More Than the Sum of Its Parts: Investigating a Combined Parent-child Treatment for Children With Social Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Change in severity of social anxiety in children
研究概览
简要总结
The aim of this pilot project is to investigate a treatment program for children with social anxiety, in which children and their parents, parallel to each other, follow separate evidence-based interventions. The added value of this pilot project is that the investigators are examining how both programs interact when offered simultaneously.
详细描述
After a diagnostic trajectory and a 2-week reflection period, children and their parents are invited to come into the lab for baseline 1. During baseline 1, children and their parents will be interviewed and they will fill in some questionnaires. They will then be randomly assigned to a 2-, 4-, or 6-week waiting period. During this waiting period they will fill in Experience Sampling Method (ESMs) daily, every other week. One week before the end of the waiting period, baseline 2 will take place. After the waiting period children and their parents will start their separate treatments in parallel. Children will get an individually tailored cognitive behavioural therapy (CBT)-protocol for social anxiety and parents will get SPACE. In the treatment period, they will fill in ESMs daily. There is another assessment with interviews and questionnaires at mid-treatment (after 6 sessions) and post-treatment (after 12 sessions), as well as 1- and 2-months after treatment has ended. After the treatment period, the frequency of the ESMs will go back to daily every other week.
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
- Double (Care Provider, Outcomes Assessor)
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
- •Diagnosis social anxiety
- •At least 1 parent is willing to participate
排除标准
- •Currently under treatment for anxiety
- •Other complaints that need attention first
- •Not understanding instructions/treatment
研究组 & 干预措施
2-week waiting period
Children and parents have to wait 2 weeks between baseline 1 and the start of the treatment. In the first week, they fill in ESMs daily.
干预措施: Supportive Parenting for Anxious Childhood Emotions (Other)
2-week waiting period
Children and parents have to wait 2 weeks between baseline 1 and the start of the treatment. In the first week, they fill in ESMs daily.
干预措施: Denken + Doen = Durven (Other)
4-week waiting period
Children and parents have to wait 4 weeks between baseline 1 and the start of the treatment. In the first and third week, they fill in ESMs daily.
干预措施: Denken + Doen = Durven (Other)
4-week waiting period
Children and parents have to wait 4 weeks between baseline 1 and the start of the treatment. In the first and third week, they fill in ESMs daily.
干预措施: Supportive Parenting for Anxious Childhood Emotions (Other)
6-week waiting period
Children and parents have to wait 6 weeks between baseline 1 and the start of the treatment. In the first, third, and fifth week, they fill in ESMs daily.
干预措施: Denken + Doen = Durven (Other)
6-week waiting period
Children and parents have to wait 6 weeks between baseline 1 and the start of the treatment. In the first, third, and fifth week, they fill in ESMs daily.
干预措施: Supportive Parenting for Anxious Childhood Emotions (Other)
结局指标
主要结局
Change in severity of social anxiety in children
时间窗: From baseline to the end of treatment and follow-up (1 and 2 months post-treatment)
Severity of social anxiety will be assessed using the Anxiety Disorder Interview Schedule (ADIS-V), which will provide a clinician severity rating (CSR)-score. This is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The ADIS-V will be administered to children and parents.
次要结局
- Change in anxiety-related symptoms and family accommodation(From baseline to the end of treatment and follow-up (1 and 2 months post-treatment))
研究者
Anke M Klein, AS
Principal Investigator
Leiden University