A randomized clinical trial to support adherence regimens in children with epilepsy: Examining potential mechanisms of change

•Family-based problem-solving interventions improve adherence to antiseizure medications.•Epilepsy-specific knowledge, barriers to medication adherence, problem-solving skills, caregiver emotional distress, and family functioning do not mediate these treatment effects.•Families of young children with newly diagnosed epilepsy are generally functioning well from a psychosocial perspective.•The examination of other mediators (e.g., epilepsy-specific family conflict or communication) is warranted. A family-tailored education and problem-solving intervention, Supporting Treatment Adherence Regimens (STAR), was developed to address the adherence challenges common in youth with epilepsy and their families. Randomized clinical trial (RCT) results indicated a 21% adherence improvement in the STAR group compared with an education-only (EO) group 12-months post-intervention. The current study examined group differences (STAR vs. EO) in epilepsy-specific knowledge, barriers to medication adherence, problem-solving skills, caregiver emotional distress, and family functioning over time and whether these factors mediated group differences in adherence at 12-months post-intervention. Two-hundred children (ages 2–12) with epilepsy and their caregivers were included as RCT participants. Children with new-onset epilepsy and adherence