There is a call for sustainable, evidence-based interventions in schools to promote mental health in schoolchildren. Our primary aim of this trial is to evaluate the effectiveness in vulnerable pupils of a school teacher training programme to teach mindfulness (“.b” programme) as a part of compulsory class room teaching in Danish schools on the pupils’ self-reported mental health at 6-month follow-up. Our secondary aim is to evaluate the effectiveness of the school teacher training programme to teach the “.b”-programme as a part of compulsory class room teaching among the total pupil population on the pupils’ self-reported mental health at 3 and 6 months after baseline. The pragmatic cluster two-armed randomised controlled trial includes 110 municipal or private schools from all five regions in Denmark; 191 school teachers and approximately 2000 pupils at 11–15 years of age. Exclusion criteria; for schools: < 100 pupils; for pupils: parental opt out. Our intervention consists of (A) a school teacher training programme and (B) the “.b”-programme delivered as part of compulsory class room teaching in schools to pupils at the age of 11–15 years. The pupils in the control schools receive education as usual. Our primary study population is the vulnerable subgroup with a Strengths and Difficulties Questionnaire (SDQ) total difficulties score > 80% percentile at baseline (approximately 400 pupils). The primary outcome is change in the SDQ total score by the pupils. We also evaluate the effectiveness among the total pupil study population and in girls and boys, respectively and use other measures on mental health. Data will be analysed with repeated measurement models taken clusters into account. This large-scale trial will estimate the effectiveness of a population-based strategy on mental health in Danish schoolchildren. The trial evaluates the effect of a school teacher training programme, where teachers are trained in teaching the “.b” programme. The “.b” programme will be taught as a part of compulsory class room teaching. The intervention takes implementation issues into account. Effectiveness will be evaluated both in a vulnerable subgroup and among the total population. Trial registration number ClinicalTrials.gov Identifier: NCT04208113, registered December 23 2019, https://clinicaltrials.gov/ct2/show/NCT04208113 .

中文翻译：

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儿童和青少年无压力日常LiFe研究（SELFCARE）：一项协议随机分组试验协议，测试学校教师培训计划以教授正念（“ .b”）

呼吁在学校采取可持续的，循证的干预措施，以促进学童的心理健康。我们该试验的主要目的是评估学校教师培训计划中的正念教育（“ .b”计划）对弱势学生的有效性，这是丹麦学校关于学生自我报告的心理健康状况的义务课堂教学的一部分在六个月的随访中。我们的次要目的是评估在3个月和6个月时，根据学生自我报告的心理健康状况，在全部学生总数中，作为强制性课堂教学的一部分，学校教师培训计划的有效性，以教授“ .b”计划基线之后。实用的两臂随机对照试验包括丹麦所有五个地区的110所公立或私立学校；191位学校教师和大约2000名11至15岁的学生。排除标准; 对于学校：<100名学生；对于学生：家长选择退出。我们的干预措施包括（A）学校教师培训计划和（B）“ .b”计划，该计划是学校为11至15岁的学生提供的义务课堂教学的一部分。对照学校的学生照常接受教育。我们的主要研究人群是弱点亚组，其优势和困难问卷（SDQ）的总困难评分在基线时大于80％（大约400名学生）。主要结果是学生改变了SDQ总分。我们还评估了在总的学生研究人群中以及在女孩和男孩中的有效性，并使用了其他有关心理健康的措施。将通过考虑群集的重复测量模型来分析数据。这项大型试验将评估丹麦学龄儿童基于人群的心理健康策略的有效性。该试验评估了学校教师培训计划的效果，该课程对教师进行了“ .b”计划的教学培训。“ .b”程序将作为强制性课堂教学的一部分进行教授。干预措施考虑了实施问题。将在一个脆弱的亚组和总人群中评估有效性。试验注册号ClinicalTrials.gov标识符：NCT04208113，注册于2019年12月23日，https：//clinicaltrials.gov/ct2/show/NCT04208113。这项大型试验将评估丹麦学龄儿童基于人群的心理健康策略的有效性。该试验评估了学校教师培训计划的效果，该课程对教师进行了“ .b”计划的教学培训。“ .b”程序将作为强制性课堂教学的一部分进行教授。干预措施考虑了实施问题。将在一个脆弱的亚组和总人群中评估有效性。试验注册号ClinicalTrials.gov标识符：NCT04208113，注册于2019年12月23日，https：//clinicaltrials.gov/ct2/show/NCT04208113。这项大型试验将评估丹麦学龄儿童基于人群的心理健康策略的有效性。该试验评估了学校教师培训计划的效果，该课程对教师进行了“ .b”计划的教学培训。“ .b”程序将作为强制性课堂教学的一部分进行教授。干预措施考虑了实施问题。将在一个脆弱的亚组和总人群中评估有效性。试验注册号ClinicalTrials.gov标识符：NCT04208113，注册于2019年12月23日，https：//clinicaltrials.gov/ct2/show/NCT04208113。b”课程将作为必修课的一部分进行授课。干预措施考虑了实施问题。将在一个脆弱的亚组和总人群中评估有效性。试验注册号ClinicalTrials.gov标识符：NCT04208113，注册于2019年12月23日，https：//clinicaltrials.gov/ct2/show/NCT04208113。b”课程将作为必修课的一部分进行授课。干预措施考虑了实施问题。将在一个脆弱的亚组和总人群中评估有效性。试验注册号ClinicalTrials.gov标识符：NCT04208113，注册于2019年12月23日，https：//clinicaltrials.gov/ct2/show/NCT04208113。