Immersive Gamified Virtual Reality-Based Training for Children With Attention Deficit Hyperactivity Disorder

August 21, 2026 updated by: The Hong Kong Polytechnic University

Immersive Gamified Virtual Reality-Based Training for Children With Attention Deficit Hyperactivity Disorder for Enhancing Social Skills: A Randomized Controlled Trial

This study evaluates a gamified virtual reality (VR) training program designed to help children with ADHD. Participants will be randomly assigned to one of three groups: the VR training group, a traditional training group, or a waitlist group. Children in both training groups will complete 12 sessions over three weeks. To measure the program's effectiveness, researchers will test all participants four times: before the study starts, immediately after the training ends, and at 3-month and 6-month follow-ups. Finally, children from the VR group will be interviewed after the 6-month check-in to share their experiences, including the benefits and challenges they encountered.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study employs a mixed-methods design, incorporating both an randomized controlled trial (RCT) and post-trial qualitative interviews. An assessor-blinded, three-arm RCT will be conducted to evaluate the effects of immersive gamified virtual reality-based training (iGameVRT) for children with ADHD. Participants will be randomly assigned to one of three groups: (1) iGameVRT, (2) Traditional Group (TG), and (3) Waitlist Control (WC). Participants in the iGameVRT and TG groups will undergo three weekly intervention sessions. Our pilot study demonstrated that a 12-session VR intervention over three weeks had a substantial effect on improving social skills in participants with ADHD (Cohen's d = 1.50). This indicates that the duration and frequency of the intervention were both feasible and well-tolerated. Therefore, we propose maintaining the same intervention schedule of 12 sessions over three weeks for this large-scale RCT. Assessments will be conducted at baseline (T0), immediately after the week 3 intervention (T1), a 3-month follow-up (T2) and a 6-month follow-up (T3). The training effects will be tested using between-groups (three arms) and within-groups (measures at T0, T1, T2 and T3) comparison. After T3, participants from the iGameVRT will be invited to share their experience of the GameVR-SST and perceived benefits and challenges.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (1) children aged between 6 and 12 years;
  • (2) a diagnosis of ADHD by a psychologist or psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD;
  • (3) able to speak, listen and understand Cantonese;
  • (4) willing to provide informed consent from the participants and the legal guardian of the participants.

Exclusion Criteria:

  • (1) with comorbid conduct/behaviour problems;
  • (2) with a physical or learning disability that affects the ability to conduct the intervention;
  • (3) with an abnormal intellectual ability (unable to understand the materials delivered in the intervention);
  • (4) initiation or change of ADHD medication during the study period;
  • (5) history of severe motion sickness;
  • (6) have participated in other psychological interventions for regulating ADHD-related symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual reality-based intervention (iGameVRT)
The participants will wear a head-mounted display (HMD) for the iGameVRT. Each session of the iGameVRT 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 iGameVRT intervention will mainly help the participant 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. 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: Immersive gamified virtual reality-based training (iGameVRT)
The immersive gamified virtual reality training intervention provides children with repeated practice in coding and interpreting social cues within a controlled and safe environment. The intervention includes immediate feedback and reinforcement mechanisms, enabling children to refine their responses effectively. The virtual reality environment is designed with social challenges of varying complexities, allowing children to play and learn engagingly.
Active Comparator: Traditional social skills training
A teacher will teach the participants social interaction skills through tradidactic instructions and role-play activities. Four modules will be covered: (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. The content of this training will be as similar as possible to the iGameVRT. 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.
Behavioral: Traditional social skills training
Social skills training integrates cognitive restructuring to address underlying thoughts and beliefs, alongside behaviour modification strategies to build and strengthen social skills.
No Intervention: Waitlist control
The participants in this group will receive no training and they can participate in the social VR training after the intervention period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Social Skills
Time Frame: Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
Assessed through two methods: (1) A clinical/educational psychologist will use a modified version of Riggio's basic social skills assessment (10 items), and (2) guardians will complete the Skills Improvement System-Rating Scales (SSIS-RS) (formerly Social Skills Rating Scale), focusing on selected subscales of self-control (16 items), initiative (9 items), and cooperation (6 items). The clinical/educational psychologist's assessment involves a 15- to 20-minute conversation during which the psychologist observes and evaluates the participant's social skills. To mitigate potential unblinding bias during the assessment, each participant will be assigned a unique case number for identification.
Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Executive functions
Time Frame: Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
Assessed by guardians using the Behaviour Rating Inventory of Executive Function-Parent Form (BRIEF) (Gioia et al., 2000), focusing on selected subscales: inhibition (16 items) and emotional control (10 items). These subscales demonstrate internal consistency with Cronbach's α of 0.79 and 0.89, respectively.
Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
Motion sickness
Time Frame: Immediate after study (3-week)
Evaluated using the Simulator Sickness Questionnaire (SSQ), administered at baseline exclusively to participants in the VR training group.
Immediate after study (3-week)
Satisfaction with training
Time Frame: Immediate after study (3-week)
Assessed using a seven-point Likert scale administered at baseline to participants in both the VR and traditional training groups
Immediate after study (3-week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20240816001
  • P0058954 (Other Grant/Funding Number: RGC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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