Effectiveness of Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder: a Three-arm Pilot Randomised Controlled Trial
Phase: NA
Conditions: Virtual Reality, Social Interaction, Attention-deficit/Hyperactivity Disorder
Sponsor: The Hong Kong Polytechnic University

Official Title: Effectiveness of social virtual-reality on enhancing social 
interaction skills in children with attention-deficit/hyperactivity disorder: a 
three-arm pilot randomised controlled trial 
NCT number: NCT05778526 
Date of the document: 28 October 2024 
 
 
 

Study Protocol 
Title: Effectiveness of social virtual-reality on enhancing social interaction skills in children 
with attention-deficit/hyperactivity disorder: a three-arm pilot randomised controlled trial 
 
Background 
Attention deficit/hyperactivity disorder (ADHD) is one of the most common 
neurodevelopmental disorders frequently diagnosed in school-aged children. It is 
characterised by pervasive symptoms of inattention, hyperactivity, and impulsivity. There are 
three main types of ADHD: inattentive type, hyperactive-impulsive type, and combination 
type. ADHD impacts the children’s emotions, behaviours and ability in learning. The 
hyperactivity and inattention levels of children with ADHD are noticeably higher than 
expected, causing distress or problems at home, at school and with peers. The global 
prevalence rate of ADHD is about 5% to 7%. According to the data from the Family Council 
in Hong Kong, there are 14,580 students with ADHD in Hong Kong, which is the second-
highest number among the nine types of special education needs (SEN). Children with 
ADHD’s executive functions can be delayed by up to 32% compared with peers. Such delay 
may cause difficulty in self-control, managing emotion, paying attention and holding 
information in working memory, and likely to talk excessively and interrupt others. Hence, 
children with ADHD have challenges in understanding social cues and behaviour problems 
while entering a social setting. For example, they are difficult to comprehend some nonverbal 
expressions (body language, eye contact and facial expressions) and spoken communication 
(pitch, speed, tone, and volume), leading to difficulty in listening to others, sharing scattered 
thoughts and rapid speaking. The social skill deficit causes becoming hard to build 
friendships and integrate into society. ADHD has been associated with a wide range of 
detrimental impacts on affected subjects and with a severe financial burden to families and 
society. Several studies reported that the economic burden of raising a child with ADHD was 
five to six times more than the counterpart and parents of those with ADHD tended to be 
fired and have low work efficiency. Therefore, adequate and appropriate treatments should be 
provided to alleviate their behaviours and costly dysfunctional outcomes in the community. 
The commonly used social skill training in children with ADHD are tradidactic instructions, 
modelling, role-play activities and behaviour rehearsal; however, these methods are limited to 
time and space and short of real-life scenarios. 
Virtual reality (VR) has emerged in plenty of domains as a promising tool for therapy and 
rehabilitation. Numerous studies adopted VR in improving cognitive behaviours in children 

with ADHD; however, the focuses of these studies were cognitive functioning of daily living 
context, attentional performance and impulsivity. None of these studies utilised VR to 
improve social interaction competence and appropriateness in children with ADHD. 
Furthermore, VR provides controllable immersive environments to engage children, sustain 
their attention and allow them to effectively gain skills in a safer environment. VR systems 
generally consist of a head-mounted display and screen so that the therapy can be conducted 
in a relatively low spatial limitation. Although no study has investigated VR social interaction 
skills in children with ADHD, evidence has proposed the use of VR social skill training in 
children with Autistic Spectrum Disorder (ASD). Most of the studies regarding children with 
ASD also used some real-life scenarios, for example, classrooms, transportation and 
supermarket, in their social skills training program. The differences in social skills between 
ADHD and ASD are that children with ADHD are easy to be distracted, avoid or dislike 
concentrating on one thing and are more likely to interrupt others’ speaking; those with ASD 
are less aware of others around them, overly attached to one object that they like and hard to 
give meaning to their speech. Due to these discrepancies, the design of social VR intervention 
in this study will be put in more instantaneous events, objects and avatars in each scenario to 
improve the distraction problems of children with ADHD. In addition, social VR, which 
allows more than one user to appear as avatars in a lifelike environment and connect with 
other users in real-time, will be adopted in this study instead of VR to enhance engagement 
and interaction among children with ADHD.  
 
