Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Summary of actigraphy variables (total sleep time/sleep latency/sleep efficiency) averaged over a 1-week period |
To determine which sleep parameters change in primary carer and child dyads in different treatment groups |
1 week actigraphy (arranged centrally via Oxford unit) at baseline, 3 and 12 months |
|
Primary |
Time to 6-month seizure remission |
To determine if carbamazepine or levetiracetam are superior to no anti-epileptic drugs |
Up to 48 months |
|
Primary |
Change from baseline to total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ) |
To determine if a Parent-Based Sleep intervention is superior to standard care |
At 3 months |
|
Secondary |
Total costs measured in Quality-Adjusted Life Years (QALYs) |
To estimate the cost-utility of carbamazepine, levetiracetam and PBS |
At 0, 3, 12, 24, 36 and 48 months |
|
Secondary |
Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control or unacceptable adverse reactions |
To compare time to treatment failure due to inadequate seizure control or unacceptable adverse reactions |
At 3, 6,12, 24, 36 and 48 months |
|
Secondary |
Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control |
To compare time to treatment failure due to inadequate seizure control |
At 3, 6,12, 24, 36 and 48 months |
|
Secondary |
Time taken from recruitment to decision by child, parent or treating physician to be withdrawn from trial due to unacceptable adverse reactions |
To compare time to treatment failure due to unacceptable adverse reactions |
At 3, 6,12, 24, 36 and 48 months |
|
Secondary |
Time to first seizure based on seizure report |
To compare time to first seizure |
At 3, 6,12, 24, 36 and 48 months |
|
Secondary |
Time to 12-month seizure remission based on seizure report |
To compare time to 12-month remission from seizures |
At 3, 6,12, 24, 36 and 48 months |
|
Secondary |
Total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ) |
To determine if a Parent-Based Sleep intervention is superior to standard care |
At 12, 24, 36 and 48 months |
|
Secondary |
Total score in three chosen assessments delivered by the Cambridge Neuropsychological Test Automated Battery (CANTAB) |
To compare measures of cognition across the different treatment groups |
At 0, 3, 6,12, 24, 36 and 48 months |
|
Secondary |
Score change in Health Related Quality of Life in Children with Epilepsy - Child self-report scale (CHEQOL) |
To compare Health Related Quality of Life across the different treatment groups |
At 0, 12, 24, 36 and 48 months |
|
Secondary |
Total score on Strengths and Difficulties Questionnaire (SDQ) |
To compare measures of children's behaviour across the different treatment groups |
At 0, 12, 24, 36 and 48 months |
|
Secondary |
Records of adverse reactions |
To identify any adverse reactions and their rate |
At 3, 6, 12, 24, 36 and 48 months |
|
Secondary |
Score changes in Child Health Utility instrument (CHU9D) |
To estimate child health utilities and Quality-Adjusted Life Years (QALYs) across the different treatment groups |
At 0, 3, 12, 24, 36 and 48 months |
|
Secondary |
Score changes in EQ-5D-Y |
To estimate child health utilities and Quality-Adjusted Life Years (QALYs) across the different treatment groups |
At 0, 3, 12, 24, 36 and 48 months |
|
Secondary |
EQ-5D-5L score change |
To estimate health utilities and Quality-Adjusted Life Years (QALYs) across parents in the different treatment groups |
At 0, 3, 12, 24, 36 and 48 months |
|
Secondary |
Score changes in Parental Self-Efficacy Measure (PSAM) |
To compare parenting self-efficacy across the different treatment groups |
At 0, 3, 12, 24, 36 and 48 months |
|
Secondary |
Total sickness related school absences (days) |
To compare sickness related school absences across the different treatment groups |
At 0, 3, 6, 12, 24, 36 and 48 months |
|
Secondary |
Resource Use Questionnaire |
To determine the costs to the National Health Service (NHS) |
At 3, 12, 24, 36 and 48 months |
|
Secondary |
Hospital Episode Statistics (HES) Data |
To determine the costs to the National Health Service (NHS) |
48 months, measured for the participant's study duration |
|
Secondary |
Patient Level Information and Costing System (PLICS) Data |
To determine the costs to the National Health Service (NHS) |
48 months, measured for the participant's study duration |
|