Autism Spectrum Disorder (ASD)NCT04631432
Choice Switching and Autism
An observational study of Autism Spectrum Disorder (ASD), run by Technion, Israel Institute of Technology at 1 site in Israel.
Trial summary
The study aims to replicate and clarify a recently observed phenomenon whereby individuals with Autism Spectrum Disorder (ASD) switch between options in a repeated task to a greater extent than healthy controls do. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Pre-screening and Task session
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 114 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2021to 13 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit participants using websites for recruiting experimental participants worldwide.
Who may be able to join
- ASD group - Diagnosed with ASD
- Control - No ASD diagnosis: within age and education range of the ASD group.
Who cannot join
- Demographics: Under 18 years of age.
- Mental health: self reported brain injury and neurological disorder (besides autism).
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to replicate and clarify a recently observed phenomenon whereby individuals with Autism Spectrum Disorder (ASD) switch between options in a repeated task to a greater extent than healthy controls do. In a meta-analysis a large effect size was found (.37) yet because the effect was noisy in different studies it was not statistically significant. The investigators seek to first examine a very large population through an Internet mediated platform. The sample size will be about the size of all of the previous studies that examined this issue together. Secondly, the investigators wish to understand the discrepancy between this choice switching phenomenon and the recorded tendency of ASD individuals to avoid changing choices. First, the investigators will administer the task in which the effect was found (the Iowa Gambling task) for a longer duration than previously and evaluate whether ASD individuals show increased choice switching in the first blocks of trials but reduced switching following more experience. Secondly, the investigators will administer an additional block of trials without feedback in which participants will not be able to go through a learning process. The investigators predict that this will reduce (and possible flip) the tendency of individuals with ASD to switch choices more often.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- Pre-screening, Task session
- Keywords
- Autism Spectrum Disorder, Decision Making
- 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.
Pre-screeningDiagnostic test
Document upload of Autism diagnosis certificate. Participants can request to show their certificate via a Zoom meeting with the researcher instead of uploading it.
Task sessionBehavioural
The Iowa Gambling task- four decks of cards on the computer screen. Each card yields a reward, but might also yield a loss. In each trial, the participant selects a card. Consequently, the card is exposed, displaying the gain and the loss for that trial. Through contingent feedback, participants are expected to learn that some deck are better than others.The task will include 120 trials.
Block of trials without feedback- four decks of cards on the computer screen. Each card yields a reward, but might also yield a loss. In each trial, the participant selects a card. Consequently, the card is exposed, but the gain and the loss for that trial are not displayed. The task will include 30 trials.
Social Responsiveness Scale, 2nd Edition (SRS-2; adult-self report):(Constantino \& Gruber, 2012) The brief autism quotient scale:(AQ10; Baron-Cohen et al., 2001) Brief intelligence test (Similarities-MAB + Raven Set 1)
| Study group | Role | What they receive |
|---|---|---|
| Study participation | All participants will complete the same protocol Receives: Diagnostic Test: Pre-screening; Behavioral: Task session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean run size
Number of consecutive selections from the same deck (across trials and in different blocks).
Measured: Through study completion, an average of 1 year
Advantageous selections
Percentage of advantageous selections(across trials and in different blocks).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Jan 2021
- Primary completion13 Aug 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technion, Israel Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Eldad Yechiam, Technion, Israel Institute of Technology
- Investigators
- Dana Zeif, MSc, Study director, Technion, Israel Institute of TechnologyOfir Yakobi, PhD, Study director, University of WaterlooEldad Yechaim, Professor, Principal investigator, Technion, Israel Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631432
- Sponsor's protocol ID
- 109171
- Other IDs
- Technion institute 109171
- Status last verified
- Apr 2022
- First submitted
- 4 Nov 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zeif D, Yechiam E. Autism is not associated with poor or enhanced performance on the Iowa Gambling Task: A Meta-Analysis. Neurosci Biobehav Rev. 2020 Jun;113:440-447. doi: 10.1016/j.neubiorev.2020.04.016. Epub 2020 Apr 18.
PubMed 32311370Bechara A, Damasio AR, Damasio H, Anderson SW. Insensitivity to future consequences following damage to human prefrontal cortex. Cognition. 1994 Apr-Jun;50(1-3):7-15. doi: 10.1016/0010-0277(94)90018-3.
PubMed 8039375Ozonoff S. Reliability and validity of the Wisconsin card sorting test in studies of autism. Neuropsychology. 1995;9(4):491.
