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临床试验/NCT05019937
NCT05019937已完成不适用

A Randomized Controlled Trial in Schools Aimed at Testing the Effectiveness of Implementation Strategies, Including Mechanism of Change, on Adherence to the Guideline for the Prevention of Common Mental Disorders at the Workplace.

Lydia Kwak2 个研究点 分布在 1 个国家目标入组 2,276 人开始时间: 2021年9月1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
发起方
入组人数
2,276
试验地点
2
主要终点
Guideline adherence

研究概览

简要总结

This project is a two-armed randomized-controlled trial exploring the effectiveness and mechanisms of change of two different implementation strategies for implementing the Guideline for the prevention of mental ill-health at the workplace. The project will be conducted among public primary and secondary schools belonging to four municipalities in Sweden. Data will be collected with mixed-methods at baseline and different time-points of follow-up.

详细描述

There is an urgent need for more knowledge on effective implementation strategies, as two-thirds of implementation efforts fail to achieve the intended change, and half have no effect on outcomes of interest. These implementation failures are partly due to the limited understanding of how implementation strategies work-the mechanisms of change through which implementation strategies affect implementation. This project will fill this research-gap by exploring mechanism of change during a cluster randomized controlled trial that compares the effectiveness of two implementation strategies for implementing the Guideline for the prevention of mental ill-health at the workplace in schools. Schools are chosen as the setting for implementation given the high prevalence of mental ill-health among teachers. Moreover, schools lack a structured approach to the prevention of mental ill-health. The aim of the project is to investigate how implementation strategies affect the defined mechanisms and guideline implementation. Mechanisms that will be tested include hypothesized mediators originating from the individual behavior change theory COM-B. The project will be conducted in public primary and secondary schools in four municipalities in Sweden. Data will be collected with mixed-methods from school-management and personnel at baseline, and different time-points during follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All personnel employed by the school

排除标准

  • Personnel not employed by the school (e.g. cleaning- and canteen-personnel)

研究组 & 干预措施

Multifaceted implementation strategy

Experimental

Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components

干预措施: Workshops (Behavioral)

Multifaceted implementation strategy

Experimental

Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components

干预措施: Educational meeting (Behavioral)

Multifaceted implementation strategy

Experimental

Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components

干预措施: Implementation team (Behavioral)

Multifaceted implementation strategy

Experimental

Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components

干预措施: Plan-Do-Study-Act improvement cycles (Behavioral)

Multifaceted implementation strategy

Experimental

Schools randomized to this arm will be exposed to a multifaceted implementation strategy, which contains five implementation components

干预措施: Internal facilitator (Behavioral)

Single implementation strategy

Active Comparator

Schools randomized to this arm will be exposed to a single implementation strategy, which contains one implementation component

干预措施: Educational meeting (Behavioral)

结局指标

主要结局

Guideline adherence

时间窗: At baseline, 12- and 24 months follow-up

Change from baseline in adherence to the recommendations of the guideline during 12-, and 24-months follow-up. Guideline adherence will be assessed with a checklist and questionnaire developed for the purpose of the project.

次要结局

  • Self-reported stress(At baseline, 12- and 24-months follow-up)
  • Organisational readiness to implement(At baseline, 12- and 24-months follow-up)
  • Implementation leadership(At baseline, 12- and 24-months follow-up)
  • Self-perceived health(At baseline, 12- and 24-months follow-up)
  • Psychosocial safety climate(At baseline, 12- and 24-months follow-up)

研究者

发起方
Lydia Kwak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lydia Kwak

Associate professor, lecturer

Karolinska Institutet

研究点 (2)

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