Autism spectrum disorder (ASD)
Conditions
Interventions
The ADOS-2 examiner and an examiner using GF01 diagnose ASD based on the following procedures. An examiner, pre-appointed by study site independently from an examiner using GF01, conducts the ADOS-2
Sponsors
Hamamatsu University Hospital, Department of Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children or adolescents with a suspected diagnosis of ASD: Group1 1. Aged 5 to 17 years at consent, male or female. 2. Referred from another facility because of suspicion of ASD or suspected ASD by a doctor who conducted a clinical interview initially. 3. Children or adolescents who can take all the scheduled checkups within 3 months from the day of the initial consultation at the study site. 4. Children or adolescents whose legally acceptable representative provided a written informed consent. Typically developing children or adolescents: Group2 1. Aged 5 to 17 years at consent, male or female. 2. Recruited under conditions of not having neurodevelopmental disorders in the DSM-5 based on prior clinical information such as development history and medical history. 3. Children or adolescents who can take all the scheduled checkups within 3 months from the day of the initial consultation at the study site. 4. Children or adolescents whose legally acceptable representative provided a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Children or adolescents who cannot be obtained information about development in their toddlerhood from his/her legally acceptable representative. 2. Complication of schizophrenia in the DSM-5. 3. Cyclopia or visual dysfunctions such as severe myopia or hyperopia with difficulty in recognizing images on screen of the study device. 4. Antipsychotic treatment at consent. 5. Depression, severe anxiety, tension, or agitated state which immediately needs to start medical treatment. 6. Considered unable to keep steady during the gaze tracking test. 7. Children or adolescents who cannot take the scheduled checkups. 8. Serious physical disorder. 9. More than or equal to 90 percentile in the ADHD-RS-IV. 10. A total IQ less than 70. 11. Risk of aggravation of psychiatric symptoms or epileptic seizures triggered by using the study device. 12. Participation in another trial within a month from the day of providing of consent to this study. 13. Considered ineligible for inclusion in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity Sensitivity = ASD diagnosed based on both ADOS-2 and GF01/ASD diagnosed based on ADOS-2 2. Specificity Specificity = non-ASD diagnosed based on both ADOS-2 and GF01/non-ASD diagnosed based on ADOS-2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints 1. Positive predictive value 2. Negative predictive value 3. Correlation between each symptom of ASD and performance assessment 4. Visual function and performance assessment | — |
Countries
Japan
Contacts
Public ContactKeni Tsuchiya
Hamamatsu University School of Medicine Research Center for Child Mental Development
Outcome results
None listed