An observational study in Autism Spectrum Disorder, Autistic Disorder and Child Development Disorders, Pervasive, sponsored by Assiut University. Not yet recruiting. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Assiut University · Observational
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 84 is below the median of 101 across 189 observational studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Children aged 3 to 17 years attending Assiut University Children's Hospital (Pediatric Neurology Unit).
Inclusion Criteria
Inclusion Criteria (Cases):
Inclusion Criteria (Controls):
- Age- and sex-matched children without ASD or other neurodevelopmental disorders
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Age- and sex-matched children without autism spectrum disorder or other neurodevelopmental disorders, attending the same hospital during the same study period.
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
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
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 57 non-industry observational studies under Autistic Disorder, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 144. This study's planned 12 months is below that.
Counting every sponsor, half of 65 studies reached it within 43 months; a quarter within 20 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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