Executive Function of School-aged Children With ASDNCT06130293
VR Executive Training of School-aged Children With ASD
A study testing VR game intervention in people with Executive Function of School-aged Children With ASD, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
Many studies support that children with autism spectrum disorder (ASD) show executive dysfunction. The applicant's NSC project report also indicated that in all areas in the behavior rating inventory of executive function, the second edition (BRIEF-2), including inhibit, self-monitor, shift, emotional control… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Executive Function of School-aged Children With ASD
- What is being tested?
- VR game intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with ASD by a qualified healthcare professional
- meeting the ASD criteria by using ADOS-2
- IQ higher than 80.
Who cannot join
- not meeting the ASD criteria by using ADOS-2.
- IQ lower than 80.
- comorbid physical and/or motor disabilities.
- comorbid mental disabilities except ADHD.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Normal University
Taipei, State, 106010
Meng-Ting Chen, +886939605325, montine@gapps.ntnu.edu.tw
montine@gapps.ntnu.edu.tw
About this study
Official title: The Effect of Daily Executive Function Training in School-aged Children With Autism Spectrum Disorder
Many studies support that children with autism spectrum disorder (ASD) show executive dysfunction. The applicant's NSC project report also indicated that in all areas in the behavior rating inventory of executive function, the second edition (BRIEF-2), including inhibit, self-monitor, shift, emotional control, initiate, working memory, plan/organize, task-monitor, and organization of materials, children in the typically developmental group showed better performance than children in the ASD group. The results also indicated that compared to the diagnosis of ASD, an executive function could be a better predictor of daily life adaptation. Similarly, more and more researchers put their efforts into executive training. However, the results are mixed. A meta-analysis showed that technology-based training can effectively improve the executive function of children with ASD. Children with ASD love game-like training as it provides friendly environments to children with ASD and induces less anxiety. The applicant, therefore, plans to develop a virtual reality executive function training program in the first year based on the applicant's previous experience with executive function training. The game will include the components of visual searching, reaction time, shift, planning, and working memory. At the end of the game, the game will provide visual feedback to the children to train in self-monitoring. In the second year, the applicant will conduct a randomized controlled trial to investigate the effectiveness of the training program. I plan to include 70 children with ASD and randomly assign them to either the executive training or control groups. Executive function and daily life adaptation will be the indexes of the effectiveness of the study.
- Being tested
- VR game intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR game interventionDevice
Using self-paced VR game to train.
| Study group | Role | What they receive |
|---|---|---|
| VR training | Experimental | Using VR training. 40 minutes per session, one session per week, and a total 8 weeks. Receives: Device: VR game intervention |
| Waiting list group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire of executive function
parent's and teacher's forms
Measured: Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)
Secondary outcomes (1)
Questionnaire of adaptive behaviors
parent's and teacher's forms
Measured: Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start31 Oct 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive Function of School-aged Children With ASDStudies 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng-Ting Chen, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130293
- Sponsor's protocol ID
- 202310HM006
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Executive Function Training in School-aged Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06130293
- Acronym / sponsor ID
- 202310HM006
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Nov 2023 (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.
Many studies support that children with autism spectrum disorder (ASD) show executive dysfunction. The applicant's NSC project report also indicated that in all areas in the behavior rating inventory of executive function, the second edition (BRIEF-2), including inhibit, self-monitor, shift, emotional control, initiate, working memory, plan/organize, task-monitor, and organization of materials, children in the typically developmental group showed better performance than children in the ASD group. The results also indicated that compared to the diagnosis of ASD, an executive function could be a better predictor of daily life adaptation. Similarly, more and more researchers put their efforts into executive training. However, the results are mixed. A meta-analysis showed that technology-based training can effectively improve the executive function of children with ASD. Children with ASD love game-like training as it provides friendly environments to children with ASD and induces less anxiety. The applicant, therefore, plans to develop a virtual reality executive function training program in the first year based on the applicant's previous experience with executive function training. The game will include the components of visual searching, reaction time, shift, planning, and working memory. At the end of the game, the game will provide visual feedback to the children to train in self-monitoring. In the second year, the applicant will conduct a randomized controlled trial to investigate the effectiveness of the training program. I plan to include 70 children with ASD and randomly assign them to either the executive training or control groups. Executive function and daily life adaptation will be the indexes of the effectiveness of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR training | Experimental | Device: VR game interventionUsing VR training. 40 minutes per session, one session per week, and a total 8 weeks. |
| Waiting list group | No intervention | – |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosed with ASD by a qualified healthcare professional
- meeting the ASD criteria by using ADOS-2
- IQ higher than 80.
Key exclusion criteria (4 listed)
- not meeting the ASD criteria by using ADOS-2.
- IQ lower than 80.
- comorbid physical and/or motor disabilities.
- comorbid mental disabilities except ADHD.
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 |
|---|---|---|
| VR game interventionUsing self-paced VR game to train. | Device | VR training |
Primary outcome
Questionnaire of executive function
Time frame: Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)
parent's and teacher's forms
1 secondary outcome
Questionnaire of adaptive behaviors
Time frame: Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR game intervention in people with Executive Function of School-aged Children With ASD, run by National Taiwan Normal University at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng-Ting Chen, PhD (+886-2-77493786, montine@gapps.ntnu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire of executive function (time frame: Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.