Randomized Controlled Trial of a Family-focused CBT Skills App and Standard Self Help Options for Childhood Anxiety and Related Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Spence Children's Anxiety Scale - Parent/Child Report (SCAS)
研究概览
简要总结
Anxiety disorders are among the most common psychological disorders, with prevalent onset in childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the first-line treatment for pediatric anxiety, significant barriers remain in accessing CBT and other evidence-based treatments (EBTs), and credible self-help resources based in EBT concepts. This study evaluates a family-guided CBT game application (Anchors App), targeted to children ages 6-11 and their families, which focuses on delivering adaptive CBT-based coping skills to those who have sub-clinical to mild anxiety and related symptoms in a convenient and portable platform. Anchors App will be evaluated in two forms (standard and "parent-enhanced") in comparison to use of a self-help book or waitlist control. The rapid advancements in technology allows richer interactive capacity, content scalability, customizability, and subscription to a broader range of content, which this app capitalizes on in order to increase access to CBT skill concepts directly to pediatric stakeholder populations. If found to be effective, Anchors App has the opportunity to promote engagement of EBT concepts in every-day use through smartphone technology, and will change the landscape of mental health prevention and early intervention for children and families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
There is no masking in this study.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Availability of mobile technology (e.g., smart phone, tablet)
- •Internet access
- •English language spoken in the home
排除标准
- •Child in current or recent (last 2 months) psychotherapy
- •Child currently taking psychotropic medication
- •Parent or child endorsing symptom greater than 2 standard deviations above the mean on clinical measures
- •Parents express feeling unable to assist child with current degree of symptoms
结局指标
主要结局
Spence Children's Anxiety Scale - Parent/Child Report (SCAS)
时间窗: Entry into study, 6 weeks, 12 weeks
Parent and child report of anxiety with 6 DSM-IV criteria sub scales. Measuring change in reported anxiety levels in these 6 different domains over time.
次要结局
- DASS-21(Entry into study, 6 weeks, 12 weeks)
- Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)(Entry into study, 6 weeks, 12 weeks)
- Anxiety Sensitivity Index- 3 (ASI-3)(Entry into study, 6 weeks, 12 weeks)
- Child Anxiety Sensitivity Index (CASI)(Entry into study, 6 weeks, 12 weeks)
- Behavioral Inhibition Instrument (BII)(Entry into study, 6 weeks, 12 weeks)
- Treatment Status and Parent Confidence(Entry into study, 3 weeks, 6 weeks, 12 weeks)
- Opinion on Intervention(6 weeks)