Challenges and Innovations in a Community-Based Participatory Randomized Controlled Trial

Abstract

Randomized controlled trials (RCTs) are a long-standing and important design for conducting rigorous tests of the effectiveness of health interventions. However, many questions have been raised about the external validity of RCTs, their utility in explicating mechanisms of intervention and participants’ intervention experiences, and their feasibility and acceptability. In the current mixed methods study, academic and community partners developed and implemented an RCT to test the effectiveness of a collaboratively developed community-based advocacy, learning, and social support intervention. The goals of the intervention were to address social determinants of health and build trust and connections with other mental health services in order to reduce mental health disparities among Afghan, Great Lakes Region African and Iraqi refugee adults and engage and retain refugees in trauma-focused treatment, if needed. Two cohorts completed the intervention between 2013-2015. Ninety-three adult refugees were randomly assigned to intervention or control group and completed four research interviews (pre-, mid-, post-intervention, and follow-up). Several challenges to conducting a community-based RCT emerged, including issues related to interviewer intervention to assist participants in the control group, diffusion of intervention resources throughout the small refugee communities, and staff and community concerns about the RCT design and what evidence is meaningful to demonstrate intervention effectiveness. These findings highlight important epistemological, methodological, and ethical challenges that should be considered when conducting community-based RCTs and interpreting results from them. In addition, several innovations were developed to address these challenges, which may be useful for other community-academic partnerships engaged in RCTs.

Evaluation of a community-based intervention for health and economic empowerment of marginalized women in India

“…The community-based implementation across a large sample of women ( n = 37,324) was its strength and was better than many randomized trials not reflective of true field settings. Randomized trials are often limited by a lack of external validity, explicit mechanisms of change, and feasibility, and acceptability of the experimental design [ 54 ]. Most of the field staff were women and from the same field settings, which helped in smoothly executing the intervention.…”

Partnering with insiders: A review of peer models across community-engaged research, education and social care

“…Peers participated in intervention-related activities included screening, co-designing and/or delivering an intervention. Peer involvement in education, advisory and intervention tasks can drastically improve the cultural congruity and relevance, applicability, acceptability, credibility and reach of the project(Berge, Mendenhall, & Doherty, 2009;Coffman et al, 2017;Goodkind et al, 2016;Vaughn, Jacquez, Lindquist-Grantz, Parsons, & Melink, 2016).…”

Health-related needs and barriers for forcibly displaced women: a systematic review

“…The population investigated is frequently on the move and living in precarious situations [3], which might shift their choices and priorities compared to a stable living situation. Organizing research with a highly mobile and vulnerable population under economic constraint is a logistic challenge as well as an ethical one [13,14]. Language and culture might be very diverse in a single sample, mandating adaptation of research methodology and requiring a substantial degree of flexibility and empathy.…”

“…would bridge cultural and linguistic barriers, such as ethnographies [16], the use of pictures and index cards [17] and photovoice [16]. The challenges of conducting a randomized controlled trial (RCT) with refugees has been reported elsewhere [13].…”