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Application of a Training Program for Executive Functions in a Sample of Egyptian Children With Learning Disorder

Primary Purpose

Learning Disorders, Executive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Executive functions training-elementary and Promoting executive function in in the classroom
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Learning Disorders focused on measuring Executive Functions, learning disorder, children

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children complaining of specific learning disorder and executive function deficits

Exclusion Criteria:

  • brain damage, mentally retarded or history of fits or subclinical fits
  • hearing or visual impairment
  • psychic problems

Sites / Locations

  • Faculty of Medicine, Alexandria University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study group

Arm Description

single group who had intervention and comparison of pre and post intervention assessment

Outcomes

Primary Outcome Measures

Self-Management to Time.
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months
Self-Organization and Problem-Solving
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months
Self-Restraint.
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months
Self-Motivation.
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months
Self-Regulation of Emotion
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months

Secondary Outcome Measures

Full Information

First Posted
July 15, 2022
Last Updated
July 26, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05476133
Brief Title
Application of a Training Program for Executive Functions in a Sample of Egyptian Children With Learning Disorder
Official Title
Application of a Training Program for Executive Functions in a Sample of Egyptian Children With Learning Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
May 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In recent years, significant progress has been made on ways to improve Executive Functions (EF) skills for school readiness involving direct EF training and classroom educational programs. Due to the absence of a well-structured Arabic program for EF training in children, the rationale of this study is to implement a comprehensive, evidence-based intervention program to help Egyptian children with learning disorders to overcome their EF impairment. It uses the multimodality approach to help meet the needs of students with a variety of learning styles. The aim of this study is to adapt the combined form of the "Executive Functions Training-Elementary", and the "Promoting Executive Function In The Classroom" programs and its application in order to test its effectiveness in the rehabilitation of Egyptian learning disordered children.
Detailed Description
The study was conducted on 40 children with dyslexia and Executive dysfunction attending unit of phoniatrics, Otorhinolaryngology department, Alexandria University. The results were compared before and after intervention. The "Executive Functions Training-Elementary" program is an evidence-based practice that targets Executive function skills in the early elementary years by training students how to plan, execute, complete, and monitor tasks. It develops cognitive abilities and behavior control with classroom-related activities for varying ability levels. The "Promoting Executive Function In The Classroom" program helps to incorporate Executive function processes (such as planning, organization, prioritizing, and self-checking) into the classroom curriculum. Chapters provide effective strategies for learning by improving how to learn. Data were collected and entered to the computer using (Statistical Package for Social Science) program for statistical analysis (version 21). Data were entered as numerical or categorical, as appropriate. Kolmogorov-Smirnov test of normality revealed no significance in the distribution of the variables, so the parametric statistics was adopted. Data were described using minimum, maximum, mean, standard deviation and 95% Confidence Interval of the mean. Categorical variables were described using frequency and percentage. Comparisons were carried out between two studied dependent normally distributed variables using paired t-test. Comparisons were carried out between more than two independent normally distributed subgroups using one-way Analysis Of Variance (ANOVA) test. When F ratio of ANOVA was significant Levene test of homogeneity of variances was done, and if significant Brown-Forsythe Robust test was adopted. Post-hoc multiple comparisons was done using Games-Howell.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Learning Disorders, Executive Dysfunction
Keywords
Executive Functions, learning disorder, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
the study was carried on a single group underwent initial assessment then intervention then final assessment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
single group who had intervention and comparison of pre and post intervention assessment
Intervention Type
Other
Intervention Name(s)
Executive functions training-elementary and Promoting executive function in in the classroom
Intervention Description
evidence based practice that target executive function skills in early elementary years.
Primary Outcome Measure Information:
Title
Self-Management to Time.
Description
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months
Time Frame
3-6 months
Title
Self-Organization and Problem-Solving
Description
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months
Time Frame
3-6 months
Title
Self-Restraint.
Description
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months
Time Frame
3-6 months
Title
Self-Motivation.
Description
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months
Time Frame
3-6 months
Title
Self-Regulation of Emotion
Description
scored from 1-4 depending on the parent's answers concerning the child's performance in this item in the last 6 months
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children complaining of specific learning disorder and executive function deficits Exclusion Criteria: brain damage, mentally retarded or history of fits or subclinical fits hearing or visual impairment psychic problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham M Elmaghraby, MD
Organizational Affiliation
otorhinolaryngology department, Faculty of Medicine, Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Engy S Elhakeem, MD
Organizational Affiliation
otorhinolaryngology department, Faculty of Medicine, Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Soha AL Ibrahim, MD
Organizational Affiliation
Neuropsychiatry department, Faculty of Medicine, Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University
City
Alexandria
ZIP/Postal Code
21500
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All statistical data are available in the study once published
IPD Sharing Time Frame
6 months after publishing
IPD Sharing Access Criteria
through the email address engy.elhakeem@alexmed.edu.eg
Citations:
PubMed Identifier
31090806
Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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32098297
Citation
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Citation
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Application of a Training Program for Executive Functions in a Sample of Egyptian Children With Learning Disorder

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