Table 1.

Challenges, Resolutions, and Innovations in the Refugee Well-being Project Community-Based RCT

Challenge	Resolution and/or Innovation to Address Challenge
Epistemological
Limited external validity of RCTs	Mixed-method design allows for exploration of processes, contexts, and power dynamics of intervention implementation
Is a RCT necessary to demonstrate effectiveness? (What evidence of effectiveness is meaningful?)	Many forms of evidence valued by research team and CAC; mutual decision to implement RCT to strengthen ability to fund and disseminate intervention
Methodological
Diffusion of effects	Ask participants to provide names of their relatives; randomize by household and include close relatives in the same household; document diffusion using student advocate reports
Goal of community-level change	Document community-level changes that have occurred and ask participants specific questions to ascertain if community-level changes have impacted them (e.g., if they have used services that have been developed or made available as a result of intervention advocacy)
Positive impact of interviews	Document participant comments about interview process
RCT design can erode trust of participants and communities	Group orientations for each ethnic group to explain study design before enrollment; public randomization process; ongoing partnership and dialogue with refugee communities and service providers
Ethical
Responding to mental health needs of control group	Evidence-based trauma treatment offered to both intervention and control group participants with clinically significant PTSD symptoms
Providing help when no other help is available	Interviewers provide help according to agreed upon protocol; all provisions of help are documented
Interviewers belong to same communities as participants	Ongoing reflection, bidirectional learning among all research team members, flexibility to adapt study procedures and guidelines; intensive and ongoing training and support for interviewers