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

NCT06855446 | Recruiting

• 1 other identifier: 94-8
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.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.
4. 4.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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• Early Social Communication Scale (Échelle de la Communication Sociale Précoce, Italian adaptation, ECSP-I)

  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

  T0 (recruitment), T1 (T0 + 3 months); T2 (T0 + 6 months)

• Satisfaction Survey

  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

  T1 (T0 + 3 months)

• Robotic adaptation of two tasks of the Early Social Communication Scale (Échelle de la Communication Sociale Précoce, Italian adaptation, ECSP-I)

  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.

  T0 (recruitment), T1 (T0 + 3 months); T2 (T0 + 6 months)

Secondary Outcomes (2)

• McArthur-Bates questionnaire, child's first vocabulary (PVB) - gestures and words

  T0 (recruitment), T1 (T0 + 3 months); T2 (T0 + 6 months)

• Adaptive Behavior Assessment System (2nd ed.)

  T0 (recruitment), T1 (T0 + 3 months); T2 (T0 + 6 months)

Study Arms (2)

Group 1

EXPERIMENTAL

The group 1 will be assessed at T0, will undergo to control period of 12 weeks, continuing treatment as usual, at T1 will be re-assessed and will undergo to treatment with robot NAO + treatment as usual for 12 weeks, then will undergo to re-assessment at T2

Behavioral: Intervention with social robot NAO; Behavioral: Treatment as usual

Group 2

EXPERIMENTAL

The group 2 will be assessed at T0, will undergo to treatment with robot NAO + treatment as usual for 12 weeks, at T1 will be re-assessed and then will undergo to follow-up period of 12 weeks, continuing treatment as usual, then will undergo to re-assessment at T2

Behavioral: Intervention with social robot NAO; Behavioral: Treatment as usual

Interventions

Intervention with social robot NAO BEHAVIORAL

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

Group 1; Group 2

Treatment as usual BEHAVIORAL

Psychomotor/behavioral or speech therapy as usual

Group 1; Group 2

Eligibility Criteria

• Age: 18 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Autism Spectrum Disorder diagnosis

You may not qualify if:

• known genetic or metabolic diseases

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Politecnico di Milano: collaborator
• University of Turin, Italy: collaborator

Study Sites (1)

Santa Maria Nascente, Milano, Italy 20148

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Methods; Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Chiara Fanciullacci

CONTACT

0039055 7393653; ctu@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 3, 2025
• Study Start: July 14, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)