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临床试验/NCT03382080
NCT03382080已完成不适用

COMPLETE - a School-based Intervention Project to Improve Psychosocial Learning Environments and Increase Completion of Upper Secondary School in Norway: a Cluster Randomized Controlled Trial

University of Bergen0 个研究点目标入组 3,500 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,500
主要终点
Drop-out

研究概览

简要总结

Drop out from upper secondary school represents a risk for the future health and wellbeing of young people. Strengthening of psychosocial aspects of the learning environment may be an effective strategy to promote completion of upper secondary school. The COMPLETE study is a school based cluster randomized controlled trial (RCT) evaluating two school-based interventions, namely the Dream School Program (DSP) and the Mental Health Support Team (MHST) among 1st grade upper secondary school students in four counties in Norway. The interventions aim to improve psychosocial learning environments and subsequently school achievements and decrease drop-out and absence.

Specifically, the COMPLETE study will

  1. Evaluate whether the DSP alone

  2. increases completion

  3. increases presence

  4. improves school achievements

  5. improves mental health and wellbeing

  6. Evaluate whether the DSP and the MHST combined

  7. increase completion

  8. increase presence

  9. improve school achievements

  10. improve mental health and wellbeing

The COMPLETE study will also evaluate the effect of the DSP and MHST combined and the DSP alone against secondary outcomes of school satisfaction and loneliness. 3. Evaluate through a process evaluation whether the interventions were implemented in line with guidelines for each of the interventions, and whether the degree of program fidelity has influenced the effect of the interventions on the primary and secondary outcomes.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • School inclusion criteria: not been or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects
  • Student inclusion criteria: student enrolled at any of the included schools.

排除标准

  • Schools previously or currently involved in either of the Dream School Program or the Mental Health Support Team or similar programs or research projects.
  • Student exclusion criteria: students with special needs or who are illiterate in Norwegian are excluded from the survey assessment, but included in the interventions.

结局指标

主要结局

Drop-out

时间窗: Each participant is assessed after 58 months

If the student has not complete upper secondary school within five years or if the student quit school and is without any regular activity during the course of the study period, i.e. grade 1-3 of upper secondary school

Absence

时间窗: Each participant is assessed after 34 months

Total days and hours absent at closure of third school year in upper secondary school

Change from baseline Mental Wellbeing at 18 months

时间窗: Based on self-report in survey assessment at baseline and 18 months

Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), on a 5 point Likert scale from None of the time to All of the time, with higher values indicating a better outcome

Academic achievement

时间窗: Each participant is assessed after 34 months

Average grade at closure of third school year in upper secondary school

Change from baseline Mental Health at 6 months

时间窗: Based on self-report in survey assessment at baseline and 6 months

Short form of Symptom Check List (SCL-5), on a 4 point Likert scale ranging from Not bothered to Very bothered, with higher values indicating a worse outcome.

Change in Mental Wellbeing from baseline at 6 months

时间窗: Based on self-report in survey assessment at baseline and 6 months

Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), on a 5 point Likert scale from None of the time to All of the time, with higher values indicating a better outcome

Change from baseline Mental Health at 18 months

时间窗: Based on self-report in survey assessment at baseline and 18 months

Short form of Symptom Check List (SCL-5), on a 4 point Likert scale ranging from Not bothered to Very bothered, with higher values indicating a worse outcome.

Change from baseline Mental Health at 30 months

时间窗: Based on self-report in survey assessment at baseline and 30 months

Short form of Symptom Check List (SCL-5), on a 4 point Likert scale ranging from Not bothered to Very bothered, with higher values indicating a worse outcome.

次要结局

  • Change from baseline School satisfaction at 6 months(Based on self-report in survey assessment at baseline and 6, 18 and 30 months)
  • Change from baseline School satisfaction at 18 months(Based on self-report in survey assessment at baseline and 18 months)
  • Change from baseline School satisfaction at 30 months(Based on self-report in survey assessment at baseline and 30 months)
  • Change from baseline Loneliness at 6 months(Based on self-report in survey assessment at baseline and 6 months)
  • Change from baseline Loneliness at 18 months(Based on self-report in survey assessment at baseline and 18 months)
  • Change from baseline Loneliness at 30 months(Based on self-report in survey assessment at baseline and 30 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Torill Bogsnes Larsen

Professor

University of Bergen

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