Promoting Communication in Minimally Verbal Autistic Children with Social Robot

IRCCS Centro Neurolesi Bonino Pulejo

Status: Invitation-only

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Standard therapeutic; Behavioral: NAO-Assisted Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06805916

NAO01

Details and patient eligibility

About

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.

Full description

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by deficits in social communication and restricted, repetitive patterns of behavior, interests, or activities. Among individuals with ASD, approximately 25-30% are minimally verbal (MV), demonstrating limited verbal or non-verbal communication skills, which poses significant challenges for social interaction and learning. Early diagnosis and tailored therapeutic interventions are crucial for improving long-term outcomes in this population. However, traditional therapies often face limitations, including variability in efficacy and difficulty maintaining engagement among MV children. In recent years, the integration of advanced technologies into therapeutic programs has gained traction as an innovative approach to address communication challenges in ASD. Social robots, such as the humanoid robot NAO, offer unique opportunities to engage children with ASD through consistent and predictable interactions. NAO is equipped with capabilities including speech recognition, gestures, and responses to touch and movement, making it an effective tool for promoting communication and social behaviors. Preliminary studies suggest that social robots can enhance engagement and improve social skills in children with ASD, yet their potential remains underexplored in minimally verbal children. This single-blind, randomized, controlled study aims to evaluate the feasibility and effectiveness of a rehabilitative treatment program integrating the NAO robot for minimally verbal children with ASD. NAO-assisted therapy sessions are designed to promote communicative initiative, expressive language, and social interaction through interactive tasks tailored to each child's needs.

The study's outcomes will be measured using standardized communication assessments, including the Test of Verbalization (TVL), and observational data to evaluate engagement, responsiveness, and frequency of communicative behaviors. By leveraging advanced robotic technology, this study aims to explore new avenues for therapeutic interventions, ultimately contributing to the development of evidence-based strategies that improve the quality of life for minimally verbal children with ASD and their families.

Enrollment: 100 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Autism Spectrum Disorder (ASD)
• Minimal verbal communication
• Age between 4 and 12 years.

Exclusion criteria

• Presence of severe intellectual disability.
• Diagnosis of neurological disorders other than ASD.
• Significant medical conditions that could interfere with study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

NAO-Assisted Intervention (Experimental Group EG)

Experimental group

Description:

The treatment group consists of 50 children diagnosed with Autism Spectrum Disorder (ASD) who are minimally verbal (MV). Participants were randomly assigned and underwent a structured rehabilitative program integrated with the use of the NAO humanoid robot. The intervention was tailored to individual needs and aimed at improving communicative initiative, verbalization, and social engagement. Each child received therapy over a period of 12 weeks, totaling 12 sessions, once per week, with each session lasting 45 minutes.

Treatment:

Behavioral: NAO-Assisted Therapy

Standard Therapy (Control Group)

Active Comparator group

Description:

The control group consists of 50 children diagnosed with Autism Spectrum Disorder (ASD) who are minimally verbal (MV). Participants were randomly assigned and underwent standard therapeutic approaches, which included traditional speech therapy provided by trained therapists. The therapy followed established protocols and was adapted to meet the specific needs of minimally verbal children. Each child received therapy over a period of 12 weeks, totaling 12 sessions, once per week, with each session lasting 45 minutes.

Treatment:

Behavioral: Standard therapeutic