A pre-school communication intervention for autism practice and evidence

Jonathan GreenUniversity of Manchester, Manchester Academic Health Sciences Centre Royal Manchester Childrens Hospital Manchester, UK

Developmental Communication Focused Approach to Pre-school Intervention

BackgroundFocus on parent-child dyad - 80% of the childs communication pre-school

Abnormal communication in autismReduced shared attention and mutualityPragmatic impairmentsLanguage disorder

Imbalanced Parent-Child interactionPerplexityReduced meshing - asynchronyReduced child opportunities for communication learning, relating

But positively from the language intervention literatureAttending to communication acts increases themExpansion from childs base (semantic contingency) leads to more vocabularyChildren with autism need a high dose of this

Programme structurehttp://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)

Case StudyChild J

First sessionJ: 2 years 10 monthsVery 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.

Session 5:having worked on stage 1 targets: key target allowing J to leadFollowing Js 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.

By the endhaving 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 toAsk questions and give instructionsNegateMake commentsTake part in social routines

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

Prof Jonathan Green Dr Catherine AldredProf Andrew Pickles Dr Wendy MacdonaldDr Kathy Leadbitter

Prof Helen McConachieProf Ann Le CouteurKathryn Temple

Prof Tony CharmanDr Kristelle HudryDr Vicky Slonims

Prof Pat HowlinDr Sarah Byford Dr Barbara BarrettUniversity of ManchesterNewcastle UniversityInstitute of Education, London

Guys Hospital, LondonKings College, London

Clinician referralFull baseline assessmentDiagnostic, cognitive, interactionPACT + TAUFortnightly SALT sessions7m: Brief midpoint assessmentTAU Community services13m: Full endpoint assessmentPACT +TAUMonthly boostersTAUCommunity servicesRandomisationDesign First large RCT of an early psychosocial treatment3 site 2 arm, N=1522-4,11 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 mechanismsUse of RCT design to test basic science hypotheses

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

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

Hypotheses A targeted parent-mediated video-aided intervention will enhance parental communicative responsivenesswhich will elicit improved social responses/communication initiations from the childreduce abnormality in communicationwhich will generalise to reduction in objectively rated autism social/communicative symptomsSuggestive evidence from 2004 pilot study, other related parent interventions (for non-ASD at-risk populations) and developmental theory

Hypotheses A targeted parent-mediated video-aided intervention will enhance parental communicative responsivenesswhich will elicit improved social responses/communication initiations from the childreduce abnormality in communicationand generalise to reduction in autism social/communicative symptomsSuggestive evidence from 2004 pilot study, other related parent interventions (for non-ASD at-risk populations) and developmental theory

OutcomesPrimary outcomeADOS-G Social + Communication totalModified 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 initiationsLanguage (PLS)Social adaptation (teacher VABS) Non-blinded secondary outcomes parent ratedLanguage (MCDI)Early social communicative development (CSBS-DP-CQ)

ASSESSEDn=242

EXCLUDEDn=90

RANDOMISEDn = 152

TAUn = 75PACT + TAUn = 77 (>3 sess n=74)LOST TO FOLLOW UPn = 3

LOST TO FOLLOW UPn = 3

ENDPOINT DATA n = 72ENDPOINT DATAn = 74Study flow

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

Parent child interactionEndpoint 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

Hypotheses A targeted parent-mediated video-aided intervention will enhance parental communicative responsivenesswhich will elicit improved social responses/communication initiations from the childreduce abnormality in communicationand generalise to reduction in autism social/communicative symptomsSuggestive evidence from 2004 pilot study, other related parent interventions (for non-ASD at-risk populations) and developmental theory

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

Parental reportsLanguage (MCDI) big changes with treatmentReceptive: OR 3.4 (1.48 to 7.79)Expressive: OR 1.63 (0.76 to 3.51)Early social communication abilities (CSBS) - dittoSocial 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..

It was a revelation to me I thought I was the only person who knew my child and I didnt. When I watched the video he had his back to me he wasnt playing with me at all now I know him best but I didnt at the start of PACT.

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

InterpretationChanges in dyadic interaction and parent-rated outcomesConsequences 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?

Current/Future workProdromal intervention in infancy - iBASISPASS 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 schoolPACT Follow up in middle childhood to test developmental outcomes

Thank you!

jonathan.green@manchester.ac.uk

www.medicine.manchester.ac.uk/pact/www.medicine.manchester.ac.uk/ibasis/basisnetwork.org

Synchrony - ***2% loss in each armBalance overrecruitment by siteV low loss to FUBaseline analysis suggests excellent matching on measures

*Dyadic change variables max change in 6/12Absolute change in ADOS 4 pts like pilot*