Virtual RealityNCT05778526
Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder
A study testing Virtual reality and Traditional social skills training in people with Virtual Reality and Social Interaction, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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)… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Social Interaction, Attention-deficit/Hyperactivity Disorder
- What is being tested?
- Virtual reality and Traditional social skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Feb 2023to 6 Sep 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Virtual reality, Traditional social skills training
- Keywords
- Virtual reality, Social interaction, Attention-deficit/hyperactivity disorder, Three-arm pilot randomised controlled trial
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
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.
Traditional social skills trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 weeks post-intervention
Secondary outcomes (4)
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.
Measured: After 3 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start18 Feb 2023
- Primary completion31 Aug 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Qin, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778526
- Sponsor's protocol ID
- HSEARS20221221003
- Status last verified
- Jun 2024
- First submitted
- 27 Feb 2023
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is confidential.
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.
PubMed 39467288Wong 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.
PubMed 37721790