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

Condition(s) studied

Investigational drug(s) / intervention(s)

Intervention with social robot NAO: 12 session of 30 minutes, one sessione per week with social robot NAO and a therapist, working on social intransitive gestures

Treatment as usual: Psychomotor/behavioral or speech therapy as usual

Study summary

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.

Eligibility

Primary outcome measure(s)

• Early Social Communication Scale (Échelle de la Communication Sociale Précoce, Italian adaptation, ECSP-I) — T0 (recruitment), T1 (T0 + 3 months); T2 (T0 + 6 months)
  the ECSP-I is a structured assessment designed to provide measures of individual differences in nonverbal communication skills in children from 3 to 30 months of age for typical development and behiond for atypical development. The administration requires 15-20 min involving the presentation of approximately 23 standardised situations which provide opportunities for social communication. The ECSP-I demonstrates strong reliability and both construct and discriminant validity
• Satisfaction Survey — T1 (T0 + 3 months)
  Parents of ASD children will also be asked to anonymously complete a satisfaction survey (created ad hoc for this project) immediately after the intervention to assess their satisfaction with the services provided. The questionnaire takes 5 minutes to complete. unit of measure: likert scale, range 0-5
• Robotic adaptation of two tasks of the Early Social Communication Scale (Échelle de la Communication Sociale Précoce, Italian adaptation, ECSP-I) — T0 (recruitment), T1 (T0 + 3 months); T2 (T0 + 6 months)
  Two tasks of the ECSP-I has been adapted for the administration by a social robot. Two tasks of the ECSP-I have been adapted for administration by a social robot. 1. Respond to the robot's pointing out of the posters on the walls of the room to evaluate the response to shared attention. 2. The robot proposes a mechanical toy that it can operate itself to assess the child's joint attention initiatives.

Trial sites (1)

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