NCT03310489已完成不适用
Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 465
- 试验地点
- 2
- 主要终点
- Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports
研究概览
简要总结
The aim of the study is to evaluate the effectiveness of a digitalized cognitive-behavioral treatment for anxiety among school aged children. The participants are screened from the general population, as a part of the routine school health care check-ups. Half of the children with anxiety will receive the digitalized treatment program, while the other half will receive education about anxiety in internet.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scoring ≥22 on SCARED
排除标准
- •no access to internet
- •insufficient language (Finnish until summer 2019, Finnish and Swedish from autumn 2019 onwards, when also Swedish version of the intervention was available) skills
- •visual or hearing impairment that hinders the use of the program
- •the child's mental retardation, autism spectrum disorder, suicidal intentions or severe mental disorder
- •the child's psychotherapy (ongoing or starting within 6 months)
- •the child's medication (for anxiety) started / changed within 2 months
- •current involvement with child protection services (i.e., removal of child custody, investigation of child abuse or neglect)
- •parent's severe psychiatric / somatic disease or other reason that hinders the parent to actively participate in the program
结局指标
主要结局
Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports
时间窗: Change from baseline to 6 months follow up; symptoms during the last three months
Comprises of 41 items assessing symptoms of general anxiety, separation anxiety, panic disorder, social anxiety, and school phobia; scoring 0-82 (higher score meaning more symptoms)
次要结局
- Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reports(Change from baseline to 6 months follow up; varying time windows for different diagnoses)
- Change from Baseline to 6 months follow up; the Revised Children Quality of Life - Questionnaire - child and parent reports(Change from baseline to 6 months follow up; QoL during the last week)
- Change from Baseline to 6 months follow up; the Child Depression inventory - child report(Change from baseline to 6 months follow up; symptoms during the last two weeks)
- Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report (parental depression, anxiety and stress)(Change from baseline to 6 months follow up; symptoms during the last week)
- Change from Baseline to 6 months follow up; the Customised Client Receipt Inventory Questionnaire - parent report(Change from baseline to 6 months follow up; service use during the last six months)
- Change from Baseline to 6 months follow up; the Child Anxiety Impact Scale - child and parent reports(Change from baseline to 6 months follow up; impact of anxiety during the last month)
- Change from Baseline to 6 months follow up; the Strengths and Difficulties Questionnaire, extended version - parent report(Change from baseline to 6 months follow up; symptoms during the last six months)
- Change from Baseline to 6 months follow up of the relations with peers and school (not a standardized scale)(Change from baseline to 6 months follow up)
- Change from Baseline to 6 months follow up; the Brief resilience scale - parent report (parental resilience)(Change from baseline to 6 months follow up; experience of the current resilience)
研究者
Andre Sourander
Professor (child psychiatry)
University of Turku
研究点 (2)
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