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Идёт набор NCT06989398

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

Без фазы С лечением Occupational Health Stress Burnout Mental Health Conditions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Advancing Supervisors' Capacity for Mental Health at Work (ASCEND).
Кому может быть актуально
Состояния в реестре: Occupational Health, Stress, Burnout, Mental Health Conditions. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

The study aims to recruit 74 SMEs, randomly allocated to either the ASCEND intervention group (n = 37) or the 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. In addition, we will collect process data to inform the implementation of the intervention.

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

Вмешательства

  • Поведенческое 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 learn

Первичные конечные точки

  • Supervisor confidence in addressing employee mental health problems [Срок оценки: Change from baseline to 1 month]
Вторичные конечные точки (5)
  • Supervisor confidence in addressing employee mental health problems [Срок оценки: Change from baseline to within 1-hour post-intervention and 3 months]
  • Supervisor responsiveness to employee mental health problems [Срок оценки: Change from baseline to 1 month and 3 months]
  • Supervisor stigma towards mental health conditions [Срок оценки: Change from baseline to 1-hour post-intervention, 1 month, and 3 months]
  • Supervisor self-care [Срок оценки: Change from baseline to 1 month and 3 months]
  • Supervisor mental health literacy [Срок оценки: Change from baseline to 1-hour post-intervention and 1 month]

Критерии участия

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 public and non-profit organizations with 10 to 250 employees, and units of larger organizations employing between 10 and 250 employees

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Нидерланды · 1 центр
  • Vrije Universiteit Amsterdam — Amsterdam

Идентификаторы

NCT: NCT06989398 · 2024.0846 · ADVANCE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