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临床试验/NCT04208113
NCT04208113已完成不适用

Stress-free Everyday LiFe for Children and Adolescents REsearch (SELFCARE). A Protocol for a Cluster Randomised Trial Testing a School Teacher Training Programme to Deliver the .b Programme in Danish Schools.

University of Aarhus1 个研究点 分布在 1 个国家目标入组 1,774 人开始时间: 2020年8月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,774
试验地点
1
主要终点
The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report

研究概览

简要总结

The primary aim is to evaluate the effectiveness of a profound school teacher training programme to teach a mindfulness-based programme (.b) in Danish schools on the pupils self-reported mental well-being at seven months.

The secondary aims are to evaluate i) the effectiveness of the profound school teacher training programme to teach the .b-programme in Danish schools on the pupils self-reported mental well-being post intervention (at five months).

详细描述

The study is a cluster randomised trial. From May 2018 - May 2019, we recruited the total of 110 Danish schools (27 schools from the Capital Region of Denmark, 18 schools from Region Zealand, 25 schools from Region of Southern Denmark, 30 schools from Central Denmark Region and 10 schools from Region of Northern Denmark).

The schools included the total of 191 school teachers for teacher training (56 teachers from the Capital Region of Denmark, 28 teachers from Region Zealand, 42 teachers from Region of Southern Denmark, 50 teachers from Central Denmark Region and 15 teachers from Region of Northern Denmark). Each included teacher will be asked to recruit a class of pupils (15-25 pupils) to test the effectiveness of the .b-programme (in total approx. 3000 pupils).

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •All pupils in the enrolled school classes

排除标准

  • 未提供

研究组 & 干预措施

School teacher training /.b

Experimental

The intervention is a multi-level, multi-component complex intervention. It consists of a school teacher training programme and the .b-programme to be delivered to pupils 11-15 years in the schools.

The school teacher training programme consists of three parts: 1) the establishment of own mindfulness practice by participation in the eight week MBSR programme (2,5 hour group meeting once a week) and sustaining mindfulness with a regular formal daily practice; 2) completion of the four days .b residential course, and 3) completion of the 3x2-days seminars on relational competences and implementation issues regarding teaching .b (48 hours) The .b programme consists of well-described, weekly 40-60 minutes classroom sessions over 10 weeks. All the sessions have a specific theme, associated teachers' notes, power points and animations. The .b programme can only be delivered with fidelity by a trained .b teacher.

干预措施: School teacher training /.b (Behavioral)

Usual practice

No Intervention

Usual practice

结局指标

主要结局

The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report

时间窗: 23.03.21: Seven months after baseline

Change in the score among the subgroup with a SDQ total difficulties score \>= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the \>=80 % percentile. We identify per gender due to well-known differences)

次要结局

  • The Strengths and Difficulties Questionnaire (SDQ)- youth self-report(23.03.21: Five months after baseline)
  • Child-Adolescent Mindfulness Measure (CAMM)(23.03.21: Seven months after baseline)
  • Bullying items from the Danish student well-being questionnaire (DSWQ)(23.03.21: Seven months after baseline)
  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version(23.03.21: Seven months after baseline)
  • Brief Resilience Scale (BRS)(23.03.21: Seven months after baseline)
  • School connectedness from the Danish student well-being questionnaire (DSWQ)(23.03.21: Seven months after baseline)
  • Social competence from the Danish student well-being questionnaire (DSWQ)(23.03.21: Seven months after baseline)
  • Self-efficacy from the Danish student well-being questionnaire (DSWQ)(23.03.21: Seven months after baseline)
  • EQ-5D-Y(23.03.21: Seven months after baseline)
  • Sleep quality(23.03.21: Seven months after baseline)
  • The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales(23.03.21: Seven months after baseline)
  • The Strengths and Difficulties Questionnaire (SDQ)- youth self-report(23.03.21: Seven months after baseline)
  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version(23.03.21: Five months after baseline)
  • Brief Resilience Scale (BRS)(23.03.21: Five months after baseline)
  • School connectedness from the Danish student well-being questionnaire (DSWQ)(23.03.21: Five months after baseline)
  • Social competence from the Danish student well-being questionnaire (DSWQ)(23.03.21: Five months after baseline)
  • Self-efficacy from the Danish student well-being questionnaire (DSWQ)(23.03.21: Five months after baseline)
  • Bullying items from the Danish student well-being questionnaire (DSWQ)(23.03.21: Five months after baseline)
  • EQ-5D-Y(23.03.21: Five months after baseline)
  • Sleep quality(23.03.21: Five months after baseline)
  • Child-Adolescent Mindfulness Measure (CAMM)(23.03.21: Five months after baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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