VR Executive Training of School-aged Children With ASD

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.

Study Overview

• Status: Recruiting
• Conditions: Executive Function of School-aged Children With ASD
• Intervention / Treatment: Device: VR game intervention

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meng-Ting Chen, PhD; Phone Number: +886-2-77493786; Email: montine@gapps.ntnu.edu.tw

Study Locations

• Taiwan
  • State
    • Taipei City, State, Taiwan, 106010
      • Recruiting
      • National Taiwan Normal University
      • Contact: Meng-Ting Chen; Phone Number: +886939605325; Email: montine@gapps.ntnu.edu.tw
      • Contact: Email: montine@gapps.ntnu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting list group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: National Taiwan Normal University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 202310HM006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No