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

摘要: Naturalistic 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 and learning aspects. A-FFIP is a low-intensity intervention which can easily be implemented local health care/social welfare system. The aim of present study establish 1-year efficacy manualised early programme toddlers preschool ASD. It hypothesised that will result improved compared usual (EIAU). Child- family-specific secondary outcomes, well moderators mediators outcome, explored. A prospective, multi-centre, parallel-group, randomised controlled, phase-III trial comparing versus EIAU. total 134 (A-FFIP: 67, EIAU: 67) aged 24–66 months at baseline assessment meeting criteria (DSM-5) included. primary outcome absolute change score Brief Observation Social Communication Change (BOSCC-AT) between (T2) follow-up (T6). treatment effect tested, adjusted relevant covariates applying mixed model repeated measures. Secondary outcomes BOSCC social communication repetitive-behaviour scores, single symptoms, language, cognition, psychopathology, parental well-being family quality life. Predictors, mediating mechanisms If established, current has potential clinical practice strongly towards implementation low-intensity, evidence-based, natural requires specialist training, subsequently needs developed or included into training curricula. German Registry Clinical Trials (Deutscher Register Klinischer Studien, DRKS); ID: 00016330. Retrospectively registered 4 January 2019. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00016330.