-learning and supervision needs of the health worker, preparing a way to take this intervention to scale. We are including a systematic tracking method for children and families with a view to assessing the long term impact of an early comprehensive intervention package on symptom severity and functioning.

Government and international policy bodies will benefit from the development of an evidenced protocol for a community based ASD intervention, applicable in India and other LMICs, which will have an impact on health and wealth of individuals and communities and therefore ultimately the country as a whole. We are generating key economic data on the cost-effectiveness of the interventions, based upon which we will be able to estimate the additional cost of scaling up this intervention across the country. The scientific community will benefit from the new knowledge generated by this trial which will inform the design and delivery of future interventions in LMICs. The model for management of a developmental disability through trained community based workers and parents working in partnership with specialists could be replicated for other neurodevelopmental disabilities in LMIC.

We will build on our policy influence and engagement to disseminate the findings; for instance Divan serves on WHO consultative groups for developing interventions for child mental disorders and on national committees for autism and developmental disabilities in India; Patel serves on the WHO expert advisory group for mental health; and this project has the backing of the two leading national institutions concerned with front-line workers (the National Health Systems Resource Centre) and child development (the Rashtriya Bal Swasthya Karykram) - see Letters of Support.