Social Robotics for Autism

NCT ID: NCT06974240

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2024-11-30

Brief Summary

Socio-pragmatics focuses on the study of language in the context of social interactions. It explores how individuals use language to communicate effectively in specific social situations, taking into consideration the social, cultural and contextual factors that influence communication. Socio-pragmatics analyzes linguistic and nonlinguistic behaviors, such as gestures, facial expressions, tone of voice, and posture, to understand intended meaning, social implications, and shared communicative norms. Children with autism often present difficulties in social-pragmatic skills.

The integration of advanced technologies can play a crucial role in innovative approaches to the development of this skill.

In this experimental protocol, an attempt will be made to demonstrate the effectiveness of training through the use of social robots by comparing the performance of an ASD group performing a treatment using social robots with a control group performing the same in a traditional manner.

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group with social robot

Ten children with ASD, aged between 8 and 13 years and with verbal IQs above 75, will be included in the trial following an assessment of their socio-pragmatic skills. They will be randomly assigned to either the control group or the experimental group. Participants in the experimental group will undergo an intervention aimed at developing and/or enhancing socio-pragmatic skills through the mediation of a social robot.

Group Type: EXPERIMENTAL

Experimental Group

Intervention Type: OTHER

The training sessions were carried out following a strict order. The first phase was dedicated to improving group social skills. The beginning of the session was dedicated to greetings between participants and questions of social interest. During the second phase, videos were shown and participants answered targeted questions asked by the Nao Robot to understand if the child had correctly interpreted the general meaning of the story and to determine the degree of awareness that the expression should be understood in a non-literal sense. In the third phase, a role play was performed among the participants, which re-enacted the situations seen in the videos, involving all the members of the group in turn. During the last phase, participants were asked to share experiences in their lives in which they had used or could have used the pragmatic skill just analyzed. The protocol included 15 phases over 31 sessions, each lasting 45 minutes, twice a week.

Control Group

Ten children with ASD, aged between 8 and 13 years and with verbal IQs above 75, will be included in the trial following an assessment of their socio-pragmatic skills. Children in the control group will follow the same protocol of Experimental Group delivered through a therapist-led group format.

Group Type: OTHER

control group

Intervention Type: OTHER

The entire intervention was carried out in a group entirely mediated by an operator without the use of a social robot. The first phase is dedicated to improving group social skills. The beginning of the session was dedicated to greetings between participants and questions of social interest. During the second phase, stories were read and participants answered target questions to understand if the child had correctly interpreted the general meaning of the story and to determine the degree of awareness that the expression should be understood in a non-literal sense. In the third phase, a role play was performed among the participants, in which all members of the group participated in turn, recalling the situations seen in the videos. During the last phase, participants were asked to share experiences from their lives in which they used or could use the pragmatic skill just analyzed. The protocol included 15 phases over 31 sessions, each lasting 45 minutes, twice a week.

Interventions

Experimental Group

The training sessions were carried out following a strict order. The first phase was dedicated to improving group social skills. The beginning of the session was dedicated to greetings between participants and questions of social interest. During the second phase, videos were shown and participants answered targeted questions asked by the Nao Robot to understand if the child had correctly interpreted the general meaning of the story and to determine the degree of awareness that the expression should be understood in a non-literal sense. In the third phase, a role play was performed among the participants, which re-enacted the situations seen in the videos, involving all the members of the group in turn. During the last phase, participants were asked to share experiences in their lives in which they had used or could have used the pragmatic skill just analyzed. The protocol included 15 phases over 31 sessions, each lasting 45 minutes, twice a week.

Intervention Type: OTHER

control group

The entire intervention was carried out in a group entirely mediated by an operator without the use of a social robot. The first phase is dedicated to improving group social skills. The beginning of the session was dedicated to greetings between participants and questions of social interest. During the second phase, stories were read and participants answered target questions to understand if the child had correctly interpreted the general meaning of the story and to determine the degree of awareness that the expression should be understood in a non-literal sense. In the third phase, a role play was performed among the participants, in which all members of the group participated in turn, recalling the situations seen in the videos. During the last phase, participants were asked to share experiences from their lives in which they used or could use the pragmatic skill just analyzed. The protocol included 15 phases over 31 sessions, each lasting 45 minutes, twice a week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged between 8 and 13 years
• Clinical diagnosis of ASD according to DSM-5 criteria by a licensed child neuropsychiatrist
• Verbal and performance IQ > 75 and total IQ > 85, assessed with the WISC-IV
• No current aggressive behavior or severe oppositional tendencies
• No hearing, vision, or physical impairments that could interfere with participation
• Not currently taking any psychotropic medications

Exclusion Criteria

• Absence of a clinical diagnosis of ASD based on DSM-5 criteria
• Verbal or performance IQ ≤ 75, or total IQ ≤ 85 as assessed by WISC-IV
• Presence of aggressive behavior or severe oppositional tendencies
• Hearing, vision, or physical impairments that could hinder participation in the intervention
• Current use of psychotropic medications

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Messina, Italy

OTHER

Sponsor Role: collaborator

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role: lead

Responsible Party

Flavia Marino

Head of Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavia Marino

Role: PRINCIPAL_INVESTIGATOR

Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Locations

Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, , Italy

Countries

Italy

References

Holeva V, Nikopoulou VA, Lytridis C, Bazinas C, Kechayas P, Sidiropoulos G, Papadopoulou M, Kerasidou MD, Karatsioras C, Geronikola N, Papakostas GA, Kaburlasos VG, Evangeliou A. Effectiveness of a Robot-Assisted Psychological Intervention for Children with Autism Spectrum Disorder. J Autism Dev Disord. 2024 Feb;54(2):577-593. doi: 10.1007/s10803-022-05796-5. Epub 2022 Nov 4.

Reference Type: BACKGROUND

PMID: 36331688 (View on PubMed)

Taheri, A., Shariati, A., Heidari, R., Shahab, M., Alemi, M., & Meghdari, A. (2021). Impacts of using a social robot to teach music to children with low-functioning autism. Paladyn, Journal of Behavioral Robotics, 12(1), 256-275.

Reference Type: BACKGROUND

So WC, Cheng CH, Law WW, Wong T, Lee C, Kwok FY, Lee SH, Lam KY. Robot dramas may improve joint attention of Chinese-speaking low-functioning children with autism: stepped wedge trials. Disabil Rehabil Assist Technol. 2023 Feb;18(2):195-204. doi: 10.1080/17483107.2020.1841836. Epub 2020 Nov 13.

Reference Type: BACKGROUND

PMID: 33186058 (View on PubMed)

Other Identifiers

CNR-IRIB-PRO-2025-003

Identifier Type: -

Identifier Source: org_study_id