An Investigation of a Parent/Child Psycho-social Computerized Intervention Targeting the Error-related Negativity in Young Children
Phase: NA
Conditions: Anxiety
Sponsor: Florida State University

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 1 of 25
Revised: June 19, 2020
PROTOCOL TITLE:
An investigation of a parent/child psycho-social computerized intervention 
targeting the error-related negativity in young children
PRINCIPAL INVESTIGATOR:
Alexandria Meyer
Psychology
850-644-1969
meyer@psy.fsu.edu 
VERSION NUMBER/DATE:
Version 5
6/19/2020
REVISION HISTORY
Revision 
#
Version Date
Summary of Changes
Consent 
Change?
2
10/23/2019
Transferring protocol to RAMP
no
3
12/6/2019
Adding mailing list, interviews, self-report 
measures, etc.
yes
4
2/17/2020
Adding self-report measures, changing 
demographic questionnaire, removing $40 
incentive for between-session module 
completion
yes
5
6/19/2020
Addition of COVID-19 procedures
yes

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 2 of 25
Revised: June 19, 2020
Table of Contents
1.0
Study Summary ........................................................................................................3
2.0
Objectives* ...............................................................................................................4
3.0
Background*.............................................................................................................4
4.0
Study Endpoints*......................................................................................................4
5.0
Study Intervention/Investigational Agent.................................................................4
6.0
Procedures Involved* ...............................................................................................5
7.0
Data and Specimen Banking*...................................................................................5
8.0
Sharing of Results with Subjects* ............................................................................6
9.0
Study Timelines*......................................................................................................6
10.0
Inclusion and Exclusion Criteria* ............................................................................6
11.0
Vulnerable Populations*...........................................................................................6
12.0
Local Number of Subjects ........................................................................................7
13.0
Recruitment Methods................................................................................................7
14.0
Withdrawal of Subjects*...........................................................................................7
15.0
Risks to Subjects*.....................................................................................................7
16.0
Potential Benefits to Subjects* .................................................................................8
17.0
Data Management* and Confidentiality...................................................................8
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*...........................8
19.0
Provisions to Protect the Privacy Interests of Subjects ............................................9
20.0
Compensation for Research-Related Injury..............................................................9
21.0
Economic Burden to Subjects...................................................................................9
22.0
Consent Process........................................................................................................9
23.0
Process to Document Consent in Writing...............................................................12
24.0
Setting.....................................................................................................................13
25.0
Resources Available ...............................................................................................13
26.0
Multi-Site Research* ..............................................................................................13

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 3 of 25
Revised: June 19, 2020
1.0
Study Summary
Study Title
An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related 
negativity in young children
Study Design
This is a 5-year training grant wherein during the 1st year of 
the award, PI, Dr. Alexandria Meyer, will develop a novel 
computerized intervention for parents and children that aims 
to reduce over-reactivity to making mistakes.
Primary Objective
Reduce over-reactivity to making mistakes in children.
Secondary 
Objective(s)
Research 
Intervention(s) 
A novel computerized intervention for parents and children 
that aims to reduce over-reactivity to making mistakes.
Study Population
175 parent/child dyads with children between the ages of 5 
and 7 years-old
Sample Size
175 parent/child dyads
Study Duration for 
individual 
participants
6 months
Study Specific 
Abbreviations/ 
Definitions 
ERN = error-related negativity

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 4 of 25
Revised: June 19, 2020
2.0
Objectives*
2.1
AIM 1: Assess initial target engagement by examining whether a 
neural marker of risk for anxiety (i.e., the ERN) in children is decreased 
during a single lab visit, via a brief, computerized intervention designed to 
target error sensitivity. We hypothesize that children who receive the 
intervention will display a decrease in the ERN at the first assessment, 
compared to children in the control condition. 1a. Assess alternate 
measures of target engagement. Self-report and observational measures of 
error sensitivity will also be decreased for parents and children who 
receive parent and child active interventions, respectively. AIM 2: 
Examine whether children in the intervention conditions display a 
reduction in the ERN from the initial lab assessment to the six-month 
follow-up assessment. We expect that children in all treatment conditions 
(parent/child, parent only, child only) will display a reduced ERN 
compared to the control group. 2a. Dissociate the impact of parent/child, 
parent only, versus child only treatment conditions. We hypothesize that 
children in the combined treatment group (parent/child) will have the 
greatest reduction in the ERN. 2b. Examine the impact of utilization. We 
expect that parents and children who utilize the treatment materials more 
frequently will experience the greatest reduction in the ERN. 2c. Assess 
alternate measures of target engagement. We will also examine all 
hypotheses in relation to self-report and observed measures of parent and 
child error sensitivity. AIM 3: Examine whether parent/child dyads in the 
intervention conditions experience changes in anxiety symptoms at the 
six-month follow-up. We hypothesize that the dyads in the intervention 
conditions will experience greater changes in anxiety symptoms compared 
to the control group. We will also compare conditions, as well as examine 
the impact of utilization. In exploratory analyses, we will examine to what 
extent changes in the ERN and error-sensitivity relate to changes in 
anxiety symptoms in children.
3.0
Background*
3.1
Anxiety disorders are the most common form of psychopathology, 
and are associated with substantial impairment. Longitudinal-prospective 
work demonstrates that anxiety disorders often begin in childhood and 
persist across the lifespan. Therefore, there is a critical need and 
opportunity to identify markers of risk that predict anxious trajectories of 
development. Markers that are evident before symptoms become 
impairing may be novel targets for intervention. One promising biomarker 
of anxiety is increased brain activity in response to errors, as reflected by 
the error-related negativity (ERN). The ERN is a deflection in the event-
related potential (ERP) occurring after an individual makes a mistake on 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 5 of 25
Revised: June 19, 2020
lab-based tasks. In over 45 studies to date, the ERN has been found to be 
increased in anxious individuals, including children as young as age. 
Critically, an increased ERN has also been shown to predict the onset of 
new anxiety disorders in children and adolescents, even while controlling 
for baseline anxiety symptoms and other known risk factors.
Considering the ERN is elevated before anxiety symptoms become 
impairing, it is crucial to identify factors that may modify the ERN early 
in life – and determine if doing so can prevent the onset of clinical 
anxiety. Given that the ERN can be potentiated in the lab by punishment 
for errors8, we hypothesized that exposure to critical parenting styles may 
sensitize children to their own mistakes. Indeed, we found that both 
observational and self-report measures of critical parenting style related to 
an increased ERN in offspring in a large sample of young children. This 
finding has since been replicated in even younger children (approximately 
4 years old), suggesting that the ERN is a neural risk marker for anxiety 
that can be shaped by parenting behaviors. This raises the possibility that 
the ERN might also be modified by targeting specific parenting behaviors, 
and thus, may be a modifiable biomarker. However, no previous work has 
examined whether modifying parenting can impact the ERN. Moreover, 
no previous work has examined the extent to which any targeted 
intervention may impact the ERN in children.
3.2
In my lab, we have recently collected pilot data suggesting that the 
ERN can be reduced in children undergoing a brief, computerized, 
psychosocial intervention targeting reactivity to making mistakes. 
Drawing upon this and other work, in the current proposal, we will 
develop a novel psychosocial intervention that targets over-reactivity to 
children’s errors, which can be administered to parents and children, or 
both, which aims to reduce the ERN in children.
3.3
The proposed Mentored Career Development Award (K01) is 
designed to extend my previous work on the ERN, parenting, and risk for 
anxiety in young children to test the extent to which the ERN can be 
modulated. Specifically, we will recruit 175 parent/child dyads, high in 
error sensitivity, and randomize them to a parent/child treatment 
condition, parent only treatment condition, child only treatment condition, 
or control condition. We will measure the ERN in children pre and post 
intervention. Parents and children in active conditions will have access to 
additional online materials between the baseline and follow-up visit. At a 
six-month follow-up, we will again assess children’s ERN, error 
sensitivity, and anxiety symptoms. My training plan builds on my 
expertise on the ERN and anxiety, and integrates training in the design and 
implementation of computerized interventions, as well as advanced 
statistical analyses related to intervention outcomes.
4.0
Study Endpoints*

