Psychometric Testing: Cued vs. Learned Suppression
Phase: NA
Conditions: Healthy
Sponsor: Lehigh University

Psychometric Testing: Cued vs. Learned Suppression
Protocol Number: NCT06074523.1
National Clinical Trial (NCT) Identified Number: NCT06074523
Principal Investigator*: Nancy B. Carlisle
Sponsor: Lehigh University
Grant Title: Examining Flexibility in Attentional Control
Grant Number: R15EY030247
Funded by: National Eye Institute
Version Number: v.1
2024-10-18

CONFIDENTIALITY STATEMENT
This document is confidential communication. Acceptance of this document constitutes agreement by
the recipient that no unpublished information contained herein will be published or disclosed without
prior approval of the Principal Investigator or other participating study leadership and as consistent with
the NIH terms of award.
NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans

<Psychometric Testing: Cued vs. Learned Suppressions>
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Table of Contents
STATEMENT OF COMPLIANCE
1
INVESTIGATOR’S SIGNATURE
2
1
PROTOCOL SUMMARY
3
1.1
Synopsis
3
1.2
Schema
3
1.3
Schedule of Activities
6
2
INTRODUCTION
7
2.1
Study Rationale
7
2.2
Background
7
2.3
Risk/Benefit Assessment
7
2.3.1
Known Potential Risks
7
2.3.2
Known Potential Benefits
8
2.3.3
Assessment of Potential Risks and Benefits
8
3
OBJECTIVES AND ENDPOINTS
9
4
STUDY DESIGN
12
4.1
Overall Design
12
4.2
Scientific Rationale for Study Design
13
4.3
Justification for Intervention
13
4.4
End-of-Study Definition
13
5
STUDY POPULATION
13
5.1
Inclusion Criteria
14
5.2
Exclusion Criteria
15
5.3
Lifestyle Considerations
16
5.4
Screen Failures
16
5.5
Strategies for Recruitment and Retention
17
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
18
6.1
Study Intervention(s) or Experimental Manipulation(s) Administration
19
6.1.1
Study Intervention or Experimental Manipulation Description
19
6.1.2
Administration and/or Dosing
19
6.2
Fidelity
19
6.2.1
Interventionist Training and Tracking
19
6.3
Measures to Minimize Bias: Randomization and Blinding
20
6.4
Study Intervention/Experimental Manipulation Adherence
21
6.5
Concomitant Therapy
21
6.5.1
Rescue Therapy
22
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
22
7.1
Discontinuation of Study Intervention/Experimental Manipulation
23
7.2
Participant Discontinuation/Withdrawal from the Study
23
7.3
Lost to Follow-Up
24
8
STUDY ASSESSMENTS AND PROCEDURES
25
8.1
Endpoint and Other Non-Safety Assessments
25
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8.2
Safety Assessments
27
8.3
Adverse Events and Serious Adverse Events
28
8.3.1
Definition of Adverse Events
28
8.3.2
Definition of Serious Adverse Events
29
8.3.3
Classification of an Adverse Event
29
8.3.4
Time Period and Frequency for Event Assessment and Follow-Up
31
8.3.5
Adverse Event Reporting
33
8.3.6
Serious Adverse Event Reporting
33
8.3.7
Reporting Events to Participants
34
8.3.8
Events of Special Interest
34
8.3.9
Reporting of Pregnancy
34
8.4
Unanticipated Problems
35
8.4.1
Definition of Unanticipated Problems
35
8.4.2
Unanticipated Problems Reporting
36
8.4.3
Reporting Unanticipated Problems to Participants
37
9
STATISTICAL CONSIDERATIONS
37
9.1
Statistical Hypotheses
37
9.2
Sample Size Determination
38
9.3
Populations for Analyses
39
9.4
Statistical Analyses
39
9.4.1
General Approach
40
9.4.2
Analysis of the Primary Endpoint(s)
40
9.4.3
Analysis of the Secondary Endpoint(s)
41
9.4.4
Safety Analyses
42
9.4.5
Baseline Descriptive Statistics
42
9.4.6
Planned Interim Analyses
42
9.4.7
Sub-Group Analyses
43
9.4.8
Tabulation of Individual Participant Data
43
9.4.9
Exploratory Analyses
44
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
44
10.1
Regulatory, Ethical, and Study Oversight Considerations
44
10.1.1
Informed Consent Process
44
10.1.2
Study Discontinuation and Closure
45
10.1.3
Confidentiality and Privacy
46
10.1.4
Future Use of Stored Specimens and Data
48
10.1.5
Key Roles and Study Governance
49
10.1.6
Safety Oversight
50
10.1.7
Clinical Monitoring
50
10.1.8
Quality Assurance and Quality Control
52
10.1.9
Data Handling and Record Keeping
53
10.1.10
Protocol Deviations
56
10.1.11
Publication and Data Sharing Policy
57
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10.1.12
Conflict of Interest Policy
57
10.2
Additional Considerations
58
10.3
Abbreviations and Special Terms
58
10.4
Protocol Amendment History
60
11
REFERENCES
61
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STATEMENT OF COMPLIANCE
(1) [The trial will be carried out in accordance with International Council on Harmonisation Good
Clinical Practice (ICH GCP) and the following:
•
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR
Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are
responsible for the conduct, management, or oversight of NIH-funded clinical trials have
completed Human Subjects Protection and ICH GCP Training.
