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

Virtual Reality Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778526
• Other study ID #: HSEARS20221221003
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: The Hong Kong Polytechnic University
• Contact: Ka Po Wong, PhD
• Phone: 64860214
• Email: portia.wong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit/Hyperactivity Disorder
• Hyperkinesis
• Social Interaction
• Virtual Reality

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Ka Po WONG	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Satisfaction of the intervention	To evaluation the satisfaction of the participants towards to the intervention.	After the last session (after 3 weeks)
Secondary	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)