What this Trial Is About

Background: The importance of early intervention in Autism Spectrum Disorders (ASD) has been widely demonstrated, and developmental trajectories in ASD highlight the importance of nonverbal communication, such as intransitive gesture production, as a possible positive prognostic factor for language development. The use of technological tools in the therapy of individuals with ASD has also become increasingly important due to their increased engagement and responsiveness to technological objects, such as robots. Materials and methods: We developed a training protocol using the humanoid robot NAO, called IOGIOCO (Interactive mirroring Games wIth sOCial rObot), based on the use of intransitive gestures embedded in naturalistic dialogues, stimulating a triadic interaction between child, robot and therapist. The training is divided into six levels; the first 2 levels were called "familiarization levels," and the other 4 were "training levels". The technological setup includes different complexity levels, from mirroring tasks to building spontaneous interactions. We previously tested the protocol on 10 preschool children with ASD (aged 2-6 years) in a pilot study founding promising results (Annunziata et al,2024). We therefore developed a Randomized Controlled Trial to test the efficacy of this intervention. The project is to be divided into three phases. 1. Establishment, adaptation, and subsequent validation of the video recording setting, accompanied by the identification of the quantitative parameters discernible through technological tools (ECSP-I\_rob) on a sample of typically developing children aged between 18 and 24 months. 2. Setting, adaptation, and and subsequently validate the video recording setting with the measurement of the quantitative parameters detectable through technological tools (ECSP-I\_rob) on a sample of children with Autism Spectrum Disorder under the age of 72 months. 3\) Initiate training with NAO on a group of children with ASD aged 24-72 months with pre- and post-treatment ECSP-I administration Objectives 1. Evaluate the effectiveness of the robot-based intervention on social-communicative skills and in the acquisition of intransitive gestures used for communicative purposes using the ECSP-I and the MacArthur questionnaire as outcome measures. 2. Identify and describe measurable parameters of "social" interaction within the rehabilitation session with NAO and the operator. Furthermore, it is essential to verify their evolution and differences at the beginning and end of treatment and between the different social partners. We aim to enroll 20 typical children aged 18-24 months to validate the ECSP-I robot. For the phase 2 and 3 we aim to enroll 20 ASD preschool children with an ASD diagnosis according to DSM-5 criteria (confirmed by ADOS-2). We will test them at T0 (Griffiths-III, ABAS-II, MacArthur-Bates number of gestures) and randomly assign them to two groups, G1 and G2, according to a cross-over design. After T0 assessment, Group 1 will undergo to a 12-weekly-session training with the social robot NAO, while G2 will continue the therapy as usual. We will assess again at T1 (after 12 sessions, through ABAS-II and MacArthur-Bates), subsequently G1 will be included in a follow-up group, while the G2 will undergo to the social robot intervention. We will assess all the participants at T2; we will moreover administrate a satisfaction questionnaire to parents.

Interactive Mirroring Games wIth sOcial Robot (IOGIOCO) and Robotic System Adapted Into a Clinical Scale (RISCALE)