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Conducting clinical research in public sector community mental health centers (CMHCs) can be challenging. The purpose of this report is to describe the challenges our research team encountered in engaging CMHC providers in a clinical trial aimed at testing an intervention to improve parent activation and engagement in their child’s behavioral healthcare. We discuss the intervention we aimed to test, the challenges we encountered engaging providers, and the barriers to engagement that we identified. The barriers included restrictive inclusion criteria, an ambitious randomized controlled design, a dyadic (provider-parent) recruitment plan, a requirement to record provider-parent sessions, and high day-to-day practice demands on providers. The strategies we used to address the barriers and a discussion of the “trade-offs” these strategies introduced are presented. Improving provider engagement in research in CMHCs can avoid research delays or termination of studies and ultimately mitigate an early blockage in the research-to-practice pipeline. [ABSTRACT FROM AUTHOR]

Background: Intervention fidelity is a critical element of randomized controlled trials, yet reporting of intervention fidelity among attention control arms is limited. Lack of fidelity to attention control procedures can affect study outcomes by either overestimating or underestimating the efficacy of the intervention under examination. Objectives: This brief report describes the approach researchers took to promote fidelity to the attention control arm of a pediatric palliative care randomized controlled trial funded by the National Institutes of Health. Methods: The Informational Meetings for Planning and Coordinating Treatment trial aims to determine the efficacy of a communication intervention that uses care team dyads (i.e., physicians partnered with nurses or advanced practice providers) to engage parents of children with cancer who have a poor prognosis in structured conversations about prognostic information, goals of care, and care planning. The intervention is compared with an attention control arm, which provides parents with structured conversations on common pediatric cancer education topics, such as talking to their child about their cancer, clinical trials, cancer treatment, side effects, and so forth. National Institutes of Health guidelines for assessing and implementing strategies to promote intervention fidelity were used to design (a) the attention control arm of a randomized controlled trial, (b) related attention control arm training, and (c) quality assurance monitoring. Results: Attention control study procedures were designed to mirror that of the intervention arm (i.e., same number, frequency, and time spent in study visits). Cluster randomization was used to allocate care team dyads to one arm of the randomized controlled trial. Care team dyads assigned to the attention control arm participated in online training sessions to learn attention control procedures, the different roles of research team members, and quality assurance methods. Fidelity to attention control procedures is assessed by both the interveners themselves and a quality assurance team. Discussion: Study design, training, and delivery are all critical to attention control fidelity. Baseline training often needs to be supplemented with booster training when time gaps occur between study start-up and implementation. Quality assurance procedures are essential to determine whether interveners consistently deliver attention control procedures correctly. [ABSTRACT FROM AUTHOR]