Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000003471p
Ethics application status
Submitted, not yet approved
Date submitted
11/12/2024
Date registered
7/01/2025
Date last updated
7/01/2025
Date data sharing statement initially provided
7/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a Virtual Reality Intervention for Emotional Skills in Children with Autism in Oman.
Scientific title
Effectiveness of a Virtual Reality-Based Emotional Intelligence Intervention for Children with Autism Spectrum Disorder in Oman.
Secondary ID [1] 313551 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder (ASD) 336038 0
Condition category
Condition code
Mental Health 332606 332606 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Virtual Reality-Based Emotional Intelligence Training Program for Children with Autism

Description of Intervention:

The intervention being studied is a Virtual Reality (VR)-based Emotional Intelligence (EI) training program for children with autism. The primary focus of this intervention is to enhance the children's EI, specifically in emotion recognition, social interaction, and empathy, centered around four basic emotions: happiness, anger, sadness, and fear.

Physical or Informational Materials Used: The intervention utilizes the MetaQuest VR headset, a user-friendly device that allows for immersive interaction with avatars. The software used in this study is Autism Virtual Adventure Land (AVAL), a customized VR application specifically designed for children with autism. It features engaging and culturally sensitive scenarios that promote the development of emotional intelligence.

Procedures, Activities, and Processes: The intervention will be conducted over a 4 to 6-week period with 2 to 3 sessions per week, each lasting 20 to 30 minutes. Each session follows a structured format:

# Briefing: Children will be introduced to the VR tasks and provided with instructions on how to use the system.
# VR Training: Children will engage in interactions with avatars where they will make decisions based on emotional prompts, practice social interactions, and develop empathy.
# Debriefing: After each session, children will reflect on their experience with a debriefing session, helping them connect the skills learned in the VR training to real-world situations.

Mode of Delivery: The intervention will be delivered face-to-face in a quiet, controlled environment at the National Autism Centre (NAC), Muscat, Oman. The researcher, HDR student, the VR technical staff, and a therapist will be present during each session to provide guidance and ensure the comfort and safety of the participants.

Who Will Deliver the Intervention: The intervention will be delivered by the researcher, the HDR candidate, whose background is in medicine with experience in working with children with autism. The therapist of the NAC will oversee the VR sessions, monitor the children's well-being, and provide support during and after the sessions. The VR technical staff will ensure the VR environment functions correctly.

Personalization: The intervention will be adapted to meet the needs of individual participants as necessary. If needed, the researcher, along with the therapist and VR staff, will adjust the lighting, sounds to avoid any oversensitivity, and difficulty level of the VR tasks to ensure the child is appropriately challenged but not overwhelmed.

Adherence/Fidelity Assessment: The therapist will monitor each session to ensure that the intervention is delivered consistently and that the children are engaging appropriately with the VR tasks. Any deviations from the planned protocol will be recorded and addressed.

Location: The sessions will be conducted at the National Autism Centre, Muscat, in a controlled, quiet room designed to minimize distractions.
Intervention code [1] 330142 0
Behaviour
Intervention code [2] 330143 0
Treatment: Other
Comparator / control treatment
Standard Care

Standard care refers to the usual intervention or treatment that participants in the control group will receive at the National Autism Centre. This typically includes the conventional methods used by the Centre for managing children with autism, which may involve therapy, social skills training, or other supportive interventions based on the individual’s needs.
Control group
Active

Outcomes
Primary outcome [1] 340122 0
Emotional Intelligence (EI): assessed as a composite outcome using three measures.
Timepoint [1] 340122 0
1- Baseline/Pre intervention 2- Immediately Post-intervention
Secondary outcome [1] 442849 0
Emotional Intelligence (EI)
Timepoint [1] 442849 0
Follow-up at 3-months post-intervention
Secondary outcome [2] 442850 0
Feasibility: this will be assessed as a composite outcome
Timepoint [2] 442850 0
At the end of the intervention period (4-6 weeks) from the perspectives of parents/caregivers and therapists.
Secondary outcome [3] 442851 0
Performance Metrics: this will be assessed as a composite outcome
Timepoint [3] 442851 0
During each intervention session and at the end of the intervention period (4-6 weeks).

Eligibility
Key inclusion criteria
# Adolescents aged 12–18 years.

# Confirmed diagnosis of Autism Spectrum Disorder (ASD) by a medical team.

# Verbal communication abilities and capacity to understand basic instructions to ensure engagement with the VR intervention.

# Participants must express interest in participating and provide assent.

# Parents or guardians must provide informed consent.

# Participants must be on a stable dose of any ongoing medication for at least 4 weeks prior to the study to minimize the influence of medication changes on the outcomes.

#Sufficient visual acuity and motor coordination required to interact with the VR system.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
# Participants with significant cognitive, psychiatric, or physical comorbidities that may interfere with participation or confound study outcomes.

# Severe sensory impairments, such as blindness or deafness, which would prevent engagement in the VR intervention.

# History of epilepsy or seizure disorders that could be triggered by virtual reality environments.

# Participants with severe hypersensitivity to light or sound that may result in sensory overload during VR sessions. Although the VR program includes customizable settings to adjust brightness and sound, children with extreme sensitivities that cannot be mitigated will be excluded.

# Participants with severe emotional dysregulation or behavioural challenges, including aggression, self-harm, or uncontrolled tantrums, that would hinder safe and effective engagement with the VR program.

# Participants who have taken part in any other intensive emotional intelligence or virtual reality-based training programs within the last 3–6 months, to avoid carryover effects impacting the results of the current intervention.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment outside Australia
Country [1] 26775 0
Oman
State/province [1] 26775 0

Funding & Sponsors
Funding source category [1] 318013 0
University
Name [1] 318013 0
RMIT University
Country [1] 318013 0
Australia
Funding source category [2] 318016 0
Commercial sector/Industry
Name [2] 318016 0
Data Bridge
Country [2] 318016 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Country
Australia
Secondary sponsor category [1] 320355 0
None
Name [1] 320355 0
Address [1] 320355 0
Country [1] 320355 0
Other collaborator category [1] 283324 0
Government body
Name [1] 283324 0
National Autism Centre
Address [1] 283324 0
Country [1] 283324 0
Oman
Other collaborator category [2] 283325 0
Commercial sector/Industry
Name [2] 283325 0
Data Bridge
Address [2] 283325 0
Country [2] 283325 0
Oman

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316673 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 316673 0
Ethics committee country [1] 316673 0
Australia
Date submitted for ethics approval [1] 316673 0
07/11/2024
Approval date [1] 316673 0
Ethics approval number [1] 316673 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138614 0
Prof Leila Karimi
Address 138614 0
Department of Health Sciences | Psychology School of Health and Biomedical Sciences, RMIT University. Building 202, Level 4 Room 59 Bundoora, VIC, Australia
Country 138614 0
Australia
Phone 138614 0
+61 417882100
Fax 138614 0
Email 138614 0
[email protected]
Contact person for public queries
Name 138615 0
Moza Al Hatmi
Address 138615 0
School of Health and Biomedical Sciences, RMIT University. Building 202, Level 4, Bundoora, VIC, Australia |
Country 138615 0
Australia
Phone 138615 0
+610413398062
Fax 138615 0
Email 138615 0
[email protected]
Contact person for scientific queries
Name 138616 0
Leila Karimi
Address 138616 0
Department of Health Sciences | Psychology School of Health and Biomedical Sciences, RMIT University. Building 202, Level 4 Room 59 Bundoora, VIC, Australia
Country 138616 0
Australia
Phone 138616 0
+61 417882100
Fax 138616 0
Email 138616 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.