The protocol, informed consent form(s), recruitment materials, and all participant materials will
be submitted to the IRB for review and approval. Approval of both the protocol and the consent
form(s) must be obtained before any participant is consented. Any amendment to the protocol
will require review and approval by the IRB before the changes are implemented to the study. All
changes to the consent form(s) will be IRB approved; a determination will be made regarding
whether a new consent needs to be obtained from participants who provided consent, using a
previously approved consent form.
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INVESTIGATOR’S SIGNATURE
The signature below constitutes the approval of this protocol and provides the necessary assurances that
this study will be conducted according to all stipulations of the protocol, including all statements
regarding confidentiality, and according to local legal and regulatory requirements and applicable US
federal regulations and ICH guidelines, as described in the Statement of Compliance above.
Principal Investigator or Clinical Site Investigator:
Signed:
Date:
10/18
/2024
Name*: Nancy Carlisle
Title*: Associate professor of Psychology and Cognitive Science
Investigator Contact Information
Affiliation*: Lehigh University
Address: 17 Memorial Drive W, Bethlehem, PA, 18015
Telephone: 610-758-5122
Email: nbc415@lehigh.edu
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PROTOCOL SUMMARY
No text is to be entered in this section; rather it should be included under the relevant subheadings
below. It may be useful to complete this section after the relevant sections in the protocol have been
completed.
1.1
SYNOPSIS
Title:
Examining Flexibility in Attentional Control
Grant Number:
R15EY030247
Study Description:
Examination of healthy participant’s behavioral responses to determine
if cued attentional suppression and learned attentional suppression rely
on the same mechanisms
Objectives*:
The researchers will compare participants performance on a cued
suppression task (distractor cue), learned suppression task (repeated
distractor), working memory capacity, and inattentional traits.
Endpoints*:
One day measurement of cued suppression task performance, learned
suppression task performance, working memory capacity, and
self-report inattentive traits.
Study Population:
Healthy adults, recruited from Lehigh University
Phase* or Stage:
Phase 0
Description of
Sites/Facilities Enrolling
Participants:
Lehigh University
Description of Study
Intervention/Experimenta
l Manipulation:
Correlational study of four measures: cued suppression, learned
suppression, working memory capacity, and inattentive traits.
Study Duration*:
4 months
Participant Duration:
60 minutes
1.2
SCHEMA
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Flow Diagram
Pre-Screening
Visit 1
1.3
SCHEDULE OF ACTIVITIES
Pre-scr
eening
(Pre-co
nsent)
Visit 1
Day 1
Review Eligibility
X
Informed Consent
X
Demographics
X
Outcome Evaluation
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INTRODUCTION
2.1
STUDY RATIONALE
Recent research has focused on two forms of distractor ignoring.
In learned suppression, repeated
salient distractors are presented and participants learn through experience to ignore the distractor color
(Gaspelin & Luck, 2018).
While salient distractors typically capture attention, learned suppression can
lead to faster performance when a salient distractor is present compared to absent, suggesting that the
salient distractor is suppressed.
Other work on cued distractor suppression has demonstrated the
existence of negative templates, also called templates for rejection (Arita, et al., 2012).
Here,
participants use their working memory to maintain cued colors, and then utilize top-down control to
ignore items matching the distractor color. While both learned and cued suppression lead to ignoring of
distractors, it is unclear if these two types of suppression rely on the same or different underlying
mechanisms (Geng, et al, 2019).
2.2
BACKGROUND
Much of the research on visual attention has focused on how humans direct attention towards our goals
(Desimone & Duncan, 1995). However, recent research has identified two ways in which attention can be
configured to ignore distractors, also improving attentional performance.
In learned suppression
(Gaspelin & Luck, 2018), repeated salient distractors are presented, and over learning, these salient items
can become ignored.
Participants are not instructed to ignore the salient items, however they learn
through selection history to ignore the salient items.
In cued suppression (Carlisle, 2023), participants
are explicitly told to ignore a cued color presented before the search array. Here as well, participants are
able to direct attention away from the cued color. However, although both tasks rely on suppressing
colored items, it is unclear whether they rely on the same mechanisms.
