Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs
      (AEDs) as prescribed (i.e., non-adherence). Non-adherence, which is modifiable, is associated
      with continued seizures, mortality, poor quality of life, and high healthcare costs. There
      are no adherence interventions for young children with epilepsy and their families; thus, the
      current proposal examines a family-based behavioral treatment focused on improving epilepsy
      knowledge and problem-solving around barriers to adherence in young children with epilepsy
      and their families with the goal of improving adherence and ultimately, seizures and quality
      of life. It is hypothesized that children with newly diagnosed epilepsy and their families
      who participate in the problem-solving intervention will have significant improvements on
      adherence compared to those in the education only intervention.
    

Detailed description: 
      Non-adherence to antiepileptic drugs (AEDs) is a common (i.e., 58% of patients have some
      level of non-adherence) and previously under-recognized problem for young children with newly
      diagnosed epilepsy. This is surprising given the consequences of non-adherence in patients
      with epilepsy are extremely serious, including continued seizures, mortality, and high
      healthcare expenditures. Despite the critical need to develop and implement interventions to
      improve adherence, there are no family-based interventions for young children with epilepsy
      and their families. As such, we developed a family-tailored adherence intervention (STAR:
      Supporting Treatment Adherence Regimens) focused on increasing epilepsy knowledge and
      problem-solving skills around barriers to adherence for children with epilepsy and their
      families. Data from our pilot adherence intervention studies demonstrated good preliminary
      effects (effect size= 0.64) and excellent feasibility, with families reporting that the
      intervention was beneficial and a positive experience for their family. Capitalizing on these
      findings, the next logical step is to test the efficacy of the STAR intervention to improve
      AED adherence in 200 children with epilepsy via a randomized controlled trial. Thus, the aims
      of the study are to examine the short-term and long-term effects of the STAR intervention on
      electronically-monitored medication adherence in children with new-onset epilepsy compared to
      an education only (EO) intervention. In addition, exploratory aims are to examine the effect
      of the STAR intervention on seizure freedom and QOL in children with epilepsy compared to the
      EO intervention. The current study uses an innovative, sequential, randomization enrichment
      design that preventatively targets 200 patients with new-onset epilepsy, between 2-12 years,
      who demonstrate non-adherence. Using criteria established from our pilot studies, adherence
      falling below 95% within the first six months of the study will trigger participant
      randomization into one of two 8-session interventions: STAR or EO. If the aims of the project
      are achieved, this study will change the practice of pediatric epilepsy by providing a proven
      approach to the routine monitoring and treatment of AED non-adherence in epilepsy clinics
      across the nation. This study also lays the foundation for determining the long term impact
      of adherence intervention on morbidity and mortality. In addition, this study's innovative
      methodological enrichment design should be generalizable to other pediatric conditions and
      lead to the development of cost effective, clinic-based adherence promotion interventions.
    

Intervention name(s): STAR; Education Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Problem-solving and education intervention (8 total sessions); Education around epilepsy (8 total sessions)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Epilepsy