Immersive Gamified Virtual Reality-Based Training for Children With Attention Deficit Hyperactivity Disorder
21 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
120
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Comparador Ativo: 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.
|
|
Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Social Skills
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Executive functions
Prazo: 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
Prazo: Immediate after study (3-week)
|
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
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
2 de janeiro de 2027
Conclusão Primária (Estimado)
30 de junho de 2028
Conclusão do estudo (Estimado)
30 de agosto de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
21 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de agosto de 2026
Primeira postagem (Real)
25 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HSEARS20240816001
- P0058954 (Número de outro subsídio/financiamento: RGC)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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