Abstract
BackgroundNaturalistic developmental behavioural interventions (NDBI) have been shown to improve autism-specific symptoms in young children with Autism Spectrum Disorder (ASD). NDBI approaches, such as the ASD-specific Frankfurt Early Intervention Programme for ASD (A-FFIP), are based on ASD-specific developmental and learning aspects. A-FFIP is a low-intensity intervention which can easily be implemented in the local health care/social welfare system. The aim of the present study is to establish 1-year efficacy of the manualised early intervention programme A-FFIP in toddlers and preschool children with ASD. It is hypothesised that A-FFIP will result in improved ASD-specific symptoms compared to early intervention as usual (EIAU). Child- and family-specific secondary outcomes, as well as moderators and mediators of outcome, will be explored.Methods/designA prospective, multi-centre, parallel-group, randomised controlled, phase-III trial comparing A-FFIP versus EIAU. A total of 134 children (A-FFIP: 67, EIAU: 67) aged 24–66 months at baseline assessment meeting the criteria for ASD (DSM-5) will be included. The primary outcome is the absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC-AT) between baseline (T2) and 1-year follow-up (T6). The treatment effect will be tested, adjusted for relevant covariates applying a mixed model for repeated measures. Secondary outcomes are BOSCC social communication and repetitive-behaviour scores, single ASD symptoms, language, cognition, psychopathology, parental well-being and family quality of life. Predictors, moderators and mediating mechanisms will be explored.DiscussionIf efficacy of the manualised A-FFIP early intervention is established, the current study has the potential to change clinical practice strongly towards the implementation of a low-intensity, evidence-based, natural early intervention in ASD. Early intervention in ASD requires specialist training, which subsequently needs to be developed or included into current training curricula.Trial registrationGerman Registry for Clinical Trials (Deutscher Register Klinischer Studien, DRKS); ID: 00016330. Retrospectively registered on 4 January 2019. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016330.
Highlights
Naturalistic developmental behavioural interventions (NDBI) have been shown to improve autismspecific symptoms in young children with Autism Spectrum Disorder (ASD)
The confirmatory test for treatment-group difference with respect to the primary efficacy endpoint will be done applying a mixed model for repeated measures (MMRM) approach [79] modelling the difference to baseline including the fixed-effects baseline Brief Observation of Social Communication Change (BOSCC)-AT, chronological age, treatment group, time, and treatmentgroup-by-time interaction; centre will be included as random effect
The present randomised controlled, multi-centre, parallelgroup trial including an active control group aims at establishing efficacy of the manualised A-FFIP early intervention programme for toddlers and preschool-aged children with ASD on ASD-specific symptom change after 1 year
Summary
Naturalistic developmental behavioural interventions (NDBI) have been shown to improve autismspecific symptoms in young children with Autism Spectrum Disorder (ASD). Just 5–10% of adult ASD individuals are living independently in Europe [3] It is likely, that effective early intervention will decrease long-term costs and improve outcome [4]. Toddlers and preschool-aged children with ASD show severe impairments in many developmental areas, such as visuo-motor abilities, attentional control, joint attention, imitation, social orientation and motivation, social cognition, play, abstract and concept formation, communication and language, emotion regulation and executive function [5,6,7] These result in chronically impaired language, social communication and interaction with peers and adults, which are predictors of adult outcome in ASD [8]. To improve long-term outcomes, developmentally based early intervention needs to be studied for efficacy on the child’s core ASD symptoms as well as on other important developmental areas such as language, cognition and behaviour
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