Bronchial AsthmaNCT06624735
Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital
A study testing psychometry in people with Bronchial Asthma, run by Sohag University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- psychometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-12 years Confirmed diagnosed as asthma
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
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
- Conditions
- Bronchial Asthma
- Being tested
- psychometry
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychometryDiagnostic test
ADHD test and measurement of IQ level
| Study group | Role | What they receive |
|---|---|---|
| cases group | Active comparator | Children aged 4-12 years Confirmed diagnosed as asthma Receives: Diagnostic Test: psychometry |
| control group | Active comparator | Children below age of 4 years and aboveage of 12 years . not Diagnosed with any other chronic medical conditions Receives: Diagnostic Test: psychometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural changes among asthmatic children
evalaution of anaxiety , deppresion and ADHD in asthmatic childern by using psychological tests as ADHD test and IQ test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start15 Jul 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ezeldin Abdelmotgaly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624735
- Sponsor's protocol ID
- soh-Med-24-07-04MS
- Status last verified
- Oct 2024
- First submitted
- 28 Aug 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21843751Achenbach 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.
PubMed 27453078Annett 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.
PubMed 11743513McQuaid 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.
PubMed 11773808
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital
- ClinicalTrials.gov ID
- NCT06624735
- Acronym / sponsor ID
- soh-Med-24-07-04MS
- Conditions
- Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | Active comparator | Diagnostic Test: psychometryChildren aged 4-12 years Confirmed diagnosed as asthma |
| control group | Active comparator | Diagnostic Test: psychometryChildren below age of 4 years and aboveage of 12 years . not Diagnosed with any other chronic medical conditions |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 4-12 years Confirmed diagnosed as asthma
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychometryADHD test and measurement of IQ level | Diagnostic test | cases group, control group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 21843751Feitosa 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.
- Background: PubMed 27453078Achenbach 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.
- Background: PubMed 11743513Annett 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.
- Background: PubMed 11773808McQuaid 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychometry in people with Bronchial Asthma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya E Abd elmegaly, resident (01112487834, ayah.ezeldeen@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural changes among asthmatic children (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624735, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.