Immersive Gamified Virtual Reality-Based Training for Children With Attention Deficit Hyperactivity Disorder for Enhancing Social Skills: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Social Skills
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical/educational psychologist will be masked. He/She will conduct an assessment to evaluate the participant's social skills.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(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.
结局指标
主要结局
Social Skills
时间窗: 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.
次要结局
- Executive functions(Baseline, Immediate after study (3-week), 3-month follow-up, 6-month follow-up)
- Motion sickness(Immediate after study (3-week))
- Satisfaction with training(Immediate after study (3-week))