- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06355999
Levari Exp.20: 2D - Partial Feedback
Project 2: Levari Exp.20: 2D - Partial Feedback NOTE: Note, This is One of Many Studies Under Project 2 in the Original Grant
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Suppose that observers are trying to classify a spot on the skin as normal or abnormal and suppose that the two attributes that are important are the color and shape of the spot. The investigators have found that perceptual decisions of this short are shaped by the prevalence of the target abnormality and by the feedback that observers (Os) receive. If abnormal spots are rare (low prevalence), Os will tend to become more conservative about calling spots abnormal.
In this experiment, Os see items defined by color and shape. Items vary in dominant color from purple to green. Items vary in shape from relatively smooth irregular blobs (nicknamed "Bouba") to relatively bumpy blobs (nicknamed "Kiki"). Os are asked to find "Green Kikis". Since color and shape vary continuously, the border between Green Kiki and not Green Kiki will not be clear to the Os. Os will be asked to label each item as Green Kiki or not. Saying "maybe" is not an option.
The between-subject variable is the type of feedback Os receive. One set of Os will get feedback about color. That is, if the observer says "yes, this is a green kiki", they will be told only "Yes, this was a green item" or "no this was not green". The other group will get shape feedback: e.g. "Yes, this was a Kiki.".
The within-subjects variable is the target prevalence. The investigators can divide the stimuli into four quadrants: Green Kiki targets, and Green Bouba, Purple Bouba, and Purple Kiki distractors. In the high prevalence trials, 50% of the stimuli will be drawn from target quadrant (green kiki) and 17% from each of the remaining three quadrants. In the low prevalence trials, 10% of the stimuli will be drawn from the target quadrant while 30% will be drawn from each of the other three quadrants. The whole space of stimuli has 10 shape values and 10 color values for a total of 100 possible types of stimulus.
The key dependent is the proportion of target-present responses for each type of stimulus.
To analyze the data, the investigators will create a heatmap showing the percentage of times Os judge each of the 100 categories (10 colors X 10 shapes) as the target, separately for the high prevalence and low prevalence block. The investigators will calculate the response difference between the two blocks within subjects and will calculate the difference between shape and color feedback between observers.
Observers with an average accuracy below 70% will be excluded. Prior experiments have a conservative effect size of ~0.8 for differences between high and low prevalence. Some effects in experiments proposed here may have more subtle effects so power will be calculated based on an effect size of 0.6. To detect such a difference between, for instance, the 50% points on two functions like those in the data figures above, requires 26 observers to achieve alpha of 0.05 and power of 0.9. The investigators will aim for 26 observers in each condition.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Visual Attention Lab / Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
normal color vision- 20/25 or better acuity
Exclusion Criteria:
no history of visual or oculomotor disease-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Color Feedback
Observers are told if the color but not if the shape was correctly identified
|
Feedback is given about the correctness of the response on the color dimension
|
|
Experimental: Shape Feedback
Observers are told if the shape but not if the color was correctly identified
|
Feedback is given about the correctness of the response on the shape dimension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of stimuli identified as target items
Time Frame: Through study completion, an average one 1 year
|
Participants are presented with visual stimuli from a 10 by 10 set of 100 possibilities.
There are 10 levels of color (blue to green) and 10 levels of shape (smooth="Bouba" to bumpy = "Kiki", fully crossed with each other.
Participants are asked to state whether an item is or is not a "green Kiki" target.
For each of the 100 items, the primary outcome measure is the percentage of time that the specific item is called "Green Kiki" target.
|
Through study completion, an average one 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeremy M Wolfe, PhD, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2007p000646-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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