Bad News- Diagnosis: Epilepsy in Childhood

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2022
• Main ID: NCT03800992
• Date of registration: 09/01/2019
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Bad News- Diagnosis: Epilepsy in Childhood Badnews
• Scientific title: Bad News- Diagnosis: Epilepsy in Childhood
• Date of first enrolment: April 30, 2019
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03800992
• Study type: Observational

Countries of recruitment

Switzerland

Contacts

• Name: Peter Weber, Prof. Dr.
• Affiliation: Universitäts-Kinderspital beider Basel UKBB

Key inclusion & exclusion criteria

Inclusion Criteria:

- newly diagnosed epilepsy (according to International League Against Epilepsy (ILAE)
criteria):

- at least two unprovoked epileptic fits at intervals of at least 24 hours or

- one unprovoked epileptic fit and a recurrence risk of at least 60% or

- epilepsy syndrome

Exclusion Criteria:

- children with intensive care treatment as inpatients

- parents with insufficient German language capabilities

- parents and children with exposure to traumatic events in the past three months that
could probably lead to post traumatic distress (loss of a loved person, severe traffic
accident, raid, violence, sexual assault, war)



Age minimum: 3 Months
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy in Children

Intervention(s)

Other: assessment of perception and evaluation of physicians advisory skills per questionnaire

Primary Outcome(s)

perception of physicians advisory skills with respect to actual distress [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Secondary Outcome(s)

Change in Stress and Coping Inventory (SCI) [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Questionnaire on the assessment of stress and stress management in Childhood and Adolescence Revision (SSKJ 3-8 R) [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Change in Adult-Self-Report for Ages 18- 59 (ASR 18-59) [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Change in Pediatric Quality of Life Inventory (Peds-QL) [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Child behaviour checklist (CBCL) [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Pediatric Quality of Life Inventory (PedsQL 4.0) [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Change in National Comprehensive Cancer Network (NCCN) thermometer [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Change in Parenting Stress Index (PSI) [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Change in Stress Coping Style Questionnaire (SVF) 78/78-S [Time Frame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child]

Secondary ID(s)

2018-02397; ks18Weber

Source(s) of Monetary Support

Please refer to primary and secondary sponsors