The intervention is unique, not only in the application of an evidence-based program to child welfare, which many scholars and practitioners point out is all too rare, but also because the intervention requires multiple system integration.
Participating clinic staff and participants cannot be blinded because the intervention requires overt participation; however, the data analyst will be blinded to the study arm assignment.
The IDEAL Project will use a parallel cluster RCT design because the intervention requires system-level changes that make it impossible to randomise individual residents within the same nursing home to different arms without contamination [ 41].
Patients with severe cognitive problems (see below) will be excluded from this study because the intervention requires cognitive skills such as planning and evaluating activities and the structured monitoring of mood state.
Blinding is not possible for pharmacists, GPs or patients because the nature of the intervention requires their full knowledge.
Blinding will not be possible either at pharmacist or patient level because the nature of the intervention requires their full knowledge.
Neither study participants nor clinic staff were masked because of the nature of the intervention requiring overt participation.
This is because such interventions require the active cognitive and behavioural involvement of the individual [ 15, 16], as well as the ongoing practice and implementation of therapeutic skills (e.g., self-monitoring, activity scheduling, and problem solving; [ 15, 16]), often in the face of challenges and difficult experiences.
The evaluation of complex interventions requires a phased approach, because of specific difficulties in developing, identifying, documenting, and reproducing the intervention.
(The only human intervention required is refilling the tank that holds the de-icing chemical).
