Choice Switching and Autism

• ClinicalTrials.gov Identifier: NCT04631432
• Recruitment Status: Recruiting
• First Posted: November 17, 2020
• Last Update Posted: September 9, 2021
• Sponsor: Technion, Israel Institute of Technology
• Information provided by (Responsible Party): Prof. Eldad Yechiam, Technion, Israel Institute of Technology

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment
Autism Spectrum Disorder (ASD)	Diagnostic Test: Pre-screening; Behavioral: Task session

Study Design

• Study Type: Observational
• Estimated Enrollment: 400 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Choice Switching and Autism
• Actual Study Start Date: January 1, 2021
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: October 2021

Groups and Cohorts

Group/Cohort

Intervention/treatment

Study participation; All participants will complete the same protocol

Diagnostic Test: Pre-screening; Document upload of Autism diagnosis certificate. Participants can request to show their certificate via a Zoom meeting with the researcher instead of uploading it.; Behavioral: Task session; 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)

Outcome Measures

Primary Outcome Measures :

1. 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).
2. Advantageous selections [ Time Frame: Through study completion, an average of 1 year ]
   Percentage of advantageous selections(across trials and in different blocks).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Same proportion of males and females from the two groups.
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

We will recruit participants using websites for recruiting experimental participants worldwide.

Criteria

Inclusion Criteria:

• ASD group - Diagnosed with ASD
• Control - No ASD diagnosis: within age and education range of the ASD group.

Exclusion Criteria:

• Demographics: Under 18 years of age.
• Mental health: self reported brain injury and neurological disorder (besides autism).

Contacts and Locations

Contacts

Contact: Eldad Yechiam, Professor; +97248294420; yeldad@ie.technion.ac.il

Locations

Israel

Technion, Israel Institute of Technology; Recruiting

Haifa, Israel

Contact: Eldad Yechiam, PhD 972-4-8294420 yeldad@ie.technion.ac.il

Sponsors and Collaborators

Technion, Israel Institute of Technology

Investigators

• Study Director: Dana Zeif, MSc; Technion, Israel Institute of Technology
• Study Director: Ofir Yakobi, PhD; University of Waterloo
• Principal Investigator: Eldad Yechaim, Professor; Technion, Israel Institute of Technology

More Information

Study Data/Documents: Statistical Analysis Plan 

Study Protocol 

Informed Consent Form 

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. Review.

Bechara 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.

Ozonoff 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.

• Responsible Party: Prof. Eldad Yechiam, Professor, Technion, Israel Institute of Technology
• ClinicalTrials.gov Identifier: NCT04631432
• Other Study ID Numbers: 109171; Technion institute 109171 ( Other Grant/Funding Number: Technion - Israel Institute of Technology )
• First Posted: November 17, 2020
• Last Update Posted: September 9, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Eldad Yechiam, Technion, Israel Institute of Technology:

Autism Spectrum Disorder; Decision Making

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders