EpilepsyNCT00550940
Emotion/Behavior Problems, Neuropsychological Functioning, and Parental Adjustment in Children With Epilepsy
An observational study of Epilepsy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to Investigate characteristics and prevalence of emotion/behavior problems in child and adolescents with epilepsy; to identify the associated factors and their effects on these children/adolescents; and to examine their attention by using Conners' Continuous Performance Test (CPT). Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2007to Dec 2007
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: clinical sample
Who may be able to join
- Children and adolescents had the clinical diagnosis of epilepsy
- Their ages range from 6 to 15.
Who cannot join
- The subjects will be excluded from the study if they have:
- Chromosomal disorders
- Hereditary metabolic disorders
- Neurodegenerative disease
- Brain tumor; and
- Brain injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotion/Behavior Problems, Neuropsychological Functioning, and Parental Adjustment in Children and Adolescents With Epilepsy
This study aims to Investigate characteristics and prevalence of emotion/behavior problems in child and adolescents with epilepsy; to identify the associated factors and their effects on these children/adolescents; and to examine their attention by using Conners' Continuous Performance Test (CPT).
Read the detailed description
Child and adolescents with epilepsy often have comorbid conditions such as emotion/behavior problems and attention deficit, which usually result in great impact on their individual functioning and their family. Neurological factors (e.g. central neural system disease, mental retardation, and epilepsy factors), demographic factors (low socioeconomic, age, gender), family factors, child's attitude to epilepsy, parental psychopathology and their attitude may associate with the presentation of behavior and attention in child and adolescents with epilepsy. In addition, these risk factors may affect via some pathways. Previous studies were conducted mainly in Caucasians, and few researches were conducted in Chinese population. Furthermore, previous studies demonstrated inconsistent findings regarding the related risk factors for epilepsy. Therefore, it is important to conduct a study investigating systematically the potential risk factors for epilepsy.
This is a cross-sectional and hospital -based study. The participants include 80 child and adolescents who are 6 to 18 years old and 80 control subjects. The instruments include the Chinese version of Child Behavior Checklist (CBCL), 36-Item Short Form Health Survey (SF-36), Child Attitude Toward Illness Scale (CATIS), the Swanson, Nolan, and Pelham, version IV (SNAP-IV), Parental Bonding Instrument (PBI), Family APGAR, Chinese Health Questionnaire (CHQ-12), impact of childhood illness scale, drug compliance scale. We will also collect related information from chart record, and then analyze for emotion/behavior presentation and to identify the risk factors for epilepsy.
We expect that this study will reach the following objectives:
- to understand the characteristics and prevalence of emotion/behavior problems and attention deficit hyperactivity syndrome in child and adolescents with epilepsy.
- to investigate significant risk factors and the possible pathogenic pathway
- to refer child and parents who have emotion problems
- to combine research and service across departments (departments of neurology and psychiatry )
- to improve worldwide understanding of epilepsy by the results of this study
- Conditions
- Epilepsy
- Keywords
- epilepsy, attention, emotion, behavior problems, child, adolescent
- Medical subject headings
- Epilepsy, Mental Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startJul 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Study director, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550940
- Sponsor's protocol ID
- 200705066R
- Status last verified
- Apr 2012
- First submitted
- 29 Oct 2007
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion/Behavior Problems, Neuropsychological Functioning, and Parental Adjustment in Children and Adolescents With Epilepsy
- ClinicalTrials.gov ID
- NCT00550940
- Acronym / sponsor ID
- 200705066R
- Conditions
- Epilepsy
- Keywords
- epilepsy, attention, emotion, behavior problems, child, adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 30 Oct 2007 (estimated)
- 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.
This study aims to Investigate characteristics and prevalence of emotion/behavior problems in child and adolescents with epilepsy; to identify the associated factors and their effects on these children/adolescents; and to examine their attention by using Conners' Continuous Performance Test (CPT).
Detailed description
Child and adolescents with epilepsy often have comorbid conditions such as emotion/behavior problems and attention deficit, which usually result in great impact on their individual functioning and their family. Neurological factors (e.g. central neural system disease, mental retardation, and epilepsy factors), demographic factors (low socioeconomic, age, gender), family factors, child's attitude to epilepsy, parental psychopathology and their attitude may associate with the presentation of behavior and attention in child and adolescents with epilepsy. In addition, these risk factors may affect via some pathways. Previous studies were conducted mainly in Caucasians, and few researches were conducted in Chinese population. Furthermore, previous studies demonstrated inconsistent findings regarding the related risk factors for epilepsy. Therefore, it is important to conduct a study investigating systematically the potential risk factors for epilepsy.
This is a cross-sectional and hospital -based study. The participants include 80 child and adolescents who are 6 to 18 years old and 80 control subjects. The instruments include the Chinese version of Child Behavior Checklist (CBCL), 36-Item Short Form Health Survey (SF-36), Child Attitude Toward Illness Scale (CATIS), the Swanson, Nolan, and Pelham, version IV (SNAP-IV), Parental Bonding Instrument (PBI), Family APGAR, Chinese Health Questionnaire (CHQ-12), impact of childhood illness scale, drug compliance scale. We will also collect related information from chart record, and then analyze for emotion/behavior presentation and to identify the risk factors for epilepsy.
We expect that this study will reach the following objectives:
- to understand the characteristics and prevalence of emotion/behavior problems and attention deficit hyperactivity syndrome in child and adolescents with epilepsy.
- to investigate significant risk factors and the possible pathogenic pathway
- to refer child and parents who have emotion problems
- to combine research and service across departments (departments of neurology and psychiatry )
- to improve worldwide understanding of epilepsy by the results of this study
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- clinical sample
Key inclusion criteria (2 listed)
- Children and adolescents had the clinical diagnosis of epilepsy
- Their ages range from 6 to 15.
Key exclusion criteria (6 listed)
- Chromosomal disorders
- Hereditary metabolic disorders
- Neurodegenerative disease
- Brain tumor; and
- Brain injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 17 May 2012.
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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.
Susan Shur-Fen Gau, MD, PhD study director
Dept of Psychiatry, National Taiwan University Hospital
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, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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 17 May 2012. 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 Taiwan. 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.
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 17 May 2012.