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

N/ANot Yet RecruitingNCT07784933

The Hong Kong Polytechnic University120 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

Interventions

Immersive gamified virtual reality-based training (iGameVRT)BEHAVIORAL

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.

Traditional social skills trainingBEHAVIORAL

Social skills training integrates cognitive restructuring to address underlying thoughts and beliefs, alongside behaviour modification strategies to build and strengthen social skills.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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)

Satisfaction with training

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