Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-31 @ 4:50 PM
Study NCT ID:
NCT06624735
Status:
RECRUITING
Last Update Posted:
2024-10-04
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavioural changes among asthmatic children', 'timeFrame': '1 year', 'description': 'evalaution of anaxiety , deppresion and ADHD in asthmatic childern by using psychological tests as ADHD test and IQ test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchial Asthma']}, 'referencesModule': {'references': [{'pmid': '21843751', 'type': 'BACKGROUND', 'citation': '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': '27453078', 'type': 'BACKGROUND', 'citation': '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': '11743513', 'type': 'BACKGROUND', 'citation': "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': '11773808', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren aged 4-12 years Confirmed diagnosed as asthma\n\nExclusion Criteria:\n\nChildren 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) .\n\nPatient with cerebral palsy.'}, 'identificationModule': {'nctId': 'NCT06624735', 'briefTitle': 'Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital', 'orgStudyIdInfo': {'id': 'soh-Med-24-07-04MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'cases group', 'description': 'Children aged 4-12 years Confirmed diagnosed as asthma', 'interventionNames': ['Diagnostic Test: psychometry']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Children below age of 4 years and aboveage of 12 years . not Diagnosed with any other chronic medical conditions', 'interventionNames': ['Diagnostic Test: psychometry']}], 'interventions': [{'name': 'psychometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'ADHD test and measurement of IQ level', 'armGroupLabels': ['cases group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Aya E Abd elmegaly, resident', 'role': 'CONTACT', 'email': 'ayah.ezeldeen@med.sohag.edu.eg', 'phone': '01112487834'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident-pediatric department-sohag hospital university', 'investigatorFullName': 'Aya Ezeldin Abdelmotgaly', 'investigatorAffiliation': 'Sohag University'}}}}