Bad News- Diagnosis: Epilepsy in Childhood

NCT03800992 | Completed

• 1 other identifier: 2018-02397; ks18Weber
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy in Children

Keywords

SPIKES - a Six-Step Protocol for Delivering Bad News; advisory skills

Outcome Measures

Primary Outcomes (1)

• perception of physicians advisory skills with respect to actual distress

  Evaluation with Six-Step Protocol for Delivering Bad News (SPIKES); enables the physician to fulfill the four most important objectives of the interview disclosing bad news: gathering information from the patient, transmitting the medical information, providing support to the patient, and eliciting the patient's collaboration in developing a strategy or treatment plan for the future.

  1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child

Secondary Outcomes (9)

• Change in National Comprehensive Cancer Network (NCCN) thermometer

  1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child

• Change in Stress and Coping Inventory (SCI)

  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)

  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

  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)

  1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child

Interventions

assessment of perception and evaluation of physicians advisory skills per questionnaire OTHER

questionnaire according to SPIKES - a Six-Step Protocol for Delivering Bad News to be completed by parents and children (older than eleven)

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Universitäts-Kinderspital beider Basel UKBB

Basel, 4056, Switzerland

Location

Study Officials

• Peter Weber, Prof. Dr.

  Universitäts-Kinderspital beider Basel UKBB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: April 30, 2019
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

CH (1)