Clinical trial NCT06805916: Promoting Communication in Minimally Verbal Autistic Children with Social Robot
Official title: Promoting Communicative Initiative in Minimally Verbal Autistic Children Through Interaction with the Humanoid Social Robot
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Language Development Level Test (TVL)
timeFrame: T0(baseline)-T1(3months)
measure: The Child Behavior Checklist (CBCL)
timeFrame: T0(baseline)-T1(3months)
measure: Quality of Life in Autism Questionnaire (QoLA)
timeFrame: T0(baseline)-T1(3months)
measure: Repetitive Behavior Scale (RBS)
timeFrame: T0(baseline)-T1(3months)
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: T0(baseline)-T1(3months)
measure: Conners' Parent Rating Scale (CPRS)
timeFrame: T0(baseline)-T1(3months)
measure: Mand Requests During Sessions
timeFrame: During Sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
Study officials:
affiliation: IRCCS Centro Neurolesi Bonino Pulejo
name: Margherita La Fauci
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital "G. Martino"
name: Maria Tresoldi
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Centro Neurolesi Bonino Pulejo
name: Marcella Di Cara
role: PRINCIPAL_INVESTIGATOR
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citation: Korneder J, Louie WG, Pawluk CM, Abbas I, Brys M, Rooney F. Robot-mediated interventions for teaching children with ASD: A new intraverbal skill. Assist Technol. 2022 Nov 2;34(6):707-716. doi: 10.1080/10400435.2021.1930284. Epub 2021 May 28.
citation: Salimi Z, Jenabi E, Bashirian S. Are social robots ready yet to be used in care and therapy of autism spectrum disorder: A systematic review of randomized controlled trials. Neurosci Biobehav Rev. 2021 Oct;129:1-16. doi: 10.1016/j.neubiorev.2021.04.009. Epub 2021 Apr 20.