Informal caregivers – often family members or friends who provide unpaid care to loved ones – play an important role in supporting individuals with a diagnosis of a mental health condition (1, 2). For caregivers with a migration background, meaning those who have moved to a new country and are in a situation in which they might be less familiar with local customs, norms, or care system, this responsibility often comes with additional challenges and increased stress, due to stigmatizing beliefs regarding mental illness, language and cultural barriers and limited access to support services (3–5). These caregivers face a “double adaptation burden,” with stress intensified by their caregiving role and experiences as migrants. To alleviate this burden, providing appropriate support is important (5, 6). In response, the culturally sensitive intervention “Ze Zijn Toch Niet Gek?!” (translation: “They Are not Mental”; hereafter TANM) was developed to support informal caregivers with a migration background who care for a loved one with a mental illness. This paper presents the protocol for a planned realist evaluation of TANM, aiming to develop a theoretical framework which explains the mechanisms through which support programs like TANM produce their desired outcomes and gain insights for its improvement.

Members of migrant communities are often at increased psychological health risks, due to challenges such as adapting to a new culture and encountering discrimination. As such, informal caregivers play an important role in supporting those affected (4, 7, 8). Caregiving for someone with a mental illness can be stressful and difficult for all informal caregivers, irrespective of migration status, but caregivers with a migration background face additional challenges that can intensify this caregiver burden (1, 3, 9, 10). These challenges include stigma, which is a general phenomenon across societies and can be influenced by culture-specific explanatory models – such as viewing it as a result of black magic, spirits, punishment of a divine entity or higher power, or the evil eye. Stigma can foster feelings of shame within families and discourage both patients and caregivers from seeking help (3, 4, 11–15). Additionally, cultural expectations around family caregiving, including gendered norms and ideas about family obligations, can further increase caregiver burden (3, 16, 17).

These cultural taboos, combined with systemic barriers like language differences and cultural misunderstandings, can make it difficult for informal caregivers and their loved ones to acknowledge the need for support, limiting the access to formal care (5). These intersecting challenges make caregiving for individuals with mental illness particularly difficult within migrant communities.

One way to address barriers in accessibility is through integrated care, which focuses on breaking down organizational boundaries and aligning services to better meet the needs of individuals, rather than being shaped by what each organization provides separately (18). Integrated care requires collaboration between healthcare, social and community services (18, 19), and ideally, the involvement of the target group. By making care systems more navigable and tailored to the target group’s needs, integrated care is a promising way to empower vulnerable individuals (20). This is particularly relevant for informal caregivers with a migration background, who often face additional challenges in navigating healthcare systems and accessing support (5). For caregivers of individuals with mental illnesses, tailored interventions are important for addressing their physical, psychological, and social needs. Through collaboration with relevant services, integrated care can better meet these needs and enhance the overall quality of psychosocial care by supporting these informal caregivers, who may experience additional barriers due to language, cultural differences, or unfamiliarity with available services (5, 21–23).

To address the challenges faced by informal caregivers with a migration background who care for a loved one with a suspected mental illness, TANM was developed as a peer education program. A key aim of TANM is to enhances caregivers’ resilience – the dynamic process of adapting to adversity, which helps buffer against caregiver burden (24–26) - through improved access to information, reduced stigma surrounding mental health, and stronger connections between migrant families and the healthcare system. Additionally, TANM enhances coordination between community-based support and healthcare organizations, by incorporating elements of integrated care. A detailed description of the TANM, including its structure and implementation, is provided in Section 2.

