Supporting Treatment Adherence Regimens in young children with epilepsy and their families: Trial design and baseline characteristics.

This article describes the methodology, recruitment, design, and baseline participant characteristics of the Supporting Treatment Adherence Regimens (STAR) trial. STAR is a randomized controlled clinical trial of an education and problem-solving adherence intervention for young children (2-12 years old) with newly diagnosed epilepsy and their families. Using an enrichment design, only participants who demonstrated non-adherence to anti-epileptic drugs within the baseline period were randomized to treatment or control arms. Randomized participants received 8 intervention sessions over a 4-month period and completed three follow-up visits (3, 6, and 12 months following intervention). Two-hundred participants were recruited for the study. The primary outcome was electronically monitored adherence, while secondary and exploratory outcomes included seizure freedom and health-related quality of life. Novel aspects of the trial design (e.g., enrichment, sequential randomization, daily adherence data use), as well as recruitment and retention challenges are discussed.