Critical Components of Community-Based Effectiveness Trials: Lessons from the Field

Introduction: Randomized controlled trials (RCTs) have become the gold standard to assess the efficacy and effectiveness of the resulting interventions. A gap exists, however, between the large amount of information on efficacy and the very small amount of information on effectiveness and population representativeness. To determine whether an intervention works for a general audience, efficacy trials must be translated into effectiveness trials. This presentation will describe the processes of translation of culturally-based youth and parent substance-abuse prevention curricula to a Latino audience. Factors essential to consider from the perspectives of research teams and community partner organizations will be included along with critical aspects of a hybrid effectiveness trial research design combined with a community controlled implementation plan. Insights in mastering the complexities of transitioning from efficacy to effectiveness encompass a new partnership, school recruitment in high-stakes testing environments, and lessons learned about collaboration in effectiveness trial planning and implementation.

Design: Hybrid designs combine efficacy and effectiveness trial components to produce complex, multifaceted interventions delivered in real world settings, keeping some of the efficacy controls such as randomization while incorporating community-based implementers who undergo intensive training to guarantee appropriate translational research. This NIMHD funded hybrid effectiveness trial was designed by the research team with an implementation plan controlled by the community partner. RCTs that are community-based must address the complexity of transitioning from efficacy to effectiveness and integrate design components needed to measure success in real world settings.

Results: The results of the study offer critical lessons learned for effectiveness trial and program implementation that include: (1) developing trust between partners in a new collaboration; (2) understanding each partner’s systems and institutional culture; (3) identifying implementation adjustments essential to the effectiveness trial; and, (4) establishing a clear communication flow between partners.

Conclusions: Developing a research-community partnership that results in a successful effectiveness trial requires: (1) time commitment; (2) information sharing; (3) resource sharing; (4) joint in-depth planning; and, (5) flexible attitudes and actions. This presentation will offer guidelines for effectiveness trial implementation on how to replicate and disseminate efficacious programs with fidelity on a scale that impacts local, state or national prevention efforts.