Background. Participatory research (PR) trials aim to achieve the dual, and at times competing, demands of producing an intervention and research process that address community perspectives and priorities, while establishing intervention effectiveness. Objective. To identify research and community priorities that must be reconciled in the areas of collaborative processes, study design and aim and study implementation quality in order to successfully conduct a participatory trial. We describe how this reconciliation was approached in the smoking prevention participatory trial Padres Informados/Jovenes Preparados (Informed Parents/Prepared Youth) and evaluate the success of our reconciled priorities. Methods. Data sources to evaluate success of the reconciliations included a survey of all partners regarding collaborative group processes, intervention participant recruitment and attendance and surveys of enrolled study participants assessing intervention outcomes. Results. While we successfully achieved our reconciled collaborative processes and implementation quality goals, we did not achieve our reconciled goals in study aim and design. Due in part to the randomized wait-list control group design chosen in the reconciliation process, we were not able to demonstrate overall efficacy of the intervention or offer timely services to families in need of support. Conclusion. Achieving the goals of participatory trials is challenging but may yield community and research benefits. Innovative research designs are needed to better support the complex goals of participatory trials.
Bibliographical noteFunding Information:
this project was funded by National Cancer Institute U54 Center Grant, 'Minnesota Centers for Cancer Collaboration' 1U54CA153603 and supported by grant number UL1TR000114 from the National Center for Research Resources, National Institutes of Health. DGH was supported by the Health Resources and Services Administration (HRSA) of the U. S. Department of Health and Human Services (HHS) under National Research Service Award NRSA) in Primary Medical Care, grant number T32HP22239. TB was supported by the National Cancer Institute of the National Institutes of Health under award number R25CA16318. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The study sponsor had no role in study design, collection, analysis and interpretation of data; writing the report; or the decision to submit the report for publication.
- Community based participatory research
- Hybrid trial
- Research design
- Translational health research