Paediatric Autism Communication Therapy-Generalised (PACT-G) against treatment as usual for reducing symptom severity in young children with autism spectrum disorder: study protocol for a randomised controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Child Behavior* ; Communication* ; Generalization, Psychological*; Autism Spectrum Disorder/*therapy ; Early Intervention, Educational/*methods; Age Factors ; Autism Spectrum Disorder/diagnosis ; Autism Spectrum Disorder/psychology ; Child ; Child, Preschool ; Female ; Humans ; Interpersonal Relations ; Male ; Multicenter Studies as Topic ; Parent-Child Relations ; Randomized Controlled Trials as Topic ; Severity of Illness Index ; Time Factors ; Treatment Outcome ; United Kingdom

Background: Prior evidence shows that behaviours closely related to the intervention delivered for autism are amenable to change, but it is more difficult to generalise treatment effects beyond the intervention context. We test an early autism intervention designed to promote generalisation of therapy-acquired skills into home and school contexts to improve adaptive function and reduce symptoms. A detailed mechanism study will address the process of such generalisation. Objective 1 will be to test if the PACT-G intervention improves autism symptom outcome in the home and school context of the intervention as well as in the primary outcome research setting. Objective 2 will use the mechanism analysis to test for evidence of acquired skills from intervention generalizing across contexts and producing additive effects on primary outcome.
Methods/design: This is a three-site, two-parallel-group, randomised controlled trial of the experimental treatment plus treatment as usual (TAU) versus TAU alone. Children aged 2-11 years (n = 244 (122 intervention/122 TAU; ~ 82/site) meeting criteria for core autism will be eligible. The experimental intervention builds on a clinic-based Pre-school Autism Communication Treatment model (PACT), delivered with the primary caregiver, combined with additional theory- and evidence-based strategies designed to enhance the generalisation of effects into naturalistic home and education contexts. The control intervention will be TAU.
Primary Outcome: autism symptom outcome, researcher-assessed using a standardised protocol.
Secondary Outcomes: autism symptoms, child interaction with parent or teacher, language and reported functional outcomes in home and school settings. Outcomes measured at baseline and 12-month endpoint in all settings with interim interaction measurements (7 months) to test treatment effect mechanisms. Primary analysis will estimate between-group difference in primary outcome using analysis of covariance with test of homogeneity of effect across age group. Mechanism analysis will use regression models to test for mediation on primary outcome by parent-child and teaching staff-child social interaction.
Discussion: This is an efficacy and mechanism trial of generalising evidence-based autism treatment into home and school settings. It will provide data on whether extending treatment across naturalistic contexts enhances overall effect and data on the mechanism in autism development of the generalisation of acquired developmental skills across contexts.
Trial Registration: ISRCTN, ID: 25378536 . Prospectively registered on 9 March 2016.

Stat Med. 2013 May 20;32(11):1964-73. (PMID: 23303653)
Lancet. 2016 Nov 19;388(10059):2501-2509. (PMID: 27793431)
Pediatrics. 2013 Apr;131(4):e1128-34. (PMID: 23460690)
Stat Methods Med Res. 2010 Jun;19(3):237-70. (PMID: 19608601)
Health Qual Life Outcomes. 2007 Nov 27;5:63. (PMID: 18042300)
J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. (PMID: 9255702)
J Child Psychol Psychiatry. 2008 Jun;49(6):635-45. (PMID: 18341547)
Int J Speech Lang Pathol. 2014 Feb;16(1):15-8. (PMID: 24410018)
J Am Acad Child Adolesc Psychiatry. 2015 Jul;54(7):580-7. (PMID: 26088663)
Autism Res Treat. 2012;2012:121878. (PMID: 23227334)
Child Adolesc Psychiatr Clin N Am. 2008 Oct;17(4):835-56, ix-x. (PMID: 18775373)
Clin Trials. 2018 Jun;15(3):247-256. (PMID: 29552919)
J Autism Dev Disord. 2005 Dec;35(6):695-708; discussion 709-11. (PMID: 16496206)
Pediatrics. 2011 May;127(5):e1303-11. (PMID: 21464190)
J Speech Lang Hear Res. 2013 Dec;56(6):1824-36. (PMID: 23926296)
J Child Psychol Psychiatry. 2011 Jul;52(7):741-52. (PMID: 21418212)
J Child Psychol Psychiatry. 2018 Apr;59(4):424-443. (PMID: 29574740)
J Child Psychol Psychiatry. 2015 Feb;56(2):162-70. (PMID: 25039961)
Pediatrics. 2014 Jul;134(1):e72-9. (PMID: 24958585)
Autism. 2012 Jul;16(4):398-405. (PMID: 22133872)
J Autism Dev Disord. 2016 Jul;46(7):2464-79. (PMID: 27062034)
J Adv Nurs. 2005 Jul;51(2):174-81. (PMID: 15963189)
J Autism Dev Disord. 2000 Oct;30(5):373-8. (PMID: 11098871)
Dev Psychol. 2008 Nov;44(6):1691-704. (PMID: 18999331)
J Autism Dev Disord. 2009 May;39(5):693-705. (PMID: 19082876)
J Am Acad Child Adolesc Psychiatry. 2013 Jun;52(6):572-81.e1. (PMID: 23702446)
Cochrane Database Syst Rev. 2013 Apr 30;(4):CD009774. (PMID: 23633377)
J Autism Dev Disord. 2012 May;42(5):797-804. (PMID: 22089166)
Lancet. 2010 Jun 19;375(9732):2152-60. (PMID: 20494434)
Pharmacoeconomics. 2012 Aug 1;30(8):729-47. (PMID: 22788262)

G0401546 United Kingdom MRC_ Medical Research Council; 13/119/18 Efficacy and Mechanism Evaluation Programme; EME/13/119/18 United Kingdom DH_ Department of Health; MR/R006164/1 United Kingdom MRC_ Medical Research Council; MR/K005863/1 United Kingdom MRC_ Medical Research Council

Investigator: M Balabanovska; H Beach; C Bennett; S Carruthers; I Crook; H Danvers; K Dartnall; C Ellis; H Foote; J Graham; K James; S Jamieson; A Knight; J Lowe; R Madeley; O Mitchell; F Monteiro; HL Moore; H Morley; J Rose; L Taylor; S Vosper
Keywords: Autism spectrum disorder; Randomised trial; School-based intervention; Social communication intervention

Date Created: 20180923 Date Completed: 20190108 Latest Revision: 20220323

20231215

PMC6150959

10.1186/s13063-018-2881-3

30241574