Risk Factors and Prognosis of Autism Spectrum Disorder
September 11, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yasmin A Mohamed, Resident
- Phone Number: +20 11 13449521
- Email: Jasmine.18313474@med.aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Children aged 3 to 17 years attending Assiut University Children's Hospital (Pediatric Neurology Unit).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of risk factors in ASD versus controls
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response to early intervention
Time Frame: At 6 months
|
Proportion of children with ASD showing clinical improvement after speech, occupational, and behavioral therapy.
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At 6 months
|
|
Development of comorbidities
Time Frame: Through 6 months
|
Proportion of children with ASD who develop associated comorbidities (seizures, gastrointestinal problems, sleep disturbances) during follow-up.
|
Through 6 months
|
|
Change in Childhood Autism Rating Scale score
Time Frame: From baseline to 6 months
|
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.
|
From baseline to 6 months
|
|
Change in Vineland Adaptive Behavior Scales score
Time Frame: From baseline to 6 months
|
Change in Vineland Adaptive Behavior Scales composite score from baseline to 6 months in children with ASD.
Higher scores indicate better adaptive functioning.
|
From baseline to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Abdellatif M Abdelmoez, prof, pediatics Department, Assiut University Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 10, 2026
Primary Completion (Estimated)
September 20, 2027
Study Completion (Estimated)
April 10, 2028
Study Registration Dates
First Submitted
September 8, 2026
First Submitted That Met QC Criteria
September 8, 2026
First Posted (Actual)
September 14, 2026
Study Record Updates
Last Update Posted (Actual)
September 15, 2026
Last Update Submitted That Met QC Criteria
September 11, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASD-Risk-Prognosis-Assiut-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.