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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Virtual reality
Traditional social skills training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Virtual Reality focused on measuring Virtual reality, Social interaction, Attention-deficit/hyperactivity disorder, Three-arm pilot randomised controlled trial

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Ka Po WONGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Social VR Intervention

Traditional social skills training

Waitlist control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Child psychologist/psychiatrist assessment
To obtain an objective evaluation on participants' social interaction skills.
Satisfaction of the intervention
To evaluation the satisfaction of the participants towards to the intervention.
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.

Full Information

First Posted
February 27, 2023
Last Updated
June 28, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05778526
Brief Title
Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Social Interaction, Attention-deficit/Hyperactivity Disorder
Keywords
Virtual reality, Social interaction, Attention-deficit/hyperactivity disorder, Three-arm pilot randomised controlled trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigator and outcomes assessor will be blinded to the study intervention period.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Social VR Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional social skills training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional social skills training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability and compliance
Description
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.
Time Frame
After 3 weeks
Secondary Outcome Measure Information:
Title
Behaviour Rating Inventory of Executive Function
Description
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.
Time Frame
Before the first session and after the last session (after 3 weeks)
Title
Social Skills Rating Scale
Description
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.
Time Frame
Before the first session and after the last session (after 3 weeks)
Title
Child psychologist/psychiatrist assessment
Description
To obtain an objective evaluation on participants' social interaction skills.
Time Frame
Before the first session and after the last session (after 3 weeks)
Title
Satisfaction of the intervention
Description
To evaluation the satisfaction of the participants towards to the intervention.
Time Frame
After the last session (after 3 weeks)
Title
Simulator Sickness Questionnaire
Description
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.
Time Frame
After the last session (after 3 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Po Wong, PhD
Phone
64860214
Email
portia.wong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Qin, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ka Po WONG
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ka Po Wong, PhD
Phone
852-6486 0214
Email
portia.wong@polyu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is confidential.

Learn more about this trial

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

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