Pilot randomized controlled clinical trial of an adherence social norms intervention for adolescents with epilepsy

Objective: Non-adherence to anti-seizure medications (ASMs) is common for adolescents with epilepsy, with potentially devastating consequences. Existing adherence interventions in epilepsy do not meet the unique challenges faced by adolescents. Leveraging social norms capitalizes on the increased importance of peer influence while simultaneously targeting the low motivation levels of many adolescents. The cur-rent study examined the feasibility, acceptability, and satisfaction of a social norms adherence interven-tion in adolescents with epilepsy.Methods: A pilot RCT of a mHealth social norms intervention was conducted with adolescents with epi-lepsy who demonstrated non-adherence (<= 95% adherence) during baseline. Adolescents were random-ized to either (1) mHealth social norms (reminders, individualized and social norms adherence feedback) or (2) control (reminders and individualized adherence feedback). Primary outcomes included feasibility, acceptability, and satisfaction. Exploratory outcomes included electronically monitored adher-ence, seizure severity, and health-related quality of life (HRQOL). Results: One hundred four adolescents were recruited (53% female; Mage = 15.4 +/- 1.4 years; 81% White: Non-Hispanic; 5% Black, 10% Bi/Multiracial; 2% White: Hispanic; 1% Other: Hispanic; 1% Bi/Multiracial-Hispanic). Forty-five percent screen-failed due to high adherence, 16% withdrew, and 38% were random-ized to treatment (n = 19) or control (n = 21). Recruitment (75%), retention (78%), and treatment satisfac-tion were moderately high. Engagement with the intervention was moderate, with 64% of participants engaging with intervention notifications. Exploratory analyses revealed that after controlling for COVID-19 impact, the social norms intervention group maintained higher adherence over time compared to the control group. Small to moderate effect sizes were noted for seizure severity and HRQOL between groups.Conclusion: This pilot intervention appeared feasible and acceptable. Increases in adherence in the treat-ment versus control group were modest, but a future larger more adequately powered study is needed to detect effects. Notably, it appeared the COVID pandemic influenced adherence behaviors during our trial.(c) 2023 Elsevier Inc. All rights reserved.