Clinical trial NCT03800992: Bad News- Diagnosis: Epilepsy in Childhood
Official title: Bad News- Diagnosis: Epilepsy in Childhood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy in Children
Keywords: SPIKES - a Six-Step Protocol for Delivering Bad News
advisory skills
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 33
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with newly diagnosed epilepsy at the Universitäts-Kinderspital beider Basel (UKBB), Abteilung Entwicklungs-und Neuropädiatrie, Switzerland and their parents

Brief summary: "Bad news" are defined as"any information which adversely and seriously affects an individuals' view of future. Families of chronic ill children are exposed to a high stress load. This project is to investigate the stress burden directly after diagnosis of epilepsy in childhood and coping capabilities in the course of time and how quality of communication at the time of diagnosis effects stress perception and coping behaviour in the following 12 months.

Perceived/ experienced advisory skills of the physician will be assessed by parents and children (older than eleven) on the basis of SPIKES - a Six-Step Protocol for Delivering Bad News.

The subjective perception regarding quality of dialogue in relationship to childrens and their parents quality of life and their coping strategies will be assessed.


Eligibility 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)

Primary outcomes:
measure: perception of physicians advisory skills with respect to actual distress
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Secondary outcomes:
measure: Change in National Comprehensive Cancer Network (NCCN) thermometer
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
measure: Change in Stress and Coping Inventory (SCI)
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
measure: Change in Adult-Self-Report for Ages 18- 59 (ASR 18-59)
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
measure: Change in Stress Coping Style Questionnaire (SVF) 78/78-S
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
measure: Change in Parenting Stress Index (PSI)
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
measure: Change in Pediatric Quality of Life Inventory (Peds-QL)
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
measure: Questionnaire on the assessment of stress and stress management in Childhood and Adolescence Revision (SSKJ 3-8 R)
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
measure: Child behaviour checklist (CBCL)
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
measure: Pediatric Quality of Life Inventory (PedsQL 4.0)
timeFrame: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel UKBB
Study officials:
affiliation: Universitäts-Kinderspital beider Basel UKBB
name: Peter Weber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: