Choice Switching and Autism

April 26, 2022 updated by: Prof. Eldad Yechiam, Technion, Israel Institute of Technology
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 Overview

Status

Status

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

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.

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.
Observational

Enrollment (Actual)

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.
114

Contacts and Locations

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

Study Locations

  • Israel
      • Haifa, Israel
        • Technion, Israel Institute of Technology

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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)

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

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.
Technion, Israel Institute of Technology

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 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 1, 2021

Primary Completion (ACTUAL)

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.
August 13, 2021

Study Completion (ACTUAL)

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.
September 13, 2021

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).
November 4, 2020

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.
November 10, 2020

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.
November 17, 2020

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 27, 2022

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 26, 2022

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, 2022

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.
  • 109171
  • Technion institute 109171 (OTHER_GRANT: Technion - Israel Institute of Technology)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Statistical Analysis Plan
  2. Study Protocol
  3. Informed Consent Form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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