Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder

NCT05778526 | Completed Results DMC

• 1 other identifier: HSEARS20221221003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study targets children with diagnosed ADHD and aims to (1) develop a social virtual reality-based intervention, (2) investigate its effects on improving the social skills and executive functioning of inhibitions, emotional control and attention of the children compared to traditional social skills training and (3) evaluate the subjects acceptability and compliance with social VR training for enhancing social interaction skills. It is hypothesised that the social interaction skills of the participants in the social VR training group are likely to perform better than those in the traditional social skills training group. Participants in the waitlist control group will receive no change in social interaction skills compared with the two intervention groups.

Conditions

Virtual Reality; Social Interaction; Attention-deficit/Hyperactivity Disorder

Keywords

Virtual reality; Social interaction; Attention-deficit/hyperactivity disorder; Three-arm pilot randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Acceptability and Compliance

  The attendance of the participants during the trainings will be recorded. To verify the validity of the findings, training non-adherence of the participants will be terminated which will be stated in the consent form. The absence of any training session will be considered as non-adherence.

  After 3 weeks

Secondary Outcomes (5)

• Riggio Social Skills Inventory Assessment

  3 weeks post-intervention

• Social Skills Rating System - Parent Version (SSRS-P)

  3 weeks post-intervention

• Behaviour Rating Inventory of Executive Function

  3 weeks post-intervention

• Satisfaction of the Intervention

  After the last session (after 3 weeks)

• Simulator Sickness Questionnaire

  Assessments will be conducted at the end of each session of the VR intervention group (twelve sessions in total), with the total score reflecting cumulative discomfort experienced across all sessions.

Study Arms (3)

Social VR Intervention

EXPERIMENTAL

Social VR intervention is developed to enhance the social interaction skills of children. The participants will wear a head-mounted display for the Social VR intervention. Each session of the Social VR intervention lasts for a maximum of 20 minutes to ensure the participants focus on the intervention and prevent causing any physical effect. The duration will be adjusted depending on the emotion of the participants during the intervention. The Social VR intervention will mainly help the participant to enhance their social interaction skills and executive function. The intervention contains three real-life virtual scenarios, including (1) classroom and playground, (2) MTR station and compartment, and (3) supermarket and restaurant. One scenario will be adopted in each session. The sequences of the scenarios used in each session will be the same for all participants.

Behavioral: Virtual reality

Traditional social skills training

ACTIVE COMPARATOR

An experienced SEN teacher will teach the participants social interaction skills through tradidactic instructions and role-play activities. Four modules will be covered in the 3-week training: (1) how to introduce yourself and basic social skills; (2) how to listen to others; (3) how to share with others; (4) learn to know how people feel and how to empathise. These modules have been applied in many studies (Braswell \& Bloomquist, 1991; Huang et al., 2015). The content of this training will be as similar as possible to the Social VR training. The training lasts 20 minutes which depends on the emotion of the participants.

Behavioral: Traditional social skills training

Waitlist control group

NO INTERVENTION

The participants in this group will receive no training and they can participate in the social VR training after the intervention period. To ensure the consistency of the experiment, the participants are not allowed to initiate or change their pharmacological treatment during the 3-week intervention period.

Interventions

Virtual reality BEHAVIORAL

There are a total of 12 training sessions for 3 weeks (4 sessions per week). Each session of the Social VR intervention lasts for a maximum of 20 minutes. The intervention contains three real-life virtual scenarios, including (1) a classroom and playground, (2) an MTR station and compartment, and (3) a supermarket and restaurant.

Social VR Intervention

Traditional social skills training BEHAVIORAL

There are a total of 12 training sessions for 3 weeks (4 sessions per week). Each session lasts for a maximum of 20 minutes. Four modules will be covered in the 3-week training: (1) how to introduce yourself and basic social skills; (2) how to listen to others; (3) how to share with others; (4) learn to know how people feel and how to empathise.

Traditional social skills training

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• aged between 6 and 12 years
• ethnic Chinese
• residing in Hong Kong
• having received a diagnosis of ADHD by Child Assessment Service in Hong Kong or via private practice
• stable on pharmacological and/or psychological treatment for ADHD 8 weeks before baseline (determined by health care professionals on the basis of medication data and behavioural observation)
• no initiation or change of pharmacological treatment for ADHD during the intervention period
• the ability to read Chinese, and speak and listen to Cantonese by the child and by at least one of their parents or legal guardian
• willing to provide informed consent by both participants and one of their parents or legal guardian

You may not qualify if:

• comorbid autism
• mental retardation
• an estimated IQ lower than 85 (using the Wechsler Intelligence Scale for Children - Fourth Edition (Hong Kong) (WISC-IV(HK)))
• autism spectrum disorder (previously diagnosed by health care professionals)
• comorbid acute psychiatric disorder (previously diagnosed by health care professionals)
• with a severe physical disability (e.g., blindness, deafness) or learning disability (e.g., dyslexia).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Ka Po WONG

Hong Kong, Hong Kong

Location

Related Publications (2)

• Wong KP, Zhang B, Lai CYY, Xie YJ, Li Y, Li C, Qin J. Empowering Social Growth Through Virtual Reality-Based Intervention for Children With Attention-Deficit/Hyperactivity Disorder: 3-Arm Randomized Controlled Trial. JMIR Serious Games. 2024 Oct 28;12:e58963. doi: 10.2196/58963.

  PMID: 39467288 DERIVED

• Wong KP, Qin J. Effectiveness of Social Virtual Reality Training in Enhancing Social Interaction Skills in Children With Attention-Deficit/Hyperactivity Disorder: Protocol for a Three-Arm Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 18;12:e48208. doi: 10.2196/48208.

  PMID: 37721790 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Ka Po Wong
• Organization: The Hong Kong Polytechnic University.

portia.wong@polyu.edu.hk

64860214

Study Officials

• Jing Qin, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and outcomes assessor will be blinded to the study intervention period.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 21, 2023
• Study Start: February 18, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 6, 2024
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)