Emotional Skills Training with Social Robot

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: NAO intervention; Other: Traditional intervention

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giovanni Pioggia; Phone Number: +393203390892; Email: giovanni.pioggia@irib.cnr.it
• Study Contact Backup: Name: Germana Doria; Phone Number: +393465142289; Email: germana.doria@irib.cnr.it

Study Locations

• Italy
  • Messina, Italy, 98164
    • Recruiting
    • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
    • Contact: Flavia Marino; Phone Number: +393395798263; Email: flavia.marino@irib.cnr.it
    • Contact: Giovanni Pioggia; Phone Number: +393203390892; Email: giovanni.pioggia@irib.cnr.it
    • Contact: Giovanni Pioggia
    • Contact: Flavia Marino
    • Contact: Germana Doria
    • Contact: Chiara Failla
    • Contact: Noemi Vetrano
    • Contact: Ileana Scarcella
    • Contact: Roberta Minutoli
    • Contact: Paola Chilà
    • Contact: Alfio Puglisi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
• Collaborators: Messina, Italy
• Investigators: Principal Investigator: Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): February 6, 2024
• Study Completion (Estimated): April 24, 2025

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: children; autism; emotional skills; social robot
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: CNR-IRIB-PRO-2023-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No