A pilot randomized controlled clinical trial to improve antiepileptic drug adherence in young children with epilepsy

Area of Science:

• Pediatric Neurology
• Behavioral Science

Background:

• Pediatric epilepsy requires consistent antiepileptic drug (AED) adherence for effective management.
• Poor adherence to AEDs in children with epilepsy can lead to treatment failure and adverse outcomes.
• Family-centered interventions are crucial for supporting adherence in pediatric chronic conditions.

Purpose of the Study:

• To evaluate the preliminary efficacy of a family-tailored problem-solving intervention (STAR) for improving AED adherence in children with new-onset epilepsy.
• To assess the intervention's impact on adherence mechanisms, feasibility, and acceptability.
• To compare the STAR intervention with Treatment as Usual (TAU).

Main Methods:

• Fifty families of children with new-onset epilepsy completed baseline assessments and electronic monitoring for AED adherence.
• Families with adherence ≤95% were randomized to STAR (problem-solving sessions) or TAU.
• The STAR intervention comprised 4 face-to-face and 2 telephone problem-solving sessions over 8 weeks.

Main Results:

• Children receiving the STAR intervention showed significantly improved AED adherence compared to the TAU group during active treatment (weeks 4-8).
• The STAR group demonstrated significant improvements in epilepsy knowledge and management.
• Families reported positive experiences and benefits from the STAR intervention.

Conclusions:

• The STAR family problem-solving intervention shows preliminary efficacy in enhancing AED adherence for pediatric epilepsy.
• The intervention is feasible and acceptable to families, with positive impacts on knowledge and management.
• Future research should focus on larger samples and booster sessions to sustain adherence improvements.