Emotion/Behavior Problems, Neuropsychological Functioning, and Parental Adjustment in Children With Epilepsy

May 16, 2012 updated by: National Taiwan University Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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:

  1. to understand the characteristics and prevalence of emotion/behavior problems and attention deficit hyperactivity syndrome in child and adolescents with epilepsy.
  2. to investigate significant risk factors and the possible pathogenic pathway
  3. to refer child and parents who have emotion problems
  4. to combine research and service across departments (departments of neurology and psychiatry )
  5. to improve worldwide understanding of epilepsy by the results of this study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

clinical sample

Description

Inclusion Criteria:

  • Children and adolescents had the clinical diagnosis of epilepsy
  • Their ages range from 6 to 15.

Exclusion Criteria:

The subjects will be excluded from the study if they have:

  • Chromosomal disorders
  • Hereditary metabolic disorders
  • Neurodegenerative disease
  • Brain tumor; and
  • Brain injury.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Susan Shur-Fen Gau, MD, PhD, Dept of Psychiatry, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200705066R

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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