Preschool Autism Communication Trial (PACT)

Autism is a severe and chronic childhood disability affecting families from early in childhood through the lifespan. Many claims have been made for effective treatments for autism, but surprisingly (given the importance of the disorder and the progress that has been made in understanding it), there has very little systematic research evidence to support effective treatments. Families and user groups have been vocal in calling for more research on treatment, and statutory agencies have been placed under escalating legal pressure through educational tribunals to provide intensive, costly but often quite untested interventions. This study would represent a significant enhancement of the evidence for effective treatment. It tests a treatment that is aims to enhance parent child communication in autism and the social and language development of the child. Families attend sessions with a therapist every two weeks for 6 months to learn new ways of understanding and communicating with their autistic child, with monthly booster sessions for a further 6 months. Similar treatment models have been applied to other kinds of communication disorder with good results. The study will randomly allocate 144 children in three representative sites across the UK (Manchester, Newcastle and London) to a group receiving routine clinical care in the community and another group receiving routine clinical care but with the addition of this communication intervention. Our pilot study using the same design on a single site has shown very promising value of adding this additional component to routine care. We will also study the cost effectiveness of the treatment.

This treatment is not too intensive (with about 1.5 hours of therapist time and 3.5 hours of parent homework time weekly) and for this reason it would be possible to extend it practically into local health services. Because the treatment helps communication between parent and child, we find that it improves parental sense of competence and involvement with their child as well as the child?s development. These are key features identified in our focus groups with parents that are central to what families want from a treatment for Autism.

We are collaborating with the National Autistic Society in this study and are conducting focus groups with service users to identify the best ways of measuring treatment outcomes that matter to families. We will disseminate information about this study and its results through the NAS, other newsletters and professional meetings.

Autism is a severe neurodevelopmental disability resulting in a very high burden of care for families and community throughout the lifespan. Early psychosocial intervention with families is widely recommended but, as yet, there has been no large scale testing of its effectiveness.

This study will test a theory-based treatment that aims to enhance the effectiveness of parental communication in autism and promote the child?s competence. It is based on recent developmental research on the communicative deficits in children with autism and management programmes successfully applied with other communication disorders. It is of medium intensity (1.5 hours clinic time and 3.5 hrs homework a week), making it appropriate for widespread use in the NHS. A pilot RCT over 1 year (total n=28) showed a treatment effect size of 0.92 on autism symptoms and significant language improvement over controls.

This study is a 3 site single (rater) blinded RCT of two parallel groups, Treatment as Usual against Treatment as Usual supplemented by the manualised intervention. The sample will be 144 children aged between 2 years-4 yrs 11mnths fulfilling diagnostic criteria for core autistic disorder. End point assessment is at twelve months (after a six month primary intervention and six months of booster reinforcement sessions). The primary outcome measure is a standardised investigator-rated measure of severity of autism symptoms (the Autism Diagnostic Observation Schedule (ADOS)). Secondary measures are ratings of carer-child communication, child language, and classroom adaptation. Analysis will be on an intention to treat basis. The study is powered to a 99% chance of detecting the effect size in our pilot and a 90% chance of detecting half this change. The trial will include health economic evaluation and development of a functional outcome measure in collaboration with service users.

The study represents the first large multisite psychosocial treatment trial to be undertaken in this area. Demonstration of effectiveness would give a new evidence based option for enhancement of autism services in the UK and internationally. The economic analysis in the trial will generate the first large scale systematic data on economic costs associated with autism and its treatment. The trial will develop, in collaboration with service-users and the National Autistic Society, a functional assessment of the impact of autism on child and family which could have widespread application in future studies in the field.