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

Abstract

BackgroundPrior 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/designThis 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.DiscussionThis 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 registrationISRCTN, ID: 25378536. Prospectively registered on 9 March 2016:Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2881-3) contains supplementary material, which is available to authorized users.

Study protocol of the multi-centre, randomized controlled trial of the Frankfurt Early Intervention Program A-FFIP versus early intervention as usual for toddlers and preschool children with Autism Spectrum Disorder (A-FFIP study)

“…Therapists need to meet pre-specified criteria regarding their therapy related competencies before being allowed to treat the children within the study and will be supervised regularly during the study period. Most high quality studies in early intervention, such as PACT [14,85] and ESDM [11], reported on their training procedures, which are overall comparable with the one implemented in the present study.…”

“…The diagnostic team leader has received training on the BOSCC and the DCMA by the developer of the regarding instruments, before. This procedure has also been reported in similar intervention studies [45,85,86].…”

“…Only one multicentre RCT has used the blinded ADOS as primary outcome to describe change in core ASD symptoms [14,85]. In the primary analysis, no change of core ASD symptoms was observed.…”

Pre-School Teachers’ Knowledge, Belief, Identification Skills, and Self-Efficacy in Identifying Autism Spectrum Disorder (ASD): A Conceptual Framework to Identify Children with ASD

“…Moreover, a high sense of self-efficacy is positively related to promising results. For example, it is associated with encouraging in-class behavior, classroom practice, use of praise more often than criticism, increased perseverance with "low achievers," spending more time monitoring student performance, and spending more time on class preparation and paperwork, increased willingness to collaborate with other professionals regarding student concerns, increased significant effort, and increased success [87][88][89][90][91].…”

Point OutWords: protocol for a feasibility randomised controlled trial of a motor skills intervention to promote communicative development in non-verbal children with autism

“…Indeed, the answer will lie in cumulative effectiveness research and the use of common outcome measures across trials so that systematic reviews and meta-analyses can be easily conducted in the future [2]. The current trial prepares for this prospect, adopting measures such as the DCMA and BOSCC used in the PACT-G trial [69], and VABS-2 and the MSEL used in the Early Start Denver Model trial [12] and many other studies of autism. While the current trial is not sufficiently scoped to ascertain whether the Point OutWords intervention is effective in improving communication skills in children with autism, it can inform the design of larger RCTs, not only for Point OutWords but also for other early interventions in autism.…”