5 Year- Follow up of Anxious and Sad Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- Multidimensional anxiety scale for children
研究概览
简要总结
The project objectives are to investigate if a preventive intervention targeting anxious and sad children aged 8 to 12 years has haf the anticipated long-term effects, 5 years after receiving the intervention. Hence: will an indicated intervention reduce the incidence of common mental disorders in youth in the long term? The current study is a 5 year follow up of the previously completed RCT called the TIM-study (Clinical Trials identifier: NCT 02340637).
The aim of this study is to determine the long-term effects of the intervention to examine if true preventive effects are achieved as indicated by lower symptom levels, better functioning og fewer diagnosis of anxiety and depression 5 years after receiving an indicated preventiv intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the long-term follow-up design, participants and parents are aware of their original allocation to intervention or treatment-as-usual conditions from the previous TIM study. Therefore, masking of participants and care providers is not feasible in the current follow-up study.
入排标准
- 年龄范围
- 13 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who participated in the previous randomized controlled TIM study (children then aged 8- 12 years selfreporing elevated symptom levels of anxiety and/or depression)
排除标准
- •all earlier participats from the TIM study may enter the follow up study
- •participants who chose to not participate in the 5-year follow-up of the TIM study are excluded from the follow-up study.
研究组 & 干预措施
Intervention arm
Youth in this arm received the intervention over 10 weeks during one semester (recruiting children over 6 semesters in total), children meeting in groups of approx. seven children. The groups were led by school health nurses.
At the same time parents met for 7 group sessions, with the children participating in four of these
干预措施: EMOTION Kids coping with anxiety and depression (Mestrende barn in Norwegian) (Other)
Control arm
The youth in the control condition received treatment as usual, e.g. talks with school health nurses or no intervention
结局指标
主要结局
Multidimensional anxiety scale for children
时间窗: 5- year follow up
This 39-item, child self-report, assesses anxiety in youth ages 8 - 19, 0 - 117, higher score, higher anxiety
The Mood and Feelings Questionnaire Short version
时间窗: 5-year follow up
SMFQ comprised of 13 questions assessing cognitive, affective and behavioral-related depressive symptoms in youth ages 8 - 18 during the last two weeks, 0 - 26, higher score indicating higher levels of depression
The ADIS (Anxiety Disorders Interview Schedule)
时间窗: 5-year follow up
Relevant sections of this semi-structured interview (anxiety and depression), categorical outcome, have diagnosis/does not have diagnosis
次要结局
未报告次要终点
研究者
Kristin Martinsen
Principal Investigator
University of Oslo