<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03800992</url>
  </required_header>
  <id_info>
    <org_study_id>2018-02397; ks18Weber</org_study_id>
    <nct_id>NCT03800992</nct_id>
  </id_info>
  <brief_title>Bad News- Diagnosis: Epilepsy in Childhood</brief_title>
  <acronym>Badnews</acronym>
  <official_title>Bad News- Diagnosis: Epilepsy in Childhood</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Bad news&quot; are defined as&quot;any information which adversely and seriously affects an&#xD;
      individuals' view of future. Families of chronic ill children are exposed to a high stress&#xD;
      load. This project is to investigate the stress burden directly after diagnosis of epilepsy&#xD;
      in childhood and coping capabilities in the course of time and how quality of communication&#xD;
      at the time of diagnosis effects stress perception and coping behaviour in the following 12&#xD;
      months.&#xD;
&#xD;
      Perceived/ experienced advisory skills of the physician will be assessed by parents and&#xD;
      children (older than eleven) on the basis of SPIKES - a Six-Step Protocol for Delivering Bad&#xD;
      News.&#xD;
&#xD;
      The subjective perception regarding quality of dialogue in relationship to childrens and&#xD;
      their parents quality of life and their coping strategies will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Actual">December 28, 2021</completion_date>
  <primary_completion_date type="Actual">December 28, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>perception of physicians advisory skills with respect to actual distress</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in National Comprehensive Cancer Network (NCCN) thermometer</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>numeric scale ranging from 0 = no distress to 10 = most extreme distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stress and Coping Inventory (SCI)</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adult-Self-Report for Ages 18- 59 (ASR 18-59)</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stress Coping Style Questionnaire (SVF) 78/78-S</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parenting Stress Index (PSI)</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pediatric Quality of Life Inventory (Peds-QL)</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire on the assessment of stress and stress management in Childhood and Adolescence Revision (SSKJ 3-8 R)</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>assessing composite score: subscale 1 (stress-vulnerability) summed with subscale 3 (stress symptoms and well-being), lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child behaviour checklist (CBCL)</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Quality of Life Inventory (PedsQL 4.0)</measure>
    <time_frame>1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child</time_frame>
    <description>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</description>
  </secondary_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>Epilepsy in Children</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>assessment of perception and evaluation of physicians advisory skills per questionnaire</intervention_name>
    <description>questionnaire according to SPIKES - a Six-Step Protocol for Delivering Bad News to be completed by parents and children (older than eleven)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with newly diagnosed epilepsy at the Universitäts-Kinderspital beider Basel&#xD;
        (UKBB), Abteilung Entwicklungs-und Neuropädiatrie, Switzerland and their parents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newly diagnosed epilepsy (according to International League Against Epilepsy (ILAE)&#xD;
             criteria):&#xD;
&#xD;
          -  at least two unprovoked epileptic fits at intervals of at least 24 hours or&#xD;
&#xD;
          -  one unprovoked epileptic fit and a recurrence risk of at least 60% or&#xD;
&#xD;
          -  epilepsy syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with intensive care treatment as inpatients&#xD;
&#xD;
          -  parents with insufficient German language capabilities&#xD;
&#xD;
          -  parents and children with exposure to traumatic events in the past three months that&#xD;
             could probably lead to post traumatic distress (loss of a loved person, severe traffic&#xD;
             accident, raid, violence, sexual assault, war)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Weber, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitäts-Kinderspital beider Basel UKBB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitäts-Kinderspital beider Basel UKBB</name>
      <address>
        <city>Basel</city>
        <zip>4056</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>September 13, 2022</last_update_submitted>
  <last_update_submitted_qc>September 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SPIKES - a Six-Step Protocol for Delivering Bad News</keyword>
  <keyword>advisory skills</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03800992
org study id: 2018-02397; ks18Weber
nct id: NCT03800992
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
"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.
observational model: Cohort
time perspective: Prospective
measure: 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
description: 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.
measure: 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
description: numeric scale ranging from 0 = no distress to 10 = most extreme distress
measure: 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
description: 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)
measure: 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
description: 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
measure: 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
description: 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.
measure: 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
description: 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)
measure: 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
description: 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
measure: 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
description: assessing composite score: subscale 1 (stress-vulnerability) summed with subscale 3 (stress symptoms and well-being), lower score meaning a better outcome
measure: 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
description: 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.
measure: 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
description: 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
intervention type: Other
intervention name: assessment of perception and evaluation of physicians advisory skills per questionnaire
description: questionnaire according to SPIKES - a Six-Step Protocol for Delivering Bad News to be completed by parents and children (older than eleven)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Months
maximum age: 18 Years
healthy volunteers: No
last name: Peter Weber, Prof. Dr.
role: Principal Investigator
affiliation: Universitäts-Kinderspital beider Basel UKBB
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Epilepsy