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NCT Number: NCT06179953

Emotional Skills Training with Social Robot

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.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Messina, Italy, 98164

Location status: Recruiting

Location contact

Alfio Puglisi

CONTACT

Chiara Failla

CONTACT

Flavia Marino

CONTACT

[email protected]

+393395798263

Flavia Marino

CONTACT

Germana Doria

CONTACT

Giovanni Pioggia

CONTACT

[email protected]

+393203390892

Giovanni Pioggia

CONTACT

Ileana Scarcella

CONTACT

Noemi Vetrano

CONTACT

Paola Chilà

CONTACT

Roberta Minutoli

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NAO intervention

Other

The protocol is divided into 4 stages:

  • EMOTION RECOGNITION - "Mime Game": activity aimed at acquiring the ability to label basic emotions.
  • 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.
  • 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.
  • 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.

Traditional intervention

Other

The protocol is divided into 4 stages:

  • EMOTION RECOGNITION - "Mime Game": activity aimed at acquiring the ability to label basic emotions.
  • 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.
  • 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.
  • 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.

Primary outcomes

  1. Test of Emotional Vocabulary

    Time frame: The administration has a duration of 15 minutes.

    The Test of Emotional Vocabulary contains an initial board, with which the child is introduced to the two protagonists of the subsequent stories, a boy and a girl; there is then a pretest board and 14 storyboards. For each of them, the examiner reads the short story to the child and then asks the child to choose, from two alternative emotional words, the one that best expresses what the protagonist of the story is feeling. In the first part, the child's understanding of emotional vocabulary referring to six basic emotions plus one complex emotion (joy, happiness, sadness, anger, fear, disgust and shame) is assessed; in the second part, the emotional terms all refer to complex emotions (guilt, envy, jealousy, contempt, hate, longing and pride).

  2. Test of emotion comprehension

    Time frame: The administration has a duration of 15-20 minutes.

    The Test of emotion comprehension (TEC) is an instrument to assess a child's understanding of emotions, in its various aspects, that is, the nature, causes, and ways of controlling and regulating emotions. It is used for children aged 3-4 to 10-11 years. It is administered by telling a story in pictures, the child responds by indicating and finally, it takes about 15-20 minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Germana Doria

CONTACT

[email protected]

+393465142289

Giovanni Pioggia

CONTACT

[email protected]

+393203390892

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Collaborators

  • Messina, Italy

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 22, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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