NCT01851057

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2019

Enrollment Period

6.7 years

First QC Date

May 1, 2013

Last Update Submit

January 22, 2020

Conditions

Epilepsy

Keywords

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Adherence rate (short-term)

    This is a measure of adherence, using an electronic monitor called the Medication Event Monitoring System (MEMS) TrackCap, and adherence rates range from 0 to 100%. Adherence rates will be calculated at baseline and represent a rate from 0 to 100. Similarly, an adherence rate will be calculated for the 30 day post intervention period, with a rate between 0-100%. The change score for the mean of the 30 days of adherence immediately following the end of intervention relative to the mean adherence obtained during the30 day screening period will be calculated.

    30 day post intervention adherence rate

Secondary Outcomes (1)

  • Adherence rate (long-term)

    3, 6 and 12 months post intervention

Other Outcomes (2)

  • Health related quality of life

    6 and 12 months post intervention

  • Seizure absence/presence

    6 and 12 months post intervention

Study Arms (2)

Education Only

ACTIVE COMPARATOR

Education only arm (8 total sessions)

Behavioral: Education Only

STAR: Education and Problem Solving

EXPERIMENTAL

Problem-solving and education intervention (8 total sessions)

Behavioral: STAR

Interventions

STARBEHAVIORAL

Problem-solving and education intervention (8 total sessions)

STAR: Education and Problem Solving
Education OnlyBEHAVIORAL

Education around epilepsy (8 total sessions)

Education Only

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

  • Williford DN, Guilfoyle SM, Modi AC. Demystifying a family-based epilepsy adherence problem-solving intervention: Exploring adherence barriers and solutions. Clin Pract Pediatr Psychol. 2023 Mar;11(1):66-73. doi: 10.1037/cpp0000436. Epub 2022 Feb 3.

    PMID: 36969546DERIVED

  • Al-Aqeel S, Gershuni O, Al-Sabhan J, Hiligsmann M. Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD008312. doi: 10.1002/14651858.CD008312.pub4.

    PMID: 33089492DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Avani C Modi, Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2013

First Posted

May 10, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 23, 2020

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Not being shared

Locations

US(1)