Assessment and Treatment - Anxiety in Children and Adults (Child Part)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Anxiety disorders according to the ADIS-IV C/P interview
研究概览
简要总结
The study aims to evaluate the effectiveness of a cognitive behaviour therapy program (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child and adolescent mental health clinics in Western Norway.
详细描述
Cognitive behaviour therapy (CBT) has been shown to be an efficacious treatment for anxiety disorders in youths when delivered in university settings. However, there is a lack of studies evaluating the effectiveness of CBT in regular clinical settings.
The current study will compare a CBT program developed for anxiety in youths (the FRIENDS program by Paula Barrett, Australia), with a wait-list control condition. Group and individual treatment will also be compared in the study. Groups will be divided by age, with younger including 8-12-year-olds, and older 12-15-year-olds. Parents are also involved at the end of all therapy sessions, as well as in separate parent sessions. Assessment and treatment is delivered by clinicians working in seven outpatient clinics in Western Norway.
There will be 10 therapy sessions, with booster sessions 4 and 12 weeks later. Effectiveness will be evaluated post-treatment, and at 1 and 5 years follow-up. The study will have a randomized design. Children randomized to the wait-list condition will be offered treatment if they still meet inclusion criteria after the waiting period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting DSM-IV criteria for separation anxiety, social anxiety or generalized anxiety disorder based on the ADIS interview schedule
排除标准
- •Pervasive developmental disorders, Selective mutism, Mental retardation
- •Having severe obsessional/compulsive, conduct or language problems.
研究组 & 干预措施
Group CBT
The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered in groups of 4 to 8. 10 weekly sessions plus 2 booster sessions.
干预措施: Cognitive behavioural therapy (Behavioral)
Individual CBT
The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually.
10 weekly sessions plus 2 booster sessions.
干预措施: Cognitive behavioural therapy (Behavioral)
Wait-list control
Wait-list control condition for 5 weeks after last child has been included.
结局指标
主要结局
Anxiety disorders according to the ADIS-IV C/P interview
时间窗: Post-treatment and 1 and 5 year follow-up
Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.
次要结局
- Depressive symptoms according to the Mood and Feelings Questionnaire(Post-treatment, 1 and 5 year follow-up)
- Anxiety symptom score according to the Spence Children Anxiety Scale(Post-treatment, 1 and 5 year follow-up)