Learned suppression is an
implicit phenomenon, while cued suppression is based on explicit top-down control.
Here, the researchers will look for correlations between the amount of suppression generated in cued
suppression and learned suppression. The researchers will also measure working memory capacity, as an
index of overall cognitive control.
And researchers will take a measure of everyday distraction, an
inattentive traits scale. The researchers will examine the correlations between all of these measures to
determine if cued and learned suppression have shared underlying mechanisms.
2.3
RISK/BENEFIT ASSESSMENT
No text is to be entered in this section; rather it should be included under the relevant subheadings
below.
The following subsections should include a discussion of known risks and benefits, if any, to human
participants. Text from the corresponding sections of the Human Subjects section of the grant
application, and/or IRB package may be used here.
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2.3.1
KNOWN POTENTIAL RISKS
The risks associated with the behavioral tasks are similar to working on a computer or playing a video game. They include
possible eye strain, and boredom. Researchers will try to reduce the possibility of these risks by providing frequent breaks
during the experiment (approximately every 5 minutes during data recording).
2.3.2
KNOWN POTENTIAL BENEFITS
There are no direct benefits expected for the participants, however many participants enjoy being able to learn more about how
The researchers use behavioral responses to understand more about cognition.
2.3.3
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS
Given that the risks are similar to daily tasks, the benefits to science are considered to outweigh the risks
of the study.
3
OBJECTIVES AND ENDPOINTS
Provide a description of the study objectives and endpoints, as well as a justification for selecting the
particular endpoints, in the table format included below. This will provide clear articulation of how the
selected primary and secondary endpoint(s) are linked to achieving the primary and secondary objectives
and an explanation of why endpoint(s) were chosen. Data points collected in the study should support an
objective or have a regulatory purpose. Therefore, careful consideration should be given prospectively to
the amount of data needed to support the study’s objectives.
An objective is the purpose for performing the study in terms of the scientific question to be answered.
Express each objective as a statement of purpose (e.g., to assess, to determine, to compare, to evaluate)
and include the general purpose (e.g., feasibility, acceptability, engagement of the intervention target,
identifying mechanisms of action, mediation, moderation, efficacy, effectiveness, dissemination,
implementation).
A study endpoint is a specific measurement or observation to assess the effect of the study intervention.
Study endpoints should be prioritized and should correspond to the study objectives and hypotheses
being tested. Give succinct and precise definitions of the study endpoints used to address the study’s
primary objective and secondary objectives (e.g., specific diagnostic tests that define safety or efficacy,
clinical assessments of disease status, assessments of psychosocial characteristics, patient reported
outcomes, behaviors or health outcomes). A full description of study endpoints, including administration,
scoring, psychometrics, adjudication of endpoints, etc., belongs in Section 8, Study Assessments and
Procedures.
A putative mechanism of action is the theorized explanation for how the intervention functions.
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Consider whether primary and secondary endpoints should be adjusted for multiple comparisons,
family-wise error rates, alpha inflation, etc. Details of any such adjustments should be included in Section
9.4.2, Analysis of the Primary Endpoint(s) and Section 9.4.3, Analysis of the Secondary Endpoint(s).
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR
ENDPOINTS
Primary
To assess the degree of
relatedness between cued
and learned suppression
Learned
suppression
performance, cued
suppression
performance,
working memory
capacity,
inattentive traits
By measuring performance in
both cued and learned
suppression within the same
individuals, the researchers
can look for correlations
indicating a shared underlying
mechanism. Including
measures associated with
cognitive control (working
memory capacity) and
everyday distractability
(inattentive traits), the
researchers can further
confirm whether shared
mechanisms are at play.
4
STUDY DESIGN
4.1
OVERALL DESIGN
Hypothesis: Cued and learned suppression rely on separate underlying mechanisms. This is a Phase 0,
single site study with a within-subjects design in healthy participants. Order of templates (intervention)
within participants is counterbalanced.
4.2
SCIENTIFIC RATIONALE FOR STUDY DESIGN
Within subjects designs are considered a desirable design in cognitive studies, if possible. Within-subjects
designs ensure that differences between conditions are not driven by differences in the individuals
assigned to each group.
4.3
JUSTIFICATION FOR INTERVENTION
Single-day designs are typical for the assessment of different attentional templates (Arita, et al, 2012;
Carlisle & Nitka, 2019; Zhang & Carlisle, 2023).
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4.4
END-OF-STUDY DEFINITION
A participant is considered to have completed the study if he or she has completed each of the tasks of
the study.
