Autism Spectrum Disorder (ASD)NCT06924008
Developing an Intervention Facilitating the Use of Eye Contact in Adults With Autism
An observational study of Autism Spectrum Disorder (ASD) and Relative (Related Person), run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The aim of this study is to develop a methodological intervention for adults with autism that will help them reduce problems arising from eye contact. 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), Relative (Related Person), Care Giver
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jul 2025to 2 Nov 2026
- How long will I take part?
- 6 Days
- Phase
- Observational
- 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
Study population: The study population consists of adults with autism, caregivers of adults with autism, and healthcare providers (psychiatrists, psychologists and nursing specialists in psychiatry).
Who may be able to join
- Adults classified with autism, determined according to an internationally recognized classification system.
- Outpatient treatment within a specialized autism center in the Netherlands.
- Able to understand the topics to be discussed.
- Motivation to participate in research.
- Adults without DSM classification.
- Living in the Netherlands.
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- Able to understand the topics to be discussed.
- Motivation to participate in research.
- Practicing psychiatrist, clinical psychologist or nurse specialist at an autism expertise center in the Netherlands.
- Living in the Netherlands.
- Motivation to participate in research.
Who cannot join
- No good command of the Dutch language.
- Use of alcohol and/or recreational drugs during the study.
- Mentally too unstable to participate in the study.
- Familiarity with treatment in the VGZ.
- No good command of the Dutch language.
- Use of alcohol and/or recreational drugs during the study.
- No good command of the Dutch language.
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: Development of an Intervention Aimed at Facilitating the Use of Eye Contact in Adults With Autism: A Qualitative Study With Methodological Triangulation
The aim of this study is to develop a methodological intervention for adults with autism that will help them reduce problems arising from eye contact.
Read the detailed description
Eye contact is fundamental to human interaction, not only in terms of the experience of connection with others, but also in terms of cognitive skills and social-emotional development. In adults with autism, eye contact is sometimes atypical, which in individual cases can lead to problems in the aforementioned areas. An intervention could possibly lead to a reduction of these problems. However, to date, there is no insight into the problems that this population experiences due to eye contact, how this differs from people without autism, to what extent adults with autism wish to optimize eye contact with others, what they themselves see as solutions for this, and when it proves fruitful to develop an intervention based on all these facets; what an effective intervention could be for this (and who the target group is). While insight into all of this could lead to a reduction in problems that adults with autism and/or their interaction partner experience due to their eye contact. To gain this insight, it is necessary to inventory, among both adults with and without autism, what problems adults with autism actually experience with regard to eye contact, and what their ideas are to reduce these problems. In addition, it is necessary to investigate in a substantiated methodical way which intervention forms a solution for the distilled problems and to test these, in order to be able to assess their effectiveness. If effective, then this intervention could at least contribute to the well-being of adults with autism and a mutually pleasant contact with interaction partners. The current study aims to provide for this and to arrive at an effective intervention that will help adults with autism experience less difficulty as a result of eye contact.
The research design chosen is qualitative research using triangulation by means of descriptive research in the form of semi-structured interviews and Intervention Mapping. The interviews have now taken place. These interviews, in addition to available scientific literature on eye contact in adults with autism, form the starting point for intervention development by means of Intervention Mapping. Intervention Mapping was chosen because the goal is to develop an intervention that will later be as effective as possible. This can be achieved by carefully weighing and substantiating the choices for the goal and the approach in the design phase. Intervention Mapping provides a theoretical basis for the intervention, which makes it more likely that the intervention will also work in practice. In addition, it provides a systematically described intervention and an implementation plan, making the intervention transferable and easier to put into practice. A major advantage of Intervention Mapping is that attention is paid to the way in which the results and effects of the project should be evaluated later, already in the development phase. In this way, Intervention Mapping contributes to increasing the effectiveness of the project. The aim of Intervention Mapping is to provide a framework for effective decision-making at every step of planning, implementation and evaluation. The Intervention Mapping protocol consists of six steps, with a number of tasks described for each step. Although Intervention Mapping is presented as a series of steps, it can be seen as iterative rather than linear. Programme planners switch back and forth between tasks and steps. The process is also cumulative: each step is based on previous steps.
- Keywords
- Intervention, Eye contact, Autism Spectrum Disorder, ASD, Intervention Mapping
- Medical subject headings
- Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing an intervention using the Intervention Mapping method.
An effective intervention for adults with autism that reduces their difficulty with eye contact problems, with use of Intervention Mapping.
The Intervention Mapping protocol consists of six steps, with a number of tasks described for each step. These steps are carried out within focus groups, with two months of time set aside for each step.
