Emotional Skills Training with Social Robot

NCT06179953 | Recruiting

• 1 other identifier: CNR-IRIB-PRO-2023-010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

autism; children; emotional skills; social robot

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Experimental group with social robot

EXPERIMENTAL

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

Control group without social robot

OTHER

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

Interventions

NAO intervention 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.

Experimental group with social robot

Traditional intervention 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.

Control group without social robot

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• presence of other medical disorders

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Messina, Italy: collaborator

Study Sites (1)

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

Messina, Italy, 98164, Italy

RECRUITING

Related Publications (2)

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

  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.

  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Flavia Marino

  Istituto per la Ricerca e l'Innovazione Biomedica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Germana Doria

CONTACT

+393465142289; germana.doria@irib.cnr.it

Giovanni Pioggia

CONTACT

+393203390892; giovanni.pioggia@irib.cnr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: June 5, 2023
• Primary Completion: February 6, 2024
• Study Completion: April 24, 2025
• Last Updated: January 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)