Autism Spectrum Disorder (ASD)NCT06925308
Course of Face-to-face Interactions in Adults With Autism
A study testing Conversation in people with Autism Spectrum Disorder (ASD) and Neurotypical, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This research explores how adults with autism make eye contact during formal and informal interactions; to what extent the nature of a conversation influences how eye contact is made in terms of length, frequency and overall presentation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Neurotypical
- What is being tested?
- Conversation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Feb 2025to 30 Apr 2026
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neurotypical adults and adults with an ASD, determined according to an internationally recognized classification system.
- Able to understand the instructions.
- Motivation to participate in research.
Who cannot join
- No good command of the Dutch language.
- Use of alcohol and/or recreational drugs during the research.
- Mentally too unstable to participate in the research.
- Familiarity with treatment in the VGZ.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nynke Boonstra, Professor contact
Netherlands1 site, 1 recruiting
- Recruiting
Dimence Groep
Deventer, Overijssel, 7416 SB
Nynke Boonstra, Professor, +31 6 22678011, tboonst2@umcutrecht.nl
Bram Sizoo, Professor, b.b.sizoo@uva.nl
About this study
Official title: Course of Face-to-face Interactions in Adults With Autism: An Exploratory Mixed Methods Experimental Design
This research explores how adults with autism make eye contact during formal and informal interactions; to what extent the nature of a conversation influences how eye contact is made in terms of length, frequency and overall presentation. Also what physiological responses to eye contact are, in order to determine to what extent eye contact leads to an increased, decreased or unchanged stress level. In addition, to gain insight into the similarities and differences in how people with ASD respond to eye contact of others compared to their own eye contact.
Read the detailed description
This research explores how adults with autism make eye contact during formal and informal interactions; to what extent the nature of a conversation influences how eye contact is made in terms of length, frequency and overall presentation. Also what physiological responses to eye contact are, in order to determine to what extent eye contact leads to an increased, decreased or unchanged stress level. In addition, to gain insight into the similarities and differences in how people with ASD respond to eye contact of others compared to their own eye contact.
The research design chosen is an exploratory mixed methods study, which was developed in co-design with an expert by experience. The design consists of two parts. In the first part, the researcher will have a conversation (with a formal and informal phase, in which the subject will be given the idea that only the formal part is part of the research) with an adult with ASD, during which hidden recordings of the subject's eye behavior will be made, and in addition, skin conductance and duration/frequency of the subject's eye contact will be recorded, without the subject knowing that this is intended for research into eye contact. In the second part, the researcher and subject watch the hidden recording of the subject's eye behavior, during which the subject's skin conductance will be recorded and special features of the subject, as seen by the researcher. Both the arrangement of the subjects and researcher, as well as the physiological measurements, will be tested in advance.
- Conditions
- Autism Spectrum Disorder (ASD), Neurotypical
- Being tested
- Conversation
- Keywords
- Eye contact, Autism Spectrum Disorder, ASD, Experiment, Neurotypical, Interaction, Physiology, Reflection
- 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.
ConversationBehavioural
The design consists of two parts. In the first part, the researcher will have a conversation (with a formal and informal phase, where the subject will be given the idea that only the formal part is part of the study) with an adult with ASD during which covert recordings of the subject's eye behavior will be made, and in addition skin conductance and duration/frequency of eye contact of the subject will be recorded, without the subject knowing that this is intended for the purpose of studying eye contact. In the second part, the researcher and subject will watch the covert recording of the subject's eye behavior, during which the subject's skin conductance will be recorded and details of the subject's behavior as seen by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Social interaction | Experimental | Received intervention is a social interaction on which is reflected afterwards, in adults with and without autism, living in The Netherlands. Receives: Behavioral: Conversation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of eye contact in adults with autism, measured with video, audio and push button.
The research consists of two parts. During the first part, the conversation, the frequency of eye contact will be investigated. This will be measured by video recordings of the eye region combined with the pressing of a push button by the researcher at moments when eye contact is present.
Data will be analyzed using software programs Observer XT and Matlab for the integration of push button, video recordings and audio recordings.
Measured: Baseline
Duration of eye contact in adults with autism, measured with video, audio and push button.
The research consists of two parts. During the first part, the conversation, the duration of eye contact will be investigated. This will be measured by video recordings of the eye region combined with the pressing of a push button by the researcher at moments when eye contact is present. Data will be analyzed using software programs Observer XT and Matlab for the integration of push button, video recordings and audio recordings.
Measured: Baseline
Arousal during eye contact in adults with autism, measured with skin conductance
The research consists of two parts. During the first part, the arousal during eye contact will be investigated. This will be measured by a skin conductance meter and analysed with the software program VSRRP.
Measured: Baseline
Arousal during reflection on ones own eye contact in adults with autism, measured with skin conductance
During the second part, the reflection on video recordings of ones own eye contact in aduls with autism, the degree of arousal to seeing their own eye contact will be investigated. For this, skin conductance meter will be used and analysed with the software program VSRRP.
