Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial
Completed · Not applicable
Conditions studied: Epilepsy
In brief
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.
Key facts
- Study ID
- NCT01851057
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 200
- Starts
- 2013-04-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-01-23
Who can join
Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ages 2-12 years
- diagnosis of epilepsy within approximately 6 months
- only one prescribed AED
- family lives < 75 miles from Cincinnati Children's Hospital Medical Center (CCHMC)
- ability to read English
You may not qualify if…
- comorbid medical disorders requiring daily medication
- parent-reported significant developmental delays (e.g. Autism)
- liquid AED formulation due to electronic monitoring incompatibility.
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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