NCT07367256

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Keywords

autismchildrenemotional skillsvirtual realityemotional recognition

Outcome Measures

Primary Outcomes (1)

  • Test of Emotional Vocabulary (TLE)

    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).

    The administration has a duration of 15 minutes.

Study Arms (2)

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.

Other: Oculus intervention

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.

Other: Traditional intervention

Interventions

Phase 1: Basic Emotions (happiness, sadness, anger, fear, disgust, surprise) * Step 1-3: Sequential recognition and identification of emotions on faces, using sets of 4 or 6 images. * Step 4-6: Association of thoughts, emotions, and situations in everyday scenarios. All activities are conducted through immersive virtual reality (Oculus), allowing children to interact with structured environments and scenarios that facilitate socio-emotional learning. Phase 2: Complex Emotions (guilt, shame, pride, frustration, jealousy) * Step 1-6: Same structure as Phase 1, using complex emotions. * Activities are mediated via Oculus, providing an interactive and immersive learning experience

Experimental group with virtual reality

Phase 1: Basic Emotions (happiness, sadness, anger, fear, disgust, surprise) * Step 1-3: Sequential recognition and identification of emotions on faces, using sets of 4 or 6 images. * Step 4-6: Association of thoughts, emotions, and situations in everyday scenarios. All activities are conducted in a traditional format, without the use of immersive technology, with the therapist guiding the child directly through the exercises to support socio-emotional learning. Phase 2: Complex Emotions (guilt, shame, pride, frustration, jealousy) * Step 1-6: Same structure as Phase 1, using complex emotions. * Activities are performed under direct therapist supervision in a non-technological setting.

Control group

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • presence of other medical disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto per la Ricerca e l'Innovazione Biomedica

Messina, Italy, 98164, Italy

RECRUITING

Related Publications (3)

  • Papoutsi, C., Drigas, A., & Skianis, C. (2021). Virtual and augmented reality for developing emotional intelligence skills. Int. J. Recent Contrib. Eng. Sci. IT (IJES), 9(3), 35-53.

    BACKGROUND
  • Frolli A, Savarese G, Di Carmine F, Bosco A, Saviano E, Rega A, Carotenuto M, Ricci MC. Children on the Autism Spectrum and the Use of Virtual Reality for Supporting Social Skills. Children (Basel). 2022 Feb 1;9(2):181. doi: 10.3390/children9020181.

    PMID: 35204903BACKGROUND
  • American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.) https://doi.org/10.1176/appi.books.9780890425596.

    BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Flavia Marino

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

January 16, 2026

First Posted

January 26, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations