NCT06624735

Brief 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 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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

July 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

August 28, 2024

Last Update Submit

October 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Behavioural changes among asthmatic children

    evalaution of anaxiety , deppresion and ADHD in asthmatic childern by using psychological tests as ADHD test and IQ test

    1 year

Study Arms (2)

cases group

ACTIVE COMPARATOR

Children aged 4-12 years Confirmed diagnosed as asthma

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

Diagnostic Test: psychometry

Interventions

psychometryDIAGNOSTIC_TEST

ADHD test and measurement of IQ level

cases groupcontrol group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4-12 years Confirmed diagnosed as asthma

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21843751BACKGROUND
  • 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.

    PMID: 27453078BACKGROUND
  • 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.

    PMID: 11743513BACKGROUND
  • 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.

    PMID: 11773808BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Aya E Abd elmegaly, resident

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-pediatric department-sohag hospital university

Study Record Dates

First Submitted

August 28, 2024

First Posted

October 3, 2024

Study Start

July 15, 2024

Primary Completion

July 15, 2025

Study Completion

July 15, 2025

Last Updated

October 4, 2024

Record last verified: 2024-10

Locations