Considering the prevalence and advantages of social VR, we plan to develop a social VR 
training program that contains three real-life scenarios and compare the effects of social VR 
training and traditional social skills training on social interaction skills, inhibitions, emotional 
control, behavioural and emotional difficulties and conduct disorders for children with 
ADHD in Hong Kong using receiving no training as a control. 
 
Cultivating sufficient and appropriate social interaction skills for children with ADHD is a 
vital step to assist them in integrating into the community. The real-life scenarios created by 
VR offer a more effective alternative to therapeutic strategies for children with ADHD. 
However, no previous study adopted social VR to assess social interaction competence and 
appropriateness in children with ADHD and no randomised controlled trial (RCT) compared 
the effectiveness of social VR training and traditional social skills training on enhancing the 
social interaction skills in children with ADHD. The traditional social skills training for 

children with ADHD lacked the provision of real-life scenarios and was limited by time and 
space. Social VR allowing real-time connection and interaction between patients and the 
virtual instructor was absent in previous studies. To fill these research gaps, we proposed to 
conduct a three-arm RCT to answer the research question of whether social VR training has 
higher effectiveness than traditional social skills training in enhancing the social interaction 
skills of children with ADHD in Hong Kong. The findings of this study are expected to 
unveil the clinical impacts and compliance and acceptability of social VR training for 
enhancing social interaction skills among children with ADHD. 
 
To fill these research gaps, we proposed to conduct a three-arm RCT to answer the research 
question of whether social VR training has higher effectiveness than traditional social skills 
training in enhancing the social interaction skills of children with ADHD in Hong Kong. The 
findings of this study are expected to unveil the clinical impacts and compliance and 
acceptability of social VR training for enhancing social interaction skills among children with 
ADHD. 
 
Aims and hypotheses  
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. 
 
Methods/ Design 
The study will be a three-arm randomised controlled trial comparing the effects of a 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. The overall design of the study is illustrated in Figure 1. Ethical 

approval for the study has been obtained by the Human Subjects Ethics Application Review 
Committee of The Hong Kong Polytechnic University. 
 
Figure 1. Study design 
 
Participants 
Individuals who meet the inclusion criteria will be recruited. The criteria are as follows: 1) 
aged between 6 and 12 years; 2) ethnic Chinese; 3) residing in Hong Kong; 4) having 
received a diagnosis of ADHD by Child Assessment Service in Hong Kong or via private 
practice; 5) 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); 6) no initiation or change of pharmacological treatment for ADHD 
during the intervention period; 7) ability to read Chinese, and speak and listen to Cantonese 
by the child and by at least one of their parents or legal guardian; 8) willing to provide 
informed consent by both participants and one of their parents or legal guardian. 
 
Exclusion criteria are as follows: 1) comorbid autism; 2) mental retardation; 3) an estimated 

IQ lower than 85 (using the Wechsler Intelligence Scale for Children – Fourth Edition (Hong 
Kong) (WISC-IV(HK))); 4) autism spectrum disorder (previously diagnosed by health care 
professionals), 5) comorbid acute psychiatric disorder (previously diagnosed by health care 
professionals); and 6) with a severe physical disability (e.g., blindness, deafness) or learning 
disability (e.g., dyslexia). 
 
Sample size 
The guidelines of Whitehead et al. (2016) suggested that recommended that at least 16 
subjects per group for medium effect size in pilot RCT and 15% attrition over time can be 
expected. A total of 90 participants will be recruited which fulfils the minimum number 
suggested by Whitehead et al. (2016). 30 participants in the social VR group, 30 in the 
traditional social skills group and 30 in the waitlist control group. This sample size is 
comparable to those used in the published pilot study on children with ADHD. For instance, 
van der Oord et al. (2014) recruited 40 participants (20 in the control group and 20 in the 
interventional group) to examine the efficacy of computerized executive functioning 
remediation training with game elements in children with ADHD. 
 
