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Starting soon Observational

Investigation of the Genetic and Environmental Causes of Autism: a Multi-Center Study

NCT06662591 · tracked via the Priya Life Science Turkey tracker
Sponsor
Research and Treatment Society of Genetic Disorders
Phase
Observational
Started
2025-12-27
Last updated
2024-10-29

Condition(s) studied

Autism Spectrum Disorder (ASD)

Study summary

The goal of this observational study is to investigate the genetic and epigenetic mechanisms that may contribute to the development of Autism Spectrum Disorder (ASD) in individuals of different age groups. The study aims to explore how genetic variants and environmental factors interact to influence the risk of ASD.

The main questions it aims to answer are:

* Which genetic variants are most strongly associated with the development of ASD?
* How do environmental factors, such as prenatal exposure, influence these genetic risks?
* Can the combination of genetic and epigenetic data improve early detection or intervention strategies for ASD?

Participants will:

* Provide biological samples for genetic and epigenetic analysis.
* Complete detailed questionnaires regarding environmental exposures and family history.
* Participate in clinical assessments to evaluate the severity of ASD symptoms.

Researchers will compare genetic and environmental data between individuals with ASD and those without the disorder to understand how these factors may contribute to the risk of ASD. This multi-center study will take place across several universities and hospitals in Türkiye, focusing on the potential interplay between inherited genetic factors and environmental influences.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
\- Inclusion Criteria: Autism Spectrum Disorder (ASD) or Autism-like Traits: Individuals diagnosed with ASD based on DSM-5 diagnostic criteria, or those displaying significant autism traits without a formal diagnosis. Healthy Control Group: Age-, gender-, and socio-demographically matched individuals without any psychiatric or neurological disorder. ASD Individuals of Varying Functional Levels: Participants with ASD from a broad range of functional abilities, from high-functioning to low-functioning autism. Comorbid Conditions: Inclusion of volunteers with developmental profiles and comorbid conditions such as ADHD and learning disabilities. Informed Consent: Written informed consent from participants over 18 years of age. For participants under 18, consent from parents or legal guardians. \- Exclusion Criteria: Severe Psychotic Disorders: Individuals diagnosed with conditions like schizophrenia or schizoaffective disorder. Known Genetic Syndromes or Chromosomal Anomalies: Individuals with genetic conditions such as Down syndrome or Fragile X syndrome. History of Genetic or Experimental Therapies: Participants with previous gene or cell therapy, frequent blood transfusions, or bone marrow transplants. Severe Communication or Cognitive Impairments: Participants with communication or cognitive disorders that would hinder their ability to participate in data collection, or those with aggressive behavioral disorders. Non-compliance or Medical Restrictions: Individuals unable to comply with study procedures or with medical conditions that prevent biological sample collection. \- Control Group: Healthy Individuals: Participants without ASD or any psychiatric or neurological disorders. Age and Gender Matching: Matched with the ASD group in terms of age, gender, and socio-demographic status. No History of Genetic or Neurodevelopmental Disorders: Individuals with no genetic syndromes, chromosomal anomalies, or neurodevelopmental disorders. No Chronic Disease History: Participants with no history of chronic diseases such as cancer, autoimmune diseases, or metabolic conditions. Informed Consent: Written informed consent from individuals over 18 years old or from parents/legal guardians for participants under 18.

Primary outcome measure(s)

  • Finalization of Clinical Data Recruitment — Expected to complete within 24 months of study initiation.
    The primary outcome will be the recruitment of individuals diagnosed with Autism Spectrum Disorder (ASD) and unaffected controls. Comprehensive clinical, sociodemographic, and phenotypic data will be collected, including diagnostic assessments using standardized tools (e.g., ADOS, SCQ).

Trial sites (20)

FacilityCityRegionStatus
Konya Selcuk University Faculty of Medicine, Department of Child and Adolescent Psychiatry Konya Selçuklu
Konya Selcuk University Faculty of Medicine, Department of Psychiatry Konya Selçuklu
Afyonkarahisar University of Health Sciences, Faculty of Medicine, Department of Child and Adolescent Psychiatry Afyonkarahisar Turkey (Türkiye)
Ankara Başkent University, Department of Psychiatry Ankara Turkey (Türkiye)
Ankara Gazi Faculty of Medicine, Department of Child and Adolescent Psychiatry Ankara Turkey (Türkiye)
Ankara SBÜ Gülhane Faculty of Medicine, Department of Child and Adolescent Psychiatry Ankara Turkey (Türkiye)
Bursa Uludağ University, Department of Child and Adolescent Psychiatry Bursa Turkey (Türkiye)
Denizli Pamukkale University Faculty of Medicine, Department of Child and Adolescent Psychiatry Denizli Turkey (Türkiye)
Erzurum Atatürk University Faculty of Medicine, Department of Child and Adolescent Psychiatry Erzurum Turkey (Türkiye)
Gaziantep University, Department of Child and Adolescent Psychiatry Gaziantep Turkey (Türkiye)
Giresun University, Department of Child and Adolescent Psychiatry Giresun Turkey (Türkiye)
Istanbul Cerrahpasa Faculty of Medicine, Department of Child and Adolescent Psychiatry Istanbul Turkey (Türkiye)
Istanbul Medeniyet University Faculty of Medicine, Department of Child and Adolescent Psychiatry Istanbul Turkey (Türkiye)
Istanbul Medeniyet University, Department of Psychiatry Istanbul Turkey (Türkiye)
Istanbul Çam and Sakura City Hospital, Department of Child and Adolescent Psychiatry Istanbul Turkey (Türkiye)
Izmir Katip Çelebi Faculty of Medicine, Department of Child and Adolescent Psychiatry Izmir Turkey (Türkiye)
Konya Necmettin Erbakan University Faculty of Medicine, Department of Child and Adolescent Psychiatry Konya Turkey (Türkiye)
Konya Selcuk University Faculty of Medicine, Department of Medical Genetics Konya Turkey (Türkiye)
Şanlıurfa Harran University Faculty of Medicine, Department of Child and Adolescent Psychiatry Sanliurfa Turkey (Türkiye)
Trabzon Karadeniz Technical University Faculty of Medicine, Department of Child and Adolescent Psychiatry Trabzon Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06662591 on ClinicalTrials.gov ↗ ← All trials in Turkey