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Clinical Trials/NCT06179953
NCT06179953RecruitingNot Applicable

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

Istituto per la Ricerca e l'Innovazione Biomedica2 sites in 1 country20 target enrollmentStarted: June 5, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
Test of Emotional Vocabulary

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
5 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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).

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Flavia Marino

Head of Unit

Istituto per la Ricerca e l'Innovazione Biomedica

Study Sites (2)

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