Autism spectrum disorder (ASD) Mental and Behavioural Disorders
Conditions
Interventions
The study evaluates the effectiveness of a robot-assisted behavioral intervention aimed at improving action sequencing skills in children with Autism Spectrum Disorder (ASD). The intervention is compa
Sponsors
Istituto Italiano di Tecnologia
Eligibility
Sex/Gender
All
Age
6 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Children aged 6 to 15 years at the time of enrollment 2. Formal diagnosis of Autism Spectrum Disorder (ASD) confirmed through standardized tools: 2.1. Autism Diagnostic Interview–Revised (ADI-R) 2.2. Autism Diagnostic Observation Schedule – Second Edition (ADOS-2) 3. Sufficient receptive language and cognitive ability to understand and follow task instructions 4. Regular attendance at the participating clinical center(s) 5. Parental or legal guardian consent obtained, with age-appropriate assent from the child 6. Inclusive of all genders, ethnicities, and socioeconomic backgrounds 7. Not currently enrolled in any conflicting experimental therapy programs
Exclusion criteria
Exclusion criteria: 1. Presence of severe intellectual disability that would prevent meaningful engagement with the training protocol 2. Significant behavioral disturbances (e.g., severe aggression, self-injury) that could interfere with participation or safety 3. Uncorrected sensory impairments (e.g., vision or hearing problems) that would limit interaction with the robot or materials 4. Diagnosed neurological or medical conditions not related to ASD that may confound outcomes 5. Ongoing participation in other experimental or non-standardized interventions 6. Irregular attendance at the clinical center, preventing completion of the training protocol or assessments 7. Inability to obtain informed consent from a parent or legal guardian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Action sequencing and adaptive functioning: 1. Theory of Mind, facial affect recognition, and contextual understanding of social interactions, assessed using NEPSY-II – Social Perception Subscale 2. Ability to comprehend, recall, and execute sequential actions in both cognitive and practical domains, assessed using Batteria per la Valutazione della Sequenzialità Cognitiva e Operativa (BVSCO) 3. Practical, social, and conceptual skills essential for daily functioning and autonomy in real-life contexts, assessed using the Adaptive Behavior Assessment System (ABAS) Assessment Timeline: T0 (Baseline) – Before any intervention T1 (Midpoint) – After the first phase (training or control) T2 (Post-crossover) – After the second phase Blinding: All assessments are conducted by clinicians blind to the intervention phase of the participant to reduce bias. Scoring and Interpretation: Improvement is quantified through pre-post differences across all three tools, focusing on gains in social cognition, sequencing ability, and adaptive functioning. Statistical comparisons are made across and within groups (crossover design). | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinician feedback via focus groups: structured focus groups were conducted with clinical professionals at three key time points during the study: 17 July 2024, 15 January 2025, and 21 May 2025. These sessions served as both a participatory research method and a tool to assess the clinical relevance, usability, and perceived effectiveness of the robot-assisted intervention. Assessment Focus: 1. Observed changes in children's autonomy and behavior in clinical settings 2. Perceived generalization of training effects to daily life 3. Suggestions for improving training protocols and personalization 4. Practical feasibility of long-term implementation Analysis Method: Qualitative content analysis of transcribed focus group discussions, coded for themes such as engagement, skill transfer, adaptability, and clinical utility. Purpose: These qualitative insights support the interpretation of quantitative outcomes and guide the iterative development of the RONIN intervention for future clinical trials. | — |
Countries
Italy
Contacts
Public ContactAgnieszka Wykowska
Outcome results
None listed