- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06925308
Course of Face-to-face Interactions in Adults With Autism
Course of Face-to-face Interactions in Adults With Autism: An Exploratory Mixed Methods Experimental Design
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jos Boer, MSc
- Phone Number: +31 6 20083507
- Email: j.c.boer-30@umcutrecht.nl
Study Contact Backup
- Name: Nynke Boonstra, Professor
- Email: tboonst2@umcutrecht.nl
Study Locations
-
-
Overijssel
-
Deventer, Overijssel, Netherlands, 7416 SB
- Recruiting
- Dimence Groep
-
Contact:
- Nynke Boonstra, Professor
- Phone Number: +31 6 22678011
- Email: tboonst2@umcutrecht.nl
-
Contact:
- Bram Sizoo, Professor
- Email: b.b.sizoo@uva.nl
-
Contact:
- Jos Boer, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Social interaction
Received intervention is a social interaction on which is reflected afterwards, in adults with and without autism, living in The Netherlands.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Nynke Boonstra, Professor, UMC Utrecht
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 559902
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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