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 6 of 25
Revised: June 19, 2020
4.1
Participants will come into the lab for a baseline visit and return to 
the lab 6 months later for a follow-up visit.
5.0
Study Intervention
1.1
Description: As part of the current proposal, during Year 1, we 
plan to develop a computerized intervention to be administered to parents and 
children separately. All participants in an active condition (parent/child, parent 
only, or child only) will receive the initial treatment session in the baseline lab 
visit. Additional materials that expand upon the concepts presented in the 1st 
session will be available online for children and parents between the baseline and 
follow-up assessment (depending on condition, e.g., in parent only condition, 
only parents will have access to between-session materials). These materials will 
include worksheets, games, and handouts. Participants will be told that 
participation in these additional online modules is optional and we will send a 
weekly reminder (via email or text) to remind them of concepts from the initial 
session, as well as provide the links to the additional materials. We will track 
utilization of the additional materials in parents and children. Additionally, as 
part of these additional modules, we will periodically ask parents and children to 
complete the Error Sensitivity Index to track changes across the 6 months 
between lab assessments. The development of this intervention, and testing its 
impact on ERN, is the primary goal of the proposed training grant. Dr. Brad 
Schmidt is an expert in the area of computerized treatments for anxiety and will 
aid in the development and implementation of the intervention. Additionally, 
Drs. Rapee, Cougle, Comer, and Chronis-Tuscano all have expertise in 
intervention development and I will consult with them regularly during the 
development phase of the training grant. For the child intervention, we will use 
developmentally appropriate language, as well as stories that children between 
the ages of 5 and 7 can understand and relate to. We will train research assistants 
to guide children through the computer intervention and answer questions when 
children appear to be confused. We used this approach successfully when 
administering the Child Error Sensitivity Index to children between the ages of 5 
and 7 years-old, as well as during pilot data collection. This intervention will be 
based on the constructs in the Child Error Sensitivity Index, as well as other 
constructs, that relate to the ERN – for example, perfectionism, fear of 
evaluation from others, and over-valuation of the negative consequences of 
errors. The intervention will focus on basic concepts such as: “making mistakes 
is how we learn new things”, “everybody makes mistakes”, and “good things 
come from mistakes.” While the first session will focus primarily on constructs 
in the Child Error Sensitivity Index, the additional online materials will expand 
beyond this. For example, we will cover other constructs that may also relate to 
the ERN: e.g., tolerance of uncertainty, distress tolerance, mindfulness, 
constructive self-talk, facing fears, identifying sensations of anxiety, avoidance, 
behavioral inhibition, checking behavior, etc. – all in the context of, or relating 
to, performance monitoring or error sensitivity. The intervention will be 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 7 of 25
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interactive, including games and recorded vignettes, as well as questions to gage 
children’s comprehension of the concepts being presented. To collect pilot data, 
we created a very preliminary version of this computerized intervention to 
collect pilot data in young children. This preliminary intervention can be viewed 
at: https://www.youtube.com/watch?v=1wUNqdQ91Io&t=10s.
The parent version of the intervention will include these same basic 
concepts, but will also target parenting style and provide psychoeducation on the 
negative impact of over-reacting to children’s mistakes. The parent version will 
also include examples of how to model appropriate reactivity to mistakes, and 
provide video vignettes and examples of both critical and adaptive parenting 
reactions to mistakes. The parent intervention will also provide feedback to the 
parent on how reactive they tend to be to their children’s errors and provide a 
structured way for parents to plan to reduce their reactivity to their children’s 
mistakes. For example, planning positive reinforcement strategies and how to 
avoid criticality in specific situations. We will also explore various motivations 
that parents may have for hyper-reactivity to children’s errors (for example, the 
motivation to punish errors vs. preventing the child from failing and 
experiencing negative emotions) and discuss ways to increase awareness of these 
motivations, as well as the negative consequences of this behavior on children. 
Additionally, we will offer replacement behaviors, as well as examples of how to 
integrate these new behaviors into daily activities. Both interventions will be 
designed to last approximately 45 minutes. The format of the interventions will 
be based on Dr. Schmidt’s previous work using brief-computerized 
interventions. We will also consult with Drs. Rapee, Comer, and Chronis-
Tuscano, who all have expertise in the design of parenting interventions. 
Additionally, as stated above, we will provide parents in the active condition 
with weekly reminders and additional online materials. We have created a 
preliminary version of this computerized intervention for our pilot sample. This 
preliminary intervention can be viewed at: 
https://www.youtube.com/watch?v=3qN0Hco17VI.
For the control condition, we plan to utilize an active control previously 
used by Dr. Schmidt. This will be a computerized presentation, in the same 
format as the active intervention, but will focus on self-care topics – unrelated to 
error sensitivity. The computerized control presentation will be administered to 
both parents and children. Participants in the control condition will have access 
to online materials related to self-care between assessments. We view the current 
proposal as a first step in the development of a novel intervention targeting error 
sensitivity. If we are able to demonstrate initial target engagement (i.e., reduce 
the ERN), in future studies, we plan to examine the potential impact of dose and 
whether this intervention can provide incremental symptom reduction, in 
addition to existing treatment approaches for child anxiety.
6.0
Procedures Involved*

