Using the Stage Model of Behavioral Therapies we developed a Targeted Service Delivery Approach which is designed to optimize people with SMI's ability to engage and benefit from criminogenic interventions. In accordance with the Stage Model, initial intervention development activities focused on building the intervention and testing its acceptability and feasibility. The success of this early stage intervention research led to an NIMH funded pilot study of the efficacy of a criminogenic intervention when delivered using the TSDA. This study involves two phases, an open trial (n=32) where study activities focus on finalizing the intervention materials and developing the study materials needed to support the second RCT (n=80) phase.
Many presentations and articles present the outcomes of RCTs, but few provide details on how intervention research moves from the early development phase to efficacy testing. This symposium addresses this gap with a set of four papers that present results from the open trial phase of this NIMH funded study. Collectively, these papers illustrate how this project moved from intervention development to efficacy testing within the context of a federally funded clinical trial.
The first paper examines the results of the project's final intervention development activity which was a gender responsive analysis designed to assess whether the needs of both men and women with SMI are being adequately addressed by the intervention. The second paper explores the development of the fidelity checklist- a key element of efficacy studies and considers methodological issues that have to be addressed when measuring fidelity in a prison setting. The final two papers examine issues that impact both the conduct and management of research in efficacy studies. The first examines recruitment patterns in the open trial phase and identifies strategies that will maximize recruitment efforts during the RCT phase. The second paper provides an overview of the monitoring and oversight procedures associated with the reclassification of most mental health services intervention research as clinical trials and the impact of these changes on study operations. The papers in this symposium will present findings from four study activities that played a central role in finalizing the intervention materials and developing the study materials needed to optimize the success of the study as it moves into the efficacy testing phase.