- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06624735
Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital
October 2, 2024 updated by: Aya Ezeldin Abdelmotgaly, Sohag University
Asthma is considered the most common chronic childhood disease and mainly affects children resident in urban areas.
Asthma has been designated a serious public health problem due to the increase in its prevalence over the last two decades and the associated high health service costs in admissions and hospitalizations The cause of asthma is not yet completely understood, and there is no consensus about its etiology.
A vast body of research emphasizes the role of genetic and environmental factors in the appearance of asthma, and a great deal of interest has recently emerged concerning the relationship between psychosocial factors and asthma morbidity Behavioural problems in children are generally described as "internalizing", which includes "anxiety, depressive, and somatic symptoms" or "externalizing", which includes "oppositional, hyperactive conduct".
Both internalizing and externalizing problems can be experienced by healthy children with abnormal and "borderline" personality disorder, the latter referring to a mental illness marked by an ongoing pattern of varying moods, self-image, and behaviour
Study Overview
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aya E Abd elmegaly, resident
- Phone Number: 01112487834
- Email: ayah.ezeldeen@med.sohag.edu.eg
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University Hospital
-
Contact:
- Magdy M Amin, professor
-
-
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
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Children aged 4-12 years Confirmed diagnosed as asthma
Exclusion Criteria:
Children below age of 4 years and aboveage of 12 years . Diagnosed with any other chronic medical conditions (e.g., cardiac , liver , renal and other chronic chest diseases) .
Patient with cerebral palsy.
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
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: cases group
Children aged 4-12 years Confirmed diagnosed as asthma
|
ADHD test and measurement of IQ level
|
|
Active Comparator: control group
Children below age of 4 years and aboveage of 12 years .
not Diagnosed with any other chronic medical conditions
|
ADHD test and measurement of IQ level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioural changes among asthmatic children
Time Frame: 1 year
|
evalaution of anaxiety , deppresion and ADHD in asthmatic childern by using psychological tests as ADHD test and IQ test
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Annett RD, Bender BG, Lapidus J, Duhamel TR, Lincoln A. Predicting children's quality of life in an asthma clinical trial: what do children's reports tell us? J Pediatr. 2001 Dec;139(6):854-61. doi: 10.1067/mpd.2001.119444.
- Feitosa CA, Santos DN, Barreto do Carmo MB, Santos LM, Teles CA, Rodrigues LC, Barreto ML. Behavior problems and prevalence of asthma symptoms among Brazilian children. J Psychosom Res. 2011 Sep;71(3):160-5. doi: 10.1016/j.jpsychores.2011.02.004. Epub 2011 Mar 21.
- Achenbach TM, Ivanova MY, Rescorla LA, Turner LV, Althoff RR. Internalizing/Externalizing Problems: Review and Recommendations for Clinical and Research Applications. J Am Acad Child Adolesc Psychiatry. 2016 Aug;55(8):647-56. doi: 10.1016/j.jaac.2016.05.012. Epub 2016 May 31.
- McQuaid EL, Kopel SJ, Nassau JH. Behavioral adjustment in children with asthma: a meta-analysis. J Dev Behav Pediatr. 2001 Dec;22(6):430-9. doi: 10.1097/00004703-200112000-00011.
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 (Actual)
July 15, 2024
Primary Completion (Estimated)
July 15, 2025
Study Completion (Estimated)
July 15, 2025
Study Registration Dates
First Submitted
August 28, 2024
First Submitted That Met QC Criteria
October 2, 2024
First Posted (Actual)
October 3, 2024
Study Record Updates
Last Update Posted (Actual)
October 4, 2024
Last Update Submitted That Met QC Criteria
October 2, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soh-Med-24-07-04MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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