Emotional Skills Training With Social Robot

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179953
• Other study ID #: CNR-IRIB-PRO-2023-010
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: April 24, 2025

Study information

• Verified date: December 2023
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: Germana Doria
• Phone: +393465142289
• Email: germana.doria[@]irib.cnr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 24, 2025
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Other:
• NAO intervention
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
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.

Locations

Country	Name	City	State
Italy	Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)	Messina

Sponsors (2)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica	Comune di Messina

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test of Emotional Vocabulary	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).	The administration has a duration of 15 minutes.
Primary	Test of emotion comprehension	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.	The administration has a duration of 15-20 minutes.