Since its development in 2014, TANM has undergone slight adjustments, including changes in funding and target groups. Its evolving nature requires an evaluation method that can adapt to these changes. A realist evaluation (RE) design was chosen because it provides a framework not only to assess whether the intervention works, but also to explore why, for whom, and under what circumstances it works. This approach is well-suited for an exploration to understand how underlying contexts and mechanisms – such as stigma and taboos – impact the intended outcomes of TANM (27). Given the complexity of these factors, this research takes a transdisciplinary approach, involving collaboration with the intervention’s coordinating organizations to ensure that different perspectives are integrated into the evaluation process circumstances (27–29). This research aims to evaluate TANM using a RE approach, in order to develop a program theory that explores how contexts and mechanisms, such as stigma and taboos, impact its intended outcomes. The research will answer the following questions:

Considering the goals of TANM, we expect these changes to have a positive direction; that is, we anticipate that participants will discuss mental health taboos with their friends and families, develop a better understanding of mental illnesses and caregiver support, and hold a more positive perception of the healthcare sector.

In the following sections, we describe key components of our realist evaluation design, including the program theory, data collection methods, and planned analyses.

TANM is a peer-facilitated intervention aimed at strengthening the resilience of informal caregivers with a migration background who support a loved one with a suspected mental illness in the second largest city of the Netherlands, Rotterdam. Developed collaboratively by a community empowerment organization, a mental health prevention agency and a support association for families affected by mental health issues, TANM is a 3-session program that aims to increase resilience in the long-term, by (1) addressing mental health taboos (2); improving access to information and care and (3) fostering trust between migrant communities and the healthcare sector. Since the long-term goal of increasing caregivers’ resilience extends beyond the scope of the current research, we will focus on evaluating its short-term objectives, which include: encouraging open discussions about mental health within migrant communities, improving understanding of mental illnesses and available support for caregivers, and fostering trust between migrant families and the healthcare sector to reduce barriers to professional support.

TANM relies on peer educators, referred to as ambassadors, who share similar lived experiences with the participants, particularly through their migration background and, for some ambassadors, their caregiving role. Peer education is an approach to engage ‘hard-to-reach’ populations, such as those with limited resources, language barriers or distrust in the healthcare system. Peers serve as intermediaries who can leverage cultural understandings and trust to identify participants and adapt the intervention’s messages to meet the group’s needs (30–32).

Within TANM, ambassadors are volunteers who are active community members, often demonstrated through a strong social network or prior volunteer experience in their neighborhoods, and they recognize the importance of discussing mental health. Ambassadors are invited through outreach by the community empowerment organization, as well as through referrals from ambassadors of previous years. They are selected based on the following criteria:

Once selected, ambassadors receive specialized training, covering three main areas: (1) basic knowledge of mental health conditions, such as depression, psychosis and schizophrenia, which includes symptoms, causes, treatment options and the effects of medication and substance use; (2) informal caregiving, including definitions, perceptions, signs of caregiver burden, and available support services; and (3) practical skills in peer education, such as presentation techniques and an introduction of the content of the peer education sessions. The training is delivered in the Dutch language by a prevention specialist with a background in psychology, a Family Experience Expert (FEE; explained in Section 2.1 about Phase 3) and a caregiver support coach affiliated with the local caregiver support service, which has been part of TANMs coordinating organizations since 2023. The training is highly interactive and fosters a culturally sensitive approach by encouraging ambassadors to share personal experiences and explanatory models they are familiar with. A key message throughout the training is that differing perspectives on mental health conditions can coexist, and that creating space for these perspectives during the peer education sessions is essential.

After completing the training, ambassadors recruit participants for their groups and lead the intervention’s peer education sessions in the dominant language spoken within their group. This could be Dutch, but also, for example, Arabic or Turkish. Ongoing support is provided to the ambassadors in two ways, through regular feedback meetings with members of the coordinating organizations and fellow ambassadors, and through direct access to a designated contact person within the coordinating organizations who is available for individual questions, support or guidance through phone, messaging or in-person contact.

Our evaluation will focus on the current round of TANM (September 2024 – March 2025), which is co-organized by four partners, following the addition of a helpline and support service for caregivers in Rotterdam in 2023.

