Evaluating the feasibility of a group psychosocial intervention for migrant and host community women in Ecuador and Panamá: protocol for a multi-site feasibility cluster trial
Authors: Greene M. Claire , Bonz Annie , Cristobal Maria , Vega Carolina , Andersen Lena S. , Angulo Alejandra , Armijos Andrea , Guevara María Esther , Benavides Lucia , de la Cruz Alejandra , Lopez Maria Jose , Moyano Arianna , Murcia Andrea , Noboa Maria Jose , Rodriguez Abhimeleck , Solis Jenifer , Vergara Daniela , Scharf Jodi , Dutt Priya , Wainberg Milton , Tol Wietse A. 
Published: June 2022

AbstractBackgroundCommunity- 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 Nosotrasis 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 intoEntre Nosotras.MethodsThis 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 integratedEntre Nosotras+ stress management intervention versusEntre Nosotrasalone 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.DiscussionResults 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 registrationClinicalTrials.govidentifier:NCT05130944. Registered November 23, 2021—retrospectively registered.