Procedure 
Recruitment 
Participants will be recruited from six primary schools and community centres. Interested 
participants or parents who provide written informed consent will be further evaluated for 
inclusion and exclusion criteria by a trained research assistant. Participants who meet the 
inclusion criteria in the study will be invited to perform an IQ test at the university at 
baseline. 
 
Randomisation 
Eligible participants will be randomized to the social VR (Social VR) group, traditional social 
skills training group or waitlist control group. A computer-generator randomiser will be used 
to generate the random allocation list. The randomisation will be undertaken by another 
research assistant not directly involved in the study. A number generated by the computer will 
be assigned to each eligible subject who will be randomly allocated to the three different 
groups by using the number. The participants and their parents or legal guardians will be 
blind to the assignment process. Parents or legal guardians will receive an email and a 
telephone call with notification to Group 1, Group 2 or Group 3. 

 
Social VR Intervention 
Social VR intervention is developed to enhance the social interaction skills of children. The 
participants will wear a head-mounted display (HMD) 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) street 
and building. One scenario will be adopted in each session. The sequences of the scenarios 
used in each session will be the same for all participants. During the Social VR intervention, 
one RA will also appear as one avatar in the scenario to guide the participants to complete a 
series of tasks. Each intervention session will be conducted in a classroom independently for 
each participant. 
 
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. 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. Each training session will be conducted in a classroom 
independently for each participant. 
 
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 consistency of the experiment, the 
participants are not allowed to initiate or change their pharmacological treatment during the 
3-week intervention period. 
 
Measures 
Questionnaires 

The parents or legal guardians of the participants will complete a structured questionnaire at 
the baseline and after the last session. Demographic information, including age, gender, 
Medication, ADHD symptoms and game experience will be recorded at the baseline. The 
questionnaires include questions about social skills and executive functioning. The 
satisfaction of the participants and their parents or legal guardians towards the training 
program will be assessed at week 3. The VR sickness of the participant will be evaluated after 
each session. The assessor will be blind to the treatment condition. The questionnaires will 
include the following scales:  
 
Primary outcome measure 
1. Process evaluation 
The process evaluation of the training will be assessed by investigating: (i) training 
acceptability as measured by the participants’ attendance and compliance; (ii) recruitment 
rate; (iii) participant completion. 
(i) 
Assessment of training 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. The participants will be asked about their willingness of partaking in this 
kind of training by one 7-point Likert scale question which is used to reflect the 
acceptability to the intervention. The retention rate should be at least 85% according to the 
feasibility RCT. 
The compliance with the training program will be evaluated by the communication log 
which the parents record their children’s daily activity and emotion in the 3-week 
intervention period. The participants’ parents will be reminded to attend the training 
through telephone in the first four training sessions and WhatsApp or WeChat in the fifth 
and eighth training sessions. No reminder follow-up will be made in the remaining four 
sessions. These data will be used to evaluate their compliance. 
(ii) 
Recruitment rate 
The recruitment rate is at least 48.5% of all referrals according to the feasibility study. 
(iii) 
Participant completion 
Participants attending at least nine (i.e., 75%) of the 12 sessions are considered to have 
completed the program. 
 

Secondary outcome measure 
1. Social Skills Rating Scale (SSRS-P) 
The social skills of the children will be assessed by Chinese-translated SSRS-P which will 
be scored by the participants’ parents before the first session and after the last session. This 
scale consists of 3 subscales, including self-control, assertiveness and initiative and 
cooperation, with a total of 31 items. A 3-point Likert scale (never, sometimes, often) is 
used to score. The SSRS-P is a validated instrument that has been commonly adopted in 
clinical trials of psychiatric and neurological disorders. 
2. Child psychologist’s assessment 
One child psychiatrist will score the performance of the participants in the 5-minute tasks 
to obtain an objective evaluation. Broken blinding is unavoidable in child psychiatrist’s 
assessment. To minimise unblinding bias during the assessment, each participant will be 
identified by a case number. 
3. Behaviour Rating Inventory of Executive Function (BRIEF) 
Chinese-translated BRIEF used to assess the executive functioning of children which will 
be scored by the participants’ parents before the first session and after the last session. The 
subscales of inhibitions (16-item) and emotional control (10-item) will be adopted in this 
study. A 3-point Likert scale (never, sometimes, often) is used to score.  
4. Satisfaction 
Satisfaction is measured by a 7-point Likert scale, ‘What grade would you give to this 
training program?’. Both participants and parents/ guardians have to answer. 
5. Simulator Sickness Questionnaire (SSQ)  
The SSQ measures 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. 
6. Assessment of safety  
a) Adverse events  
RA1 will ask participants’ parents/ guardians, using open-ended questions, whether the 
participants experienced any adverse events during training. The severity and 
relationship of the adverse event to the intervention will be documented and investigated. 
b) Reasons for withdrawal 
When a subject withdraws before completing the study, the reasons for withdrawal will 
be recorded. 

