Risk Factors and Prognosis of Autism Spectrum Disorder

NCT07818460 | Not Yet Recruiting

• 1 other identifier: ASD-Risk-Prognosis-Assiut-2026
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive

Keywords

Autism spectrum disorder; Risk factors; Prognosis; CARS; Children; Assiut

Outcome Measures

Primary Outcomes (1)

• Prevalence of risk factors in ASD versus controls

  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.

  Baseline

Secondary Outcomes (4)

• Change in Childhood Autism Rating Scale score

  From baseline to 6 months

• Change in Vineland Adaptive Behavior Scales score

  From baseline to 6 months

• Response to early intervention

  At 6 months

• Development of comorbidities

  Through 6 months

Study Arms (2)

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.

Controls

Age- and sex-matched children without autism spectrum disorder or other neurodevelopmental disorders, attending the same hospital during the same study period.

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 3 to 17 years attending Assiut University Children's Hospital (Pediatric Neurology Unit).

You may qualify if:

• 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
• \- Age- and sex-matched children without ASD or other neurodevelopmental disorders

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 40657467 BACKGROUND

• 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.

  PMID: 41246720 BACKGROUND

• 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.

  PMID: 40232988 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Abdellatif M Abdelmoez, prof

  pediatics Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Yasmin A Mohamed, Resident

CONTACT

+20 11 13449521; Jasmine.18313474@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): April 10, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09