Immersive Gamified Virtual Reality-Based Training for Children With Attention Deficit Hyperactivity Disorder
2026年8月21日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
120
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Social Skills
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Executive functions
時間枠：Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up
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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
時間枠：Immediate after study (3-week)
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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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月2日
一次修了 (推定)
2028年6月30日
研究の完了 (推定)
2028年8月30日
試験登録日
最初に提出
2026年8月21日
QC基準を満たした最初の提出物
2026年8月21日
最初の投稿 (実際)
2026年8月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月25日
QC基準を満たした最後の更新が送信されました
2026年8月21日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。