Gaeth GJ, Levin IP, Jain G, Data EV. Toward understanding everyday decision making by adults across the autism spectrum. Judgment and Decision Making. 2016 Nov 1;11(6):537.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice Switching and Autism
- ClinicalTrials.gov ID
- NCT04631432
- Acronym / sponsor ID
- 109171
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- Autism Spectrum Disorder, Decision Making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Technion, Israel Institute of TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 17 Nov 2020 (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 study aims to replicate and clarify a recently observed phenomenon whereby individuals with Autism Spectrum Disorder (ASD) switch between options in a repeated task to a greater extent than healthy controls do. In a meta-analysis a large effect size was found (.37) yet because the effect was noisy in different studies it was not statistically significant. The investigators seek to first examine a very large population through an Internet mediated platform. The sample size will be about the size of all of the previous studies that examined this issue together. Secondly, the investigators wish to understand the discrepancy between this choice switching phenomenon and the recorded tendency of ASD individuals to avoid changing choices. First, the investigators will administer the task in which the effect was found (the Iowa Gambling task) for a longer duration than previously and evaluate whether ASD individuals show increased choice switching in the first blocks of trials but reduced switching following more experience. Secondly, the investigators will administer an additional block of trials without feedback in which participants will not be able to go through a learning process. The investigators predict that this will reduce (and possible flip) the tendency of individuals with ASD to switch choices more often.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participation | – | Diagnostic Test: Pre-screening, Behavioral: Task sessionAll participants will complete the same protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit participants using websites for recruiting experimental participants worldwide.
Key inclusion criteria (2 listed)
- ASD group - Diagnosed with ASD
- Control - No ASD diagnosis: within age and education range of the ASD group.
Key exclusion criteria (2 listed)
- Demographics: Under 18 years of age.
- Mental health: self reported brain injury and neurological disorder (besides autism).
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 |
|---|---|---|
| Pre-screeningDocument upload of Autism diagnosis certificate. Participants can request to show their certificate via a Zoom meeting with the researcher instead of uploading it. | Diagnostic test | Study participation |
| Task sessionThe Iowa Gambling task- four decks of cards on the computer screen. Each card yields a reward, but might also yield a loss. In each trial, the participant selects a card. Consequently, the card is exposed, displaying the gain and the loss for that trial. Through contingent feedback, participants are expected to learn that some deck are better than others.The task will include 120 trials. Block of trials without feedback- four decks of cards on the computer screen. Each card yields a reward, but might also yield a loss. In each trial, the participant selects a card. Consequently, the card is exposed, but the gain and the loss for that trial are not displayed. The task will include 30 trials. Social Responsiveness Scale, 2nd Edition (SRS-2; adult-self report):(Constantino \& Gruber, 2012) The brief autism quotient scale:(AQ10; Baron-Cohen et al., 2001) Brief intelligence test (Similarities-MAB + Raven Set 1) | Behavioural | Study participation |
Primary outcome
Mean run size
Time frame: Through study completion, an average of 1 year
Number of consecutive selections from the same deck (across trials and in different blocks).
Advantageous selections
Time frame: Through study completion, an average of 1 year
Percentage of advantageous selections(across trials and in different blocks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 32311370Zeif D, Yechiam E. Autism is not associated with poor or enhanced performance on the Iowa Gambling Task: A Meta-Analysis. Neurosci Biobehav Rev. 2020 Jun;113:440-447. doi: 10.1016/j.neubiorev.2020.04.016. Epub 2020 Apr 18.
- Background: PubMed 8039375Bechara A, Damasio AR, Damasio H, Anderson SW. Insensitivity to future consequences following damage to human prefrontal cortex. Cognition. 1994 Apr-Jun;50(1-3):7-15. doi: 10.1016/0010-0277(94)90018-3.
- BackgroundOzonoff S. Reliability and validity of the Wisconsin card sorting test in studies of autism. Neuropsychology. 1995;9(4):491.
- BackgroundGaeth GJ, Levin IP, Jain G, Data EV. Toward understanding everyday decision making by adults across the autism spectrum. Judgment and Decision Making. 2016 Nov 1;11(6):537.
- Individual participant dataSharing planned: Undecided
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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.
Dana Zeif, MSc study director
Technion, Israel Institute of Technology
Ofir Yakobi, PhD study director
University of Waterloo
Eldad Yechaim, Professor principal investigator
Technion, Israel Institute of Technology
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), run by Technion, Israel Institute of Technology at 1 site in Israel.
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: finished, as of the sponsor's last update on 27 Apr 2022. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean run size (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT04631432, which also lists 4 linked publications.
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 27 Apr 2022.