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Recruiting NCT06179953

Emotional Skills Training with Social Robot

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NAO intervention, Traditional intervention.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 5 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluate the Effect of Social Robot Mediation on the Development of Emotional Skills

Overview

Autism is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns. In particular, emotional regulation is a central developmental skill. In fact, the emotional dysregulation observed in children with autism results in increased social and behavioral difficulties over time. Therefore, the present protocol aims to test the role of a human-assisted social robot as a mediator of social-emotional understanding intervention for children with autism spectrum disorders (ASD). The children, will be divided into two groups, an experimental one in which training will be conducted through the use of social robot and control group which will be conducted through traditional therapy.

Interventions

  • Other NAO intervention
    The protocol is divided into 4 stages: 1. EMOTION RECOGNITION - "Mime Game": activity aimed at acquiring the ability to label basic emotions. 2. EMOTION/SITUATION ASSOCIATION - "How do I feel when...?" game: presentation of social situations to acquire the ability to attribute the emotion associated with the situation presented. 3. DIFFERENTIATION BETWEEN EMOTIONS AND THOUGHTS - "Think-Feel Game": activity aimed at differentiating thoughts from emotions and acquiring the skill of linking a thou
  • Other Traditional intervention
    The protocol is divided into 4 stages: 1. EMOTION RECOGNITION - "Mime Game": activity aimed at acquiring the ability to label basic emotions. 2. EMOTION/SITUATION ASSOCIATION - "How do I feel when...?" game: presentation of social situations to acquire the ability to attribute the emotion associated with the situation presented. 3. DIFFERENTIATION BETWEEN EMOTIONS AND THOUGHTS - "Think-Feel Game": activity aimed at differentiating thoughts from emotions and acquiring the skill of linking a thou

Primary outcome measures

  • Test of Emotional Vocabulary [Time frame: The administration has a duration of 15 minutes.]
  • Test of emotion comprehension [Time frame: The administration has a duration of 15-20 minutes.]

Eligibility criteria

Inclusion criteria

  • Language in sentences
  • use of connectors
  • ability to narrate events not present
  • ADOS level: module 2
  • Griffiths: QS>75

Exclusion criteria

  • presence of other medical disorders

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) — Messina

Publications

  • American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.) https://doi.org/10.1176/appi.books.9780890425596.
  • Berkovits, L., Eisenhower, A. e Blacher, J. (2017). Regolazione delle emozioni nei bambini piccoli con disturbi dello spettro autistico. Giornale di autismo e disturbi dello sviluppo, 47(1), 68-79.

Identifiers

NCT: NCT06179953 · CNR-IRIB-PRO-2023-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