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Risk Factors and Prognosis of Autism Spectrum Disorder

Risk Factors and Prognosis of Autism Spectrum Disorder in Children Attending Assiut University Children's Hospital

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07818460
Enrollment
84
Registered
2026-09-14
Start date
2026-09-10
Completion date
2028-04-10
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of risk factors in ASD versus controlsBaselineProportion 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.

Secondary

MeasureTime frameDescription
Change in Childhood Autism Rating Scale scoreFrom baseline to 6 monthsChange 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.
Change in Vineland Adaptive Behavior Scales scoreFrom baseline to 6 monthsChange in Vineland Adaptive Behavior Scales composite score from baseline to 6 months in children with ASD. Higher scores indicate better adaptive functioning.
Response to early interventionAt 6 monthsProportion of children with ASD showing clinical improvement after speech, occupational, and behavioral therapy.
Development of comorbiditiesThrough 6 monthsProportion of children with ASD who develop associated comorbidities (seizures, gastrointestinal problems, sleep disturbances) during follow-up.

Contacts

CONTACTYasmin A Mohamed, Resident
Jasmine.18313474@med.aun.edu.eg+20 11 13449521
STUDY_CHAIRAbdellatif M Abdelmoez, prof

pediatics Department, Assiut University Hospitals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026