VR Executive Training of School-aged Children With ASD

Sponsor
National Taiwan Normal University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06130293
Collaborator
(none)
60
1
2
14
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VR game intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Daily Executive Function Training in School-aged Children With Autism Spectrum Disorder
Actual Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: VR training

Using VR training. 40 minutes per session, one session per week, and a total 8 weeks.

Device: VR game intervention
Using self-paced VR game to train.

No Intervention: Waiting list group

Outcome Measures

Primary Outcome Measures

  1. Questionnaire of executive function [Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)]

    parent's and teacher's forms

Secondary Outcome Measures

  1. Questionnaire of adaptive behaviors [Week 0 (pre-intervention), Week 9 (post-intervention), and follow-up (Week 18 to Week 26)]

    parent's and teacher's forms

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan Normal University Taipei City State Taiwan 106010

Sponsors and Collaborators

  • National Taiwan Normal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Meng-Ting Chen, Assistant professor, National Taiwan Normal University
ClinicalTrials.gov Identifier:
NCT06130293
Other Study ID Numbers:
  • 202310HM006
First Posted:
Nov 14, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 14, 2023