1. A p re-school communication intervention for autism – practice and evidence Jonathan Green University of Manchester, Manchester Academic Health Sciences Centre Royal Manchester Childrens Hospital Manchester, UK

2. Developmental Communication Focused Approach to Pre-school Intervention

3. Background Focus on parent-child dyad - 80% of the child’s communication pre-school Abnormal communication in autism – Reduced shared attention and mutuality – Pragmatic impairments – Language disorder Imbalanced Parent-Child interaction – Perplexity – Reduced ‘meshing’ - ‘asynchrony’ – Reduced child opportunities for communication learning, relating But positively – from the language intervention literature – Attending to communication acts increases them – Expansion from child’s base (‘semantic contingency’) leads to more vocabulary – Children with autism need a high dose of this

4. Programme structure http://www.medicine.manchester.ac.uk/pact/ Parent-mediated video-aided intervention Developmentally staged: – Shared attention, parental synchronous response, adapted communication strategies, communication enhancement Initial 6 months – Biweekly clinic visits (3 hrs) + home work (30 mins/day) – viz 2hrs/wk Next 6 months – Consolidation – Monthly clinic visits + homework (30 mins/day) and generalisation 18 sessions possible (median 16 (IQR 13-17) attended in PACT)

5. Case Study Child J

6. First session J: 2 years 10 months Very object focused. No initiation of play. Mum having to work hard to try and engage him, but with little success. Very little language: observed “ready steady go” some colours and numbers used.

7. Session 5: having worked on stage 1 targets: key target allowing J to lead Following J’s lead has been a key factor in this stage of treatment. J is now initiating some play activities, interaction and joint attention. Mum is having to work less hard to engage J. Language: Some use of single words and some jargon.

8. By the end… having looked at communication functions and discussing ideas for setting up situations in which different functions of language could be firstly modelled and then elicited through sensitive use of teasers (we discussed the use of these in play but mum found it much more useful to discuss the use of these in everyday contexts), J was using language to… Ask questions and give instructionsNegate Make comments Take part in social routines

9. The Lancet (2010), 375, 9732; 2152-2160

10. Prof Jonathan Green Dr Catherine Aldred Prof Andrew Pickles Dr Wendy Macdonald Dr Kathy Leadbitter Prof Helen McConachie Prof Ann Le Couteur Kathryn Temple Prof Tony Charman Dr Kristelle Hudry Dr Vicky Slonims Prof Pat Howlin Dr Sarah Byford Dr Barbara Barrett University of Manchester Newcastle University Institute of Education, London Guys Hospital, London Kings College, London

11. Clinician referral Full baseline assessment Diagnostic, cognitive, interaction PACT + TAU Fortnightly SALT sessions 7m: Brief midpoint assessment TAU Community services 13m: Full endpoint assessment PACT +TAU Monthly boosters TAU Community services Randomisation Design First large RCT of an early psychosocial treatment 3 site 2 arm, N=152 2-4,11 yrs; core autistic disorder (ADOS-G/ADI-R) Testing a model deliverable in the NHS Pre-specified primary outcome and analysis plan Blinded rating of outcomes Testing mediating mechanisms Use of RCT design to test basic science hypotheses

12. Hypotheses A targeted parent-mediated video-aided intervention will enhance parental communicative responsiveness …which will in turn elicit improved social responses/communication initiations from the child ….and reduced abnormality in communication …which will generalise to reduction in objectively rated autism social/communicative symptoms – Suggestive evidence from 2004 pilot study, other related parent interventions (for non-ASD ‘at-risk’ populations) and developmental theory

13. Hypotheses A targeted parent-mediated video-aided intervention will enhance parental communicative responsiveness …which will elicit improved social responses/communication initiations from the child ….and reduced abnormality in communication …which will generalise to reduction in objectively rated autism social/communicative symptoms – Suggestive evidence from 2004 pilot study, other related parent interventions (for non-ASD ‘at-risk’ populations) and developmental theory

14. Hypotheses A targeted parent-mediated video-aided intervention will enhance parental communicative responsiveness …which will elicit improved social responses/communication initiations from the child …reduce abnormality in communication …which will generalise to reduction in objectively rated autism social/communicative symptoms – Suggestive evidence from 2004 pilot study, other related parent interventions (for non-ASD ‘at-risk’ populations) and developmental theory

15. Hypotheses A targeted parent-mediated video-aided intervention will enhance parental communicative responsiveness …which will elicit improved social responses/communication initiations from the child …reduce abnormality in communication …and generalise to reduction in autism social/communicative symptoms – Suggestive evidence from 2004 pilot study, other related parent interventions (for non-ASD ‘at-risk’ populations) and developmental theory

