Immersive Gamified Virtual Reality-Based Training for Children With Attention Deficit Hyperactivity Disorder
21 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
120
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur actif: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Social Skills
Délai: Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
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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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Executive functions
Délai: 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
Délai: 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
Délai: Immediate after study (3-week)
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Assessed using a seven-point Likert scale administered at baseline to participants in both the VR and traditional training groups
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Immediate after study (3-week)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
2 janvier 2027
Achèvement primaire (Estimé)
30 juin 2028
Achèvement de l'étude (Estimé)
30 août 2028
Dates d'inscription aux études
Première soumission
21 août 2026
Première soumission répondant aux critères de contrôle qualité
21 août 2026
Première publication (Réel)
25 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSEARS20240816001
- P0058954 (Autre subvention/numéro de financement: RGC)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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