Risk Factors and Prognosis of Autism Spectrum Disorder

N/ANot Yet RecruitingNCT07818460

Assiut University84 enrolled

Overview

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.

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

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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: Baseline

Secondary Outcomes

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 months

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 months

Response to early intervention

Proportion of children with ASD showing clinical improvement after speech, occupational, and behavioral therapy.

Time frame: At 6 months

Development of comorbidities

Proportion of children with ASD who develop associated comorbidities (seizures, gastrointestinal problems, sleep disturbances) during follow-up.

Time frame: Through 6 months

Central Contacts

Yasmin A Mohamed, Resident

CONTACT

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

Data from ClinicalTrials.gov

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