Immersive Gamified Virtual Reality-Based Training for Children With Attention Deficit Hyperactivity Disorder
21 de agosto de 2026 actualizado por: The Hong Kong Polytechnic University
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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Comparador activo: 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.
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Social skills training integrates cognitive restructuring to address underlying thoughts and beliefs, alongside behaviour modification strategies to build and strengthen social skills.
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Sin intervención: Waitlist control
The participants in this group will receive no training and they can participate in the social VR training after the intervention period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Social Skills
Periodo de tiempo: Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
|
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.
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Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Executive functions
Periodo de tiempo: Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
|
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.
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Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
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Motion sickness
Periodo de tiempo: Immediate after study (3-week)
|
Evaluated using the Simulator Sickness Questionnaire (SSQ), administered at baseline exclusively to participants in the VR training group.
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Immediate after study (3-week)
|
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Satisfaction with training
Periodo de tiempo: Immediate after study (3-week)
|
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)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
2 de enero de 2027
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
30 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
21 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de agosto de 2026
Publicado por primera vez (Actual)
25 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSEARS20240816001
- P0058954 (Otro número de subvención/financiamiento: RGC)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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