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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05778526
Collaborator
(none)
90
1
3
14.4
6.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual reality
  • Behavioral: Traditional social skills training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
The investigator and outcomes assessor will be blinded to the study intervention period.
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Feb 18, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
May 2, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Social VR Intervention

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
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.

Active Comparator: 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.

Behavioral: 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.

No Intervention: Waitlist control group

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Behaviour Rating Inventory of Executive Function [Before the first session and after the last session (after 3 weeks)]

    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.

  2. Social Skills Rating Scale [Before the first session and after the last session (after 3 weeks)]

    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.

  3. Child psychiatrist's assessment [Before the first session and after the last session (after 3 weeks)]

    To obtain an objective evaluation on participants' social interaction skills.

  4. Satisfaction of the intervention [After the last session (after 3 weeks)]

    To evaluation the satisfaction of the participants towards to the intervention.

  5. Simulator Sickness Questionnaire [After the last session (after 3 weeks)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ka Po WONG Hong Kong Hong Kong

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Jing Qin, PhD, School of Nursing, The Hong Kong Polytechnic University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT05778526
Other Study ID Numbers:
  • HSEARS20221221003
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Hong Kong Polytechnic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2023