title: Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial.
abstract: BACKGROUND
  Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children. We therefore investigated the efficacy of such an intervention in a larger trial.
  
  
  METHODS
  Children with core autism (aged 2 years to 4 years and 11 months) were randomly assigned in a one-to-one ratio to a parent-mediated communication-focused (Preschool Autism Communication Trial [PACT]) intervention or treatment as usual at three specialist centres in the UK. Those assigned to PACT were also given treatment as usual. Randomisation was by use of minimisation of probability in the marginal distribution of treatment centre, age (</=42 months or >42 months), and autism severity (Autism Diagnostic Observation Schedule-Generic [ADOS-G] algorithm score 12-17 or 18-24). Primary outcome was severity of autism symptoms (a total score of social communication algorithm items from ADOS-G, higher score indicating greater severity) at 13 months. Complementary secondary outcomes were measures of parent-child interaction, child language, and adaptive functioning in school. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN58133827.
  
  
  RESULTS
  152 children were recruited. 77 were assigned to PACT (London [n=26], Manchester [n=26], and Newcastle [n=25]); and 75 to treatment as usual (London [n=26], Manchester [n=26], and Newcastle [n=23]). At the 13-month endpoint, the severity of symptoms was reduced by 3.9 points (SD 4.7) on the ADOS-G algorithm in the group assigned to PACT, and 2.9 (3.9) in the group assigned to treatment as usual, representing a between-group effect size of -0.24 (95% CI -0.59 to 0.11), after adjustment for centre, sex, socioeconomic status, age, and verbal and non-verbal abilities. Treatment effect was positive for parental synchronous response to child (1.22, 0.85 to 1.59), child initiations with parent (0.41, 0.08 to 0.74), and for parent-child shared attention (0.33, -0.02 to 0.68). Effects on directly assessed language and adaptive functioning in school were small.
  
  
  CONCLUSIONS
  On the basis of our findings, we cannot recommend the addition of the PACT intervention to treatment as usual for the reduction of autism symptoms; however, a clear benefit was noted for parent-child dyadic social communication.
  
  
  BACKGROUND
  UK Medical Research Council, and UK Department for Children, Schools and Families.
authors.affiliation: Psychiatry Research Group, University of Manchester, Manchester, UK. jonathan.green@manchester.ac.uk
authors.forename: Jonathan
authors.initials: J
authors.lastname: Green
authors.forename: Tony
authors.initials: T
authors.lastname: Charman
authors.forename: Helen
authors.initials: H
authors.lastname: McConachie
authors.forename: Catherine
authors.initials: C
authors.lastname: Aldred
authors.forename: Vicky
authors.initials: V
authors.lastname: Slonims
authors.forename: Pat
authors.initials: P
authors.lastname: Howlin
authors.forename: Ann
authors.initials: A
authors.lastname: Le Couteur
authors.forename: Kathy
authors.initials: K
authors.lastname: Leadbitter
authors.forename: Kristelle
authors.initials: K
authors.lastname: Hudry
authors.forename: Sarah
authors.initials: S
authors.lastname: Byford
authors.forename: Barbara
authors.initials: B
authors.lastname: Barrett
authors.forename: Kathryn
authors.initials: K
authors.lastname: Temple
authors.forename: Wendy
authors.initials: W
authors.lastname: Macdonald
authors.forename: Andrew
authors.initials: A
authors.lastname: Pickles
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D000367:Age Factors; D001288:Attention; D001321:Autistic Disorder / Q000145:classification / Q000523:psychology / Q000628:therapy*; D002652:Child Behavior; D002663:Child Language; D002675:Child, Preschool; D003142:Communication; D004522:Educational Status; D005191:Family Characteristics; D005260:Female; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D009633:Nonverbal Communication; D010287:Parent-Child Relations; D010290:Parents / Q000193:education; D012737:Sex Factors; D012917:Social Adjustment; D012919:Social Behavior; D012923:Social Class; D016896:Treatment Outcome; D014705:Verbal Behavior; D055815:Young Adult