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 8 of 25
Revised: June 19, 2020
6.1
We plan to recruit 175 parent/child dyads, high in error sensitivity (measured 
with self-report), and randomize 150 to an intervention condition (50 to 
parent/child, 50 to parent only, 50 to child only) and 25 to an active control 
condition. We plan to utilize an unbalanced design (150 intervention versus 25 
controls) due to the fact that longitudinal data in developmental samples suggests 
the ERN is typically stable or increases across development. Therefore, a 
decrease in the ERN is not expected to occur in the control group. We will 
measure the ERN in children pre and post intervention, as well as error 
sensitivity and anxiety symptoms. At a six-month follow-up, we will again 
assess children’s ERN, as well as error sensitivity and anxiety symptoms. We 
chose a six-month follow-up assessment to allow for adequate time for the 
parenting intervention to impact children (1-month may be too brief to observe 
impact), as well as to allow for children and parents to access the additional 
online materials (24 modules will be offered). This time was also selected to 
minimize drop-out that might occur over longer follow-up periods.
Further, before and during all in-person lab visits, we plan to take protective 
measures in order to reduce any possible spread of COVID-19 and to prevent 
any individuals at higher risk from participating in our study. Provided IRB 
approval, we plan to resume lab visits on August 1 with these protective 
measures in place.
6.2
Year 1: intervention development, collect pilot data from 10 parent/child 
dyads.
Year 2 – 4: recruit and collect data from 6 parent/child dyads per month, total N 
= 175 parent/child dyads. We will also collect 6-month follow-up data in the lab 
for each parent/child dyad.
Year 5: complete all follow-ups. Data processing, analysis, statistical procedures 
and manuscript preparation.
Risks are fairly minimal. There is a chance that some parents or children may 
experience mild, transient distress during parts of the assessments. All questions 
(self-report) are the type typically asked during a routine psychological or 
medical evaluations. If necessary, the assessment can be interrupted or 
terminated. The family (parent and patient) will be clearly informed that they are 
free to terminate participation at any point in the protocol.
Upon scheduling their visit, subjects will be asked a series of questions to 
determine if they or anyone in their immediate family is at higher risk to being 
exposed to Coronavirus. Individuals who meets these criteria will be excluded 
from participation in the study. These questions will include:
1. “Are you or anyone in your immediate 65 years of age or older?”
2. “Do you, or anyone in your immediate family, have a serious medical condition 
such as diabetes, heart, lung, kidney, or liver disease, or severe obesity?”

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 9 of 25
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3. "Do you or anyone in your immediate family have poor immunity due to cancer 
treatment or other conditions involving weakened immune systems?”
Prior to their in-lab visit, subjects will receive a phone call from research 
personnel updating them on the steps being taken to reduce the risk of 
Coronavirus transmission. On the day of each in-person lab visit, subjects will be 
called and asked an additional series of screening questions in order to see who 
may have been exposed to Coronavirus. Individuals who meets these criteria will 
be excluded from participation in the study. The screening questions and script to 
be used are as follows: 
“In the past 14 days, has your family: 
1. Traveled outside of the Tallahassee area?
2. Had flu-like symptoms such as cough, low-grade fever or high temperature 
(100.4°F), shortness of breath, and/or difficulty breathing?
3. Been in contact with a person who has flu-like symptoms or a person with 
suspect, probable or confirmed coronavirus (COVID-19)? 
4. Been to a nursing home or state hospital?”
The EEG and startle recording is completely non-invasive. The EEG will be 
recorded with an ActiveTwo EEG recording system, which does not require 
abrading the skin. There is the possibility that some participants will experience 
mild, temporary itching or tingling sensation in response to the electrode cap or 
electrode gel.
Informed consent and assent will be obtained prior to participation, and risks will 
be explained carefully to the participants’ parent. All information with 
identifying information collected during the project will be kept in a locked 
storage cabinet to which only Dr. Meyer and the study coordinator will have 
access. All data will be stored separately from identifying information and will 
be password protected. No names will be maintained in data records; rather, 
information will be coded by ID numbers only. Each individual will receive a 
unique I.D. number thereby allowing handling of data on all subjects without 
using individual names. PI Meyer will be responsible for monitoring the 
maintenance of confidentiality. In the event of a breach of confidentiality, he will 
inform the subject and his/her parents that the breach occurred; any breaches of 
confidentiality will be reported to the Institutional Review Board. Codifying 
participants by unique identifiers is an extensive practice that is highly efficient 
at protecting anonymous participation. No individual child or family will be 
identified in any publications or presentations of the research findings.
Upcoming procedures are repeatedly explained to the children and their parent, 
giving them a sense of control over what is happening in their environment. 
Rather than closed yes/no questions, open-ended questions with regard to comfort 
and well-being will be used throughout the procedures to give subjects the 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 10 of 25
Revised: June 19, 2020
opportunity to voice any concerns or discomfort. Subjects will also be given the 
opportunity to ask questions regarding the research procedures at any time during 
the protocol.
Although we don’t expect it frequently, some subjects may endorse suicidality or 
increased risk for suicidality; in this event, safety assessments will be conducted 
and, when necessary, appropriate consultation with Dr. Meyer will be held to 
determine disposition. Dr. Meyer is a clinical psychologist, with an office on the 
same floor where the research will take place. In the event that a participant is in 
imminent danger to themselves, their parents will be informed. The participant 
and Dr. Meyer will meet with the subject and their parent to establish a safety 
plan – which may include transporting the child to the emergency room for 
further psychological evaluation or a referral for follow-up evaluation with an 
outside provider. Referrals will be on hand and can be provided. We will use 
validated procedures for suicide assessment, specifically the structured interview 
recommended by Joiner et al. (1999) & Chu et al. (2015), and use the following 
method to designate risk severity (refer to ABHC Suicide Risk Assessment form 
for detailed information on the assessment):
1. An individual’s risk for suicide is designated nonexistent if he or she has no 
current suicidal symptoms, no history of suicide, and no or few other risk factors.
2. Risk for suicide is considered mild if the individual is a multiple attempter with 
no other risk factors or is a non-multiple attempter experiencing suicidal ideation 
of limited intensity and duration, no or mild resolved plans and preparation, and 
no or few other risk factors.
3. An individual is designated at moderate risk if he or she is a multiple attempter 
with any other significant risk factor. A non-multiple attempter with moderate to 
severe resolved plans and preparations or moderate to severe suicidal desire and 
ideation accompanied by at least two other risk factors is also considered to be at 
moderate risk for suicide.
4. A multiple attempter with two or more risk factors or a non-multiple attempter 
with moderate to severe symptoms of resolved plans and preparations 
accompanied by one other risk factor is designated at severe risk for suicide.
5. An individual is at extreme risk for suicide if he or she is a multiple attempter 
with severe resolved plans and preparation or is a non-multiple attempter with 
resolved plans and preparations and two or more other risk factors.
Once an individual has been assessed for suicide risk, we will take the following 
actions, as suggested by Joiner et al. (1999) and Chu et al. (2015):
In addition, if children and/or their parents endorse experiencing significant 
psychological distress (e.g., significant anxiety or depression) during any portion 
of the study, the participants will be offered referral information for 
psychotherapy and/or pharmacologic treatment at Florida State University and 
the surrounding community. Participants who are initially enrolled in the study 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 11 of 25
Revised: June 19, 2020
will not be excluded from completing study procedures if they begin receiving 
treatment during the study. Because information relating to child abuse may be 
assessed, the staff will follow federal and state child abuse reporting 
requirements. Participants will be informed of the need to report child abuse 
prior to eliciting this information. In case of any reported abuse by the child or 
parent, the parents will be informed about the federal mandated reporting laws, 
verbally and in writing. In cases where it is necessary to make a child abuse 
report, the family will always be informed prior to contacting any state agency, 
and given the option of making a self-referral to protective services.
6.3
EEG, self-report, observational video data, and clinical interviews 
will be collected.  
Self-report. The current proposal will utilize dimensional measures of anxiety symptoms 
measured by the Screen for Child Anxiety Related Emotional Disorders (SCARED) 
questionnaire. Both the parent and child will complete the SCARED regarding anxiety 
symptoms experienced by the child before and after the treatment at the baseline 
assessment, and at the follow-up assessment.
To capture a broad spectrum of symptoms, we will also administers the Child Behavior 
Checklist (CBCL) at the baseline and follow-up assessment. The CBCL is a 113-tiem 
parent-report checklist that assesses emotional and behavioral problems (internalizing 
and externalizing) over the past 6 months. We will utilize the depression scale from this 
measure, as well as the obsessive compulsive scale.
Additionally, to assess error sensitivity in children, we will use our previously validated 
measure (i.e., the Child Error Sensitivity Index), before and after the intervention, and at 
follow-up. This measure includes 9 items indexing error sensitivity, for example: “I feel 
upset when other people don’t like something I have done”, “If I make a mistake, I 
always want to fix it”, and “When I make a mistake, I feel anxious”, and has good 
psychometric properties.
We will also assess parent’s sensitivity to their child’s errors before and after the 
intervention, and at follow-up. Our measure of Parent Sensitivity to Children’s Errors 
includes 20 items, such as the following: “When I notice a mistake my child made, I feel 
upset”, “If my child makes a mistake, I have a strong urge to fix it immediately”, “When 
my child makes a mistake, I feel anxious”, “I like to watch my child do things to make 
sure she/he doesn’t make mistakes.”
Additional self-report measures include the following (all will be uploaded under 
documents section):
Child:
Child and Adolescent Perfectionism Scale
CRPBI 
CASI
Child report: parent sensitivity to my errors
Acceptability Measure
Parent:

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 12 of 25
Revised: June 19, 2020
IDAS
Parent ASI to child
Parent ASI
FASA
Parent report on child’s error sensitivity
Parent sensitivity to child’s errors
Parent error sensitivity
Avoidance questionnaire
CBQ
PSDQ
CRPBI
Acceptability Measure
Child Anxiety Life Interference Scale – Preschool Version (CALIS-PV)
Coping with Children’s Negative Emotions Scale (CCNES)
Spence Preschool Anxiety Scale (Parent Report)
Observational behavioral task. We will also use a lab-based observational task to 
measure error sensitivity in children, as well as parent’s sensitivity to their children’s 
errors, before and after the intervention, and at the follow-up lab visit. These will be  
tasks that we have utilized in a previous study at FSU in this same age-range.
Episode 1: Guessing Card Game (Headbands).
“For this game, you will each wear one of these headbands.  (demonstrate and then help 
participants get headbands on their head) You are each going to be given 10 cards.  
Please do not look at your cards.  You will take turns guessing your own cards.  When it 
is your turn, take the card from the top pile and put it in your headband, like this 
(demonstrate).  You should NOT look at your card when you do this.  You will ask 
questions to your partner to guess what your card is.  Your questions can be things like: 
Am I an animal? Do I have feathers? Am I a thing? Am I a food?  You cannot ask: What 
is my card?, but you can ask pretty much anything else.  When you correctly guess your 
card, then you put the card face up in a pile and switch turns.  Your goal is to correctly 
guess as many cards as possible before your time is up.  Do you have any questions?”  
Make sure parent and child have headbands on and have a pile of 10 cards each.  Then 
tell the participants they can start and make sure to start the 3 minute timer and record the 
episode .  
When timer goes off, enter the room and tell the family that they did a great job and that 
now it is time to start a new activity.
Episode 2: Drawing while taking turns.
“For this activity, we want you to draw these pictures yourselves.  We want you to try to 
be as accurate as possible.  You will take turns drawing.  Each of you will only draw one 
line and then pass the drawing to your partner so that they can draw the next line.  You 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 13 of 25
Revised: June 19, 2020
will go back and forth.  Try to get as many completed as you can, while being accurate, 
within 3 minutes.”
Give parent/child the pictures and blank paper and pens (not pencils).  Tell the 
participants that they can start and set the 3 minute timer and record the episode .
When timer goes off, enter the room and tell the family that they did a great job and that 
now it is time to start a new activity.
Episode 3: Picasso Tiles.
“For this activity, _______(child’s name) will build with the Picasso Tiles, while 
_______ (parent’s name) will give directions.  We would like you to use the Picasso Tiles 
to build, as accurately as possible, the design on this picture (point to image).  If you 
finish this, you can move to the next one.  We want _______ (parent’s name) to be 
looking at the image and giving directions to ________ so that he/she can build the 
design.  Please do not let _______ (child’s name) look at the picture. We would like you 
to work together.  Do you have any questions?”
Give child the Picasso Tiles and give the parent the images.  Tell the participants they can 
start and set the 3 minute timer and record the episode . 
When timer goes off, enter the room and tell the family that they did a great job and that 
now it is time to start a new activity.
Episode 4: Negative Discussion.
“For this activity, we want you to talk together about a time this week when ________ 
(child’s name) did something wrong. If you can’t think of something from this week, you 
can talk about the most recent situation that you can remember.  You will have 3 minutes 
to have this discussion.  Do you have any questions?”
Tell the participants that they can start and set the 3 minute timer and record the episode .
When timer goes off, enter the room and tell the family that they did a great job and that 
now it is time to start a new activity.
Episode 5: Positive Discussion.
“For this activity, we want you to talk together about a time this week when ________ 
(child’s name) did something right. If you can’t think of something from this week, you 
can talk about the most recent situation that you can remember.  You will have 3 minutes 
to have this discussion.  Do you have any questions?”
Tell the participants that they can start and set the 3 minute timer and record the episode .
When timer goes off, enter the room and tell the family that they did a great job and that 
now it is time to start a new activity.
The parent and child will be given directions for each task (which will last approximately 
2 - 3 minutes) while being video-taped. The videos will be coded for sensitivity to 
mistakes (modified from Dr. Luby’s coding schemes). For example, negative or positive 
statements regarding errors or imperfections will be coded (e.g., I hate making mistakes, 
I’m bad, I’ll never do this right, etc.). After meeting with Dr. Luby at her lab for training 
on this approach, I will train a team of coders (undergraduate assistants) to code these 
observations reliably and use Mangold coding software to track codes second by second 
and to do reliability analyses.