Realist evaluation (RE) is a theory-driven approach that provides a framework for evaluating interventions, policies, measures, and other complex social programs or systems. It examines what works, how, for whom, why and under which circumstances, considering the influence of factors like culture and socioeconomic status on outcomes (27, 28, 34, 35). The underlying idea behind REs is that outcomes are the product of multiple causes and depend on mechanisms and contextual elements (36, 37). Together, these form context-mechanism-outcome (CMO) configurations, which form the basis of the so-called program theory (37). There is no standard methodology for REs, but it is encouraged to use a mixed-methods approach, combining both quantitative and qualitative methods (35, 38). This flexibility makes RE particularly suited for evaluating complex interventions, like TANM (27, 28, 35). Our RE of TANM consists of both qualitative and quantitative methods and will follow the RE reporting standards as made clear by the RAMESES-II project (37).

The RE of TANM, combines these methods in four phases. The first phase, which has already been completed (see Figures 2, 3), focused on developing an initial program theory. This theory, presented in section 3.1, serves as the foundation for the remaining phases of our RE. This protocol outlines the steps for phases 2–4, involving: (1) interviews with participants, peer educators, and other stakeholders; (2) post-intervention questionnaires; and (3) observations of the peer education cycle sessions. This study is conducted by a research team with experience in intercultural research, including two researchers who have a migration background themselves. The following sections provide detailed descriptions of each phase and method (see Figure 2).

The study protocol was approved by the Ethics Review Committee of the Department of Psychology, Education and Child Studies, Erasmus University Rotterdam (application number ETH2425-0079).

While previous studies have explored experiences of informal caregivers with a migration background [e.g., (50, 51)] and the stigma surrounding mental illness within migrant communities [e.g., (52–54)], this study will build on that foundation by evaluating an intervention that is aimed at supporting informal caregivers with a migration background who care for a loved one with a mental illness. This protocol shows how we plan to investigate how, why, for whom and under what circumstances TANM produces its intended outcomes.

This protocol employs a RE approach, which is suitable for evaluating interventions that are dynamic, culturally sensitive and context-dependent – like TANM. Unlike traditional randomized experiments, which may not capture the complexity or nuances of real-world settings, RE allows for the consideration of variations in context and experiences as integral to understanding outcomes (27, 55). Its flexibility helps to overcome challenges such as language barriers (35). This makes it a fitting approach for evaluating culturally sensitive interventions like TANM. RE extend qualitative insights to broader patterns by linking context, mechanisms and outcomes, making it more useful for informing policy and practice (27, 55) – which is ultimately the goal of our evaluation of TANM.

However, the flexibility of RE also presents challenges, such as the lack of clear methodological guidance (56). To address this, we employed a mixed-methods approach (35) and multiple data sources for triangulation. Additionally, while RE often uses arrows within program theories, they do not always establish universal causality. Depending on the selection of methods applied in a RE, causality is not necessarily implied. Instead of aiming for universally applicable explanations, REs develop so-called “middle-range” theory – explanations that are specific enough to be useful in practice but broad enough to apply beyond a single case. These theories link empirical findings to hypotheses about how an intervention works, helping to guide future research and program implementation, rather than providing definitive conclusions (56). This study’s program theory will serve as a foundation for future research on culturally sensitive caregiver interventions, such as longitudinal studies assessing long-term impacts or comparative research across different cultural contexts to explore their influence on outcomes.

Our RE approach aligns with its growing use in health system research, particularly in transdisciplinary collaborations. Similar to previous studies [e.g., (57, 58)] we primarily employ qualitative and exploratory methods to evaluate TANM. By sharing the lessons learned from implementing this protocol, we aim to inform the design and evaluation of culturally tailored interventions in integrated healthcare, particularly in reaching underserved and hard-to-reach populations (5, 20).

This protocol outlines our approach for evaluating and refining TANM’s program theory. By integrating multiple data collection methods and applying both inductive and deductive analyses, we aim to understand the intervention’s mechanisms and whether participants, ambassadors, and coordinators perceive improvements in discussing mental health taboos, understanding mental illnesses and caregiver support, and fostering trust in the healthcare system. Beyond TANM, this study contributes to broader research, policy, and practice in integrated care, particularly in reaching vulnerable populations, including those with a migration background.