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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Virtual Reality, Social Interaction, Attention-deficit/Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Virtual reality
* Behavioral: Traditional social skills training


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social VR Intervention<br>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<br>* 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.<br>|
| Active Comparator: Traditional social skills training<br>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<br>* 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.<br>|
| No Intervention: Waitlist control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behaviour Rating Inventory of Executive Function | To assess the executive functioning of participants which will be scored by the participants' parents. 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. | Before the first session and after the last session (after 3 weeks) | 
| Social Skills Rating Scale | To evaluate the self-control, assertiveness and initiative and cooperation of the participants. 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. | Before the first session and after the last session (after 3 weeks) | 
| Child psychologist/psychiatrist assessment | To obtain an objective evaluation on participants' social interaction skills. | Before the first session and after the last session (after 3 weeks) | 
| Satisfaction of the intervention | To evaluation the satisfaction of the participants towards to the intervention. | 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. | After the last session (after 3 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Social interaction, Attention-deficit/hyperactivity disorder, Three-arm pilot randomised controlled trial