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

Effectiveness of Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder: a Three-arm Pilot Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Attention-deficit/Hyperactivity Disorder; Virtual Reality; Social Interaction
• Intervention / Treatment: Behavioral: Virtual reality; Behavioral: Traditional social skills training

Detailed Description

The study will be a three-arm randomised controlled trial comparing the effects of social VR-based intervention with traditional social skills training on social skills and executive functioning of children with ADHD. Participants in the social VR intervention group and traditional social skill training group will receive 12 training sessions for 3 weeks (4 sessions per week), and participants in the waitlist control group will be asked to retain their usual lifestyles for 3 weeks.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Ka Po Wong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social VR Intervention; 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; 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.
Active Comparator: Traditional social skills training; 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; 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.
No Intervention: Waitlist control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Riggio Social Skills Inventory Assessment	[Protocol-to-Publication Realignment Explanation]: In the initial protocol, trial feasibility (attendance/compliance) was registered as the primary focus. In the final published pilot RCT, to address the core therapeutic objective of this intervention, the evaluation was refined to focus on clinical efficacy. Therefore, this blinded clinical assessment of Social Skills was designated as a Primary Outcome to directly report behavioral improvements. This assessment uses the Riggio Social Skills Inventory to objectively evaluate participants' social interaction skills. The total score ranges from 10 to 40, where higher scores indicate better social interaction skills. The inventory consists of 10 items, each scored on a scale from 1 (Never) to 4 (Always). Scores for each item are summed to compute a total score, with higher total scores representing better outcomes in social skills. The inventory includes subscales that measure aspects of verbal and non-verbal communication.	3 weeks post-intervention
Social Skills Improvement System Rating Scales - Parent Version (SSIS-RS)	[Protocol-to-Publication Realignment Explanation]: Outcome Level: Shifted from a feasibility framework in the protocol to a primary clinical outcome in the published paper to evaluate targeted efficacy. Scale Upgrade: The tool was upgraded from the older SSRS-P (as planned in the protocol) to its revised version, the SSIS-RS, which provides updated contemporary clinical norms for children with ADHD. This assessment evaluates participants' self-control, assertiveness, and initiative and cooperation. The SSIS-RS consists of 3 subscales with a total of 31 items. A 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often) is used for scoring. The total score ranges from 31 to 93, where higher scores indicate better social skills. Scores for each subscale are summed, contributing to the total score. The SSIS-RS is a validated instrument commonly adopted in clinical trials of psychiatric and neurological disorders.	3 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behaviour Rating Inventory of Executive Function	To assess the executive functioning of participants using the Behavior Rating Inventory of Executive Function (BRIEF), which will be scored by the participants' guardians. The subscales of inhibition (16 items) and emotional control (10 items) will be adopted in this study. A 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often) is used to score. The total score ranges from 26 to 78, with higher scores indicating poor executive functions.	3 weeks post-intervention
Satisfaction of the Intervention	Satisfaction with the intervention was measured using a 7-point Likert scale (1 = very dissatisfied, 7 = very satisfied) administered at the last session of the VR training group. The total score ranges from 1 to 7, with higher scores indicating greater satisfaction.	After the last session (after 3 weeks)
Simulator Sickness Questionnaire	To measure the motion sickness or physical discomfort of participants in VR environment. Nine items will be measured, including discomfort, fatigue, headache, eyestrain, sweating, nausea, difficulty concentrating, blurred vision and dizziness, with yes or no questions for each item.	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.
Acceptability and Compliance	[Protocol-to-Publication Realignment Explanation]: This parameter was originally listed as a Primary Outcome in the feasibility protocol. In the final published pilot RCT, all feasibility targets were successfully achieved (sample size of 90 randomized, accounting for the anticipated 25%-30% attrition rate). For structural reporting in the peer-reviewed paper, it was repositioned under secondary/feasibility outcomes while clinical efficacy took priority as the primary measure. 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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Jing Qin, PhD, School of Nursing, The Hong Kong Polytechnic University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): September 6, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Virtual reality; Attention-deficit/hyperactivity disorder; Social interaction; Three-arm pilot randomised controlled trial
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: HSEARS20221221003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is confidential.

Drug and device information, study documents

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