- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03800992
Bad News- Diagnosis: Epilepsy in Childhood (Badnews)
"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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Basel, Switzerland, 4056
- Universitäts-Kinderspital beider Basel UKBB
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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numeric scale ranging from 0 = no distress to 10 = most extreme distress
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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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
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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)
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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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
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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
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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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
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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.
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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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
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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)
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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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
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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
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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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
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assessing composite score: subscale 1 (stress-vulnerability) summed with subscale 3 (stress symptoms and well-being), lower score meaning a better outcome
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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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
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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.
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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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
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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
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1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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Collaborators and Investigators
Investigators
- Principal Investigator: Peter Weber, Prof. Dr., Universitäts-Kinderspital beider Basel UKBB
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-02397; ks18Weber
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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