Attention-deficit/Hyperactivity Disorder, Social Interaction, Virtual Reality
Conditions
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
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
Study design
Masking description
The investigator and outcomes assessor will be blinded to the study intervention period.
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Riggio Social Skills Inventory Assessment | 3 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and Compliance | After 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 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. |
| 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. |
Countries
Hong Kong
Contacts
School of Nursing, The Hong Kong Polytechnic University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 90 |
Baseline characteristics
| Characteristic | Social VR Intervention | Traditional Social Skills Training | Waitlist Control Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.63 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 practice | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 30 Participants | 30 Participants | 90 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Hong Kong | 30 participants | 30 participants | 30 participants | 90 participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 23 Participants | 26 Participants | 24 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Social VR Intervention | Acceptability and Compliance | 100 Percentage of sessions attended |
| Traditional Social Skills Training | Acceptability and Compliance | 96.6 Percentage of sessions attended |
| Waitlist Control Group | Acceptability and Compliance | 63.3 Percentage of sessions attended |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social VR Intervention | Behaviour Rating Inventory of Executive Function | 16.83 score on a scale | Standard Deviation 3.08 |
| Traditional Social Skills Training | Behaviour Rating Inventory of Executive Function | 17.98 score on a scale | Standard Deviation 2.68 |
| Waitlist Control Group | Behaviour Rating Inventory of Executive Function | 19.63 score on a scale | Standard Deviation 4.91 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social VR Intervention | Riggio Social Skills Inventory Assessment | 38.20 score on a scale | Standard Deviation 2.83 |
| Traditional Social Skills Training | Riggio Social Skills Inventory Assessment | 30.63 score on a scale | Standard Deviation 6.57 |
| Waitlist Control Group | Riggio Social Skills Inventory Assessment | 24.50 score on a scale | Standard Deviation 5.17 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social VR Intervention | Satisfaction of the Intervention | 6.8 Score on a scale | Standard Deviation 1.6 |
| Traditional Social Skills Training | Satisfaction of the Intervention | 6.7 Score on a scale | Standard Deviation 1.7 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Social VR Intervention | Simulator Sickness Questionnaire | 0 Participants |
| Traditional Social Skills Training | Simulator Sickness Questionnaire | 0 Participants |
| Waitlist Control Group | Simulator Sickness Questionnaire | 0 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Social VR Intervention | Social Skills Rating System - Parent Version (SSRS-P) | 33.33 score on a scale | Standard Deviation 3.56 |
| Traditional Social Skills Training | Social Skills Rating System - Parent Version (SSRS-P) | 31.93 score on a scale | Standard Deviation 2.78 |
| Waitlist Control Group | Social Skills Rating System - Parent Version (SSRS-P) | 31.50 score on a scale | Standard Deviation 4.7 |