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NCT Number: NCT07818460

Risk Factors and Prognosis of Autism Spectrum Disorder

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.

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Key information

Conditions

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

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Response to early intervention

    Time frame: At 6 months

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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yasmin A Mohamed, Resident

CONTACT

[email protected]

+20 11 13449521

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 14, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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