5
STUDY POPULATION
5.1
INCLUSION CRITERIA
Healthy adults aged 18+ with normal or corrected-to-normal visual acuity, and normal color vision will be recruited. Participants
may be recruited from the Lehigh University student body as well as the local area. Some participants will be recruited through
the University's online participant recruitment system, SONA, where participants will see a brief description of the study and
choose to sign-up. Researchers may also post notices on Lehigh's daily emails (these notices will contain the same text as the
provided flier). Participants may also be recruited through fliers (see example flier) and word-of-mouth. Fliers may be posted on
campus, or in the local community on public bulletin boards (e.g. in a grocery store). All fliers will explain what characteristics The
researchers are looking for in our participants, and the compensation provided to our participants. These participants may email
or phone the researchers to express their interest, and may be contacted by email or phone to schedule their participation, or be
directed to sign up for the SONA experimental participation system. Individuals who choose to participate may let others know
about the studies by word-of-mouth.
Researchers will not require that participants see the fliers themselves in order for them to participate, but will allow all
participants who meet the requirements the opportunity to participate. If a participant would like to be contacted about further
studies in our lab when they finish their experiment, The researchers may also add them to a lab database of potential
participants. This lab database may receive emails to let them know about new studies The researchers conduct in the lab
(emails will contain the same information included in the flier, as well as 'We are recruiting participants for a new behavioral study
on attention').
5.2
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
1.
Under age 18
2.
Abnormal color vision
3.
Visual acuity which is not normal, and has not been corrected to normal (20/20)
5.3
LIFESTYLE CONSIDERATIONS
●
N/A
5.4
SCREEN FAILURES
Participants are pre-screened for eligibility before signing up for the study.
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5.5
STRATEGIES FOR RECRUITMENT AND RETENTION
●
Participants will be recruited from the Lehigh participant pool, which includes students who are
currently enrolled in PSYC 001 and fulfilling a research experience requirement for the class.
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
6.1
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION
6.1.1
STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION
Learned suppression : Participants will perform a learned suppression task, where the same color of
salient distractor repeats across trials of a visual search task. Salient distractors do not appear on each
trial, creating a baseline performance condition.
Researchers will measure the effect of salient
distractors by comparing reaction time on salient distractor present and salient distractor absent trials.
Cued suppression: Participants will perform a cued suppression task, where they receive an informative
negative cue indicating the color of a large number of distractors on the upcoming search trials. On
other trials they will receive a neutral cue which provides no information about the upcoming array.
Participants will also perform a positive cue condition, where the cue indicates the color of the upcoming
target. Researchers will examine the benefits from receiving the informative negative cue compared to
the neutral cue.
Working memory capacity: Participants will perform a visual change localization task, leading to an
estimate of their working memory capacity based on change localization performance.
Inattentive traits task: Adult Attention Deficit Hyperactivity Disorder (ADHD) Self Report Scale (used on
healthy adults), Inattentive Traits subscale. Higher values indicate more ADHD-like inattentive trait
symptoms (0-45).
6.1.2
ADMINISTRATION AND/OR DOSING
Each participant will perform each task.
6.2
FIDELITY
6.2.1
INTERVENTIONIST TRAINING AND TRACKING
Each participant will receive the same instructions before performing each task block.
Research
assistants will read from the same script to ensure equivalent information provided to each participant,
and address any participant questions.
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6.3
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING
N/A
6.4
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE
Researchers check participant understanding of each task by having them perform a practice block. (No
practice for answering the questionnaire.)
6.5
CONCOMITANT THERAPY
N/A
6.5.1
RESCUE THERAPY
N/A
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
7.1
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
Participants can discontinue performance of the study at any time, if they no longer wish to participate,
by informing the research assistant. Participants will be asked why they are discontinuing participation,
but will be able to discontinue participation without providing a reason.
7.2
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY
Researchers will attempt to have all participants complete study, but if time allotted is exceeded, they
may not finish the study.
7.3
LOST TO FOLLOW-UP
If a participant leaves the study without telling the researcher, the participant will be lost.
8
STUDY ASSESSMENTS AND PROCEDURES
8.1
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS
Participants will be screened for inclusion.
Participants will provide informed consent before
commencing the study. Researchers will measure performance on visual search tasks, but the
performance on working memory probe trials is the key measure of the study.
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8.2
SAFETY ASSESSMENTS
RAs will continuously monitor for any adverse effects, and report any issues to the
PI immediately.
8.3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS
8.3.1
DEFINITION OF ADVERSE EVENTS
Adverse events would be any event that does not include the possible typical effects of boredom or eye
strain from looking at a computer screen.
8.3.2
DEFINITION OF SERIOUS ADVERSE EVENTS
Any event beyond typical eye strain and boredom will be reported to the Lehigh IRB for evaluation as
possible serious adverse events.
