Attention-Deficit/Hyperactivity DisorderNCT05568446
Social VR Based Intervention on Enhancing Social Interaction Skills in Children With AD/HD
A study testing Social virtual reality and Traditional social skills in people with Attention-Deficit/Hyperactivity Disorder, run by The Hong Kong Polytechnic University.
Trial summary
The study targets children with diagnosed ADHD and aims to (1) develop a social virtual reality based (SocVR) intervention and (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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Social virtual reality and Traditional social skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Social Virtual Reality Based Intervention on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder: a Pilot Randomised Controlled Trial
The study targets children with diagnosed ADHD and aims to (1) develop a social virtual reality based (SocVR) intervention and (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.
The study will be a three-arm parallel randomised controlled trial comparing the effects of a SocVR with traditional social skills training on social skills and executive functioning of children with ADHD. The study period is 2 months, including 4 weeks (2 sessions per week) of intervention and control, followed by a 4-week follow-up. The participants will be assessed at three time points (i.e. at baseline, 4 weeks and 4 weeks follow-up).
The guidelines of Whitehead et al. (2016) suggested that recommended that at least 16 subjects per group for medium effect size in pilot RCT and 15% attrition over time can be expected. Thus, the minimum sample size per group was 20. A total of 60 participants will be recruited in which 20 participants in the social VR group, 20 in the traditional social skills group and 20 in the waitlist control group.
Read the detailed description
Social VR Intervention During the Social VR intervention, one RA will also appear as one avatar in the scenario to guide the participants to complete a series of tasks. Each intervention session will be conducted in a classroom independently for each participant.
Traditional social skills training The training lasts 20 minutes which depends on the emotion of the participants. Each training session will be conducted in a classroom independently for each participant.
Sample size The guidelines of Whitehead et al. (2016) suggested that recommended that at least 16 subjects per group for medium effect size in pilot RCT and 15% attrition over time can be expected. Thus, the minimum sample size per group was 20. Based on the guideline of Whitehead et al. (2016), a total of 60 participants will be recruited in which 20 participants in the social VR group, 20 in the traditional social skills group and 20 in the waitlist control group. This sample size is comparable to those used in the published pilot study on children with ADHD. For instance, van der Oord et al. (2014) recruited 40 participants (20 in the control group and 20 in the interventional group) to examine the efficacy of computerized executive functioning remediation training with game elements in children with ADHD.
Recruitment Participants will be recruited from six primary schools and community centres. Interested participants or parents who provide written informed consent will be further evaluated for inclusion and exclusion criteria by a trained research assistant. Participants who meet the inclusion criteria in the study will be invited to perform an IQ test at the university at baseline.
Randomisation Eligible participants will be randomized to the SocVR group, traditional social skills training group or waitlist control group. A computer-generator randomiser will be used to generate the random allocation list. The randomisation will be undertaken by another research assistant not directly involved in the study. A number generated by the computer will be assigned to each eligible subject who will be randomly allocated to the three different groups by using the number. The participants and their parents or legal guardians will be blind to the assignment process. Parents or legal guardians will receive an email and a telephone call with notification to Group 1, Group 2 or Group 3.
Statistical analysis All statistical analyses will be performed in SPSS version 26.0 software (IBM Corp, Armonk, NY, USA) and are two-sided with a level of significance of < 0.05. Demographic information of the participants will be summarised with frequency and percentage for categorical variables. The continuous variables will be summarised by mean and standard deviation. The change between baseline and week 4 within each arm will be tested using t-tests. To examine the between-group difference in terms of measure outcomes from baseline to week 4, repeated analyses of covariance (ANCOVA) with adjustment of baseline characteristics will be conducted. To evaluate the improvement during the intervention period among the three groups, f-tests will be performed on primary and secondary outcome measures at the beginning of the first session and at the end of the last session. An intention-to-treat analysis will be performed. This analysis is regarded as the most appropriate approach to analyse RCT data by the highest-quality journals, which have utilised the CONSORT standard.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Social virtual reality, Traditional social skills
- Keywords
- Attention-deficit/hyperactivity disorder, Virtual reality, Social interaction skills, Children
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social virtual realityBehavioural
The participants will receive eight training sessions in 4 weeks (2 sessions per week). Each session is about 20 minutes.
