Using robots-assisted training to boost social skills in children with autism

Simulating social cognition: a randomized controlled trial of a humanoid-based approach to improve theory of mind skills in autism

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15341724

Enrollment

Registered

2025-05-06

Start date

2019-01-02

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodevelopmental disorders, specifically Autism Spectrum Disorder (ASD), with a focus on social cognition and Theory of Mind (ToM) interventions. Mental and Behavioural Disorders

Interventions

The study follows a two-period crossover design to compare the effectiveness of robot-assisted therapy and traditional therapy in improving Theory of Mind (ToM) skills in children with Autism Spectrum

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants included children aged 5 to 9 years with a formal diagnosis of Autism Spectrum Disorder (ASD). 2. Diagnosis was confirmed through the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule - Second Edition (ADOS-2). 3. Participants were required to have the ability to understand game instructions to ensure meaningful engagement in the intervention. 4. Participants were selected from those regularly attending the clinical center for ongoing therapy. 5. Inclusion was non-discriminatory, ensuring broad representation regardless of race, ethnicity, culture, gender, or socioeconomic status. 6. All participants had parental or legal guardian consent.

Exclusion criteria

Exclusion criteria: 1. Severe intellectual disabilities 2. Significant behavioral disturbances 3. Uncorrected sensory impairments 4. Medical or neurological conditions unrelated to ASD 5. Concurrent experimental therapies 6. Inconsistent attendance at the clinical center

Design outcomes

Primary

Measure	Time frame
Theory of Mind (ToM) improvements measured using the NEPSY-II Social Perception subscale at T0 (Baseline), T1 (Midpoint) and T2 (Final) In this crossover design, participants experience both interventions, ensuring direct comparisons: T0 (Baseline): Measures ToM skills before any therapy T1 (Midpoint): After approximately 8 weeks of either robot-assisted or traditional therapy, ToM skills are reassessed, then the groups switch interventions with a 1-2 week wash-out to prevent carryover effects. T2 (Final): After the second therapy phase, a final assessment determines whether gains persisted and if additional improvements occurred	—

Measure

Time frame

Theory of Mind (ToM) improvements measured using the NEPSY-II Social Perception subscale at T0 (Baseline), T1 (Midpoint) and T2 (Final) In this crossover design, participants experience both interventions, ensuring direct comparisons: T0 (Baseline): Measures ToM skills before any therapy T1 (Midpoint): After approximately 8 weeks of either robot-assisted or traditional therapy, ToM skills are reassessed, then the groups switch interventions with a 1-2 week wash-out to prevent carryover effects. T2 (Final): After the second therapy phase, a final assessment determines whether gains persisted and if additional improvements occurred

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Italy

Contacts

Public ContactAgnieszka Wykowska

agnieszka.wykowska@iit.it+390102897242

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026