Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 3
- 主要终点
- Change from baseline in anxiety at 8 weeks
研究概览
简要总结
Anxiety is a common mental health problem for Canadian youth. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all youth by the age of 16. Anxiety disorders can have serious negative effects on a young person's personal relationships, school performance, and family life. These disorders may not be discovered by youth, parents and health care providers. Even if anxiety disorders are discovered, youth may not get the right therapy. Anxious youth can become sick if their anxiety is not treated properly.
The investigative team will carry out research to test Breathe, their new Internet-based treatment for youth with anxiety problems. Youth can use this treatment at home. Breathe includes information materials and personalized homework assignments to help anxious youth learn ways to manage anxiety.
This study is a pilot randomized controlled trial (RCT) with two groups, an Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage (control group; considered treatment as usual for youth waiting for services). The investigators will evaluate several methodological processes and outcomes through the following objectives:
- To evaluate the change in youths' anxiety (primary outcome) from pre- to post- intervention.
- To estimate recruitment and retention rates for a full-scale RCT.
- To estimate a sample size for a full-scale RCT.
- To define the minimal clinically important difference (MCID) for the primary outcome measure.
- To measure intervention acceptability.
- To determine the use of co-interventions during the trial.
- To conduct a preliminary economic analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-IV social anxiety, generalized anxiety, anxiety not otherwise specified, or adjustment disorder as the primary clinical problem
- •ability to read and write English
- •regular access to a telephone and a computer system with high speed Internet service
- •ability to use a computer to interact with web material
- •youth aged 13-14 must have a consenting parent
排除标准
- •youth with an anxiety problem that is not included above
- •youth who receive cognitive behavioural therapy
- •youth who cannot provide consent
研究组 & 干预措施
Internet-based CBT
Internet-based cognitive behavioural therapy
干预措施: cognitive behavioural therapy (Behavioral)
Internet-based resource page
Static webpage
干预措施: Internet-based resource page (Other)
结局指标
主要结局
Change from baseline in anxiety at 8 weeks
时间窗: at 8 weeks (i.e., post-intervention)
Anxiety will be measured using the Multidimensional Anxiety Scale for Children (MASC2)
次要结局
- Recruitment rate(at 27 months)
- Retention rate(at 30 months)
- Minimal Clinically Important Difference (MCID)(at 8 weeks (i.e., post-intervention))
- Intervention acceptability(at 8 weeks (i.e., post-intervention))
- Co-intervention use(at 8 weeks (i.e., post-intervention))
- Resource use/costs(at 8 weeks)
- Intervention adherence(at 8 weeks (i.e., post-intervention))
研究者
Mandi Newton
Assistant Professor
University of Alberta