Multicentre, randomized controlled trial of the Frankfurt Early Intervention Program for toddlers and preschool aged children with Autism Spectrum Disorder - ASD-FFIP-net

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The present study is a phase-III confirmatory multicentre, randomized controlled trial of the Frankfurt Early Intervention Program for toddlers and preschool children with Autism Spectrum Disorder (A-FFIP). A-FFIP is a manualised, model-based program. It is classified as a low frequency (2 hrs/week) naturalistic, developmental behavioural intervention (NDBI), i.e. belonging to the group of approaches which currently are considered to best improve social communication in toddlers and preschool-aged children with Autism-Spectrum-Disorder. In a pilot controlled study (N=40), medium improvements in the ADOS comparison score were found after one year. Here, we hypothesize, that A-FFIP will lead to less autism-specific symptoms in the intervention compared to the active control group after one year.Main inclusion criteria: Autism Spectrum Disorder (DSM-5), age 2;0 – 5;6 years old at T2; non-verbal ID/DQ > 30. Primary endpoint: Absolute change in the total score of the Brief Observation of Social Communication Change (BOSCC) between baseline and 12 months after the first intervention session. The BOSCC is obtained from a standardised play situation with an unknown tester to assess generalisation of distant social-communication skills. It is blindly rated from video by an independent, reliable rater.The current study goes beyond previous RCTs regarding the choice of outcome measures, exploring innovative moderators and mediators, and ensuring high study quality. 1. Outcomes: In addition to the blinded BOSCC, we include secondary outcomes capturing social-communication and repetitive behaviour. Similar to other RCTs, we study change in child’s cognition and language, but go beyond by adding the child’s internalising and externalising psychopathology, executive function abilities, and parental and family related measures as secondary outcomes.2. Moderators: In addition to the child’s age, cognitive ability and core ASD symptoms, her/his social orienting and attention abilities objectively assessed by eye-tracking at start of intervention, and parental education status will be explored as moderator of treatment effect.3. Mediators: The child’s gain regarding joint attention, social interaction, cognitive and fine-motor skills during intervention as well as parental synchrony and treatment adherence are explored as mediators of change in core ASD symptoms, cognition and language.4. Quality: Risk of bias is minimized by study design. Execution of the study is monitored by two pre-trial and ongoing visits. Constant training and supervision of objective diagnostic assessment and manual based intervention across all centres. Taken together, the present A-FFIP study has chosen a design which fits very well into the current state of research, and will add new results on efficacy, moderators and mediators of low frequency, therapist and centre based NDBI approaches, including parents and kindergarten teachers into the intervention.