Measured: Baseline
Reflection on ones own eye contact in adults with autism, measured with video and audio
During the second part, reflection first part, it will be investigated how subjects respond with words. For this, audio and video recordings will be used. Data analysis will be conducted with use of thematic analysis and software programs Atlas.ti, Microsoft Excel and Microsoft Word.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start3 Feb 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dimence Groep
- Responsible party
- Principal investigator, Jos Boer, UMC Utrecht
- Investigators
- Nynke Boonstra, Professor, Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925308
- Sponsor's protocol ID
- 559902
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Course of Face-to-face Interactions in Adults With Autism: An Exploratory Mixed Methods Experimental Design
- ClinicalTrials.gov ID
- NCT06925308
- Acronym / sponsor ID
- 559902
- Conditions
- Autism Spectrum Disorder (ASD), Neurotypical
- Keywords
- Eye contact, Autism Spectrum Disorder, ASD, Experiment, Neurotypical, Interaction, Physiology, Reflection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dimence Groep
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 13 Apr 2025 (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 research explores how adults with autism make eye contact during formal and informal interactions; to what extent the nature of a conversation influences how eye contact is made in terms of length, frequency and overall presentation. Also what physiological responses to eye contact are, in order to determine to what extent eye contact leads to an increased, decreased or unchanged stress level. In addition, to gain insight into the similarities and differences in how people with ASD respond to eye contact of others compared to their own eye contact.
Detailed description
This research explores how adults with autism make eye contact during formal and informal interactions; to what extent the nature of a conversation influences how eye contact is made in terms of length, frequency and overall presentation. Also what physiological responses to eye contact are, in order to determine to what extent eye contact leads to an increased, decreased or unchanged stress level. In addition, to gain insight into the similarities and differences in how people with ASD respond to eye contact of others compared to their own eye contact.
The research design chosen is an exploratory mixed methods study, which was developed in co-design with an expert by experience. The design consists of two parts. In the first part, the researcher will have a conversation (with a formal and informal phase, in which the subject will be given the idea that only the formal part is part of the research) with an adult with ASD, during which hidden recordings of the subject's eye behavior will be made, and in addition, skin conductance and duration/frequency of the subject's eye contact will be recorded, without the subject knowing that this is intended for research into eye contact. In the second part, the researcher and subject watch the hidden recording of the subject's eye behavior, during which the subject's skin conductance will be recorded and special features of the subject, as seen by the researcher. Both the arrangement of the subjects and researcher, as well as the physiological measurements, will be tested in advance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social interaction | Experimental | Behavioral: ConversationReceived intervention is a social interaction on which is reflected afterwards, in adults with and without autism, living in The Netherlands. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neurotypical adults and adults with an ASD, determined according to an internationally recognized classification system.
- Able to understand the instructions.
- Motivation to participate in research.
Key exclusion criteria (4 listed)
- No good command of the Dutch language.
- Use of alcohol and/or recreational drugs during the research.
- Mentally too unstable to participate in the research.
- Familiarity with treatment in the VGZ.
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 |
|---|---|---|
| ConversationThe design consists of two parts. In the first part, the researcher will have a conversation (with a formal and informal phase, where the subject will be given the idea that only the formal part is part of the study) with an adult with ASD during which covert recordings of the subject's eye behavior will be made, and in addition skin conductance and duration/frequency of eye contact of the subject will be recorded, without the subject knowing that this is intended for the purpose of studying eye contact. In the second part, the researcher and subject will watch the covert recording of the subject's eye behavior, during which the subject's skin conductance will be recorded and details of the subject's behavior as seen by the researcher. | Behavioural | Social interaction |
Primary outcome
Frequency of eye contact in adults with autism, measured with video, audio and push button.
Time frame: Baseline
The research consists of two parts. During the first part, the conversation, the frequency of eye contact will be investigated. This will be measured by video recordings of the eye region combined with the pressing of a push button by the researcher at moments when eye contact is present. Data will be analyzed using software programs Observer XT and Matlab for the integration of push button, video recordings and audio recordings.
Duration of eye contact in adults with autism, measured with video, audio and push button.
Time frame: Baseline
The research consists of two parts. During the first part, the conversation, the duration of eye contact will be investigated. This will be measured by video recordings of the eye region combined with the pressing of a push button by the researcher at moments when eye contact is present. Data will be analyzed using software programs Observer XT and Matlab for the integration of push button, video recordings and audio recordings.
Arousal during eye contact in adults with autism, measured with skin conductance
Time frame: Baseline
The research consists of two parts. During the first part, the arousal during eye contact will be investigated. This will be measured by a skin conductance meter and analysed with the software program VSRRP.
Arousal during reflection on ones own eye contact in adults with autism, measured with skin conductance
Time frame: Baseline
During the second part, the reflection on video recordings of ones own eye contact in aduls with autism, the degree of arousal to seeing their own eye contact will be investigated. For this, skin conductance meter will be used and analysed with the software program VSRRP.
Reflection on ones own eye contact in adults with autism, measured with video and audio
Time frame: Baseline
During the second part, reflection first part, it will be investigated how subjects respond with words. For this, audio and video recordings will be used. Data analysis will be conducted with use of thematic analysis and software programs Atlas.ti, Microsoft Excel and Microsoft Word.
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 13 Apr 2025.
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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.
Nynke Boonstra, Professor contact
Nynke Boonstra, Professor study chair
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversation in people with Autism Spectrum Disorder (ASD) and Neurotypical, run by UMC Utrecht at 1 site in Netherlands.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Apr 2025. 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 Netherlands. 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?
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 Jos Boer, MSc (+31 6 20083507, j.c.boer-30@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of eye contact in adults with autism, measured with video, audio and push button. (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2025.