Epilepsy in ChildrenBadnewsNCT03800992
Bad News- Diagnosis: Epilepsy in Childhood
An observational study of Epilepsy in Children, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Epilepsy in Children
- What is being tested?
- assessment of perception and evaluation of physicians advisory skills per questionnaire
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2019to 28 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with newly diagnosed epilepsy at the Universitäts-Kinderspital beider Basel (UKBB), Abteilung Entwicklungs-und Neuropädiatrie, Switzerland and their parents
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
"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
- Being tested
- assessment of perception and evaluation of physicians advisory skills per questionnaire
- Keywords
- SPIKES - a Six-Step Protocol for Delivering Bad News, advisory skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of perception and evaluation of physicians advisory skills per questionnaireOther
questionnaire according to SPIKES - a Six-Step Protocol for Delivering Bad News to be completed by parents and children (older than eleven)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
numeric scale ranging from 0 = no distress to 10 = most extreme distress
Measured: 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)
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)
Measured: 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)
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
Measured: 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
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.
Measured: 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)
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)
Measured: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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
Measured: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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
Measured: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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.
Measured: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
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
Measured: 1 -2 days and 6 months and 12 months after first communication of epilepsy diagnosis to parents and child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start30 Apr 2019
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Weber, Prof. Dr., Principal investigator, Universitäts-Kinderspital beider Basel (UKBB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800992
- Sponsor's protocol ID
- 2018-02397; ks18Weber
- Other IDs
- 2018
- Acronym
- Badnews
- Status last verified
- Sep 2022
- First submitted
- 9 Jan 2019
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bad News- Diagnosis: Epilepsy in Childhood
- ClinicalTrials.gov ID
- NCT03800992
- Acronym / sponsor ID
- Badnews / 2018-02397; ks18Weber
- Conditions
- Epilepsy in Children
- Keywords
- SPIKES - a Six-Step Protocol for Delivering Bad News, advisory skills
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with newly diagnosed epilepsy at the Universitäts-Kinderspital beider Basel (UKBB), Abteilung Entwicklungs-und Neuropädiatrie, Switzerland and their parents
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of perception and evaluation of physicians advisory skills per questionnairequestionnaire according to SPIKES - a Six-Step Protocol for Delivering Bad News to be completed by parents and children (older than eleven) | Other | – |
Primary outcome
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
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Weber, Prof. Dr. principal investigator
Universitäts-Kinderspital beider Basel (UKBB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy in Children, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.