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

Not Applicable

Completed

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

Interventions: Behavioral: Virtual reality
Behavioral: Traditional social skills training

Registration Number: NCT05778526

Lead Sponsor: The Hong Kong Polytechnic University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social VR Intervention	Virtual reality	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.
Traditional social skills training	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 (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.

Primary Outcome Measures

Name	Time	Method
Acceptability and Compliance	After 3 weeks	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

Name	Time	Method
Simulator Sickness Questionnaire	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.	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.
Riggio Social Skills Inventory Assessment	3 weeks post-intervention	This assessment utilizes 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 interaction skills. The inventory includes subscales that measure aspects of verbal and non-verbal communication.
Social Skills Rating System - Parent Version (SSRS-P)	3 weeks post-intervention	This assessment evaluates participants' self-control, assertiveness, and initiative and cooperation. The SSRS-P 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 SSRS-P is a validated instrument commonly adopted in clinical trials of psychiatric and neurological disorders.
Behaviour Rating Inventory of Executive Function	3 weeks post-intervention	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.
Satisfaction of the Intervention	After the last session (after 3 weeks)	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.