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

Effectiveness of Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder: a Three-arm Pilot Randomised Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05778526
Enrollment
90
Registered
2023-03-21
Start date
2023-02-18
Completion date
2024-09-06
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Virtual reality, Social interaction, Attention-deficit/hyperactivity disorder, Three-arm pilot randomised controlled trial

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.

Interventions

BEHAVIORALVirtual 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.

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The investigator and outcomes assessor will be blinded to the study intervention period.

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
Riggio Social Skills Inventory Assessment3 weeks post-intervention\[Protocol-to-Publication Realignment Explanation\]: In the initial protocol, trial feasibility (attendance/compliance) was registered as the primary focus. In the final published pilot RCT, to address the core therapeutic objective of this intervention, the evaluation was refined to focus on clinical efficacy. Therefore, this blinded clinical assessment of Social Skills was designated as a Primary Outcome to directly report behavioral improvements. This assessment uses 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 skills. The inventory includes subscales that measure aspects of verbal and non-verbal communication.
Social Skills Improvement System Rating Scales - Parent Version (SSIS-RS)3 weeks post-intervention\[Protocol-to-Publication Realignment Explanation\]: Outcome Level: Shifted from a feasibility framework in the protocol to a primary clinical outcome in the published paper to evaluate targeted efficacy. Scale Upgrade: The tool was upgraded from the older SSRS-P (as planned in the protocol) to its revised version, the SSIS-RS, which provides updated contemporary clinical norms for children with ADHD. This assessment evaluates participants' self-control, assertiveness, and initiative and cooperation. The SSIS-RS 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 SSIS-RS is a validated instrument commonly adopted in clinical trials of psychiatric and neurological disorders.

Secondary

MeasureTime frameDescription
Acceptability and ComplianceAfter 3 weeks\[Protocol-to-Publication Realignment Explanation\]: This parameter was originally listed as a Primary Outcome in the feasibility protocol. In the final published pilot RCT, all feasibility targets were successfully achieved (sample size of 90 randomized, accounting for the anticipated 25%-30% attrition rate). For structural reporting in the peer-reviewed paper, it was repositioned under secondary/feasibility outcomes while clinical efficacy took priority as the primary measure. 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.
Behaviour Rating Inventory of Executive Function3 weeks post-interventionTo 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 InterventionAfter 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.
Simulator Sickness QuestionnaireAssessments 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.

Countries

Hong Kong

Contacts

PRINCIPAL_INVESTIGATORJing Qin, PhD

School of Nursing, The Hong Kong Polytechnic University

Participant flow

Participants by arm

ArmCount
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. 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.
30
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. 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.
30
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.
30
Total90

Baseline characteristics

CharacteristicSocial VR InterventionTraditional Social Skills TrainingWaitlist Control GroupTotal
Age, Categorical
<=18 years
30 Participants30 Participants30 Participants90 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous8.63 years
STANDARD_DEVIATION 1.9
8.30 years
STANDARD_DEVIATION 1.7
8.67 years
STANDARD_DEVIATION 1.45
8.53 years
STANDARD_DEVIATION 1.7
Having received a diagnosis of ADHD by Child Assessment Service in Hong Kong or via private practice30 Participants30 Participants30 Participants90 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
30 Participants30 Participants30 Participants90 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
Hong Kong
30 participants30 participants30 participants90 participants
Sex: Female, Male
Female
7 Participants4 Participants6 Participants17 Participants
Sex: Female, Male
Male
23 Participants26 Participants24 Participants73 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 300 / 30
other
Total, other adverse events
0 / 300 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 300 / 30

Outcome results

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.

Time frame: After 3 weeks

ArmMeasureValue (NUMBER)
Social VR InterventionAcceptability and Compliance100 Percentage of sessions attended
Traditional Social Skills TrainingAcceptability and Compliance96.6 Percentage of sessions attended
Waitlist Control GroupAcceptability and Compliance63.3 Percentage of sessions attended
Secondary

Behaviour Rating Inventory of Executive Function

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.

Time frame: 3 weeks post-intervention

Population: Data were collected from the guardians of all participants who completed the BRIEF assessments, resulting in 30 participants in each group.

ArmMeasureValue (MEAN)Dispersion
Social VR InterventionBehaviour Rating Inventory of Executive Function16.83 score on a scaleStandard Deviation 3.08
Traditional Social Skills TrainingBehaviour Rating Inventory of Executive Function17.98 score on a scaleStandard Deviation 2.68
Waitlist Control GroupBehaviour Rating Inventory of Executive Function19.63 score on a scaleStandard Deviation 4.91
Secondary

Riggio Social Skills Inventory Assessment

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.

Time frame: 3 weeks post-intervention

Population: Data were collected from all participants who completed the assessments, including those from the waitlist control group who did not receive the intervention. This resulted in an analysis population of 30 participants in each group: 30 in the Social VR Intervention group, 30 in the Traditional Social Skills Training group, and 30 in the Waitlist Control group.

ArmMeasureValue (MEAN)Dispersion
Social VR InterventionRiggio Social Skills Inventory Assessment38.20 score on a scaleStandard Deviation 2.83
Traditional Social Skills TrainingRiggio Social Skills Inventory Assessment30.63 score on a scaleStandard Deviation 6.57
Waitlist Control GroupRiggio Social Skills Inventory Assessment24.50 score on a scaleStandard Deviation 5.17
Secondary

Satisfaction of the Intervention

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.

Time frame: After the last session (after 3 weeks)

Population: Data were collected from 30 participants in the VR training group and 30 participants in the traditional social skills training group to assess satisfaction at the last session of the intervention.

ArmMeasureValue (MEAN)Dispersion
Social VR InterventionSatisfaction of the Intervention6.8 Score on a scaleStandard Deviation 1.6
Traditional Social Skills TrainingSatisfaction of the Intervention6.7 Score on a scaleStandard Deviation 1.7
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.

Time frame: 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.

Population: Only the participants in the Social VR Intervention were assessed.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Social VR InterventionSimulator Sickness Questionnaire0 Participants
Traditional Social Skills TrainingSimulator Sickness Questionnaire0 Participants
Waitlist Control GroupSimulator Sickness Questionnaire0 Participants
Secondary

Social Skills Rating System - Parent Version (SSRS-P)

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.

Time frame: 3 weeks post-intervention

Population: Data were collected from the guardians of all participants who completed the SSRS-P assessments, resulting in 30 participants in each group.

ArmMeasureValue (MEAN)Dispersion
Social VR InterventionSocial Skills Rating System - Parent Version (SSRS-P)33.33 score on a scaleStandard Deviation 3.56
Traditional Social Skills TrainingSocial Skills Rating System - Parent Version (SSRS-P)31.93 score on a scaleStandard Deviation 2.78
Waitlist Control GroupSocial Skills Rating System - Parent Version (SSRS-P)31.50 score on a scaleStandard Deviation 4.7

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026