8.3.3
CLASSIFICATION OF AN ADVERSE EVENT
1.1.1.1
SEVERITY OF EVENT
Any AE beyond eye strain and boredom, especially those which lead to participant withdrawal, will be
reported to the IRB. Evaluation of severity of adverse events will be undertaken in consultation with the
Lehigh IRB.
1.1.1.2
RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
Any AE beyond eye strain and boredom, especially those which lead to participant withdrawal, will be
reported to the IRB. Evaluation of likelihood of relatedness to study protocol of adverse events will be
undertaken in consultation with the Lehigh IRB.
1.1.1.3
EXPECTEDNESS
Any expected adverse events (boredom or eye strain) may be reported in our subject run sheet.
1.1.2
TIME PERIOD
AND FREQUENCY
FOR EVENT ASSESSMENT
AND
FOLLOW-UP
AE will be assessed during the single day of study, only during the measurement period.
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1.1.3
ADVERSE EVENT REPORTING
Research assistants will report all AEs to the PI. Any AEs beyond expected (e.g. beyond boredom or eye
strain) will be reported to the IRB to initiate a discussion of the AE between the PI and Lehigh IRB.
1.1.4
SERIOUS ADVERSE EVENT REPORTING
Research assistants will report all AEs to the PI. Any AEs beyond expected (e.g. beyond boredom or eye
strain) will be reported to the IRB to initiate a discussion of the AE between the PI and Lehigh IRB.
1.1.5
REPORTING EVENTS TO PARTICIPANTS
N/A
1.1.6
EVENTS OF SPECIAL INTEREST
N/A
1.1.7
REPORTING OF PREGNANCY
N/A
1.2
UNANTICIPATED PROBLEMS
1.2.1
DEFINITION OF UNANTICIPATED PROBLEMS
UPs include the inability to finish the study protocol, and would require a reevaluation of the
current study procedures.
1.2.2
UNANTICIPATED PROBLEMS REPORTING
UPs will be discussed with Lehigh IRB
See CD Section 8.4.1 for additional example text applicable for devices.
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1.2.3
REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS
N/A
2
STATISTICAL CONSIDERATIONS
2.1
STATISTICAL HYPOTHESES
Researchers hypothesize that cued and learned suppression rely on separate underlying mechanisms,
leading to no correlation in suppression between the two tasks.
2.2
SAMPLE SIZE DETERMINATION
Data collection procedures
Researchers requested 75 participants in this study.
75 completed the task by the end of
participant recruitment. Participants were at least 18 years old. It was a standard lab
experiment. This study took 60 minutes to complete.
In this experiment, participants received verbal instructions from the experimenter before
performing each task.
Both their color vision and their visual acuity have to be normal or corrected-to-normal (with
glasses or contacts) (inclusion criteria).
No files selected
Sample size
A power analysis thus suggested that 48 participants would be sufficient (by using G*Power 3.1,
when setting alpha error = to 0.05 and 90% power, with two-tailed testing). Researchers
decided to include a larger sample size (75) to ensure enough power to detect the correlation,
following participant exclusion.
Sample size rationale
Regarding the hypothesis on correlations, researchers anticipate discovering a moderate effect
size of 0.45. This assumption is based on the previous studies discussed in the introduction,
suggesting strong relationship between cued- and learned-suppression, as well as relationships
with visual working memory and distractibility in everyday life thoughts.
A power analysis thus suggested that 48 participants would be sufficient (by using G*Power 3.1,
when setting alpha error = to 0.05 and 90% power, with two-tailed testing).
Stopping rule
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Researchers planned to use as many good participants as the researchers were able to collect
within the sample of 75 requested. 21 participants were excluded for either bad accuracy in one
of the cognitive tasks (n = 11) or for incomplete data recording (n = 10).
2.3
POPULATIONS FOR ANALYSES
Participants will be recruited from Lehigh’s participant pool
2.4
STATISTICAL ANALYSES
2.4.1
GENERAL APPROACH
Statistical models
To explore if the capacity to suppress cued distractors relies on the same mechanisms that the
learned-suppression, Pearson correlation analysis will be performed between raw behavioral
performance or indices (e.g., RT benefits and probe suppression) between the cued- and the
learned-suppression task. In the same manner, to explore if the attentional suppression abilities
(cued- and learned-suppression) were similarly associated with the visual working memory ability
and the everyday life suppression ability, Pearson correlation has been used.
No files selected
Transformations
Researchers will calculate cued suppression benefits from informative negative cues in the search
task by comparing informative cue RT/accuracy to neutral.
Researchers will measure the singleton presence effect by contrasting the reaction time when a
salient singleton item is presents compared to absent in the array.
For the visual working memory task, k score was computed for each subject in line with Zhao et al.
