- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04946877
Clinical Study of Comorbidities of Attention Deficit Hyperactivity in Children and Adolescents.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: salma mohmed fahmi, msc
- Telefonnummer: 01067151755
- E-mail: saloma151@yahoo.com
Undersøgelse Kontakt Backup
- Navn: Ahmed Abdelbaky Abd elrahman, MD
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Case group will include 100 ADHD patients; will be taken from outpatient clinic of child and adolescence psychiatry of Assiut university hospitals.
Control group will include 100 normal children; they will be selected from neurology clinic complaining from minor neurological complaint e.g : headache, will match with the case group for age, sex and educational level.
Beskrivelse
Inclusion Criteria:
- Age: 6-17 years.
- Sex: both sexes will be included in the study.
- IQ≥70.
Exclusion Criteria:
- Age: less than 6 years or more than 17 years.
- IQ<70.
- Patients with major neurological deficits, cerebral palsy and uncontrolled epilepsy.
- Patients with major psychiatric disorders e.g schizophrenia spectrum disorder.
- Patient who refusing to participate in the study or their caregiver refusing to give informed consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
case group
100 ADHD patients; will be taken from outpatient clinic of child and adolescence psychiatry of Assiut university hospitals.
|
IQ assessment using Wechsler intelligence scale for children third edition (WISC-III): is consists of several subtests, each classified into a verbal or performance scale .
Andre navne:
|
|
control group
100 normal children; they will be selected from neurology clinic complaining from minor neurological complaint e.g : headache, will match with the case group for age, sex and educational level.
|
IQ assessment using Wechsler intelligence scale for children third edition (WISC-III): is consists of several subtests, each classified into a verbal or performance scale .
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Determine psychiatric comorbidities in children and adolescents with ADHD using Mini international neuropsychiatric interview for children and adolescents (M.I.N.I. Kid).
Tidsramme: baseline
|
Mini international neuropsychiatric interview for children and adolescents (M.I.N.I.
Kid): is structured clinical diagnostic interview designed to assess the presence of current ICD-10 and DSM-IV psychiatric disorders in children and adolescents age 6-17 years
|
baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
determinate presence of soft neurological sign in children and adolescents with ADHD using Cambridge neurological inventory.
Tidsramme: baseline
|
Neurological assessment using Cambridge neurological inventory: this is a clinical instrument constructed for standardized neurological assessment of psychiatric patients.
It is useful for identifying neurological soft sign and other patterns of neurological impairments
|
baseline
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Gillberg C, Gillberg IC, Rasmussen P, Kadesjo B, Soderstrom H, Rastam M, Johnson M, Rothenberger A, Niklasson L. Co-existing disorders in ADHD -- implications for diagnosis and intervention. Eur Child Adolesc Psychiatry. 2004;13 Suppl 1:I80-92. doi: 10.1007/s00787-004-1008-4.
- Faraone SV, Asherson P, Banaschewski T, Biederman J, Buitelaar JK, Ramos-Quiroga JA, Rohde LA, Sonuga-Barke EJ, Tannock R, Franke B. Attention-deficit/hyperactivity disorder. Nat Rev Dis Primers. 2015 Aug 6;1:15020. doi: 10.1038/nrdp.2015.20.
- Jensen CM, Steinhausen HC. Comorbid mental disorders in children and adolescents with attention-deficit/hyperactivity disorder in a large nationwide study. Atten Defic Hyperact Disord. 2015 Mar;7(1):27-38. doi: 10.1007/s12402-014-0142-1. Epub 2014 Jun 19.
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Comorbidities with ADHD
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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