Preschool Autism Communication Trial

Conditions

Autism Mental and Behavioural Disorders Autism

Pickles A, Le Couteur A, Leadbitter K, Salomone E, Cole-Fletcher R, Tobin H, Gammer I, Lowry J, Vamvakas G, Byford S, Aldred C, Slonims V, McConachie H, Howlin P, Parr JR, Charman T, Green J.

2016-10-25274 citations

10.1016/s0140-6736(16)31229-6

Cost-effectiveness analysis of a communication-focused therapy for pre-school children with autism: results from a randomised controlled trial.

Byford S, Cary M, Barrett B, Aldred CR, Charman T, Howlin P, Hudry K, Leadbitter K, Le Couteur A, McConachie H, Pickles A, Slonims V, Temple KJ, Green J, PACT Consortium.

2015-12-2137 citations

10.1186/s12888-015-0700-x

Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial.

Green J, Charman T, McConachie H, Aldred C, Slonims V, Howlin P, Le Couteur A, Leadbitter K, Hudry K, Byford S, Barrett B, Temple K, Macdonald W, Pickles A, PACT Consortium.

2010-05-20438 citations

10.1016/s0140-6736(10)60587-9

Interventions

Treatment versus treatment as usual, evaluated on standard autism and behavioural instruments and including health economic analysis. Trial treatment: the PACT intervention targets core social intera

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children between the ages of 2 and 4 years 11 months, fulfilling diagnostic criteria for core autistic disorder on both social and communication domains of the Autism Diagnostic Observation Schedule-Generic (ADOS-G) - the primary outcome measure, and on two out of the three functional domains of the Autism Diagnostic Interview-Revised (ADI-R).

Exclusion criteria

Exclusion criteria: 1. Cases where primary language at home is not English 2. Significant hearing or visual impairment in child or adult 3. Clinically severe psychiatric illness in parents We judge that the above features could make a treatment based on dyadic communication unreliable to administer. 4. Children below a threshold of 11-month non-verbal developmental age assessed on the Mullen scales of early learning will also be excluded Additional exclusion criteria added as of 01/08/2007: 5. Twins 6. Epilepsy requiring regular medication

Design outcomes

Primary

Measure	Time frame
Primary outcome measures amended as of 01/08/2007: Endpoint is 13 months after start of treatment. The primary outcome will be the total score on the ADOS-G, a structured play-based assessment between researcher and child, videotaped for independent coding within domains of reciprocal social interaction, language, communication and autism specific behaviours. It will be rated blind to case status. The ADOS-G is the gold standard observational measure of autism specific symptoms. There will also be economic analysis including cost effectiveness. Primary outcome measures provided at time of registration: Endpoint is 12 months after start of treatment. The primary outcome will be the total score on the ADOS-G, a structured play-based assessment between researcher and child, videotaped for independent coding within domains of reciprocal social interaction, language, communication and autism specific behaviours. It will be rated blind to case status. The ADOS-G is the gold standard observational measure of autism specific symptoms. There will also be economic analysis including cost effectiveness.	—

Measure

Time frame

Primary outcome measures amended as of 01/08/2007: Endpoint is 13 months after start of treatment. The primary outcome will be the total score on the ADOS-G, a structured play-based assessment between researcher and child, videotaped for independent coding within domains of reciprocal social interaction, language, communication and autism specific behaviours. It will be rated blind to case status. The ADOS-G is the gold standard observational measure of autism specific symptoms. There will also be economic analysis including cost effectiveness. Primary outcome measures provided at time of registration: Endpoint is 12 months after start of treatment. The primary outcome will be the total score on the ADOS-G, a structured play-based assessment between researcher and child, videotaped for independent coding within domains of reciprocal social interaction, language, communication and autism specific behaviours. It will be rated blind to case status. The ADOS-G is the gold standard observational measure of autism specific symptoms. There will also be economic analysis including cost effectiveness.

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Secondary

Measure	Time frame
Added as of 31/07/2007: Parent-Child Interaction measure (PCI): MacArthur Communication Development Inventory (MCDI), Preschool Language Scales (PLS) and the Teacher Vineland Adaptive Behaviour Schedule (TVABS)	—

Countries

United Kingdom

Outcome results

None listed