Traditional social skillsBehavioural
The participants will receive eight training sessions in 4 weeks (2 sessions per week). Each session is about 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Social VR group | Experimental | Social VR (SocVR) intervention is developed to enhance the social interaction skills of children. The participants will wear a head-mounted display (HMD) for the SocVR intervention. Each session of the SocVR intervention lasts for a maximum of 20 minutes to ensure the participants focus on the intervention and prevent causing any physical effect (Yamaguchi, 1999). The intervention contains three real-life virtual scenarios, including (1) classroom and playground, (2) MTR station and compartment, and (3) street and building. One scenario will be adopted in each session. The sequences of the scenarios used in each session will be the same for all participants. During the SocVR intervention, one RA will also appear as one avatar in the scenario to guide the participants to complete a series of tasks. Each intervention session will be conducted in a classroom independently for each participant. Receives: Behavioral: Social virtual reality |
| Traditional social skills group | Active comparator | An experienced special educational needs (SEN) teacher will teach the participants social interaction skills through tradidactic instructions and role-play activities. Four modules will be covered in the 4-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 SocVR training. The training lasts 20 minutes which depends on the emotion of the participants. Each training session will be conducted in a classroom independently for each participant. Receives: Behavioral: Traditional social skills |
| Waitlist control group | No intervention | With reference to Beck et al. (2010), 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 8-week intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Skills Rating Scale
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.
Measured: Baseline
Social Skills Rating Scale
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.
Measured: Change from baseline social skills at week 4 post-interventioin
Social Skills Rating Scale
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.
Measured: Week 8 follow-up
Secondary outcomes (3)
Behavior Rating Inventory of Executive Function
This scale is used to assess the executive functioning of children which will be scored by the participants' parents. The subscales of inhibitions (16-item), emotional control (10-item) and shifting (10-item) will be adopted in this study. A 3-point Likert scale (never, sometimes, often) is used to score.
Measured: Baseline
Behavior Rating Inventory of Executive Function
This scale is used to assess the executive functioning of children which will be scored by the participants' parents. The subscales of inhibitions (16-item), emotional control (10-item) and shifting (10-item) will be adopted in this study. A 3-point Likert scale (never, sometimes, often) is used to score.
Measured: Change from baseline social skills at week 4 post-interventioin
Behavior Rating Inventory of Executive Function
This scale is used to assess the executive functioning of children which will be scored by the participants' parents. The subscales of inhibitions (16-item), emotional control (10-item) and shifting (10-item) will be adopted in this study. A 3-point Likert scale (never, sometimes, often) is used to score.
Measured: Week 8 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start15 Nov 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WONG Portia, The Hong Kong Polytechnic University
- Investigators
- Ka Po Wong, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568446
- Sponsor's protocol ID
- HSEARS20220823001
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Social Virtual Reality Based Intervention on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05568446
- Acronym / sponsor ID
- HSEARS20220823001
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- Attention-deficit/hyperactivity disorder, Virtual reality, Social interaction skills, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study targets children with diagnosed ADHD and aims to (1) develop a social virtual reality based (SocVR) intervention and (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.
The study will be a three-arm parallel randomised controlled trial comparing the effects of a SocVR with traditional social skills training on social skills and executive functioning of children with ADHD. The study period is 2 months, including 4 weeks (2 sessions per week) of intervention and control, followed by a 4-week follow-up. The participants will be assessed at three time points (i.e. at baseline, 4 weeks and 4 weeks follow-up).
The guidelines of Whitehead et al. (2016) suggested that recommended that at least 16 subjects per group for medium effect size in pilot RCT and 15% attrition over time can be expected. Thus, the minimum sample size per group was 20. A total of 60 participants will be recruited in which 20 participants in the social VR group, 20 in the traditional social skills group and 20 in the waitlist control group.
Detailed description
Social VR Intervention During the Social VR intervention, one RA will also appear as one avatar in the scenario to guide the participants to complete a series of tasks. Each intervention session will be conducted in a classroom independently for each participant.
Traditional social skills training The training lasts 20 minutes which depends on the emotion of the participants. Each training session will be conducted in a classroom independently for each participant.