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 14 of 25
Revised: June 19, 2020
EEG task. Children will complete a developmentally appropriate go-no/go task wherein 
they are instructed to “shoot” aliens when they see them on the screen (by clicking a 
mouse button) and “save” astronauts by not clicking when they are on the screen. After 
completing 5 practice trials, children complete 200 trials. Children will complete the go-
no/go task before and after the intervention at the first lab assessment, and once at the 
follow-up lab assessment. We have used this task in children in this same age-range at 
Florida State University, with no adverse events.
The EEG assesses brain electrical activity through surface recording disks (electrodes) 
which are placed near the participant's head. The electrodes transmit the signals, which 
are then amplified and stored on a computer. The procedure is entirely non-invasive.
A custom designed 32-electrode Lycra cap will be placed on the participant's head. In 
order to record the brain's activity, these disks need to be filled will a gel which allows 
the electrodes to better record brain activity at the scalp. Therefore, the participants in this 
study will need to clean their hair after participation. The gel is completely water soluble, 
and the procedure is painless. Dr. Meyer’s laboratory has sinks and towels, and the 
investigators will help to make sure the participant has thoroughly rinsed all the gel from 
their hair. After an accurate signal is assured, the signal derived from the electrode cap is 
then amplified, transmitted to a computer, and stored for later analysis.
In addition to the EEG recording, muscle activity from around the eyes may be recorded 
from the subjects. Muscle activity from around the eyes is recorded by small sensors that 
will be placed above and below the participant’s left eye, as well as on the outer canthi 
(just below the eyebrow) of each eye. These procedures are completely non-invasive and 
painless.
EEG data processing and analyses. While participants complete the Go/No-Go task, EEG 
will be recorded from 32 scalp locations. The response-locked ERPs will be averaged 
separately for each trial type (e.g., correct and incorrect responses), and baseline 
correction will be performed using the interval from -500 to -300 ms before response 
commission. Average activity at three electrode sites (FCz, Cz, and Fz) between 0 and 
100 ms after the response will be exported for each subject – we have previously shown 
that this is where the ERN is maximal and most reliable in children 82. In order to obtain 
a measure of differentiation between errors and correct responses, the average activity on 
correct trials will be subtracted from the average activity on error trials (i.e., the ERN).
Procedure. Research assistants will explain the study to parents and children and obtain 
consent for participation. Families will be randomized to a group (parent only, child only, 
parent/child, or control). Parents and children will participate in a brief observational task 
and complete questionnaires. Children will then complete the go-no/go task. After this, a 
trained research assistant will guide the child through the computer intervention or 
control. After the intervention, children will complete the go-no/go task again, and 
complete the observational task and questions. Simultaneously, parents will be 
completing questionnaires and will be administered the intervention or control. The first 
lab assessment will take approximately 2 – 3 hours.

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 15 of 25
Revised: June 19, 2020
The second lab assessment will take place approximately 6 months later. At this lab visit, 
both parents and children will complete follow-up questionnaires and behavioral 
observation. Additionally, children will complete the go-no/go task.
Clinical Interviews.  We plan to conduct two clinical interviews with the parent, at each 
lab visit.  Both interviews are assessments we routinely utilize in our research studies at 
FSU and will be conducted by a research assistant or graduate student who is trained in 
the administration of these interviews and has demonstrated reliability.  We plan to 
complete the Schedule for Affective Disorders and Schizophrenia for School-Age 
Children: Present and Lifetime Version (K-SADS-PL: Kaufman, Birmaher et al., 1997) 
with the parent regarding the child’s symptoms.  Additionally, we plan to complete the 
Mini-International Neuropsychiatric Interview (MINI SCID) with the parent regarding 
their own symptoms. We anticipate that these interviews (together) will take 
approximately 30 – 40 minutes to complete.  As in previous studies, the interviews will 
be audio recorded for the purposes of coding reliability. Participants will be asked if it is 
ok to record the interview before each interview begins.   
6.4
There is no plan for follow-up after the second lab assessment.
7.0
Data and Specimen Banking*
7.1
All information with identifying information collected during the 
project will be kept in a locked storage cabinet to which only Dr. Meyer 
and the study coordinator will have access. All data will be stored 
separately from identifying information and will be password protected. 
No names will be maintained in data records; rather, information will be 
coded by ID numbers only. Each individual will receive a unique I.D. 
number thereby allowing handling of data on all subjects without using 
individual names. PI Meyer will be responsible for monitoring the 
maintenance of confidentiality. In the event of a breach of confidentiality, 
he will inform the subject and his/her parents that the breach occurred; any 
breaches of confidentiality will be reported to the Institutional Review 
Board. Codifying participants by unique identifiers is an extensive practice 
that is highly efficient at protecting anonymous participation. No 
individual child or family will be identified in any publications or 
presentations of the research findings.
7.2
EEG data, self-report data, observation video data will be stored 
for each participant.
7.3 If a participant requests their data (EEG, self-report, or observational 
video data), we will provide a summary of relevant data, along with 
a brief description of the measure.  Data will not be released to 
anyone other than a participant.    

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 16 of 25
Revised: June 19, 2020
8.0
Sharing of Results with Subjects*
8.1
We do not plan to share results with participants (unless they request 
us to do so). 
9.0
Study Timelines*
9.1
Describe:

Each subject will participate in the study for 6 months.
Year 1: intervention development, collect pilot data from 
10 parent/child dyads.
Year 2 – 4: recruit and collect data from 6 parent/child 
dyads per month, total N = 175 parent/child dyads. We will 
also collect 6-month follow-up data in the lab for each 
parent/child dyad.
Year 5: complete all follow-ups. Data processing, analysis, 
statistical procedures and manuscript preparation.
10.0
Subject Population*
10.1
Participants in the study will be 175 parent and child dyads 
recruited using the Family Registry at Florida State University (FSU).  I 
plan to recruit families with children between the ages of 5 and 7 years of 
age. 
10.2 We plan to recruit parent/child dyads who are high in error 
sensitivity (as measured by the Child Error Sensitivity Index, self-
report). Because our intervention will be designed to target error 
sensitivity, we will recruit families who score at least .5 standard 
deviations above the mean on the Child Error Sensitivity Index or 
the Parent Sensitivity to Children’s Errors Index. We will derive 
means and standard deviations from our previous study, which was 
conducted in this same age-range and community. Additionally, we 
will request that the primary caregiver accompany the child to the 
lab visit (i.e, spends at least 50% or more of total parenting time with 
the child). Prior to the in-lab visit, participants will complete an 
additional phone screen to determine whether they meet any 
Coronavirus-specific exclusion criteria. This phone screen will 
assess whether participants may have contacted Coronavirus and 
whether they are at higher risk for severe illness. Any participants 
who do not pass this screening will not be permitted to take part in 
the study.
10.3 This study will not include: adults unable to consent, pregnant 
women, prisoners.  The study will include: children. 
11.0
Vulnerable Populations*

