NCT06805916

Promoting Communication in Minimally Verbal Autistic Children with Social Robot

ENROLLING BY INVITATION NA Last updated 11 February 2025

What this trial tests

NA trial testing NAO-Assisted Therapy in Autism Spectrum Disorder in 100 participants. Enrolling by invitation.

Timeline

2 January 2023

Primary endpoint
30 September 2025

30 September 2025

Quick facts

Lead sponsor	IRCCS Centro Neurolesi Bonino Pulejo
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	2 January 2023
Primary completion	30 September 2025
Estimated completion	30 September 2025
Sites	1 location across Italy

Drugs / interventions tested

• NAO-Assisted Therapy
• Standard therapeutic

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

IRCCS Centro Neurolesi Bonino Pulejo — full company profile →

Who can join

Adults 4 to 12, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Minimally verbal (MV) children with Autism Spectrum Disorder (ASD) face significant challenges in communication and social interaction, which are fundamental to learning and development. Current therapeutic approaches, such as speech therapy and augmentative communication systems, often have variable efficacy due to engagement and responsiveness challenges. This pilot study investigates using of the humanoid robot NAO as part of a rehabilitative program designed for MV children with ASD. NAO, with its predictable and engaging interaction style, is hypothesized to enhance communicative initiative, expressive communication, and social interaction in this population. The study employs a randomized controlled trial design, assigning participants to either an NAO-assisted intervention group or a control group receiving standard therapy. Outcomes will be assessed using standardized measures of communication, social interaction, and observational data. This research aims to explore the potential of social robots as an innovative tool to addressing the unique needs of MV children with ASD, contributing to the development of effective, accessible therapeutic options that improve their quality of life and that of their families.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enhancing Communication in Minimally Verbal Autistic Children: A Study on NAO-Assisted Therapy.
   Di Cara M, La Fauci M, Tresoldi M, Caputo MR, et al · · 2025 · cited 1× · PMID 40507497 · DOI 10.3390/jcm14113735