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Clinical Trials/NCT07367256
NCT07367256
Recruiting
Not Applicable

Efficacy of a Virtual Reality-Mediated Intervention on Emotion Recognition and Understanding in Children With Autism Spectrum Disorder

Istituto per la Ricerca e l'Innovazione Biomedica1 site in 1 country30 target enrollmentStarted: February 2, 2026Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Enrollment
30
Locations
1
Primary Endpoint
Test of Emotional Vocabulary (TLE)

Overview

Brief Summary

Autism Spectrum Disorders (ASD) are neurodevelopmental conditions characterized by difficulties in social interaction, communication, and in understanding one's own and others' mental and emotional states. In particular, skills related to the recognition, understanding, and regulation of emotions represent a significant area of vulnerability in children with high-functioning ASD, with important consequences for social and relational functioning.

The present study aims to evaluate the effectiveness of an intervention protocol designed to enhance socio-emotional understanding, with a specific focus on the recognition of basic and complex emotions, the expansion of emotional vocabulary, the association between situations, thoughts, and emotions, and the differentiation between thoughts and emotions. Furthermore, the study seeks to investigate the role of immersive technology (Oculus) as a potential facilitator of emotional learning compared to a traditional intervention approach. The sample will consist of children with a diagnosis of high-functioning ASD, aged between 7 and 10 years, with sentence-level language abilities, the capacity to narrate non-present events, and an intellectual quotient above 80 (assessed using the Griffiths Scales or the WISC-IV). Participants will be divided into two groups: an experimental group (OCULUS), which will receive the intervention mediated by the use of Oculus technology, and a control group which will undergo the same protocol without technological support.

Study Design

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

Eligibility Criteria

Ages
7 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Language in sentences
  • Ability to narrate events not present
  • QS/QI\>80

Exclusion Criteria

  • presence of other medical disorders

Arms & Interventions

Experimental group with virtual reality

Experimental

The intervention protocol is designed to enhance socio-emotional skills in children with high-functioning autism spectrum disorder. The intervention focuses on the recognition and understanding of basic and complex emotions, the expansion of emotional vocabulary, and the ability to associate situations, thoughts, and emotions, promoting the differentiation between mental and emotional states.

The treatment consists of weekly sessions over a total duration of four months and is structured around gradual activities based on visual stimuli and everyday social situations. These activities are carried out by the experimental group through the use of immersive virtual reality technology (Oculus), which allows children to interact with structured environments and scenarios designed to facilitate emotional and social learning.

Intervention: Oculus intervention (Other)

Control group

Other

The control group follows the same intervention protocol aimed at enhancing socio-emotional skills in children with high-functioning autism spectrum disorder. In this group as well, the intervention focuses on the recognition and understanding of basic and complex emotions, the expansion of emotional vocabulary, and the ability to associate situations, thoughts, and emotions, promoting the differentiation between mental and emotional states.

The treatment consists of weekly sessions over a total duration of four months and is structured around gradual activities based on visual stimuli and everyday social situations. However, unlike the experimental group, the activities are conducted in a traditional format, without the use of immersive technology (Oculus), with the therapist directly guiding the child through the activities and supporting their emotional and social understanding.

Intervention: Traditional intervention (Other)

Outcomes

Primary Outcomes

Test of Emotional Vocabulary (TLE)

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

The test 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).

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 (1)

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