(2022): k = (Accuracy*N2 −N)/(N −1), where the setsize N equals 6.
Based on Stanton et al., 2018, reseachers isolated a set of items in the ASRS to measure the
inattentive and hyperactivity/ impulsivity traits of each individual. A confirmatory factor analysis
(CFA) with the factor Inattention (Q1, Q2, Q3, Q4, Q7, Q8, Q9, Q10, Q11) and the factor
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hyperactivity/impulsivity (Q5, Q6, Q12, Q13, Q14, Q15, Q16, Q17, Q18) was conducted to verify that a
priori selected items reflect the same inattentive trait construct in the current dataset. The CFA
revealed that the model did not fit the data correctly, as revealed by X2(134) = 198, p < 0.001; and
the fit indices CFI = 0.74; RMSEA = 0.093. In the next step, Q10 was excluded from the analysis
because of a bad estimate for the Inattentive traits factor. After exclusion, the model fit the data with
X2(118) = 130, p = 0.213; and appropriate fit indices CFI = 0.94; RMSEA = 0.043.
Inference criteria
Significant level of 0.05 will be used in all tests.
Data exclusion
Participants with 2.5 deviation below the mean accuracy will be excluded.
Trials with RT less than 300 ms, greater than 2.5 sd above the mean for that condition, will be
excluded from all analyses. Trials with incorrect responses will be excluded from the RT analysis.
Missing data
If a subject misses a cue condition, that subject will not be included in the analysis.
Exploratory analysis
N/A
2.4.2
ANALYSIS OF THE PRIMARY ENDPOINT(S)
Statistical models
To explore if the capacity to suppress cued distractors relies on the same mechanisms that the
learned-suppression, Pearson correlation analysis will be performed between raw behavioral
performance or indices (e.g., RT benefits and probe suppression) between the cued- and the
learned-suppression task. In the same manner, to explore if the attentional suppression
abilities (cued- and learned-suppression) were similarly associated with the visual working
memory ability and the everyday life suppression ability, Pearson correlation has been used.
2.4.3
ANALYSIS OF THE SECONDARY ENDPOINT(S)
N/A
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2.4.4
SAFETY ANALYSES
N/A
2.4.5
BASELINE DESCRIPTIVE STATISTICS
N/A
2.4.6
PLANNED INTERIM ANALYSES
N/A
2.4.7
SUB-GROUP ANALYSES
2.4.8
TABULATION OF INDIVIDUAL PARTICIPANT DATA
No.
2.4.9
EXPLORATORY ANALYSES
N/A
3
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
3.1
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
3.1.1
INFORMED CONSENT PROCESS
Participants will provide written informed consent.
3.1.1.1
CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS
Text of the consent form is as follows:
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CONSENT FORM
Studies on Attention and Cognition: Behavior
You are invited to be in a research study of visual attention and cognition. You were selected as a possible
participant because you are 18 years of age or older, have normal or corrected-to-normal visual acuity and normal
color vision. We ask that you read this form and ask any questions you may have before agreeing to be in the study.
Your participation is entirely voluntary.
This study is being conducted by: Dr. Nancy Carlisle, Assistant Professor of Psychology, Lehigh University
Background Information
The purpose of this study is:
Learn more about how we are able to control our attention, and why we are sometimes distracted. We are looking at
aspects of behavioral performance to learn more about the cognitive abilities underlying this performance.
Procedures
If you agree to be in this study, we would ask you to do the following things:
We will be recording your behavioral responses including reaction times and accuracy while you perform various
types of tasks. For instance, in one task you may be looking at simple shapes on the computer screen pressing
buttons after you find a target and responding to an aspect of the target. Another example task involves performing
simple arithmetic tasks. For each task, you will receive clear instructions before performing the task and will need to
follow the task instructions. You may ask your researcher now if you would like an overview of all the simple tasks
you will be asked to perform today. The tasks will involve using your attention and/or other aspects of cognition to
perform to the best of your ability. This study will not use random assignment to treatment conditions. For some
studies, we may ask you to return for a second session. This study does not provide a clinical treatment, meaning
there are no alternative treatments or procedures available.
Risks and Benefits of being in the Study
The study involves the following foreseeable risks: The risks associated with the behavioral tasks are similar to
working on a computer or playing a video game. They include possible eye strain, and boredom. We will try to
reduce the possibility of these risks by providing frequent breaks during the experiment (approximately every 5
minutes during data recording). This study does not include any foreseeable risks to an embryo, fetus, or nursing
infant.
The benefits to participation are: There are no direct benefits expected for the participants, and no clinical benefits,
however many participants enjoy being able to learn more about how we use behavioral measures to understand
more about cognition. More broadly, this research will help us learn more about how attention works, which is a
critical aspect of daily life.
