Group intervention to improve social understanding in children with autism
Enhancing Theory of Mind Skills in Children With Autism Spectrum Disorder.
This study is testing a new program that helps children with autism understand social situations better by using a tablet and robot over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 10 Years |
| Sex | All |
| Sponsor | Istituto per la Ricerca e l'Innovazione Biomedica Academic / other |
| Locations | 1 site (Messina) |
| Trial ID | NCT06179927 on ClinicalTrials.gov |
What this trial studies
This project involves 40 children aged 6 to 10 with Autism Spectrum Disorder who will participate in a structured intervention aimed at enhancing their Theory of Mind abilities. The children will be randomly assigned to either an experimental group, which will engage with social scenes presented on a tablet, or a control group. The intervention consists of 12 weekly sessions, each lasting 45 minutes, where participants will select appropriate mental states based on visual stimuli narrated by a robot. The effectiveness of the intervention will be assessed through pre- and post-tests using the NEPSY battery.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 10 with a confirmed diagnosis of Autism Spectrum Disorder.
Not a fit: Patients with other medical disorders or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve social understanding and emotional recognition in children with autism.
How similar studies have performed: While similar interventions have been explored, this specific approach using a robot and tablet-based scenarios is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Proven diagnosis of autism * QS ≥ 75 assessed by administration of the GRIFFITHS scales * Passing the emotional recognition test of the NEPSY II battery Exclusion Criteria: * presence of other medical disorders
Where this trial is running
Messina
- Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) — Messina, Italy (Recruiting)
Study contacts
- Principal investigator: Flavia Marino — Istituto per la Ricerca e l'Innovazione Biomedica
- Study coordinator: Germana Doria
- Email: germana.doria@irib.cnr.it
- Phone: +393465142289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.