Risk Factors and Prognosis of Autism Spectrum Disorder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-17
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Children aged 3 to 17 years attending Assiut University Children's Hospital (Pediatric Neurology Unit).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
84 Participants
are grouped into 2 trial groupsGroup A: ASD Cases
Group B: Controls
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
Change in Childhood Autism Rating Scale score
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.
Time frame
From baseline to 6 months2
Change in Vineland Adaptive Behavior Scales score
Change in Vineland Adaptive Behavior Scales composite score from baseline to 6 months in children with ASD. Higher scores indicate better adaptive functioning.
Time frame
From baseline to 6 months3
Response to early intervention
Proportion of children with ASD showing clinical improvement after speech, occupational, and behavioral therapy.
Time frame
At 6 months4
Development of comorbidities
Proportion of children with ASD who develop associated comorbidities (seizures, gastrointestinal problems, sleep disturbances) during follow-up.
Time frame
Through 6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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