Supporting treatment adherence regimens in children with epilepsy: A randomized clinical trial.

OBJECTIVE This study was undertaken to examine the efficacy of a family-tailored education and problem-solving behavioral intervention, Supporting Treatment Adherence Regimens (STAR), in young children (2-12 years old) with new onset epilepsy compared to an attention control (i.e., education only [EO]) intervention. Participants randomized to the STAR intervention were hypothesized to demonstrate significantly improved adherence at postintervention and 3-, 6-, and 12-month follow-up visits compared to the EO intervention. Seizure and health-related quality of life (HRQOL) outcomes were also examined. METHODS Two hundred children with new onset epilepsy and their caregivers were recruited during routine epilepsy clinic visits. Baseline questionnaires were completed, and electronic adherence monitors were provided. Participants with adherence less than 95% during the run-in period were randomized to either STAR or EO intervention. Active intervention was provided to both groups for 4 months. Questionnaires were completed at conclusion of the active intervention phase and three follow-up time points (3, 6, and 12 months). Group differences in adherence, seizure outcomes, and HRQOL were examined using regression-based analyses of covariance and longitudinal mixed effect linear or logistical models. RESULTS Adherence at 12-month follow-up was significantly different between the STAR (mean = 82.34, SD = 21.29) and EO intervention groups (mean = 61.77, SD = 28.29), with the STAR group demonstrating 20.6% greater adherence (b = 19.11, p = .04, 95% confidence interval = 1.00-37.22, d = .83). No significant differences were found between groups in seizure and HRQOL outcomes. SIGNIFICANCE A family-based behavioral adherence intervention demonstrated sustained adherence improvements 1 year following epilepsy diagnosis compared to an epilepsy-specific education intervention. STAR is an efficacious adherence intervention that can easily be implemented into routine epilepsy care.