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临床试验/NCT02279251
NCT02279251已完成不适用

School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth. A Randomized Controlled Trial

NORCE Norwegian Research Centre AS3 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
313
试验地点
3
主要终点
Spence Children's Anxiety Scale

研究概览

简要总结

The study will evaluate two group CBT interventions delivered by school health nurses, in cooperation with community psychologist and mental health care personnel, to adolescents with mild to moderate levels of anxiety symptoms. The two interventions have different intensity (5 versus 10 group meetings). The two group interventions will be compared to a waitlist control group.

详细描述

Anxiety disorders are among the major mental health problems in children and adolescents, with regard to prevalence and long-term consequences. Cognitive behavioural therapy (CBT) has proven to be effective as treatment, early intervention and prevention of youth anxiety disorders. The majority of youth with anxiety problems, however, is not in contact with mental health services and do not receive effective help. This is due to shortage of personnel, resources and time among mental health-personal delivering treatment, as well as health services not being easily accessable for adolescents. School-based, low-intensity early intervention programs (indicated prevention) may improve access to effective treatment for youth with internalizing problems, and also promote more effective use of health services. The present study is a multi-site randomized controlled study with early intervention to be conducted within the primary health care service in three parts of Norway; including nine municipalities from west, east and south of Norway. A brief CBT program will be compared to a longer CBT program, and a wait-list control group. The effects will be evaluated with regard to decrease in youth internalizing symptoms. The CBT interventions are given to adolescents with mild to moderate levels of anxiety symptoms. Interventions are delivered by trained school-health nurses in collaboration with and/or supervised by experienced CBT therapists. The study involves researchers from three research environments in Norway, and collaboration with prominent international researchers from USA and Australia.The study has potential impact on how to deliver effective low-threshold interventions to anxious youth.

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

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • An overall score of > 25 on the anxiety inventory Spence Children's Anxiety Scale (SCAS) and a score of > 1 on the first question of the Children's Anxiety Life Interference Scale (CALIS), indicating that anxiety interferes with daily life of the youth, rated either by the adolescents or by one parent.
  • The adolescent and at least one parent understand and read Norwegian.
  • Assent from the youth and signed informed consent from the parent.

排除标准

  • The adolescent has a behavior that makes participation in groups with other adolescents challenging. This is evaluated by the school nurse, based on information from the adolescent, the parent and the teacher. In each case, the school nurse makes an evaluation based on the following questions:
  • Is the adolescent able to follow group-rules?
  • Will the adolescent behave in ways that disrupts the group?
  • Does the adolescent have learning problems to an extent that will make it difficult to follow the group program?

结局指标

主要结局

Spence Children's Anxiety Scale

时间窗: Changes from baseline to 4 weeks, 10 weeks, and 1 year

Self-reported (child and parent version) child anxiety symptoms, 38 items questionnaire, rated at a 4-point scale.

Children Anxiety Life Interference Scale

时间窗: Changes from baseline to 4 weeks,10 weeks, and 1 year

Self-reported (child and parent version) of degree of life interference of child anxiety symptoms

次要结局

  • Questionnaire for Measuring Health-Related Quality of Life Children and Adolescents (KINDL-R)(Changes from baseline to 10 weeks, and 1 year)
  • Short Mood and Feeling Questionnaire(Changes from baseline to 4 weeks,10 weeks,and 1 year)
  • Clinical Global Impression Scale, severity/improvement (CGI-S/I)(Changes from baseline to 10 weeks, and 1 year)
  • Sleep problems(Changes from baseline, up to 10 weeks, and after 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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