Duration
Participation in the study involves the following time commitment:
Studies may last from 0.5-2 hours, with the expected time for your study being _______ hours. You will receive
participation credit or compensation for the amount of time required to complete the study.
Compensation
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If you have signed up for this study using the for-credit SONA system at Lehigh University, you will be granted credit
within the system that may serve as partial completion of an experimental psychology requirement or extra credit for
a course. You will be granted credits for the amount of time you participate.
You will receive payment:
If you have signed up for this study for compensating payment, you will receive payment at a rate of $12/hr for your
participation. You will be paid based on the amount of time you participate.
Confidentiality
Participation in research involves some loss of privacy. The researchers will make every effort to ensure that
information about you remains confidential, but cannot guarantee total confidentiality. Your identity will not be
revealed in any publications, presentations, or reports resulting from this research study.
We will collect your data through behavioral responses and eye tracking. This data will be stored in a restricted
access folder on Google Drive, secure Lehigh drives, and/or on password protected machines. This informed
consent form will be kept for at least three years after the study is complete, and then it will be destroyed.
Any personal information that could identify you may be removed from the data you have provided and then the
de-identified data may be used for future research studies, or distributed to another investigator for future research,
without asking for your additional permission.
It is unlikely, but possible, that we may be required to share the information you give us from the study to ensure that
the research was conducted safely and appropriately. We will only share your information if law or policy requires
us to do so. The monitors, auditors, IRB, and regulatory authorities will be granted direct access to your original
medical records (if provided) and data for verification of clinical trial procedures and data, without violating the
confidentiality of the participant, to the extent permitted by applicable laws and regulations and that, by signing the
consent document, the participant or their legally authorized representative is authorizing such access.
Finally, you should understand that the investigator is not prevented from taking steps, including reporting to
authorities, to prevent serious harm to yourself or others.
Voluntary Nature of the Study
Participation in this study is entirely voluntary:
Your decision whether or not to participate will not affect your current or future relations with the Lehigh
University. If you decide to participate, you are free to not answer any question or withdraw at any time without
affecting those relationships.
Contact About Future Studies
If you would like to be contacted about future studies being run in the lab for monetary compensation, we can add
you to our participant database which includes email addresses of interested participants. The database is be
maintained on password-protected computers and password-protected online storage (Lehigh storage and Lehigh
Google Storage). Your email address will not be associated with your data or participation information, and you
can remove your email at any time by contacting the researchers or replying to an email about a study opportunity.
You are not obligated to participate in any future research if you add your email to the database.
Print
your
email
address
here
only
if
you
wish
to
be
contacted
about
future
studies:
___________________________
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Contacts and Questions
The Institutional Review Board (IRB) for the protection of human research participants at Lehigh University has
reviewed and approved this study. If you have questions about the research study itself, please contact the Principal
Investigator (610) 758-5122 or nbc415@lehigh.edu. If you have questions about your rights or would simply like to
speak with someone other than the research team about the questions or concerns, please contact the IRB at
(610) 758-2871 or inirb@lehigh.edu. All reports or correspondence will be kept confidential.
You will be given a copy of this information to keep for your records.
Statement of Consent
I have read the above information. I have had the opportunity to ask questions and have my questions answered. I
consent to participate in the study.
Signature:_____________________________________________________
Date: _________
Signature of Investigator:_________________________________________
Date: _________
3.1.1.2
CONSENT PROCEDURES AND DOCUMENTATION
Participants will be given a brief overview of the study requirements (e.g. see stimuli and respond) and
then be given the consent document.
3.1.2
STUDY DISCONTINUATION AND CLOSURE
If multiple AEs are reported, or SAE, discontinuation of the study will be discussed and decided in
consultation with the Lehigh IRB.
3.1.3
CONFIDENTIALITY AND PRIVACY
3.1.4
FUTURE USE OF STORED SPECIMENS AND DATA
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Consent documents will be maintained in a locked space. All participant data will be saved using a participant code
at recording, and will be analyzed in this anonymous format. All reported data will be anonymous.
Coded data will be maintained on password-protected machines or storage, and will be anonymous. Nothing in the
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Any personal information that could identify the participant will be removed from the data you have provided and
then the de-identified data may be used for future research studies, or distributed to another investigator for future
research, without asking for additional permission from participants.
3.1.5
KEY ROLES AND STUDY GOVERNANCE
Principal Investigator
Nancy B. Carlisle, PhD
Lehigh University
Chandler-Ullmann Hall
610-758-5122
nbc415@lehigh.edu
3.1.6
SAFETY OVERSIGHT
Safety oversight will initially be conducted by the research assistants conducting the study, and oversight
will be provided by the PI.
3.1.7
CLINICAL MONITORING
Monitoring will be provided by the research assistants, and oversight will be provided by the PI.