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 17 of 25
Revised: June 19, 2020
11.1 This research study involves children between the ages of 5 – 7 years 
old.  We will collect parental consent for all study procedures, as 
well as child assent.  Additionally, children will be reminded 
throughout the lab visit that they can take a break or stop the study at 
any time.  
12.0
Local Number of Subjects
12.1 175 parent/child dyads.
13.0
Recruitment Methods
13.1
Participants in the study will be 175 parent and child dyads 
recruited using the Family Registry at Florida State University (FSU) or a 
targeted mailing list. The FSU Center for Developmental Science 
implements on-going recruitment throughout the Tallahassee community, 
focusing on children and families. They maintain a database, which 
includes the names, ages, and contact information of children and families 
interested in participating in research studies. The Family Registry is 
comprised of over 1,500 families to date, and continues to grow each week 
due to regular recruitment events in the community. I plan to recruit 
families with children between the ages of 5 and 7 years of age. In 
addition to utilizing the Registry at FSU, I plan to post fliers in the 
community and recruit families at additional community events.
13.2 Source of recruitment: FSU Center for Developmental Science 
Family Registry and fliers that will be posted through-out the 
community.  We also plan to utilize a targeted mailing list for 
children and families in the Tallahassee community.  
13.3
We plan to recruit parent/child dyads who are high in error 
sensitivity (as measured by the Child Error Sensitivity Index, self-report). 
Because our intervention will be designed to target error sensitivity, we 
will recruit families who score at least .5 standard deviations above the 
mean on the Child Error Sensitivity Index or the Parent Sensitivity to 
Children’s Errors Index. We will derive means and standard deviations 
from our previous study, which was conducted in this same age-range and 
community. Additionally, we will request that the primary caregiver 
accompany the child to the lab visit (i.e, spends at least 50% or more of 
total parenting time with the child). If interested in participating, 
caregivers will complete an additional phone screen to determine whether 
they meet any Coronavirus-specific exclusion criteria. This phone screen 
will assess whether participants may have contacted Coronavirus and 
whether they are at higher risk for severe illness. Any participants who do 
not pass this screening will not be permitted to take part in the study.
13.4
The flier that we plan to use for recruitment will be attached to this 
submission.  It includes a picture of a minions stuffed animal with an EEG 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 18 of 25
Revised: June 19, 2020
cap on.  We state that families with children between the ages of 5 and 7 
are eligible to participate in our study and provide our lab contact 
information. Additionally, we plan to send letters to families in the 
Tallahassee area who have children between the ages of 5 – 7 years old.  
This mailing list will be purchased from Direct Mail.  The letter that we 
plan to send to potential participants will be attached to this submission.   
13.5
The families will also receive a significant honorarium, $60.00 for 
the baseline visit and $60.00 for the follow-up assessment, and each visit 
should last no more than 3 hours. Providing the honorarium to the family, 
rather than the child, reduces the possibility that payment could be 
coercive—we leave it up to the parent to decide how to allocate the 
honorarium. If participants live more than 30 miles away, we will offer 
travel reimbursement of up to $40.  Additionally, families will be offered a 
t-shirt for parents and children for completion of the between assessment 
online modules.
14.0
Withdrawal of Subjects*
14.1 We do not anticipate subjects being withdrawn from the study 
without their consent. 
14.2 n/a
15.0
Risks to Subjects*
15.1 Risks:
Risks are fairly minimal. There is a chance that some parents or children 
may experience mild, transient distress during parts of the assessments. 
All questions (self-report) are the type typically asked during a routine 
psychological or medical evaluations. If necessary, the assessment can be 
interrupted or terminated. The family (parent and patient) will be clearly 
informed that they are free to terminate participation at any point in the 
protocol.
The EEG and startle recording is completely non-invasive. The EEG will 
be recorded with an ActiveTwo EEG recording system, which does not 
require abrading the skin. There is the possibility that some participants 
will experience mild, temporary itching or tingling sensation in response 
to the electrode cap or electrode gel.
Informed consent and assent will be obtained prior to participation, and 
risks will be explained carefully to the participants’ parent. An additional 
“Coronavirus Information Sheet” will be provided to participants in order 
to address any concerns about the steps being taken by research staff.
All information with identifying information collected during the project will be 
kept in a locked storage cabinet to which only Dr. Meyer and the study 
coordinator will have access. All data will be stored separately from identifying 
information and will be password protected. No names will be maintained in data 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 19 of 25
Revised: June 19, 2020
records; rather, information will be coded by ID numbers only. Each individual 
will receive a unique I.D. number thereby allowing handling of data on all 
subjects without using individual names. PI Meyer will be responsible for 
monitoring the maintenance of confidentiality. In the event of a breach of 
confidentiality, he will inform the subject and his/her parents that the breach 
occurred; any breaches of confidentiality will be reported to the Institutional 
Review Board. Codifying participants by unique identifiers is an extensive 
practice that is highly efficient at protecting anonymous participation. No 
individual child or family will be identified in any publications or presentations of 
the research findings.
Upcoming procedures are repeatedly explained to the children and their parent, 
giving them a sense of control over what is happening in their environment. 
Rather than closed yes/no questions, open-ended questions with regard to comfort 
and well-being will be used throughout the procedures to give subjects the 
opportunity to voice any concerns or discomfort. Subjects will also be given the 
opportunity to ask questions regarding the research procedures at any time during 
the protocol.
Although we don’t expect it frequently, some subjects may endorse suicidality or 
increased risk for suicidality; in this event, safety assessments will be conducted 
and, when necessary, appropriate consultation with Dr. Meyer will be held to 
determine disposition. Dr. Meyer is a clinical psychologist, with an office on the 
same floor where the research will take place. In the event that a participant is in 
imminent danger to themselves, their parents will be informed. The participant 
and Dr. Meyer will meet with the subject and their parent to establish a safety 
plan – which may include transporting the child to the emergency room for 
further psychological evaluation or a referral for follow-up evaluation with an 
outside provider. Referrals will be on hand and can be provided. We will use 
validated procedures for suicide assessment, specifically the structured interview 
recommended by Joiner et al. (1999) & Chu et al. (2015), and use the following 
method to designate risk severity (refer to ABHC Suicide Risk Assessment form 
for detailed information on the assessment):
1. An individual’s risk for suicide is designated nonexistent if he or she has no 
current suicidal symptoms, no history of suicide, and no or few other risk factors.
2. Risk for suicide is considered mild if the individual is a multiple attempter with 
no other risk factors or is a non-multiple attempter experiencing suicidal ideation 
of limited intensity and duration, no or mild resolved plans and preparation, and 
no or few other risk factors.
3. An individual is designated at moderate risk if he or she is a multiple attempter 
with any other significant risk factor. A non-multiple attempter with moderate to 
severe resolved plans and preparations or moderate to severe suicidal desire and 
ideation accompanied by at least two other risk factors is also considered to be at 
moderate risk for suicide.
4. A multiple attempter with two or more risk factors or a non-multiple attempter 
with moderate to severe symptoms of resolved plans and preparations 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 20 of 25
Revised: June 19, 2020
accompanied by one other risk factor is designated at severe risk for suicide.
5. An individual is at extreme risk for suicide if he or she is a multiple attempter 
with severe resolved plans and preparation or is a non-multiple attempter with 
resolved plans and preparations and two or more other risk factors.
Once an individual has been assessed for suicide risk, we will take the following 
actions, as suggested by Joiner et al. (1999) and Chu et al. (2015):
In addition, if children and/or their parents endorse experiencing significant 
psychological distress (e.g., significant anxiety or depression) during any portion 
of the study, the participants will be offered referral information for 
psychotherapy and/or pharmacologic treatment at Florida State University and the 
surrounding community. Participants who are initially enrolled in the study will 
not be excluded from completing study procedures if they begin receiving 
treatment during the study. Because information relating to child abuse may be 
assessed, the staff will follow federal and state child abuse reporting 
requirements. Participants will be informed of the need to report child abuse prior 
to eliciting this information. In case of any reported abuse by the child or parent, 
the parents will be informed about the federal mandated reporting laws, verbally 
and in writing. In cases where it is necessary to make a child abuse report, the 
family will always be informed prior to contacting any state agency, and given the 
option of making a self-referral to protective services.
In addition to other possible harms or discomforts related to this research, 
there may be risks by having participants take part in face-to-face study 
activities during this time of the Coronavirus emergency. Face-to-face 
activities and contact with other persons may increase the risk of getting 
Coronavirus. No one is yet quite sure how easily Coronavirus passes from 
person to person, how to know for certain when someone has or does not 
have Coronavirus, or what works best at preventing Coronavirus from 
spreading.
Getting Coronavirus may result in a person being isolated or quarantined 
at home and away from work, family and other activities. Coronavirus is a 
serious illness that may require medical care including hospital care, long-
term disability, and even death. 
Certain persons are at higher risk for severe illness from Coronavirus, and 
these persons are not permitted to take part in our study. Persons thought 
to be at higher risk include:

