Implementation of the ASCEND Training for Supervisors in Dutch Small and Medium-sized Enterprises (SMEs)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-14

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Leading Well-being and the Psychosocial Working Environment - A Cluster-randomized Waitlist Controlled Trial

NCT05623371

Stress Well-being Burn Out

UNKNOWN NA

Chronobiological and ACT-based Training to Handle Stress at Work

NCT04290117

Stress

UNKNOWN NA

COMPRESSED - A Longitudinal Study of Compressed Work Schedules Within the Health, Care and Welfare Services

NCT05784324

The Focus of the Study is Shift Work

NOT_YET_RECRUITING

Burnout and Resilience in Hospital-based Nursing and Medical Personnel and Trainees

NCT06818539

Stress Burnout

NOT_YET_RECRUITING

Mindfulness Training for Staff (MTS)

NCT01082497

Stress

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Occupational Health Stress Burnout Mental Health Conditions Sickness Absence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

The intervention will consist of a training that incorporates evidence-based content and interactive exercises. Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) covers five core topics designed to equip supervisors with the knowledge and practical skills needed to effectively support the mental health of their employees. The full training is delivered over approximately 8 hours in an in-person group setting. Trainings are facilitated by a trained professional.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

The intervention will consist of a training that incorporates evidence-based content and interactive exercises. Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) covers five core topics designed to equip supervisors with the knowledge and practical skills needed to effectively support the mental health of their employees. The full training is delivered over approximately 8 hours in an in-person group setting. Trainings are facilitated by a trained professional.

To support learning and skill application, participants will also receive a Manager Reference Booklet during the training. This booklet consolidates key information from the ASCEND training, serving both as a learning aid during the sessions and a practical, quick-reference tool afterward. It includes summaries of key concepts, tips, and exercises, along with space for participants to record notes.

Waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

The intervention will consist of a training that incorporates evidence-based content and interactive exercises. Advancing Supervisors' Capacity for Mental Health at Work (ASCEND) covers five core topics designed to equip supervisors with the knowledge and practical skills needed to effectively support the mental health of their employees. The full training is delivered over approximately 8 hours in an in-person group setting. Trainings are facilitated by a trained professional.

To support learning and skill application, participants will also receive a Manager Reference Booklet during the training. This booklet consolidates key information from the ASCEND training, serving both as a learning aid during the sessions and a practical, quick-reference tool afterward. It includes summaries of key concepts, tips, and exercises, along with space for participants to record notes.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Toolkit Mental Health for Supervisors Toolkit Mentale Gezondheid voor Leidinggevenden

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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:

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes