Behavioral side effects and the family burden in children and adolescents with epilepsy receiving antiepileptic drugs

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031703

Enrollment

150

Registered

2024-02-22

Start date

2023-11-24

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G40

Interventions

Group 1: Children and adolescents in Germany aged from 2- 17,11 years with newly diagnosed epilepsy who need antiepileptic drug therapy to control seizures.

Eligibility

Sex/Gender

All

Age

2 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children and adolescents with newly diagnosed epilepsy who require drug therapy to control seizures.

Exclusion criteria

Exclusion criteria: Taking other medications that have psychiatric disorders listed as a side effect. Patients whose parent is not able to fill out the questionnaire independently (e.g. due to insufficient language skills).

Design outcomes

Primary

Measure	Time frame
Recording behavioral problems in children and adolescents with new-onset epilepsy using the German version of the standardized parent questionnaire “Child Behavior Checklist” (CBCL) [Plück,Döpfner et al.] and monitoring how these develop under the respective drug therapy for seizure control. The first survey takes place directly at the doctor's appointment after the epileptic seizure and before taking the antiepileptic medication for the first time. The second and third survey points take place approximately 6 weeks and 3 months after the start of drug therapy.	—

Measure

Time frame

Recording behavioral problems in children and adolescents with new-onset epilepsy using the German version of the standardized parent questionnaire “Child Behavior Checklist” (CBCL) [Plück,Döpfner et al.] and monitoring how these develop under the respective drug therapy for seizure control. The first survey takes place directly at the doctor's appointment after the epileptic seizure and before taking the antiepileptic medication for the first time. The second and third survey points take place approximately 6 weeks and 3 months after the start of drug therapy.

—

Secondary

Measure	Time frame
Recording of predictors, which promote behaviorial side effects under therapy with antiepileptic drugs. The variables include the socioeconomic status of the families and the family burden of the childrens illness, which was measured using the shortened and the standardized version of the german verson of the Impact on Family Scale (FaBel) by Ravens-Sieberer et al. Furthermore added by exploratory questions. The socioeconomic status is determined immediately at the doctor's presentation after the epileptic seizure and before the first intake of antiepileptic medication. The family's burden of the child's illness is only assessed after 6 weeks and 3 months after the start of drug therapy.	—

Measure

Time frame

Recording of predictors, which promote behaviorial side effects under therapy with antiepileptic drugs. The variables include the socioeconomic status of the families and the family burden of the childrens illness, which was measured using the shortened and the standardized version of the german verson of the Impact on Family Scale (FaBel) by Ravens-Sieberer et al. Furthermore added by exploratory questions. The socioeconomic status is determined immediately at the doctor's presentation after the epileptic seizure and before the first intake of antiepileptic medication. The family's burden of the child's illness is only assessed after 6 weeks and 3 months after the start of drug therapy.

—

Countries

Germany

Contacts

Public ContactMichael Griesbach

Universitätsmedizin Halle Universitätsklinik und Poliklinik für Pädiatrie I

michael.griesbach@uk-halle.de49 (345) 557 1506

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026