Risk Factors and Prognosis of Autism Spectrum Disorder
11. september 2026 opdateret af: Yasmin Abdelrahman Fathallah Mohamed, Assiut University
Risk Factors and Prognosis of Autism Spectrum Disorder in Children Attending Assiut University Children's Hospital
This case-control study with prospective follow-up aims to identify risk factors associated with autism spectrum disorder and to evaluate the prognosis of children with ASD attending Assiut University Children's Hospital.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret beskrivelse
Autism spectrum disorder is a neurodevelopmental condition with multifactorial etiology involving genetic and environmental factors. This observational case-control study will include children aged 3 to 17 years diagnosed with ASD according to DSM-5 criteria and age- and sex-matched controls without neurodevelopmental disorders.
Risk factors (antenatal, perinatal, and postnatal) will be compared between cases and controls. Children with ASD will be followed for 6 months to assess changes in symptom severity and adaptive functioning.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
84
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yasmin A Mohamed, Resident
- Telefonnummer: +20 11 13449521
- E-mail: Jasmine.18313474@med.aun.edu.eg
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Children aged 3 to 17 years attending Assiut University Children's Hospital (Pediatric Neurology Unit).
Beskrivelse
Inclusion Criteria
Inclusion Criteria (Cases):
- Age 3 to 17 years
- Confirmed diagnosis of ASD according to DSM-5 criteria, supported by standardized tools (e.g., CARS)
- Parent or legal guardian able and willing to provide informed consent
Inclusion Criteria (Controls):
- Age- and sex-matched children without ASD or other neurodevelopmental disorders
Exclusion Criteria:
- Age below 3 years or above 17 years
- Known chromosomal or genetic syndrome associated with secondary autistic features (e.g., Fragile X, Down syndrome), unless studied as a separate subgroup
- Incomplete medical records
- Refusal of parents/guardians to participate
- Loss to follow-up before the minimum 6-month prognostic assessment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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ASD Cases
Children aged 3 to 17 years with confirmed diagnosis of autism spectrum disorder according to DSM-5 criteria, supported by standardized assessment tools (e.g., CARS), attending the Pediatric Neurology Unit of Assiut University Children's Hospital.
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Controls
Age- and sex-matched children without autism spectrum disorder or other neurodevelopmental disorders, attending the same hospital during the same study period.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of risk factors in ASD versus controls
Tidsramme: Baseline
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Proportion of children with specific antenatal, perinatal, and postnatal risk factors (advanced parental age, consanguinity, maternal infection, gestational diabetes, birth asphyxia, NICU admission, and family history of ASD) among ASD cases compared with age- and sex-matched controls.
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Baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Response to early intervention
Tidsramme: At 6 months
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Proportion of children with ASD showing clinical improvement after speech, occupational, and behavioral therapy.
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At 6 months
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Development of comorbidities
Tidsramme: Through 6 months
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Proportion of children with ASD who develop associated comorbidities (seizures, gastrointestinal problems, sleep disturbances) during follow-up.
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Through 6 months
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Change in Childhood Autism Rating Scale score
Tidsramme: From baseline to 6 months
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Change in Childhood Autism Rating Scale (CARS) total score from baseline to 6 months in children with ASD.
CARS ranges from 15 to 60; higher scores indicate greater autism severity.
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From baseline to 6 months
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Change in Vineland Adaptive Behavior Scales score
Tidsramme: From baseline to 6 months
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Change in Vineland Adaptive Behavior Scales composite score from baseline to 6 months in children with ASD.
Higher scores indicate better adaptive functioning.
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From baseline to 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Abdellatif M Abdelmoez, prof, pediatics Department, Assiut University Hospitals
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Shaw KA, Williams S, Patrick ME, Valencia-Prado M, Durkin MS, Howerton EM, Ladd-Acosta CM, Pas ET, Bakian AV, Bartholomew P, Nieves-Munoz N, Sidwell K, Alford A, Bilder DA, DiRienzo M, Fitzgerald RT, Furnier SM, Hudson AE, Pokoski OM, Shea L, Tinker SC, Warren Z, Zahorodny W, Agosto-Rosa H, Anbar J, Chavez KY, Esler A, Forkner A, Grzybowski A, Agib AH, Hallas L, Lopez M, Magana S, Nguyen RHN, Parker J, Pierce K, Protho T, Torres H, Vanegas SB, Vehorn A, Zhang M, Andrews J, Greer F, Hall-Lande J, McArthur D, Mitamura M, Montes AJ, Pettygrove S, Shenouda J, Skowyra C, Washington A, Maenner MJ. Prevalence and Early Identification of Autism Spectrum Disorder Among Children Aged 4 and 8 Years - Autism and Developmental Disabilities Monitoring Network, 16 Sites, United States, 2022. MMWR Surveill Summ. 2025 Apr 17;74(2):1-22. doi: 10.15585/mmwr.ss7402a1.
- Al-Mamari W, Idris AB, Fadlallah N, Jalees S, Al-Jabri M, Al-Shehhi H, Mohammed M, Alsayegh A. Consanguinity: The innocent culprit in autism severity. Sultan Qaboos Univ Med J. 2025 May 2;25(1):114-121. doi: 10.18295/squmj.10.2024.052. eCollection 2025.
- Hamed NF, Alqahtani AM, Alshaibani F, Elsharif SM, Alamri SAS, Serhan A. Genetic and Environmental Risk Factors for Autism Spectrum Disorder in Saudi Arabia: A Systematic Review. Cureus. 2025 Oct 14;17(10):e94607. doi: 10.7759/cureus.94607. eCollection 2025 Oct.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
10. september 2026
Primær færdiggørelse (Anslået)
20. september 2027
Studieafslutning (Anslået)
10. april 2028
Datoer for studieregistrering
Først indsendt
8. september 2026
Først indsendt, der opfyldte QC-kriterier
8. september 2026
Først opslået (Faktiske)
14. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ASD-Risk-Prognosis-Assiut-2026
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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