VR Executive Training of School-aged Children With ASD | NCT06130293

Studies
VR Executive Training of School-aged Children With ASD

NCT06130293

Sponsor

National Taiwan Normal University

Status

Unknown status

Last Update Posted

Nov 14, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Executive Function of School-aged Children With ASD

Interventions

VR game intervention

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2023Actual

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Nov 6, 2023

First Submission Date that Met QC Criteria

Nov 12, 2023

First Posted Date

Nov 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2023

Last Update Posted Date

Nov 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Meng-Ting Chen, Assistant professor, National Taiwan Normal UniversityPrincipal Investigator

Lead Sponsor

National Taiwan Normal UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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, 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VR training	Experimental	Using VR training. 40 minutes per session, one session per week, and a total 8 weeks.	Device: VR game intervention
Waiting list group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VR game intervention	Device	Using self-paced VR game to train.	VR training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Questionnaire of executive function	parent's and teacher's forms	Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)

Secondary Outcomes

Measure	Description	Time Frame
Questionnaire of adaptive behaviors	parent's and teacher's forms	Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosed with ASD by a qualified healthcare professional
meeting the ASD criteria by using ADOS-2
IQ higher than 80.

Exclusion Criteria:

not meeting the ASD criteria by using ADOS-2.
IQ lower than 80.
comorbid physical and/or motor disabilities.
comorbid mental disabilities except ADHD.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meng-Ting Chen, PhD	Contact	+886-2-77493786		montine@gapps.ntnu.edu.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan Normal University	Recruiting	Taipei	State	106010	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided