The overall objective of this study is to develop and pilot test Weyera to assess feasibility, acceptability, and safety before conducting a fully powered trial. We aim to accomplish this through two specific objectives: (1) to develop Weyera, a culturally responsive mental health support intervention for Ethiopian and Eritrean emerging adults, in partnership with youth and community stakeholders; and (2) to conduct a pilot trial of Weyera and evaluate its feasibility, acceptability, and safety among emerging adults in Atlanta.

The Institutional Review Board at Emory University has reviewed and approved all procedures outlined in this protocol (STUDY00008231 approved on August 25, 2024). The study is registered with ClinicalTrials.gov (NCT06960187). Our team works closely with a Licensed Master Social Worker, who is on-call during all sessions, to consult the PFs in case participants exhibit signs of a mental health crisis or distress. PFs are also trained in the correct referral methods in such situations. Informed consent will be obtained by the research team during the initial Zoom call before enrollment into the study. The team will explain the potential risks and adverse effects associated with participation, including potential discomfort or unpleasant experiences during group activities, as well as the possibility of confidentiality breaches. All participants are also provided with a list of affordable local mental health resources upon enrollment. Additionally, participants are encouraged to step away if they feel uncomfortable during a session. If any study participant reports feeling uncomfortable or unsafe during any session, the study team will work to address the issue as best as possible and offer the participant the option to withdraw from the study at any time. The study team will also track and report any adverse events to the Institutional Review Board. Participants will receive US $25 compensation for each session attended.

This protocol is being carried out in Atlanta, home to one of the largest Ethiopian and Eritrean communities in the United States [4,5]. We work with 2 community-based organizations (CBOs) partners in the area, the Ethiopian Community Association of Atlanta and the Eritrean American Community Association of Georgia.

Our intervention is based on a conceptual model (Figure 1) grounded in Fergus and Zimmerman’s theorization of resilience as including assets (internal to the individual) and resources (external to the individual) [20]. Resilience is defined as the achievement of positive health outcomes despite risk [21], with resilience factors acting as effect modifiers on the expected risk-outcome relationship [20]. Our preliminary work identified resilience processes operating at multiple levels within Ethiopian and Eritrean communities, including strong family ties, affirming ethnic identity beliefs, and a culture of collective efficacy and support. Weyera aims to strengthen resilience assets and resources, such as social support, positive identity beliefs, and mental health service use, thereby reducing the adverse effects of background risk factors like immigration-related trauma, acculturative stress, racism, socioeconomic challenges, and harmful community norms on mental health outcomes such as depression, anxiety, and trauma among Ethiopian and Eritrean emerging adults. Of note, Weyera translates to “olive tree” (a symbol of peace) in Amharic, a language of Ethiopia.

Our study is grounded in principles of community-based participatory research [22], to increase cultural relevance, community ownership, uptake, and sustainability [23]. To this end, in addition to partnering with the CBOs, we assembled a Youth Advisory Board (YAB) to cocreate, develop, or design the intervention. Our current YAB includes 13 members (n=5 men, n=8 women; n=5 Eritrean, n=8 Ethiopian). They were recruited through community outreach and social media advertisements. YAB duties include (1) advising on recruitment and retention; (2) reviewing surveys and interview guides; (3) finalizing design and testing pilot intervention sessions; (4) participatory data analysis for context; and (5) assisting with dissemination. YAB members are compensated at an hourly rate (US $15/h) for their involvement in this study. Our intervention development approach will be guided by the intervention mapping framework, an established, iterative process for systematically developing theory-based interventions, and builds on our team’s extensive work [19]. The investigative and analytic team consists of first- and second-generation Ethiopian American and African American faculty and students.

The goals of this study are to assess feasibility, acceptability, and safety. The proposed sample size of 60 participants was not derived based on estimating effect size estimates (which are often unreliable from small pilot studies [32-41]), but to provide a sufficiently large sample to obtain reasonable descriptive data and to pilot test our data collection procedures, intervention manual, and recruitment and retention methods, in anticipation of a future fully powered efficacy trial. The qualitative sample size is based on Kvale’s estimate that 15±5 individuals are typically sufficient to reach thematic saturation [42].

We will use REDCap [31] to create and allow self-administration of surveys measuring background factors, resilience processes, and mental health outcomes at baseline 2-, 4-, and 6-month time points (Table 2). Surveys will primarily be completed remotely but can be done in person if a participant prefers. We estimate that completing each survey will take approximately 30 minutes. We will use best practices for web-based data collection to detect suspicious response patterns [43]. Upon completing the survey, respondents will receive US $25. Short postsession participant and facilitator surveys will capture satisfaction and challenges with each session. In addition to the survey measures outlined in Table 2, the study team will conduct a fidelity check at each session to ensure that each session closely follows the intervention design. We will use a participant attendance and engagement tracker to monitor participants’ engagement throughout each session closely.

To qualitatively evaluate feasibility and acceptability, we will conduct brief exit interviews with a subset of study participants (n=20), purposively sampled to represent different ethnicities, religions, genders, and immigrant backgrounds. Additionally, we will conduct interviews with each PF at the end of the study. These interviews will be conducted by trained staff via Zoom.

We will conduct descriptive analysis to assess the acceptability, feasibility, and safety of Weyera. To evaluate the acceptability of the intervention, descriptive quantitative analyses of the intervention data will focus on tabulating and summarizing the results of the postsession satisfaction survey measures. To determine feasibility, we will monitor recruitment rates, effort required (eg, staff hours), number of screenings, and the proportion of eligible participants who agree to enroll. We will summarize rescheduled, canceled, and missed sessions to help estimate staffing needs and retention protocols for a future full trial. Additionally, we will compare the characteristics of participants lost to follow-up with those who remain to identify any systematic patterns that may affect the results. Safety will be assessed by tabulating and describing any adverse events during study participation.

Additionally, we will measure mental health outcomes, hypothesized moderators, and background (risk) factors to evaluate the feasibility of data collection (eg, time to complete surveys), as depicted in Table 1. To analyze changes over time, we will plot means and proportions from baseline to follow-ups. Exploratory hypotheses will be evaluated using linear mixed models, estimated via maximum likelihood, and fitted to provide all necessary information for analyses typical of a full randomized controlled trial [44]. We will also assess the feasibility of interaction analyses (for effect modification). As of March 2026, the study has enrolled 65 participants (33 in the intervention group, 32 in the control group) who have completed the baseline survey. We have not started data analysis.

Qualitative analyses will be guided by a thematic analysis and use a team approach to enhance rigor and reproducibility [45]. Analytic steps will include the following: (1) after each interview, interviewers will document field notes including emerging topics for further exploration; (2) verbatim transcripts will be entered into MAXQDA qualitative software (VERBI Software GmbH); (3) we will develop a preliminary codebook to include predetermined deductive codes related to the domains of interest, and inductive codes that emerge; (4) analysts will code a subset of transcripts and compare coding, with differences discussed in team meetings until consensus is reached; similarities and differences across transcripts will be examined, revising codes accordingly. We will cease developing new codes when no new themes are seen; (5) analysts will proceed to individually code full transcripts and meet weekly to troubleshoot concerns and; (6) properties and dimensions of salient themes will be summarized and interpreted in detailed analytic memos.

The trial is well positioned to make a significant contribution by demonstrating that the Weyera intervention is feasible, acceptable, and safe among Ethiopian and Eritrean immigrant youth. There are currently no published studies of interventions that specifically target the mental health needs of Ethiopian and Eritrean youth in the United States. Given this research gap, this trial will provide evidence on whether a community-based, peer-led mental health intervention can begin to address the mental health needs of this community. Studies involving different immigrant groups indicate that peer-led mental health interventions are both acceptable and feasible, and these programs can improve self-rated anxiety and happiness levels, depressive symptoms [17], and psychosocial functioning while decreasing social isolation [16]. This trial builds on this evidence to specifically develop an intervention for and with Ethiopian and Eritrean immigrant youth.

This randomized wait-list control trial is designed to minimize bias. Beyond the study team, participants remain unaware of their specific group assignment; they are only notified of the start dates for their respective group sessions. Sessions for both the immediate and wait-list groups are designed and implemented identically. Nevertheless, this methodology does not entirely eliminate potential selection bias, given the inherent challenges associated with this study design, in which the wait-list group may be prone to higher dropout rates due to the interval between enrollment and the start of the intervention. Furthermore, varying expectations among participants may affect their motivation to fully engage with the intervention following the waiting period. In addition, the presurvey and postsurvey measures are self-reported by study participants, which can introduce biases due to reduced accuracy and potential social desirability bias.

Upon the conclusion of this trial, in collaboration with the CBOs, the team will conduct webinars to present our qualitative and quantitative findings. In addition, further dissemination will include scientific and academic journal publication and conference presentations. Building upon the findings of this research, the subsequent objective of the project is to undertake a statistically powered trial designed to evaluate the efficacy of the intervention in addressing the mental health needs of Ethiopian and Eritrean immigrant youth.