Behavioral Economics and Adherence in Teens (BEAT!)
Condition: Epilepsy; Adherence, Medication
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      Non-adherence to antiepileptic drug therapy is a significant problem for adolescents with
      epilepsy and has a critical impact on health and patient-reported outcomes. Evidence-based
      adherence interventions are lacking in this population and are critically needed. This
      proposal seeks to develop and evaluate a mHealth social norms adherence intervention for
      adolescents with epilepsy.
    

Detailed description: 
      Non-adherence to antiepileptic drugs (AEDs) is a common problem (i.e., 58% of patients have
      some level of non-adherence) for youth with epilepsy, with potentially devastating
      consequences. Adolescents with epilepsy represent a particularly vulnerable group, given
      their increased independence, decreased parental supervision, higher risk for deficits in
      organization and memory, busy and changing schedules, low motivation, and increased
      susceptibility to peer influence. Existing adherence interventions in epilepsy are not
      designed to meet the unique challenges faced by adolescents, and there are no efficacious
      interventions for adolescents with epilepsy. Not surprisingly, without efficacious
      interventions, adherence worsens during adolescence, further increasing the risk of poor
      health outcomes during this developmental period. While reminder strategies (e.g., automated
      digital reminders) are effective for the most common adherence barriers of forgetting and
      busy schedules, they are likely to be ineffective in increasing motivation. Leveraging social
      norms comparison methods (i.e., feedback about someone else's behavior related to one's own
      behavior) offers an opportunity to capitalize on the increased importance of peer influence
      while simultaneously targeting the low motivation characteristic of adolescents. Recent data
      in adolescents indicates that social norms interventions have incremental value and improve
      health behaviors above and beyond standard feedback without peer comparisons. Consistent with
      the ORBIT model for behavioral intervention development, our aims are to: 1) develop a
      feasible, accessible, and acceptable mHealth social norms intervention for improving AED
      adherence in adolescents with epilepsy and 2) obtain preliminary efficacy data and effect
      sizes for a future clinical trial. We conducted a pilot RCT of an mHealth social norms
      intervention (ORBIT Phase II). Adolescents with epilepsy who demonstrate non-adherence (< 95%
      adherence based on PI's previous RCTs; 58% of sample) during baseline will be randomized to
      either 1) mHealth social norms (automated digital reminders, individualized adherence
      feedback, and social norms feedback) or 2) control (automated digital reminders and
      individualized adherence feedback). Both groups will receive active intervention for five
      months. Primary (i.e., electronically-monitored adherence) and secondary outcomes (i.e.,
      seizure severity, HRQOL) will be assessed post-treatment and 3 months later, respectively. If
      successful, the results of this study would have a large impact on pediatric epilepsy, with
      the potential to change clinical practice for treating non-adherence by reducing common
      barriers to behavioral health care. Because minimal clinician time is required, our mHealth
      social norms intervention also has potential for sustainability and broad dissemination for
      epilepsy and other pediatric conditions
    

Intervention name(s): Automated Digital Reminders; Individualized Adherence Feedback Report; Individual Adherence Feedback Report with Social Norms
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Reminders from electronic monitors via texts or alarms/lights; Feedback report on individual adherence behaviors; Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is 2-arm randomized controlled clinical trial to improve adherence in adolescents with epilepsy
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: adolescents, behavioral economics, mHealth