Statistical analysis plan 
All statistical analyses will be performed in SPSS version 26.0 software (IBM Corp, Armonk, 
NY, USA) and are two-sided with a level of significance of < 0.05. Demographic information 
of the participants will be summarised with frequency and percentage for categorical 
variables. The continuous variables will be summarised by mean and standard deviation. The 
change between baseline and week 3 within each arm will be tested using t-tests. To examine 
the between-group difference in terms of measure outcomes from baseline to week 3, 
repeated analyses of covariance (ANCOVA) with adjustment of baseline characteristics will 
be conducted. To evaluate the improvement during the intervention period among the three 
groups, f-tests will be performed on primary and secondary outcome measures at the 
beginning of the first session and at the end of the last session. An intention-to-treat analysis 
will be performed. This analysis is regarded as the most appropriate approach to analyse RCT 
data by the highest-quality journals, which have utilised the CONSORT standard. 

 
 
CONSENT TO PARTICIPATE IN RESEARCH  
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 aims to develop a social virtual reality-based intervention for children with ADHD 
and investigate its effects on improving the social skills and executive functioning of inhibitions, 
emotional control and attention of the children with ADHD compared to traditional social skills 
training. The social VR training program is important for children with ADHD because the 
innovativeness of the VR technology may engage and enhance children with ADHD’s learning 
ability. The findings will provide healthcare professionals with the most effective mean for 
mental health services for ADHD in Hong Kong. These findings will facilitate the development 
of the social VR training program that is tailor-made for Hong Kong children with ADHD, 
resulting in the improvement of these children’s social skills and psychological wellbeing that 
will be beneficial in integrating them into society. 
 
During the social virtual reality training session, participants had to wear head-mounted display 
devices for an approximately 20-minute session. In the traditional social skills training process, 
the instructor will lead the participants in the 20-minute session. 
 
All data collected this time will only be used for scientific research and will be analyzed 
anonymously, and all personal data will be kept strictly confidential. 
 
I _______________________ hereby consent to participate in the captioned research conducted 
by the researcher of School of Nursing at The Hong Kong Polytechnic University. 
I understand that information obtained from this research may be used in future research and 
published. However, my right to privacy will be retained, i.e. my personal details will not be 
revealed. Participating in this study may cause physical discomfort to me, such as headaches, 
eyestrain, dizziness, and nausea after using the headset. 
The procedure as set out in the attached information sheet has been fully explained. I understand 
the benefit and risks involved. My participation in the project is voluntary. I acknowledge that I 
have the right to question any part of the procedure and can withdraw at any time without 
penalty of any kind. 
If you have any questions, you may contact Dr Harry Jin Qin (email: harry.qin@polyu.edu.hk). 
 
  
Name of participant                                                                                                    
Name of Parent or Guardian                                                                                       
Signature of Parent or Guardian                                                                                  

Name of researcher                                                                                               
Signature of researcher                                                                                          
Date                                                                                                                        
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hung Hom Kowloon Hong Kong 香港 九龍 紅磡 
Tel 電話 (852) 2766 5111 Fax 傳真 (852) 2784 3374 
Email 電郵 polyu@polyu.edu.hk 
Website 網址 www.polyu.edu.hk