Sample size The guidelines of Whitehead et al. (2016) suggested that recommended that at least 16 subjects per group for medium effect size in pilot RCT and 15% attrition over time can be expected. Thus, the minimum sample size per group was 20. Based on the guideline of Whitehead et al. (2016), a total of 60 participants will be recruited in which 20 participants in the social VR group, 20 in the traditional social skills group and 20 in the waitlist control group. This sample size is comparable to those used in the published pilot study on children with ADHD. For instance, van der Oord et al. (2014) recruited 40 participants (20 in the control group and 20 in the interventional group) to examine the efficacy of computerized executive functioning remediation training with game elements in children with ADHD.
Recruitment Participants will be recruited from six primary schools and community centres. Interested participants or parents who provide written informed consent will be further evaluated for inclusion and exclusion criteria by a trained research assistant. Participants who meet the inclusion criteria in the study will be invited to perform an IQ test at the university at baseline.
Randomisation Eligible participants will be randomized to the SocVR group, traditional social skills training group or waitlist control group. A computer-generator randomiser will be used to generate the random allocation list. The randomisation will be undertaken by another research assistant not directly involved in the study. A number generated by the computer will be assigned to each eligible subject who will be randomly allocated to the three different groups by using the number. The participants and their parents or legal guardians will be blind to the assignment process. Parents or legal guardians will receive an email and a telephone call with notification to Group 1, Group 2 or Group 3.
Statistical analysis All statistical analyses will be performed in SPSS version 26.0 software (IBM Corp, Armonk, NY, USA) and are two-sided with a level of significance of < 0.05. Demographic information of the participants will be summarised with frequency and percentage for categorical variables. The continuous variables will be summarised by mean and standard deviation. The change between baseline and week 4 within each arm will be tested using t-tests. To examine the between-group difference in terms of measure outcomes from baseline to week 4, repeated analyses of covariance (ANCOVA) with adjustment of baseline characteristics will be conducted. To evaluate the improvement during the intervention period among the three groups, f-tests will be performed on primary and secondary outcome measures at the beginning of the first session and at the end of the last session. An intention-to-treat analysis will be performed. This analysis is regarded as the most appropriate approach to analyse RCT data by the highest-quality journals, which have utilised the CONSORT standard.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social VR group | Experimental | Behavioral: Social virtual realitySocial VR (SocVR) intervention is developed to enhance the social interaction skills of children. The participants will wear a head-mounted display (HMD) for the SocVR intervention. Each session of the SocVR intervention lasts for a maximum of 20 minutes to ensure the participants focus on the intervention and prevent causing any physical effect (Yamaguchi, 1999). The intervention contains three real-life virtual scenarios, including (1) classroom and playground, (2) MTR station and compartment, and (3) street and building. One scenario will be adopted in each session. The sequences of the scenarios used in each session will be the same for all participants. During the SocVR intervention, one RA will also appear as one avatar in the scenario to guide the participants to complete a series of tasks. Each intervention session will be conducted in a classroom independently for each participant. |
| Traditional social skills group | Active comparator | Behavioral: Traditional social skillsAn experienced special educational needs (SEN) teacher will teach the participants social interaction skills through tradidactic instructions and role-play activities. Four modules will be covered in the 4-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 SocVR training. The training lasts 20 minutes which depends on the emotion of the participants. Each training session will be conducted in a classroom independently for each participant. |
| Waitlist control group | No intervention | –With reference to Beck et al. (2010), 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 8-week intervention period. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social virtual realityThe participants will receive eight training sessions in 4 weeks (2 sessions per week). Each session is about 20 minutes. | Behavioural | Social VR group |
| Traditional social skillsThe participants will receive eight training sessions in 4 weeks (2 sessions per week). Each session is about 20 minutes. | Behavioural | Traditional social skills group |
Primary outcome
Social Skills Rating Scale
Time frame: Baseline
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.
Social Skills Rating Scale
Time frame: Change from baseline social skills at week 4 post-interventioin
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.
Social Skills Rating Scale
Time frame: Week 8 follow-up
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.
3 secondary outcomes
Behavior Rating Inventory of Executive Function
Time frame: Baseline
Behavior Rating Inventory of Executive Function
Time frame: Change from baseline social skills at week 4 post-interventioin
Behavior Rating Inventory of Executive Function
Time frame: Week 8 follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Po Wong, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Social virtual reality and Traditional social skills in people with Attention-Deficit/Hyperactivity Disorder, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Po Wong, PhD (64860214 ext. 852, portia.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Skills Rating Scale (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.