Course of Face-to-face Interactions in Adults With Autism

April 10, 2025 updated by: Jos Boer, UMC Utrecht

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Overijssel
      • Deventer, Overijssel, Netherlands, 7416 SB
        • Recruiting
        • Dimence Groep
        • Contact:
        • Contact:
        • Contact:
          • Jos Boer, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Social interaction
Received intervention is a social interaction on which is reflected afterwards, in adults with and without autism, living in The Netherlands.
Behavioral: Conversation
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UMC Utrecht

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dimence Groep

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nynke Boonstra, Professor, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 559902

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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