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

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: Not yet recruiting
• Conditions: ADHD; Social Skills
• Intervention / Treatment: Behavioral: Immersive gamified virtual reality-based training (iGameVRT); Behavioral: Traditional social skills training

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: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
Motion sickness	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	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

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2027
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: August 21, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Behavior; Social Behavior; Attention Deficit Disorder with Hyperactivity; Social Skills
• Other Study ID 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