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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00550940
Other study ID # 200705066R
Secondary ID
Status Completed
Phase N/A
First received October 29, 2007
Last updated May 16, 2012
Start date July 2007
Est. completion date December 2007

Study information

Verified date April 2012
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical 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).


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


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 15 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

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