Emotional Skills Training with Social Robot

NCT ID: NCT06179953

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-05

Study Completion Date

2025-04-24

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group with social robot

The emotional skills protocol aims to achieve the following objectives:

* Acquisition of appropriate emotional skills and understanding of emotions;
* Construction of functional thoughts related to emotions;
* Enhancement of interpersonal and social skills. It is aimed at a sample of children diagnosed with high-functioning autism spectrum disorder (ASD) between the ages of 5 and 10. The experimental group will carry out training through the use of social robots. The robot provides instructions and if the child requests it, it gives prompts.

Group Type EXPERIMENTAL

NAO intervention

Intervention Type OTHER

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 thought to an emotion.
4. LEARNING A REPERTOIRE OF USEFUL THOUGHTS: acquisition of useful thoughts related to certain emotional situations. The robot provides instructions and if the child requests it, it elects prompts.

Control group without social robot

The emotional skills protocol aims to achieve the following objectives:

* Acquisition of appropriate emotional skills and understanding of emotions; Construction of functional thoughts related to emotions;
* Enhancement of interpersonal and social skills. It is aimed at a sample of children diagnosed with high-functioning autism spectrum disorder (ASD) between the ages of 5 and 10. Control group which will be conducted through traditional therapy. The therapist provides instructions, and if the child has difficulty responding, he gives prompts.

Group Type OTHER

Traditional intervention

Intervention Type OTHER

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 thought to an emotion.
4. LEARNING A REPERTOIRE OF USEFUL THOUGHTS: acquisition of useful thoughts related to certain emotional situations. The therapist provides instructions, and if the child has difficulty responding, he or she may ask the operator for prompts.

Interventions

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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 thought to an emotion.
4. LEARNING A REPERTOIRE OF USEFUL THOUGHTS: acquisition of useful thoughts related to certain emotional situations. The robot provides instructions and if the child requests it, it elects prompts.

Intervention Type 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 thought to an emotion.
4. LEARNING A REPERTOIRE OF USEFUL THOUGHTS: acquisition of useful thoughts related to certain emotional situations. The therapist provides instructions, and if the child has difficulty responding, he or she may ask the operator for prompts.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Messina, Italy

OTHER

Sponsor Role collaborator

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role lead

Responsible Party

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Flavia Marino

Head of Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Flavia Marino

Role: PRINCIPAL_INVESTIGATOR

Istituto per la Ricerca e l'Innovazione Biomedica

Locations

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Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Germana Doria

Role: CONTACT

+393465142289

Giovanni Pioggia

Role: CONTACT

+393203390892

Facility Contacts

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Flavia Marino

Role: primary

+393395798263

Giovanni Pioggia

Role: backup

+393203390892

Flavia Marino

Role: backup

Germana Doria

Role: backup

Chiara Failla

Role: backup

Noemi Vetrano

Role: backup

Ileana Scarcella

Role: backup

Roberta Minutoli

Role: backup

Paola ChilĂ 

Role: backup

Giovanni Pioggia

Role: backup

Alfio Puglisi

Role: backup

References

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American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.) https://doi.org/10.1176/appi.books.9780890425596.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Other Identifiers

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CNR-IRIB-PRO-2023-010

Identifier Type: -

Identifier Source: org_study_id

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