3.1.8
QUALITY ASSURANCE AND QUALITY CONTROL
RAs will be trained by senior researchers in appropriate informed consent and task instruction
procedures, and given oversight until satisfactory performance is achieved.
3.1.9
DATA HANDLING AND RECORD KEEPING
3.1.9.1
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES
Data collection will be the responsibility of the clinical trial staff at the site under the supervision of the
site investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility,
and timeliness of the data reported.
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of
data, and electronic data will be maintained and backed up regularly.
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3.1.9.2
STUDY RECORDS RETENTION
Study documents will be retained for a minimum of 2 years after publication. Researchers plan to
upload anonymized study data to OSF for further use.
3.1.10 PROTOCOL DEVIATIONS
Senior researchers will look for evidence of protocol deviation. RAs will be trained to follow scripts and
observed before independently testing participants.
It will be the responsibility of the site investigator to use continuous vigilance to identify and correct any
deviations in protocol.
3.1.11 PUBLICATION AND DATA SHARING POLICY
This study will be conducted in accordance with the following publication and data sharing policies and
regulations:
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for
publication.
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in
peer-reviewed journals. Data from this study may be requested from other researchers x years after the
completion of the primary endpoint by contacting Dr. Carlisle or examining the OSF repository for this
study. Considerations for ensuring confidentiality of these shared data are described in Section 10.1.3.
3.1.12 CONFLICT OF INTEREST POLICY
The independence of this study from any actual or perceived influence, such as by the pharmaceutical
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design,
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore,
persons who have a perceived conflict of interest will be required to have such conflicts managed in a
way that is appropriate to their participation in the design and conduct of this trial. The study leadership
in conjunction with the NEI has established policies and procedures for all study group members to
disclose all conflicts of interest and will establish a mechanism for the management of all reported
dualities of interest.
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3.2
ADDITIONAL CONSIDERATIONS
N/A
3.3
ABBREVIATIONS AND SPECIAL TERMS
AE
Adverse Event
ANCOVA
Analysis of Covariance
CFR
Code of Federal Regulations
CLIA
Clinical Laboratory Improvement Amendments
CMP
Clinical Monitoring Plan
COC
Certificate of Confidentiality
CONSOR
T
Consolidated Standards of Reporting Trials
CRF
Case Report Form
DCC
Data Coordinating Center
DHHS
Department of Health and Human Services
DSMB
Data Safety Monitoring Board
DRE
Disease-Related Event
EC
Ethics Committee
eCRF
Electronic Case Report Forms
FDA
Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act of
2007
FFR
Federal Financial Report
GCP
Good Clinical Practice
GLP
Good Laboratory Practices
GMP
Good Manufacturing Practices
GWAS
Genome-Wide Association Studies
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICH
International Council on Harmonisation
ICMJE
International Committee of Medical Journal Editors
IDE
Investigational Device Exemption
IND
Investigational New Drug Application
IRB
Institutional Review Board
ISM
Independent Safety Monitor
ITT
Intention-To-Treat
LSMEANS
Least-squares Means
MedDRA
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NCT
National Clinical Trial
NIH
National Institutes of Health
NIH IC
NIH Institute or Center
OHRP
Office for Human Research Protections
PI
Principal Investigator
QA
Quality Assurance
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QC
Quality Control
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SMC
Safety Monitoring Committee
SOA
Schedule of Activities
SOC
System Organ Class
SOP
Standard Operating Procedure
UP
Unanticipated Problem
US
United States
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3.4
PROTOCOL AMENDMENT HISTORY
The table below is intended to capture changes of IRB-approved versions of the protocol, including a
description of the change and rationale. A Summary of Changes table for the current amendment is
located in the Protocol Title Page.
Version
Date
Description of Change
Brief Rationale
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REFERENCES
Arita, J. T., Carlisle, N. B., & Woodman, G. F. (2012). Templates for rejection: configuring attention to
ignore task-irrelevant features. Journal of experimental psychology: human perception and performance,
38(3), 580.
Carlisle, N. B. (2023). Negative and positive templates: Two forms of cued attentional control. Attention,
Perception, & Psychophysics, 85(3), 585-595.
Desimone, R., & Duncan, J. (1995). Neural mechanisms of selective visual attention. Annual review of
neuroscience, 18(1), 193-222.
Gaspelin, N., & Luck, S. J. (2018). The role of inhibition in avoiding distraction by salient stimuli. Trends in
cognitive sciences, 22(1), 79-92.
Geng, J. J., Won, B. Y., & Carlisle, N. B. (2019). Distractor ignoring: Strategies, learning, and passive
filtering. Current Directions in Psychological Science, 28(6), 600-606.
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