Autism Spectrum DisorderNCT04010409
Mindreading in Adults With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to investigate the ability of reading emotions by the Eyes task in adults with ASD, and examine the gazing pattern and frontal activation during the task. We plan to recruit 50 adults with ASD and 50 typically-developing adults. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jan 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The 30 adults with ASD will be recruited from Adult ASD clinics in Department of Psychiatry, National Taiwan University Hospital.
Who may be able to join
- Adult aged between 20 and 50 years who had a diagnosis of ASD based on DSM-5.
- Had a full-scale IQ > 70 on WAIS-IV.
Who cannot join
- A history of major mental illness (e.g., bipolar affective disorder, schizophrenia) or neurological diseases.
- Visual impairment and that would preclude participation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yi Ling Chien, M.D., Ph.D., 886-2-2312-3456 ext. 66013, ylchien@hotmail.com
About this study
This study aims to investigate the ability of reading emotions by the Eyes task in adults with ASD, and examine the gazing pattern and frontal activation during the task. We plan to recruit 50 adults with ASD and 50 typically-developing adults. Eye-tracking and frontal activation (measured by functional near-infrared spectroscopy) will be examined during the Eyes task.
Read the detailed description
Autism spectrum disorder (ASD) is a clinical syndrome characterized by mindreading deficits, or Theory of Mind deficits. The Reading the Mind in the Eyes task (abbreviated as the Eyes task) was developed to assess the mindreading deficits as a hallmark of social deficits of ASD. This study aims to investigate the ability of reading emotions by the Eyes task in adults with ASD, and examine the gazing pattern and frontal activation during the task. We plan to recruit 50 adults with ASD and 50 typically-developing adults. All the participants will complete clinical measures and the Eyes task. Eye-tracking and frontal activation (measured by functional near-infrared spectroscopy) will be examined during the Eyes task.
- Conditions
- Autism Spectrum Disorder
- Being tested
- no intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| ASD Group | Autism spectrum disorder participants, no intervention Receives: Other: no intervention | |
| TD Group | Typically developmental controls,no intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
eye tracking indicators
eye tracking indicators
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start8 Jan 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 National Taiwan University HospitalThe 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Ling Chien, M.D., Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010409
- Sponsor's protocol ID
- 201809069RINA
- Status last verified
- Dec 2022
- First submitted
- 4 Jul 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chien YL, Tseng YL, Tsai WC, Chiu YN. Assessing Frontal Lobe Function on Verbal Fluency and Emotion Recall in Autism Spectrum Disorder by fNIRS. J Autism Dev Disord. 2025 May;55(5):1648-1659. doi: 10.1007/s10803-024-06306-5. Epub 2024 Apr 18.
PubMed 38635133
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindreading in Adults With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04010409
- Acronym / sponsor ID
- 201809069RINA
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jul 2019 (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 study aims to investigate the ability of reading emotions by the Eyes task in adults with ASD, and examine the gazing pattern and frontal activation during the task. We plan to recruit 50 adults with ASD and 50 typically-developing adults. Eye-tracking and frontal activation (measured by functional near-infrared spectroscopy) will be examined during the Eyes task.
Detailed description
Autism spectrum disorder (ASD) is a clinical syndrome characterized by mindreading deficits, or Theory of Mind deficits. The Reading the Mind in the Eyes task (abbreviated as the Eyes task) was developed to assess the mindreading deficits as a hallmark of social deficits of ASD. This study aims to investigate the ability of reading emotions by the Eyes task in adults with ASD, and examine the gazing pattern and frontal activation during the task. We plan to recruit 50 adults with ASD and 50 typically-developing adults. All the participants will complete clinical measures and the Eyes task. Eye-tracking and frontal activation (measured by functional near-infrared spectroscopy) will be examined during the Eyes task.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD Group | – | Other: no interventionAutism spectrum disorder participants, no intervention |
| TD Group | – | Other: no interventionTypically developmental controls,no intervention |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The 30 adults with ASD will be recruited from Adult ASD clinics in Department of Psychiatry, National Taiwan University Hospital.
Key inclusion criteria (2 listed)
- Adult aged between 20 and 50 years who had a diagnosis of ASD based on DSM-5.
- Had a full-scale IQ > 70 on WAIS-IV.
Key exclusion criteria (2 listed)
- A history of major mental illness (e.g., bipolar affective disorder, schizophrenia) or neurological diseases.
- Visual impairment and that would preclude participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | ASD Group, TD Group |
Primary outcome
eye tracking indicators
Time frame: 30 min
eye tracking indicators
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 38635133Chien YL, Tseng YL, Tsai WC, Chiu YN. Assessing Frontal Lobe Function on Verbal Fluency and Emotion Recall in Autism Spectrum Disorder by fNIRS. J Autism Dev Disord. 2025 May;55(5):1648-1659. doi: 10.1007/s10803-024-06306-5. Epub 2024 Apr 18.
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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. This study is not recruiting at the moment.
Yi Ling Chien, M.D., Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Ling Chien, M.D., Ph.D. (886-2-2312-3456 ext. 66013, ylchien@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eye tracking indicators (time frame: 30 min). 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 NCT04010409, which also lists 1 linked publication.
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 18 Apr 2023.