Immersive Gamified Virtual Reality-Based Training for Children With Attention Deficit Hyperactivity Disorder
21 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
120
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Social Skills
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Executive functions
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Immediate after study (3-week)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
2 gennaio 2027
Completamento primario (Stimato)
30 giugno 2028
Completamento dello studio (Stimato)
30 agosto 2028
Date di iscrizione allo studio
Primo inviato
21 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
21 agosto 2026
Primo Inserito (Effettivo)
25 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HSEARS20240816001
- P0058954 (Altro numero di sovvenzione/finanziamento: RGC)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .