跳至主要内容
临床试验/NCT06989398
NCT06989398招募中不适用

Cluster RCT of the WHO's Advancing Supervisor Capabilities for Mental Health at Work (ASCEND) in Dutch Small and Medium-sized Enterprises (SMEs)

VU University of Amsterdam2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2025年5月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
148
试验地点
2
主要终点
Supervisor confidence in supporting employees with mental health conditions

研究概览

简要总结

This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of the Dutch adaptation of an in-person group intervention for workplace supervisors - Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) - in Dutch Small and Medium-sized Enterprises (SMEs). The ASCEND intervention is designed to equip supervisors with the skills to: i) know when to support their workers; ii) how to direct workers to support, and iii) advocate for action on mental health at work.

The primary objectives of this project are to:

  • Assess to what extent the Dutch adaptation of the WHO-developed ASCEND intervention is effective in enhancing supervisors' confidence, responsiveness, mental health literacy, and self-care practices, and in reducing supervisor stigma towards mental health conditions within Dutch SMEs.
  • Evaluate the impact of the ASCEND intervention on employee outcomes, including mental health and work-related outcomes among supervisees (i.e., subordinates), as well as overall organizational absenteeism rates.
  • Identify barriers, facilitators, and key implementation and adoption indicators to support future opportunities for scaling up the ASCEND intervention.

Researchers will compare two groups to evaluate the effectiveness of the ASCEND intervention. One group will receive the training (the intervention group), while the other group will receive the training after the final follow-up period (the control group).

Data will be collected from both supervisors and their supervisees (i.e., subordinates) via online questionnaires at various time points. In addition, general organizational information, including absenteeism rates, will be gathered through a representative from each participating organization.

To further explore the feasibility of scaling up the ASCEND intervention within the Netherlands, qualitative data will be collected through interviews and/or focus group discussions.

详细描述

Small and Medium-sized enterprises (SMEs) often lack the resources to effectively address the negative consequences of work-related stressors (e.g., high workplace digitalization). Moreover, supervisors play a pivotal role in protecting employee well-being, yet they frequently report feeling poorly equipped to recognize and support employees experiencing mental health problems.

This project aims to evaluate the effectiveness of the Dutch adaptation of Advancing Supervisors' Capacity for Mental Health at Work (ASCEND), an in-person group intervention developed by the World Health Organization (WHO). The ASCEND intervention is designed to equip supervisors with the skills to: i) know when to support their workers; ii) how to direct workers to support, and iii) advocate for action on mental health at work.

The first phase of this study concerns a cluster randomized controlled trial (cRCT) comparing ASCEND and control, where supervisors in the control group receive the intervention approx. 6 months after baseline. The second phase consists in the qualitative process evaluation that pertains individual interviews and/or focus group discussions.

In the first study phase, data will be collected through online questionnaires administered to supervisors and their supervisees (i.e., subordinates). Additionally, general organizational information, including absenteeism rates, will be gathered from a designated representative within each organization. Supervisors will complete surveys at baseline, immediately post-intervention, and at 1-month and 3-month follow-ups. Supervisees will complete surveys at baseline, 1-month follow-up, and 3-month follow-up.

The primary outcome is supervisor confidence in addressing employee mental health problems at the 1-month follow-up. Secondary outcomes include supervisor responsiveness, stigma toward mental health conditions, mental health literacy, and self-care practices. Supervisees will be invited to provide exploratory outcome data on perceived supervisor responsiveness, perceived supervisor staff care, psychological distress, help-seeking intentions, work stress, absenteeism, and presenteeism. Additionally, general absenteeism figures for the participating SMEs will be collected.

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
Single (Outcomes Assessor)

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

  • 18 years or older
  • Working in an organization in the Netherlands
  • Sufficient mastery (written and spoken) of the language in which the ASCEND intervention is being delivered (i.e., Dutch or English)
  • Written informed consent before entering the study
  • Supervise at least 1 supervisee within the same organization
  • Supervisees are included if they fit the following inclusion criteria:
  • 18 years or older
  • Have a direct supervisor who is participating in ASCEND (either intervention or control group)
  • Sufficient mastery of English or Dutch
  • Written informed consent before entering the study

排除标准

  • 未提供

研究组 & 干预措施

Advancing Supervisors' Capacity for Mental Health at Work (ASCEND)

Experimental

Participants in the treatment group will receive the Dutch adaptation of the ASCEND group intervention, delivered in person over approximately 8 hours in a single day. Participants will be permitted to participate in other programs or training courses after enrolling in the trial.

干预措施: Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) (Behavioral)

Control

No Intervention

Supervisors from organizations in the control arm will receive no ASCEND training during the trial. They will be provided with the ASCEND training approx. 6 months after baseline, after the last follow-up.

Participants will be permitted to participate in other programs or training courses after enrolling in the trial.

结局指标

主要结局

Supervisor confidence in supporting employees with mental health conditions

时间窗: Change from baseline to 1-hour post-intervention, 1 month, and 3 months

Confidence in supporting employees with mental health conditions will be measured among supervisors using a 6-item scale used in other trials that investigated a similar intervention. Participants will be asked to rate their degree of confidence from 1 (not confident at all) to 5 (extremely confident) for various activities that are related to the construct of supporting employee mental health. A mean score will be calculated by averaging participants' ratings across all items. Scores range from 1 to 5, with a higher score indicating more confidence.

Supervisor confidence in addressing employee mental health problems

时间窗: Change from baseline to 1 month

Confidence in addressing employee mental health problems will be measured among supervisors using a 6-item scale used in other trials that investigated a similar intervention. Participants will be asked to rate their degree of confidence from 1 (not confident at all) to 5 (extremely confident) for various activities that are related to the construct of supporting employee mental health. A mean score will be calculated by averaging participants' ratings across all items. Scores range from 1 to 5, with a higher score indicating more confidence.

次要结局

  • Supervisor responsiveness to employee mental health conditions(Change from baseline to 1 month and 3 months)
  • Supervisor stigma towards mental health conditions(Change from baseline to 1-hour post-intervention, 1 month, and 3 months)
  • Supervisor SelfCare(Change from baseline to 1 month and 3 months)
  • Supervisor mental health literacy(Change from baseline to 1-hour post-intervention and 1 month)
  • Implementation indicator: acceptability(1-hour post-intervention)
  • Implementation indicator: appropriateness(1-hour post-intervention)
  • Supervisor confidence in addressing employee mental health problems(Change from baseline to within 1-hour post-intervention and 3 months)
  • Supervisor responsiveness to employee mental health problems(Change from baseline to 1 month and 3 months)
  • Supervisor self-care(Change from baseline to 1 month and 3 months)

研究者

发起方
VU University of Amsterdam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark van Vugt

Full Professor

VU University of Amsterdam

研究点 (2)

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