Challenges of Recruiting Children and Adolescents Into a Randomized Controlled Risperidone Discontinuation Trial

BACKGROUND: Randomized controlled trials (RCTs) are essential for evaluating treatment efficacy and safety, but recruitment is often challenging. This study investigated barriers to enrollment in a 4-center RCT examining discontinuation of long-term risperidone treatment in children and adolescents and provides recommendations to improve recruitment in future studies. METHODS: To identify clinician-related and patient/parent-related barriers, we recorded all screening and recruitment steps completed in our lead center, as well as reasons for non-eligibility or nonparticipation. Organizational barriers were evaluated based on experiences across all 4 participating centers. RESULTS: A total of 1008 patients were pre-screened, of whom 39.8% seemed to be still receiving risperidone treatment. Of these, 56.5% met our inclusion criteria. Among eligible patients, 60.1% were informed about the study, and 10.8% provided informed consent. Approximately 40% of eligible patients were not invited to participate. Patient-related and parent-related barriers accounted for 50% of nonparticipation, primarily due to preferences for continued risperidone treatment (36.6%) or immediate discontinuation (9%), practical barriers (15.7%), and objections to aspects of the study protocol (12.7%). Organizational barriers included insufficient facilitation and integration of research within participating centers. CONCLUSIONS: The main barriers to recruitment were clinician gatekeeping, treatment preferences, and the burden of study participation. Additional challenges included restrictive inclusion and exclusion criteria and insufficient integration of research in clinical practice. We recommend strengthening the integration of research in clinical settings, educating clinicians and patients/parents about RCTs, minimizing participant burden, and considering more pragmatic study designs that accommodate treatment preferences.