ClinicalTrials.gg
Not yet recruitingNCT07784933Updated Aug 25, 2026

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

An interventional study of Immersive gamified virtual reality-based training (iGameVRT) and Traditional social skills training in ADHD and Social Skills, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 120 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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)

  • 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

  • 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.

Interventions

  • BehavioralImmersive 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.

  • BehavioralTraditional 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.

06

What researchers measure

Primary outcomes

  1. Social Skills

    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.

    Time frame: Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up

Secondary outcomes

  1. Executive functions

    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.

    Time frame: Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up

  2. Motion sickness

    Evaluated using the Simulator Sickness Questionnaire (SSQ), administered at baseline exclusively to participants in the VR training group.

    Time frame: Immediate after study (3-week)

  3. Satisfaction with training

    Assessed using a seven-point Likert scale administered at baseline to participants in both the VR and traditional training groups

    Time frame: Immediate after study (3-week)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07784933
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Jan 2, 2027 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Aug 25, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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