Brief Summary

The most common neuropsychiatric disorder in early childhood is attention deficit/hyperactivity disorder (ADHD) with evidence of abnormality in structure and function of brain. Epilepsy is one of the commonest comorbidity associated with ADHD with negative outcome on childrens' quality of life, and is considered to be a risk for academic underachievement. These two disorders are highly associated, with more possibility to be a bidirectional relationship. The mechanisms of this comorbidity are unknown. In this association, a difficult challenge is presented since antiepileptic therapy and drugs used to treat ADHD may aggravate the clinical picture of each other. The main objectives are to evaluate this overlap of those disorders, find their complications on child and his family, and to suggest possible solutions to improve the outcome of those children.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Feb 2019

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

May 9, 2018

Completed

8 months until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed

1 month until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed

Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

May 9, 2018

Last Update Submit

April 13, 2020

Conditions

Attention-Deficit Hyperactivity Disorder Epilepsy

Outcome Measures

Primary Outcomes (4)

measure intellectual equations for children with epilepsy and ADHD
WISC-III provided scores for Verbal IQ (VIQ), Performance IQ (PIQ), and Full-Scale IQ (FSIQ). The child's verbal IQ score was derived from scores on six of the subtests: information, digit span, vocabulary, arithmetic, comprehension, and similarities. The child's performance IQ was derived from scores on the remaining seven subtests: picture completion, picture arrangement, block design, object assembly, coding, mazes, and symbol search. The overall intelligence quotient, called the full scale IQ, as well as a verbal IQ and a performance IQ. The three IQ scores are standardized in such a way that a score of 100 is considered average and serves as a benchmark for higher and lower scores.
baseline
measure socioeconomic class for families and children with comorbid epilepsy and ADHD
It will be measure by Socioeconomic class scale which consist of It contain four main variables 1-the educational level of the father and mother 2-the occupation of the father and mother 3-total family income 4-life style of the family. The total score of the scale equal the sum of scores in each level, the scores 36-42 mean the high socioeconomic class, the scores 21-26 mean the low socioeconomic class, and scores between them mean the middle class.
baseline
measure mood and feeling changes in children with comorbid epilepsy and ADHD.
It will be measure by Mood and Feelings Questionnaire (MFQ) arent Report is a 13-item measure assessing recent depressive and describe feelings and mood,more than 26 is consider for evaluation of depression
baseline
measure quality of life for children with comorbid epilepsy and ADHD
It is composed of 23 items that assessment function in the following four areas: physical (eight items), emotional (five items), social (five items), and school (five items). Patients report their function using a 5-point Likert scale ranging from 0 to 4. These responses are reverse scored and linearly transformed to a 0 to 100 scale, with a higher score indicating a higher QOL. The Psychosocial Health Summary score is a computed mean of the emotional, social, and school functioning subscales of the PedsQL. The physical functioning scale is the same as the Physical Summary score. In addition, the computed mean of the Emotional, Social, School functioning, and Physical scales are used to generate a Total Summary score. PedsQL scales are composed of parallel child self-report and parent-proxy report formats.
baseline