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Clinical Trials/NCT05019937
NCT05019937
Completed
N/A

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 Kwak1 site in 1 country2,276 target enrollmentSeptember 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Disorder
Sponsor
Lydia Kwak
Enrollment
2276
Locations
1
Primary Endpoint
Guideline adherence
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Lydia Kwak
Responsible Party
Sponsor Investigator
Principal Investigator

Lydia Kwak

Associate professor, lecturer

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • All personnel employed by the school

Exclusion Criteria

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

Outcomes

Primary Outcomes

Guideline adherence

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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