MindLight: A Video Game Intervention to Reduce Children's Anxiety
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Spence Children's Anxiety Scale following intervention
研究概览
简要总结
Anxiety is the most prevalent form of children's mental health problems and demand far exceeds treatment availability. Even when children do have access to care, evidence-based treatments such as cognitive-behavioural therapy have several limitations: they are largely didactic, leaving children unmotivated and disengaged; children get little practice in using the skills they are taught, creating a large gap between their knowledge and their everyday behaviour and therapy is costly, often prohibitive for the children that most need it. Therapeutic video games can address each of these gaps: they are engaging contexts through which children practice skills (rather than memorize lessons), and they cost substantially less than conventional approaches. The proposed research will test the effectiveness of MindLight, an innovative video game that targets childhood anxiety problems. MindLight incorporates several evidence-based strategies including relaxation and exposure techniques, attention bias modification methods, and neurofeedback mechanics that together produce an immersive game world through which children learn to manage and overcome anxiety symptoms. Two randomized controlled studies with 8-16 year old children are proposed to test the effectiveness of MindLight in reducing anxiety: the first is a prevention study aimed at children at risk for developing serious anxiety problems and the second is a clinical trial aimed at decreasing symptoms in anxiety-disordered children. Children randomly assigned to the intervention group will play MindLight for 5 hours over 2-3 weeks; control participants in the prevention sample will play a commercial video game with a similar theme for the same amount of time whereas control participants in the clinical sample will use an online cognitive behavioural therapy (CBT) program. Both studies will assess children's anxiety levels before the intervention, just after, and at a 3-month follow-up. Moderators (e.g., comorbidities) and mediators (e.g., attention biases) will be assessed to identify potential mechanisms of change associated with successful intervention effects.
详细描述
Over the next two years, the investigators will be collecting data on two samples, henceforth identified as the Clinical Sample and Prevention Sample. The laboratory protocol (pre, post, and follow-up) is the same for each; however the screening and recruitment are not. In this section, only those procedures and methods of the lab visit that are common to both are described. Next the video game intervention procedures are described. Participant and recruitment details are in subsequent sections.
Each participant will visit the Adolescent Dynamics Lab three times (pre, post, and follow-up) with only minor differences where noted. Parents will accompany children to the lab and, following the completion of consent forms (pre only), complete a set of questionnaires via computer:
Child report:
- Demographics
- Spence Child Anxiety Scale (SCAS)
- Strengths and Difficulties Questionnaire (SDQ)- emotional symptoms
- Top Problems questionnaire (TP)
- Coping Questionnaire
- Self-Efficacy Questionnaire (SEQ-C)
Parent report:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elevated levels or clinical diagnosis of anxiety
排除标准
- •Developmental disorders or autism
结局指标
主要结局
Change in Spence Children's Anxiety Scale following intervention
时间窗: Pre-Tx (1st lab visit), Post-Tx (2nd lab visit 3 weeks later), Follow-up (final lab visit 3 months later)
Widely used scale for measuring children's anxiety will be used to determine the degree of reduction in anxiety symptoms immediately following the intervention and whether this reduction is maintained at a 3-month follow-up.
次要结局
未报告次要终点
研究者
Dr. Tom Hollenstein
Associate Professor
Queen's University
