Autism Spectrum DisorderNCT07818460
Risk Factors and Prognosis of Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder and Autistic Disorder, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autistic Disorder, Child Development Disorders, Pervasive
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 10 Apr 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 3 to 17 years attending Assiut University Children's Hospital (Pediatric Neurology Unit).
Who may be able to join
- 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
- Age- and sex-matched children without ASD or other neurodevelopmental disorders
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk Factors and Prognosis of Autism Spectrum Disorder in Children Attending Assiut University Children's Hospital
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.
Read the 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.
- Keywords
- Autism spectrum disorder, Risk factors, Prognosis, CARS, Children, Assiut
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASD Cases | 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. | |
| Controls | Age- and sex-matched children without autism spectrum disorder or other neurodevelopmental disorders, attending the same hospital during the same study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: From baseline to 6 months
Response to early intervention
Proportion of children with ASD showing clinical improvement after speech, occupational, and behavioral therapy.
Measured: At 6 months
Development of comorbidities
Proportion of children with ASD who develop associated comorbidities (seizures, gastrointestinal problems, sleep disturbances) during follow-up.
Measured: Through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion10 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Abdelrahman Fathallah Mohamed, Assiut University
- Investigators
- Abdellatif M Abdelmoez, prof, Study chair, pediatics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818460
- Sponsor's protocol ID
- ASD-Risk-Prognosis-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Mamari W, Idris AB, Fadlallah N, Jalees S, Al-Jabri M, Al-Shehhi H, Mohammed M, Alsayegh A. Consanguinity: The innocent culprit in autism severity. Sultan Qaboos Univ Med J. 2025 May 2;25(1):114-121. doi: 10.18295/squmj.10.2024.052. eCollection 2025.
PubMed 40657467Hamed NF, Alqahtani AM, Alshaibani F, Elsharif SM, Alamri SAS, Serhan A. Genetic and Environmental Risk Factors for Autism Spectrum Disorder in Saudi Arabia: A Systematic Review. Cureus. 2025 Oct 14;17(10):e94607. doi: 10.7759/cureus.94607. eCollection 2025 Oct.
PubMed 41246720Shaw KA, Williams S, Patrick ME, Valencia-Prado M, Durkin MS, Howerton EM, Ladd-Acosta CM, Pas ET, Bakian AV, Bartholomew P, Nieves-Munoz N, Sidwell K, Alford A, Bilder DA, DiRienzo M, Fitzgerald RT, Furnier SM, Hudson AE, Pokoski OM, Shea L, Tinker SC, Warren Z, Zahorodny W, Agosto-Rosa H, Anbar J, Chavez KY, Esler A, Forkner A, Grzybowski A, Agib AH, Hallas L, Lopez M, Magana S, Nguyen RHN, Parker J, Pierce K, Protho T, Torres H, Vanegas SB, Vehorn A, Zhang M, Andrews J, Greer F, Hall-Lande J, McArthur D, Mitamura M, Montes AJ, Pettygrove S, Shenouda J, Skowyra C, Washington A, Maenner MJ. Prevalence and Early Identification of Autism Spectrum Disorder Among Children Aged 4 and 8 Years - Autism and Developmental Disabilities Monitoring Network, 16 Sites, United States, 2022. MMWR Surveill Summ. 2025 Apr 17;74(2):1-22. doi: 10.15585/mmwr.ss7402a1.
PubMed 40232988
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Prognosis of Autism Spectrum Disorder in Children Attending Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT07818460
- Acronym / sponsor ID
- ASD-Risk-Prognosis-Assiut-2026
- Keywords
- Autism spectrum disorder, Risk factors, Prognosis, CARS, Children, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 10 Apr 2028 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD Cases | – | –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. |
| Controls | – | –Age- and sex-matched children without autism spectrum disorder or other neurodevelopmental disorders, attending the same hospital during the same study period. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 3 to 17 years attending Assiut University Children's Hospital (Pediatric Neurology Unit).
Key inclusion criteria (4 listed)
- 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
- Age- and sex-matched children without ASD or other neurodevelopmental disorders
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Change in Childhood Autism Rating Scale score
Time frame: From baseline to 6 months
Change in Vineland Adaptive Behavior Scales score
Time frame: From baseline to 6 months
Response to early intervention
Time frame: At 6 months
Development of comorbidities
Time frame: Through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 40657467Al-Mamari W, Idris AB, Fadlallah N, Jalees S, Al-Jabri M, Al-Shehhi H, Mohammed M, Alsayegh A. Consanguinity: The innocent culprit in autism severity. Sultan Qaboos Univ Med J. 2025 May 2;25(1):114-121. doi: 10.18295/squmj.10.2024.052. eCollection 2025.
- Background: PubMed 41246720Hamed NF, Alqahtani AM, Alshaibani F, Elsharif SM, Alamri SAS, Serhan A. Genetic and Environmental Risk Factors for Autism Spectrum Disorder in Saudi Arabia: A Systematic Review. Cureus. 2025 Oct 14;17(10):e94607. doi: 10.7759/cureus.94607. eCollection 2025 Oct.
- Background: PubMed 40232988Shaw KA, Williams S, Patrick ME, Valencia-Prado M, Durkin MS, Howerton EM, Ladd-Acosta CM, Pas ET, Bakian AV, Bartholomew P, Nieves-Munoz N, Sidwell K, Alford A, Bilder DA, DiRienzo M, Fitzgerald RT, Furnier SM, Hudson AE, Pokoski OM, Shea L, Tinker SC, Warren Z, Zahorodny W, Agosto-Rosa H, Anbar J, Chavez KY, Esler A, Forkner A, Grzybowski A, Agib AH, Hallas L, Lopez M, Magana S, Nguyen RHN, Parker J, Pierce K, Protho T, Torres H, Vanegas SB, Vehorn A, Zhang M, Andrews J, Greer F, Hall-Lande J, McArthur D, Mitamura M, Montes AJ, Pettygrove S, Shenouda J, Skowyra C, Washington A, Maenner MJ. Prevalence and Early Identification of Autism Spectrum Disorder Among Children Aged 4 and 8 Years - Autism and Developmental Disabilities Monitoring Network, 16 Sites, United States, 2022. MMWR Surveill Summ. 2025 Apr 17;74(2):1-22. doi: 10.15585/mmwr.ss7402a1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abdellatif M Abdelmoez, prof study chair
pediatics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Autistic Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmin A Mohamed, Resident (+20 11 13449521, Jasmine.18313474@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of risk factors in ASD versus controls (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07818460, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.