The six steps of the Intervention Mapping process are:
Step 1: Needs assessment Step 2: Change objectives Step 3: Theoretical methods and practical techniques Step 4: Programme design and production Step 5: Program Adoption and Implementation Step 6: Evaluation
Measured: Up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start7 Jul 2025 (estimated)
- Primary completion3 Jul 2026 (estimated)
- Study completion2 Nov 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (estimated)
- Target duration
- 6 Days
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
- NCT06924008
- Sponsor's protocol ID
- 559903
- Other IDs
- Dimence Groep
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 11 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Intervention Aimed at Facilitating the Use of Eye Contact in Adults With Autism: A Qualitative Study With Methodological Triangulation
- ClinicalTrials.gov ID
- NCT06924008
- Acronym / sponsor ID
- 559903
- Keywords
- Intervention, Eye contact, Autism Spectrum Disorder, ASD, Intervention Mapping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dimence Groep
- Study start
- 7 Jul 2025 (estimated)
- Primary completion
- 3 Jul 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 11 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.
The aim of this study is to develop a methodological intervention for adults with autism that will help them reduce problems arising from eye contact.
Detailed description
Eye contact is fundamental to human interaction, not only in terms of the experience of connection with others, but also in terms of cognitive skills and social-emotional development. In adults with autism, eye contact is sometimes atypical, which in individual cases can lead to problems in the aforementioned areas. An intervention could possibly lead to a reduction of these problems. However, to date, there is no insight into the problems that this population experiences due to eye contact, how this differs from people without autism, to what extent adults with autism wish to optimize eye contact with others, what they themselves see as solutions for this, and when it proves fruitful to develop an intervention based on all these facets; what an effective intervention could be for this (and who the target group is). While insight into all of this could lead to a reduction in problems that adults with autism and/or their interaction partner experience due to their eye contact. To gain this insight, it is necessary to inventory, among both adults with and without autism, what problems adults with autism actually experience with regard to eye contact, and what their ideas are to reduce these problems. In addition, it is necessary to investigate in a substantiated methodical way which intervention forms a solution for the distilled problems and to test these, in order to be able to assess their effectiveness. If effective, then this intervention could at least contribute to the well-being of adults with autism and a mutually pleasant contact with interaction partners. The current study aims to provide for this and to arrive at an effective intervention that will help adults with autism experience less difficulty as a result of eye contact.
The research design chosen is qualitative research using triangulation by means of descriptive research in the form of semi-structured interviews and Intervention Mapping. The interviews have now taken place. These interviews, in addition to available scientific literature on eye contact in adults with autism, form the starting point for intervention development by means of Intervention Mapping. Intervention Mapping was chosen because the goal is to develop an intervention that will later be as effective as possible. This can be achieved by carefully weighing and substantiating the choices for the goal and the approach in the design phase. Intervention Mapping provides a theoretical basis for the intervention, which makes it more likely that the intervention will also work in practice. In addition, it provides a systematically described intervention and an implementation plan, making the intervention transferable and easier to put into practice. A major advantage of Intervention Mapping is that attention is paid to the way in which the results and effects of the project should be evaluated later, already in the development phase. In this way, Intervention Mapping contributes to increasing the effectiveness of the project. The aim of Intervention Mapping is to provide a framework for effective decision-making at every step of planning, implementation and evaluation. The Intervention Mapping protocol consists of six steps, with a number of tasks described for each step. Although Intervention Mapping is presented as a series of steps, it can be seen as iterative rather than linear. Programme planners switch back and forth between tasks and steps. The process is also cumulative: each step is based on previous steps.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Days
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults with autism, caregivers of adults with autism, and healthcare providers (psychiatrists, psychologists and nursing specialists in psychiatry).
Key inclusion criteria (11 listed)
- Adults classified with autism, determined according to an internationally recognized classification system.
- Outpatient treatment within a specialized autism center in the Netherlands.
- Able to understand the topics to be discussed.
- Motivation to participate in research.
- Adults without DSM classification.
Key exclusion criteria (7 listed)
- No good command of the Dutch language.
- Use of alcohol and/or recreational drugs during the study.
- Mentally too unstable to participate in the study.
- Familiarity with treatment in the VGZ.
- No good command of the Dutch language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Developing an intervention using the Intervention Mapping method.
Time frame: Up to 12 months.
An effective intervention for adults with autism that reduces their difficulty with eye contact problems, with use of Intervention Mapping. The Intervention Mapping protocol consists of six steps, with a number of tasks described for each step. These steps are carried out within focus groups, with two months of time set aside for each step. The six steps of the Intervention Mapping process are: Step 1: Needs assessment Step 2: Change objectives Step 3: Theoretical methods and practical techniques Step 4: Programme design and production Step 5: Program Adoption and Implementation Step 6: Evaluation
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 11 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?
An observational study of Autism Spectrum Disorder (ASD) and Relative (Related Person), 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 11 inclusion and 7 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 11 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?
Developing an intervention using the Intervention Mapping method. (time frame: Up to 12 months.). 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 11 Apr 2025.