16. Outcomes Primary outcome – ADOS-G Social + Communication total – Modified implementation of module rules and scoring for use as an index of change (Cathy Lord) Blinded secondary outcomes – Parent-child interaction (PCI) – parent synchronous responses – child communication initiations – Language (PLS) – Social adaptation (teacher VABS) Non-blinded secondary outcomes – parent rated – Language (MCDI) – Early social communicative development (CSBS-DP-CQ)

17. ASSESSED n=242 EXCLUDED n=90 RANDOMISED n = 152 TAU n = 75 PACT + TAU n = 77 (>3 sess n=74) LOST TO FOLLOW UP n = 3 LOST TO FOLLOW UP n = 3 ENDPOINT DATA n = 72 ENDPOINT DATA n = 74 Study flow

18. Hypotheses A targeted parent-mediated video-aided intervention will enhance parental communicative responsiveness …which will elicit improved social responses/communication initiations from the child ….and reduced abnormality in communication …which will generalise to reduction in objectively rated autism social/communicative symptoms – Suggestive evidence from 2004 pilot study, other related parent interventions (for non-ASD ‘at-risk’ populations) and developmental theory

19. Parent child interaction Endpoint ES 1.22 (0.85 to 1.59) – (Midpoint 1.44) OR (quintiles) 9.10 (4.39 to 18.9, sig) Endpoint ES 0.41 (0.08 to 0.74) – (Midpoint 0.5) OR (quintiles) 2.32 (1.21 to 4.42, sig) Parental synchronyChild initiations

20. Hypotheses A targeted parent-mediated video-aided intervention will enhance parental communicative responsiveness …which will elicit improved social responses/communication initiations from the child …reduce abnormality in communication …and generalise to reduction in autism social/communicative symptoms – Suggestive evidence from 2004 pilot study, other related parent interventions (for non-ASD ‘at-risk’ populations) and developmental theory

21. ADOS-G: - 3.9 in PACT, - 2.9 in TAU, ES -0.24 (95%CIs -0.59 to 0.11, ns) Moderator analysis: centre (p=0.52), non-verbal ability (p=0.47), language (p=0.51), ADOS severity (p=0.85), age (p=0.46), SES (p=0.10 ) Primary outcome ADOS-G; modified SC algorithm total

22. Parental reports Language (MCDI) – big changes with treatment – Receptive: OR 3.4 (1.48 to 7.79) – Expressive: OR 1.63 (0.76 to 3.51) Early social communication abilities (CSBS) - ditto – Social composite: OR 2.49 (1.27 to 4.89) Highly ‘ecologically valid’ but how much result of hope/expectation? Parent Evaluations in 18 post treatment interviews…..

23. ‘It was a revelation to me … I thought I was the only person who knew my child … and I didn’t. When I watched the video he had his back to me … he wasn’t playing with me at all … now I know him best … but I didn’t at the start of PACT.’

24. PACT Interventio n Attenuation of treatment effect on generalisation across interaction and context Parent interaction with Child Parental synchrony ES=1.22 (0.85, 1.59) Child interaction with Parent Child interaction with Assessor Child in School Child initiations ES=0.41 (0.08, 0.74) Autism symptoms (ADOS)ES =-0.24 (-0.59, 0.11) Social functioning in school ES=-0.19 (-0.44, 0.07) CONTEXT MEASURE

25. PACT pilot (n=28) - Change in parental synchrony mediated effect of treatment on child ADOS (ES.95) (Aldred, Green, Emsley, McConachie 2011 JADD) PACT (n=152) - Change in synchrony (ES 1.44 at 6/12) mediated improvement in child initiations (ES.41) and ADOS (ES.24) (Pickles, Green, Charman et al IMFAR 2011) Mediation

26. Interpretation Changes in dyadic interaction and parent-rated outcomes – Consequences for child development, parental morale, family environment, parent-child relationship, child adjustment?..but in line with other recent trials; PACT effected changes to proximal outcomes but less effect on distal outcomes – Measurement sensitivity? – Improvement in TAU? – ‘Transmission gap’; need for adjunctive Rx?

27. Current/Future work Prodromal intervention in infancy - iBASIS PASS – ‘Parent-mediated intervention for ASD in South Asia’ - Adaptation and implementation of PACT in India and Pakistan (Autism Speaks GAPH) ‘PACT 2’ - use of mediation and process analysis to generate evidenced-based generalisation strategies to home and school PACT Follow up – in middle childhood to test developmental outcomes

28. Thank you! jonathan.green@manchester.ac.uk www.medicine.manchester.ac.uk/pact/ www.medicine.manchester.ac.uk/ibasis/ basisnetwork.org