Bad News- Diagnosis: Epilepsy in Childhood

Epilepsy in Children Clinical Trial

— Badnews  

Official title:

Bad News- Diagnosis: Epilepsy in Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800992
• Other study ID #: 2018-02397; ks18Weber
• Status: Completed
• Start date: April 30, 2019
• Est. completion date: December 28, 2021

Study information

• Verified date: September 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy in Children

Intervention

Other:
• assessment of perception and evaluation of physicians advisory skills per questionnaire
questionnaire according to SPIKES - a Six-Step Protocol for Delivering Bad News to be completed by parents and children (older than eleven)

Locations

Country	Name	City	State
Switzerland	Universitäts-Kinderspital beider Basel UKBB	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in National Comprehensive Cancer Network (NCCN) thermometer	numeric scale ranging from 0 = no distress to 10 = most extreme distress	1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Secondary	Change in Stress and Coping Inventory (SCI)	questionnaire to assess coping strategies; (21 questions asking for stress load assessed by Likert scale; 13 questions asking for stress symptoms assessed by Likert scale)	1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Secondary	Change in Adult-Self-Report for Ages 18- 59 (ASR 18-59)	ASR is a self-report questionnaire for ages 18-59 that assesses behavioral, emotional, and social problems, plus adaptive functioning, personal strengths, and substance use	1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Secondary	Change in Stress Coping Style Questionnaire (SVF) 78/78-S	questionnaire consists of 78 items divided into 13 scales, each representing a certain way of response to a stressful event: underevaluation, guilt denial, diversion, alternative satisfaction, situation control, reaction control, positive self-instruction, the need for social support, active avoidance, escape tendency, perseveration, resignation, and self-accusation. The levels of the positive and negative strategies are calculated; assessed by Likert scale.	1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Secondary	Change in Parenting Stress Index (PSI)	measure for evaluating the parenting system and identifying issues that may lead to problems in the child's or parent's behavior. Focuses on three major domains of stress: child characteristics, parent characteristics and situational/demographic life stress (48 Items, 12 Subscales)	1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Secondary	Change in Pediatric Quality of Life Inventory (Peds-QL)	standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions,consists of a 15-item core measure of global HRQOL and eight supplemental modules assessing specific symptom or treatment domains	1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Secondary	Questionnaire on the assessment of stress and stress management in Childhood and Adolescence Revision (SSKJ 3-8 R)	assessing composite score: subscale 1 (stress-vulnerability) summed with subscale 3 (stress symptoms and well-being), lower score meaning a better outcome	1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Secondary	Child behaviour checklist (CBCL)	parent-report questionnaire on which the child is rated on various behavioral and emotional Problems in preschool subjects aged 2 to 3 or in subjects between the ages of 4 and 18. It assesses internalizing (i.e., anxious, depressive, and overcontrolled) and externalizing (i.e., aggressive, hyperactive, noncompliant, and undercontrolled) behaviors. Several subareas were measured including social withdrawal, somatic complaints, anxiety and depression, destructive behavior, social problems, thought problems, attention problems, aggressive behavior, and delinquent behaviors.	1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Secondary	Pediatric Quality of Life Inventory (PedsQL 4.0)	The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules. The PedsQL 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations, as well as pediatric populations with acute and chronic health conditions; The PedsQL 4.0 Generic Core Scales instrument consists of the following 4 domains: (1) physical functioning, (2) emotional functioning, (3) social functioning, and (4) school functioning. It includes formats for typically developing children and adolescents 2 to 18 years old (parent-proxy report) and 5 to 18 years old (self-report); Higher scores indicate better HRQOL	1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child