Clinical trial NCT06974240: Social Robotics for Autism
Official title: Social Robotics Intervention for Improving Socio-Pragmatic Skills in Autism: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: autism
social robot
social pragmatic skills
intervention
social skills
educational technologies
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2025-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Wechsler Intelligence Scale for Children 4° edizione (WISC-IV)
timeFrame: Baseline assessment at Day 1 (prior to intervention); the test requires approximately 56-80 minutes to complete.
measure: Language Pragmatic Abilities (APL) -MEDEA
timeFrame: Baseline assessment at Day 1 (pre-intervention) and post-intervention assessment at 3 months (at the end of the intervention); each test session lasts approximately 30-45 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Taheri, A., Shariati, A., Heidari, R., Shahab, M., Alemi, M., &amp; 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.
citation: 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.