Being 65 years of age or older

Prior or current exposure to persons that have Coronavirus whether or not they 
know it

Persons of any age with serious medical conditions such as diabetes, and 
heart, lung, kidney or liver disease, or persons who are severely obese

Persons who have poor immunity, such as persons under cancer treatment or 
who have other conditions with weakened immune systems

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 21 of 25
Revised: June 19, 2020

People who reside in or have visited nursing homes or other long-term care 
facilities in the 14 days prior to the lab visit. 

People who have been experiencing or have been in contact with someone 
experiencing flu-like symptoms such as cough, low-grade fever or high 
temperature (100.4°F), shortness of breath, and/or difficulty breathing in the 
14 days prior to the lab visit.

Traveled outside of the Tallahassee area in the 14 days prior to the lab visit.
All participants and study personnel will therefore be asked some questions to see 
who may be at risk of severe illness, or who have been exposed to Coronavirus. 
Even after questions are asked, participants are strongly encouraged to inform 
research personnel if they think that at any time before or during the study they 
may been exposed to Coronavirus or are at risk of severe illness. Such participants 
will not be permitted to participate in this study. While the study staff will take 
steps to protect themselves and participants from exposure to Coronavirus when 
they take part in face-to-face activities, there is always the chance that an 
individual may still be exposed. 
In order to reduce exposure to Coronavirus, upon arrival in the lab we will take 
the temperature of all participants. If a participant has a high temperature 
(≥100.4°F), we will wait 10 to 15 minutes take temperature a second time, to 
ensure accuracy. During each visit, study staff will stay at least six feet away from 
anyone else during research activities, excluding times when closer contact is 
necessary, such as when EEG is being set up, taken down, and when some 
computer tasks are being initiated. Study staff will conduct a maximum of one lab 
visit per day to reduce the chance of overlap or contamination between 
participants. We will also limit each lab visit to the minimum amount time and 
staff required to complete the study protocol. All materials will be sanitized after 
being utilized by participants and study staff. All disposable used items will be 
thrown away immediately following the lab visit. Any items that are punctured, 
torn, or contaminated during the visit will be rotated immediately. Study staff and 
participants will also be required to wear a face mask to cover their mouth and 
nose, wear gloves to cover their hands, wash and sanitize their hands at regular 
intervals; and not touch their face or anything else during study activities. If 
participants need protective gear such a face mask and/or gloves, study staff will 
provide these materials. 
In addition to the risks of these Coronavirus-related harms or discomforts, 
this research may have risks of other Coronavirus-related harms or 
discomforts that are unknown at this time. Participants will be informed if 
any such risks are determined in the future. All participants will be 
reminded that if at any point they do not feel safe with the protective 
measures that are being taken, they can let us know and we will stop the 
study immediately. 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 22 of 25
Revised: June 19, 2020
15.2 n/a
15.3 n/a.
16.0
Potential Benefits to Subjects*
16.1
We have conducted the original study that utilized many of the 
same measures used in the current proposal, and most children enjoy 
participating in the assessments, which are presented as games, and all 
children will win prizes and receive small gifts during the course of the 
tasks. The families will also receive a significant honorarium, $60.00 for 
the baseline visit and $60.00 for the follow-up assessment, and each visit 
should last no more than 3 hours. Providing the honorarium to the family, 
rather than the child, reduces the possibility that payment could be 
coercive—we leave it up to the parent to decide how to allocate the 
honorarium. If participants live more than 30 miles away, we will offer 
travel reimbursement of up to $40. Periodic updates about selected 
research findings for the sample as a whole will be provided to subjects 
and their parents. Many participants derive satisfaction from knowing that 
they are contributing to knowledge about children’s development. 
Although this is not a clinical sample, parents who have concerns about 
their child’s adjustment or functioning will have the opportunity to meet 
with Dr. Meyer (who is a clinical psychologist), and referrals will be 
provided if appropriate.
16.2 n/a
17.0
Data Management* and Confidentiality
17.1
Data analysis plan: AIM 1: Assess initial target engagement by 
examining whether a neural marker of risk for anxiety (i.e., the ERN) in 
children is decreased during a single lab visit, via a brief, computerized 
intervention designed to target error sensitivity. We hypothesize that 
children who receive the intervention will display a decrease in the ERN at 
the first assessment, compared to children in the control condition. 1a. 
Assess alternate measures of target engagement. Self-report and 
observational measures of error sensitivity will also be decreased for 
parents and children who receive parent and child active interventions, 
respectively. AIM 2: Examine whether children in the intervention 
conditions display a reduction in the ERN from the initial lab assessment 
to the six-month follow-up assessment. We expect that children in all 
treatment conditions (parent/child, parent only, child only) will display a 
reduced ERN compared to the control group. 2a. Dissociate the impact of 
parent/child, parent only, versus child only treatment conditions. We 
hypothesize that children in the combined treatment group (parent/child) 
will have the greatest reduction in the ERN. 2b. Examine the impact of 

