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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorThe Hong Kong Polytechnic University

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 volunteers

Qualifiers

(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

Design model

Parallel

Treatments tested in this trial

  • 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 training

    Behavioral

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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Virtual reality-based intervention (iGameVRT)Experimental treatment 1 intervention
Group B: Traditional social skills trainingActive comparator 1 intervention
Group C: Waitlist controlNo intervention 0 interventions

Trial outcomes

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: