Evaluating an Internet-based Program for Anxious Adolescents: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 563
- 试验地点
- 1
- 主要终点
- Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score
研究概览
简要总结
Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all adolescents by the age of 16. The median age of onset is 11 years, making these disorders some of the earliest to develop. 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 adolescents, parents and health care providers. Even if anxiety disorders are discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if their anxiety is not treated properly. The investigators will carry out research to test Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can use this treatment from home via the computer. Breathe will include information materials and personalized homework assignments to help anxious adolescents learn ways to manage anxiety. More information can be found and www.TheBreatheStudy.com
详细描述
This study is a 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 determine the effectiveness of a self-guided Internet-based CBT program with limited telephone and email support in reducing anxiety symptoms among adolescents with mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based webpage.
- To explore mediators and moderators of the Internet-based CBT program.
- To determine the effectiveness of a self-guided Internet-based CBT program in improving quality of life as compared to a usual self-help intervention.
- To determine adherence to a self-guided Internet-based CBT program.
- To determine the cost-effectiveness of the Internet-based CBT program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Score of ≥25 on the Screen for Child Anxiety Related Disorders (SCARED)
- •Ability to read and write English
- •Regular access to a telephone and a computer system with high speed Internet service
- •Ability to use the computer to interact with web material
排除标准
- •Positive screen on the Ask Suicide-Screening Questionnaire (ASQ)
- •Positive screen on the Schizophrenia Test and Early Psychosis Indicator (STEPI; modified version)
- •Score of ≥3 on the Alcohol Use Disorders Identification Test Consumption subscale (AUDIT-C)
- •Residence outside of Canada
研究组 & 干预措施
Breathe
6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support
干预措施: Breathe (Behavioral)
Resource webpage
Webpage that provides general resources on anxiety
干预措施: Resource Webpage (Behavioral)
结局指标
主要结局
Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score
时间窗: baseline to 6 weeks post-baseline (post-intervention)
次要结局
- Change in adolescent anxiety using the total MASC 2 score(6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up))
- Change in quality of life using the Youth Quality of Life Instrument - Short Form (YQOL-SF)(baseline to 6 weeks post-baseline (post-intervention), 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up))
- User experience(6 weeks post-baseline (post-intervention))
- Intervention adherence(6 weeks post-baseline (post-intervention))
- health care utilization(baseline, 18 weeks post-baseline)