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 23 of 25
Revised: June 19, 2020
utilization. We expect that parents and children who utilize the treatment 
materials more frequently will experience the greatest reduction in the 
ERN. 2c. Assess alternate measures of target engagement. We will also 
examine all hypotheses in relation to self-report and observed measures of 
parent and child error sensitivity. AIM 3: Examine whether parent/child 
dyads in the intervention conditions experience changes in anxiety 
symptoms at the six-month follow-up. We hypothesize that the dyads in 
the intervention conditions will experience greater changes in anxiety 
symptoms compared to the control group. We will also compare 
conditions, as well as examine the impact of utilization. In exploratory 
analyses, we will examine to what extent changes in the ERN and error-
sensitivity relate to changes in anxiety symptoms in children.
17.2
Informed consent and assent will be obtained prior to participation, 
and risks will be explained carefully to the participants’ parent. All 
information with identifying information collected during the project will 
be kept in a locked storage cabinet to which only Dr. Meyer and the study 
coordinator will have access. All data will be stored separately from 
identifying information and will be password protected. No names will be 
maintained in data records; rather, information will be coded by ID 
numbers only. Each individual will receive a unique I.D. number thereby 
allowing handling of data on all subjects without using individual names. 
PI Meyer will be responsible for monitoring the maintenance of 
confidentiality. In the event of a breach of confidentiality, he will inform 
the subject and his/her parents that the breach occurred; any breaches of 
confidentiality will be reported to the Institutional Review Board. 
Codifying participants by unique identifiers is an extensive practice that is 
highly efficient at protecting anonymous participation. No individual child 
or family will be identified in any publications or presentations of the 
research findings.
Upcoming procedures are repeatedly explained to the children and their 
parent, giving them a sense of control over what is happening in their 
environment. Rather than closed yes/no questions, open-ended questions 
with regard to comfort and well-being will be used throughout the 
procedures to give subjects the opportunity to voice any concerns or 
discomfort. Subjects will also be given the opportunity to ask questions 
regarding the research procedures at any time during the protocol.
17.3 n/a.
17.4 n/a 
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*
This section is required when research involves more than Minimal Risk 
to subjects.

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 24 of 25
Revised: June 19, 2020
18.1 n/a
19.0
Provisions to Protect the Privacy Interests of Subjects
19.1
All information with identifying information collected during the 
project will be kept in a locked storage cabinet to which only Dr. Meyer 
and the study coordinator will have access. All data will be stored 
separately from identifying information and will be password protected. 
No names will be maintained in data records; rather, information will be 
coded by ID numbers only. Each individual will receive a unique I.D. 
number thereby allowing handling of data on all subjects without using 
individual names. PI Meyer will be responsible for monitoring the 
maintenance of confidentiality.
19.2
Upcoming procedures are repeatedly explained to the children and 
their parent, giving them a sense of control over what is happening in their 
environment. Rather than closed yes/no questions, open-ended questions 
with regard to comfort and well-being will be used throughout the 
procedures to give subjects the opportunity to voice any concerns or 
discomfort. Subjects will also be given the opportunity to ask questions 
regarding the research procedures at any time during the protocol.
19.3
All data will be stored separately from identifying information and 
will be password protected.
20.0
Compensation for Research-Related Injury
20.1 n/a
20.2 n/a
21.0
Economic Burden to Subjects
21.1 n/a
22.0
Consent Process
22.1
The consent and assent process will take place at the beginning of 
the lab visit in a room in the lab. Additionally, throughout the lab visit, 
upcoming procedures are repeatedly explained to the children and their 
parent, giving them a sense of control over what is happening in their 
environment. Rather than closed yes/no questions, open-ended questions 
with regard to comfort and well-being will be used throughout the 
procedures to give subjects the opportunity to voice any concerns or 
discomfort. Subjects will also be given the opportunity to ask questions 
regarding the research procedures at any time during the protocol.
Subjects who are not yet adults (infants, children, teenagers)

PROTOCOL TITLE: An investigation of a parent/child psycho-social 
computerized intervention targeting the error-related negativity in young 
children
Page 25 of 25
Revised: June 19, 2020

Participants in the study will be between the ages of 5 – 7 years 
old, so they will be individuals under the age of 18 years and 
therefore not yet adults.

Parental permission will be obtained from one parent (the 
parent who accompanies the child to the lab visits).  

Assent will be obtained from the child participant.  This will be 
documented with the child assent form (attached to this 
submission).  
23.0
Process to Document Consent in Writing
23.1 To obtain consent, we will be following “SOP: Written 
Documentation of Consent (HRP-091).” 
23.2 n/a
23.3 A consent and assent form will be submitted with this application. 
24.0
Setting
24.1 The research team will identify and recruit potential subjects from 
the FSU Family Registry and from fliers that will be distributed 
through-out the community.  Research procedures will be performed 
in the lab space in the Psychology Building on the FSU campus.  
25.0
Resources Available
25.1
We have recently completed a study at FSU where we recruited 
100 children between the ages of 5 and 7 years old, and then conducted a 
1-year follow-up assessment. We retained approximately 88% of the 
sample at the follow-up assessment. Therefore, we expect the attrition rate 
for the current proposal to be slightly lower than this (due to a shorter 
follow-up period of 6 months). We estimate that we will retain 90% of the 
sample (N = 155). Analyses will be conducted to ensure that families that 
are lost to follow-up do not differ significantly from the overall sample on 
any main study variables.  
26.0
Multi-Site Research* (Delete this section if this is not a Multi-Site 
Research Study.)
n/a