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As evidence supporting the effectiveness of mental health and psychosocial interventions grows, more research is needed to understand optimal strategies for improving their implementation in diverse contexts. We conducted a qualitative process evaluation of a multicomponent psychosocial intervention intended to promote well-being among refugee, migrant and host community women in three diverse contexts in Ecuador and Panamá. The objective of this study is to describe the relationships among implementation determinants, strategies and outcomes of this community-based psychosocial intervention. The five implementation strategies used in this study included stakeholder engagement, promoting intervention adaptability, group and community-based delivery format, task sharing and providing incentives. We identified 10 adaptations to the intervention and its implementation, most of which were made during pre-implementation. Participants (n = 77) and facilitators (n = 30) who completed qualitative interviews reported that these strategies largely improved the implementation of the intervention across key outcomes and aligned with the study’s intervention and implementation theory of change models. Participants and facilitators also proposed additional strategies for improving reach, implementation and maintenance of this community-based psychosocial intervention.

Abstract Background Community- and strengths-based psychosocial interventions are central to mental health and psychosocial support guidelines, but rigorous evidence regarding the effectiveness of these interventions is limited. The complexity and variability that is inherent to many community-based psychosocial interventions requires innovative strategies in order to facilitate the comparability and synthesis across research studies without compromising the fit and appropriateness of interventions to specific study populations and context. Entre Nosotras is a community-based psychosocial intervention developed for migrant and host community women that is designed to be flexible enough to enable integration of external intervention components and adaptable to diverse study contexts and populations. This protocol describes a study that aims to evaluate the appropriateness, acceptability, and feasibility of integrating a standardized stress management intervention into Entre Nosotras. Methods This study will evaluate the appropriateness, acceptability, feasibility, and safety of intervention and research procedures for a cluster randomized comparative effectiveness trial conducted in Ecuador and Panamá with migrant and host community women. In this feasibility trial, we will allocate communities nested within the three study sites to the integrated Entre Nosotras + stress management intervention versus Entre Nosotras alone through stratified randomization. Migrant and host community women residing in these study communities who report low to moderate levels of distress will be allocated to the intervention condition that their community is assigned (n = 220 total). We will collect quantitative measures of psychosocial wellbeing, psychological distress, coping, social support, and functioning from study participants. We will collect quantitative measures of fidelity and facilitator competencies through observation and facilitator self-assessment. Data on appropriateness, acceptability, feasibility, and safety will be gathered from participants and facilitators through quantitative assessments at 0, 5, and 10 weeks post-enrollment and qualitative interviews conducted with all facilitators and a subset of 70 study participants during the post-intervention follow-up period. Discussion Results from this feasibility trial will determine whether a multi-site cluster randomized comparative effectiveness trial of an adaptable community-based psychosocial intervention for migrant and host community women is relevant, acceptable, and feasible. Trial registration ClinicalTrials.gov identifier: NCT05130944 . Registered November 23, 2021—retrospectively registered.

Community-based psychosocial interventions are key elements of mental health and psychosocial support; yet evidence regarding their effectiveness and implementation in humanitarian settings is limited. This study aimed to assess the appropriateness, acceptability, feasibility and safety of conducting a cluster randomized trial evaluating two versions of a group psychosocial intervention. Nine community clusters in Ecuador and Panamá were randomized to receive the standard version of the Entre Nosotras intervention, a community-based group psychosocial intervention co-designed with community members, or an enhanced version of Entre Nosotras that integrated a stress management component. In a sample of 225 refugees, migrants and host community women, we found that both versions were safe, acceptable and appropriate. Training lay facilitators to deliver the intervention was feasible. Challenges included slow recruitment related to delays caused by the COVID-19 pandemic, high attrition due to population mobility and other competing priorities, and mixed psychometric performance of psychosocial outcome measures. Although the intervention appeared promising, a definitive cluster randomized comparative effectiveness trial requires further adaptations to the research protocol. Within this pilot study we identified strategies to overcome these challenges that may inform adaptations. This comparative effectiveness design may be a model for identifying effective components of psychosocial interventions.

There is increasing evidence supporting the effectiveness of scalable mental health and psychosocial support (MHPSS) interventions delivered by non-specialists for improving wellbeing among migrant populations in humanitarian settings. Balancing fidelity in the implementation of evidence-based MHPSS interventions with their fit to the needs and preferences of new populations and contexts remains a challenge when introducing MHPSS interventions in new settings. This paper describes a community-based participatory approach to MHPSS intervention design incorporating processes to promote local adaptability and fit while maintaining standardized elements of existing MHPSS interventions. We conducted a mixed-methods study to design a community-based MHPSS intervention that fit the mental health and psychosocial needs of migrant women in three sites in Ecuador and Panama. Drawing from a set of community-based participatory research methods, we identified the priority mental health and psychosocial needs among migrant women, co-developed intervention mechanisms that aligned with those needs, matched mechanisms to existing psychosocial intervention components, and iteratively piloted and refined the intervention with community stakeholders. The resulting intervention was a five-session, lay facilitator-delivered group intervention titled, Entre Nosotras (‘among/between us’). The intervention combined elements of individual and community problem solving, psychoeducation, stress management, and social support mobilization to address prioritized problems including psychological distress, safety, community connectedness, xenophobia and discrimination, and social support. This research outlines an emphasis on the social dimension of psychosocial support, as well as a process for balancing fit and fidelity in intervention design and implementation.