About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
(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.
Disqualifiers
(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;
Trial design
Parallel
Treatments tested in this trial
Immersive gamified virtual reality-based training (iGameVRT)
BehavioralThe 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 training
BehavioralSocial skills training integrates cognitive restructuring to address underlying thoughts and beliefs, alongside behaviour modification strategies to build and strengthen social skills.
Treatment groups
Trial 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.
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.
Motion sickness
Evaluated using the Simulator Sickness Questionnaire (SSQ), administered at baseline exclusively to participants in the VR training group.
Satisfaction with training
Assessed using a seven-point Likert scale administered at baseline to participants in both the VR and traditional training groups
Locations
Sponsors and contacts
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