AutismNCT07367256
Using Virtual Reality to Improve Emotion Understanding in Children With Autism
A study testing Oculus intervention and Traditional intervention in people with Autism and Autism Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Autism, Autism Disorder
- What is being tested?
- Oculus intervention and Traditional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Language in sentences
- Ability to narrate events not present
- QS/QI>80
Who cannot join
- presence of other medical disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto per la Ricerca e l'Innovazione Biomedica
Messina, Italy, 98164
Flavia Marino, +393395798263, flavia.marino@irib.cnr.it
Maria Valeria Maiorana, mariavaleria.maiorana@irib.cnr.it
About this study
Official title: Efficacy of a Virtual Reality-Mediated Intervention on Emotion Recognition and Understanding in Children With Autism Spectrum Disorder
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.
- Conditions
- Autism, Autism Disorder
- Being tested
- Oculus intervention, Traditional intervention
- Keywords
- autism, children, emotional skills, virtual reality, emotional recognition
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus interventionOther
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
Traditional interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The administration has a duration of 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367256
- Sponsor's protocol ID
- CNR-IRIB-PRO-2026-002
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Frolli A, Savarese G, Di Carmine F, Bosco A, Saviano E, Rega A, Carotenuto M, Ricci MC. RETRACTED: 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.
PubMed 35204903American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.) https://doi.org/10.1176/appi.books.9780890425596.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Virtual Reality-Mediated Intervention on Emotion Recognition and Understanding in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07367256
- Acronym / sponsor ID
- CNR-IRIB-PRO-2026-002
- Conditions
- Autism, Autism Disorder
- Keywords
- autism, children, emotional skills, virtual reality, emotional recognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group with virtual reality | Experimental | Other: Oculus interventionThe 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. |
| Control group | Other | Other: Traditional interventionThe 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. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Language in sentences
- Ability to narrate events not present
- QS/QI>80
Key exclusion criteria (1 listed)
- presence of other medical disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculus interventionPhase 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 | Other | Experimental group with virtual reality |
| Traditional interventionPhase 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. | Other | Control group |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- BackgroundPapoutsi, 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: PubMed 35204903Frolli A, Savarese G, Di Carmine F, Bosco A, Saviano E, Rega A, Carotenuto M, Ricci MC. RETRACTED: 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.
- BackgroundAmerican Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.) https://doi.org/10.1176/appi.books.9780890425596.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Flavia Marino principal investigator
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus intervention and Traditional intervention in people with Autism and Autism Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Germana Doria (+393465142289, germana.doria@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Emotional Vocabulary (TLE) (time frame: The administration has a duration of 15 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07367256, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.