Clinical trial NCT05778526: 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
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Social Interaction
Attention-deficit/Hyperactivity Disorder
Keywords: Virtual reality
Social interaction
Attention-deficit/hyperactivity disorder
Three-arm pilot randomised controlled trial
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: Acceptability and Compliance
timeFrame: After 3 weeks
Secondary outcomes:
measure: Riggio Social Skills Inventory Assessment
timeFrame: 3 weeks post-intervention
measure: Social Skills Rating System - Parent Version (SSRS-P)
timeFrame: 3 weeks post-intervention
measure: Behaviour Rating Inventory of Executive Function
timeFrame: 3 weeks post-intervention
measure: Satisfaction of the Intervention
timeFrame: After the last session (after 3 weeks)
measure: Simulator Sickness Questionnaire
timeFrame: 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.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Ka Po WONG
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Jing Qin, PhD
role: PRINCIPAL_INVESTIGATOR
References: