Clinical trial NCT06989398: Implementation of the ASCEND Training for Supervisors in Dutch Small and Medium-sized Enterprises (SMEs)
Official title: Cluster RCT of the WHO's Advancing Supervisor Capabilities for Mental Health at Work (ASCEND) in Dutch Small and Medium-sized Enterprises (SMEs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Occupational Health
Stress
Burnout
Mental Health Conditions
Sickness Absence
Keywords: Workplace mental health
Occupational stress
Sickness absence
Supervisors
Line managers
Absenteeism
Presenteeism
Employee well-being
Workplace intervention
Manager training
ASCEND
Advancing Supervisors' Capacity for Mental Health at Work
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: University of Copenhagen
name: University Hospital Heidelberg
First posted: 2025-05-25
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial has cluster-randomized study design, meaning that the organizations (i.e., SMEs) that take part in the study will form clusters that will be randomized into either the intervention or control group. This way every participating employee from a SME is part of the same group.

The SMEs will be randomized using limited block size that varies randomly (i.e., 4, 6, or 8 SMEs per block) across (1) ASCEND (n=37) or (2) Waitlist (n=37), with an equal probability of assignment to each group (allocation ratio 1:1).
Primary purpose: PREVENTION

Brief summary: This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness 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 novel, WHO-developed ASCEND intervention is effective in enhancing supervisors' confidence, responsiveness, mental health literacy, and SelfCare 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 in the context of Dutch SMEs.

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.

Detailed description: 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 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 waitlist, 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 in the intervention group will complete surveys at baseline, immediately post-intervention, and at 1-month and 3-month follow-ups. Supervisors in the control group, as well as supervisees, will complete surveys at baseline, 1-month follow-up, and 3-month follow-up.

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

The study aims to recruit 74 SMEs, randomly allocated to either the ASCEND intervention group (n = 37) or the waitlist control group (n = 37). Each SME is expected to enrol at least two supervisors, resulting in a total sample of 148 managers for this study phase. Sample size calculations indicate that a minimum of 60 SMEs is required to detect a significant increase in supervisor confidence at 1-month follow-up with an effect size of Cohen's d = 0.59, accounting for 20% attrition (power = 0.80, two-sided alpha = 0.05, ICC = 0.01).

In the second study phase, a process evaluation will be conducted to assess factors such as intervention acceptability, appropriateness, barriers, and facilitators to implementation. Qualitative data will be gathered through post-intervention online surveys and interviews with a sample of supervisors, as well as relevant other stakeholders.

This study is part of the larger EU H2022-ADVANCE project, which aims to improve the mental health of vulnerable populations in Europe.

Eligibility criteria: Inclusion for SMEs:

* Having 10 to 250 employees
* Being located in the Netherlands

In case of insufficient recruitment among SMEs, a mitigation strategy is to recruit individual departments from larger organizations.

Eligibility criteria for individual participants:

Supervisors are included if they fit the following inclusion criteria:

* 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

Primary outcomes:
measure: Supervisor confidence in supporting employees with mental health conditions
timeFrame: Change from baseline to 1-hour post-intervention, 1 month, and 3 months
Secondary outcomes:
measure: Supervisor responsiveness to employee mental health conditions
timeFrame: Change from baseline to 1 month and 3 months
measure: Supervisor stigma towards mental health conditions
timeFrame: Change from baseline to 1-hour post-intervention, 1 month, and 3 months
measure: Supervisor SelfCare
timeFrame: Change from baseline to 1 month and 3 months
measure: Supervisor mental health literacy
timeFrame: Change from baseline to 1-hour post-intervention and 1 month
measure: Implementation indicator: acceptability
timeFrame: 1-hour post-intervention
measure: Implementation indicator: appropriateness
timeFrame: 1-hour post-intervention
Other outcomes:
measure: Perceived supervisor responsiveness to mental health conditions
timeFrame: Change from baseline to 1 month and 3 months
measure: Perceived StaffCare
timeFrame: Change from baseline to 1 month and 3 months
measure: Supervisee psychological distress
timeFrame: Change from baseline to 1 month and 3 months
measure: Supervisee help-seeking intentions
timeFrame: Change from baseline to 1 month and 3 months
measure: Supervisee work stress
timeFrame: Change from baseline to 1 month and 3 months
measure: Supervisee presenteeism
timeFrame: Change from baseline to 1 month and 3 months
measure: Supervisee absenteeism
timeFrame: Change from baseline to 1 month and 3 months
measure: General absenteeism
timeFrame: Change from 6 months before to 6 months after the trial's start
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
Study officials:
affiliation: VU University of Amsterdam
name: Mark van Vugt, PhD
role: PRINCIPAL_INVESTIGATOR
References: