Impact Virtual Reality: An Emotion Recognition and Regulation Training Program for Youth With Conduct Disorder
Phase: PHASE1
Conditions: Conduct Disorder, Conduct Disorders in Children, Conduct Disorders in Adolescence, Callous-Unemotional Traits
Sponsor: Virginia Commonwealth University

Virginia Commonwealth University (VCU) 
Page 1 of 8   
 
Nicholas Thomson, PhD 
Advarra IRB Approved Version 17 Apr 2024 
 
 
RESEARCH PARTICIPANT INFORMATION AND CONSENT FORM 
AND 
AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION 
FOR PARENTS/LEGAL GUARDIANS OF MINOR PARTICIPANTS (SA3) 
 
Sponsor / Study Title: 
  
Virginia Commonwealth University (VCU) / “Impact VR: An 
Emotion Recognition and Regulation Training Program for 
Youth with Conduct Disorder” 
 
Principal Investigator: 
 
Nicholas Thomson, PhD 
 
Telephone: 
 
804-828-6386 (24 Hour) 
Address: 
VCU Health - West Hospital 
1200 E. Broad St. 
West Hospital, 5th Floor, West Wing, Rm 5-025 
Richmond, VA    23298 
 
 
NOTE: In this consent form, “you” always refers to the research participant. 
 
ABOUT THIS CONSENT FORM  
You and your child are being invited to participate in a research study. It is important that you 
carefully think about whether being in this study is right for you and your child.  
 
This consent form is meant to assist you in thinking about whether or not you want to be in this 
study. Please ask the investigator or the study staff to explain any information in this consent 
document that is not clear to you. You may take home an unsigned copy of this consent form 
to think about or discuss with family or friends before making your decision.  
 
You and your child are invited to be in this research study because your child has either 
received services through VCU Health, was a referral, or participated with/in one of our 
community partnerships. Your participation is voluntary. You may decide not to participate in 
this study. If you do participate, you may withdraw from the study at any time. Your decision 
not to take part or to withdraw will involve no penalty or loss of benefits to which you are 
otherwise entitled.  
 
Dr. Nicholas Thomson is the founder of and has an ownership interest in Arche VR, LLC, the 
small-business sponsor of this project. As a result, the investigator may benefit financially from 
a successful study. Additional steps have been taken to manage the potential conflict of interest 
that this financial arrangement may create. Please speak with your study doctor if you have 
questions about this. 
 
 

Virginia Commonwealth University (VCU) 
Page 2 of 8   
 
Nicholas Thomson, PhD 
Advarra IRB Approved Version 17 Apr 2024 
 
 
 
AN OVERVIEW OF THE STUDY AND KEY INFORMATION  
 
Why is this study being done?  
The purpose of this research study is to find out if a virtual reality emotion recognition 
intervention (Impact VR) is effective for reducing conduct problems. We think that youth who 
receive the Impact VR will see greater improvements than youth who do not receive the 
intervention. This study will allow us to learn more about the intervention’s effectiveness. We 
also want to understand if the intervention affects other behaviors, such as emotion regulation, 
antisocial behaviors, and emotion recognition. 
 
What will happen if I participate?  
You will be asked to complete questionnaires and interviews about your child’s behavior, 
personality, and experiences, as well as your own behaviors, personality, and experiences. Your 
child will also complete questionnaires and interviews about their behavior, personality, and 
experiences. This session will take you and your child about one to two hours to complete. 
 
Your child will also be randomly assigned (like the flip of a coin) to one of two groups, either the 
control group or the Impact VR group. If your child is assigned to the control group, your child 
will complete a brief PowerPoint presentation on emotional faces and how to identify these 
emotions. If your child is assigned to Impact VR, your child will receive Impact VR, which 
includes four 20-minute sessions of virtual reality intervention over four weeks. One session will 
be conducted each week. 
 
For all participants, you and your child will be invited to complete the same surveys again at 4 
weeks and 3 months. If this is not convenient, we will arrange a time for you and your child to 
complete the follow-up session over the phone or the internet. 
 
You and your child’s participation in this study will last up to 3 months. Approximately 150 
people will participate in this study.  
 
What alternative treatments or procedures are available?  
You have the option to take a paper survey instead of an electronic one. Ask the study staff if 
you would like a paper survey. This is a testing study only. No alternative treatment is provided.  
 
What are the risks and benefits of participating?  
There are both risks and benefits of participating in research studies. We want you to know 
about a few key risks right now. 
 
Risks, Discomforts and Benefits to You and Others  
• Participation in research might involve some loss 
of privacy. There is a small risk that someone 
outside the research study could see and misuse 
information about you. 
• The information from this 
research study may lead to 
improved interventions in the 

Virginia Commonwealth University (VCU) 
Page 3 of 8   
 
Nicholas Thomson, PhD 
Advarra IRB Approved Version 17 Apr 2024 
 
 
• The study questionnaires and interviews ask 
questions that are sensitive, personal, and may be 
upsetting in nature and may make you feel 
uncomfortable or upset. Some of these questions 
discuss the use of drugs and criminal activities. 
• Study randomization may be uncomfortable or 
upsetting if you, or your child, do not like the 
assigned group.  
future for violently injured 
youth. 
 
Now that you have a general overview of the study, we want to provide the details about what 
your participation involves. Please read, or have someone read to you, the rest of this 
document. If there is anything you don’t understand, be sure to ask the study staff.  
 
Non-Physical Risks (For You and Your Child)  
• Participation in research might involve some loss of privacy. There is a small risk that 
someone outside the research study could see and misuse information about you or 
your child. 
• Questionnaires may contain questions that are sensitive, personal, and potentially 
upsetting in nature. You and your child may refuse to answer any question that makes 
you feel uncomfortable.  
• This study will ask you questions about personal topics that might be embarrassing to 
talk about and that could affect your family relationships if this information were to 
become known outside of the study. You will also be asked about illegal activities, which 
could have legal and financial consequences if this information were to become known 
outside of the study.  
 
WHAT ARE THE COSTS?  
The sponsor is paying for everything in this study. You will not be charged for any study visits.  
 
WILL I BE PAID TO PARTICIPATE IN THE STUDY?  
You and your child will each be paid $75 for each study visit. If you and your child complete all 
scheduled study visits, you will each have received a total of $225.  
 
You will be paid following each completed visit. 
 
Total payments within one calendar year that exceed $600 will require the University to report 
these payments annually to the IRS and you. This may require you to claim the compensation 
you receive for participation in this study as taxable income. VCU is required by federal law to 
collect your social security number. Your social security number will be kept confidential and 
will only be used to process payment.  
 
ALTERNATIVES TO PARTICIPATION 
This research study is for research purposes only. The only alternative is to not participate in 
this study. 

Virginia Commonwealth University (VCU) 
Page 4 of 8   
 
Nicholas Thomson, PhD 
Advarra IRB Approved Version 17 Apr 2024 
 
 
NEW FINDINGS  
Any new important information that is discovered during the study which may influence your 
willingness to continue participation in the study will be provided to you. 
 
CAN I STOP BEING IN THE STUDY?  
You and your child can stop being in this research study at any time. Leaving the study will not 
affect your, or your child’s, medical care, employment status, or academic standing at VCU or 
VCU Health. Tell the study staff if you or your child are thinking about stopping or decide to 
stop.  
 
Your participation in this study may be stopped at any time by the investigator without your 
consent. The reasons might include:  
• 
The investigator thinks it necessary for your health or safety  
• 
The sponsor has stopped the study  
• 
You have not followed study instructions  
• 
Administrative reasons require your withdrawal  
 
HOW WILL INFORMATION ABOUT ME BE PROTECTED?  
VCU and the VCU Health System have established secure research databases and computer 
systems to store information and to help with monitoring and oversight of research. Your 
information may be kept in these databases but are only accessible to individuals working on 
this study or authorized individuals who have access for specific research related tasks.  
 
Identifiable information in these databases are not released outside VCU unless stated in this 
consent or required by law. Although results of this research may be presented at meetings or 
in publications, identifiable personal information about participants will not be disclosed.  
 
While every effort will be made to protect the confidentiality of your information, absolute 
confidentiality cannot be guaranteed. 
 
Personal information about you might be shared with or copied by authorized representatives 
from the following organizations for the purposes of managing, monitoring and overseeing this 
study:  
• 
The study Sponsor, representatives of the sponsor and other collaborating organizations  
• 
Representatives of VCU and the VCU Health System  
• 
Officials of the Department of Health and Human Services 
• 
Advarra IRB 
 
In general, we will not give you any individual results from the study. Once the study has been 
completed, we will send you a summary of all of the results of the study and what they mean.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the 
Website will include a summary of the results. You can search this Web site at any time.  

Virginia Commonwealth University (VCU) 
Page 5 of 8   
 
Nicholas Thomson, PhD 
Advarra IRB Approved Version 17 Apr 2024 
 
 
We will not tell anyone the answers your child gives us. However, if your child tells us that 
someone is hurting her or him, or that she might hurt herself or someone else, the law says that 
we must let people in authority know so they can protect your child.  
 
If you tell us that you may hurt yourself or someone else, the law says that we must let people 
in authority know.  
 
In the future, identifiers might be removed from the information you provide in this study, and 
after that removal, the information could be used for other research studies by this study staff 
or another researcher without asking you for additional consent.  
 
If you or your child are or should become involuntarily detained, confined or incarcerated (in a 
jail, prison, juvenile, or alternative facility), you should be aware that confidentiality regarding 
your or your child’s status cannot be guaranteed. Personal information about you or your child 
might be shared with or copied by authorized representatives of the prison/juvenile facility 
and/or prison/juvenile system.  
 
Certificate of Confidentiality  
To help us protect your privacy, we will apply for a Certificate of Confidentiality from the 
National Institutes of Health. If this certificate is obtained, it will offer the protections described 
here. A Certificate of Confidentiality helps the researchers keep your information private. For 
example, researchers can refuse to give out your information in a court case. Researchers may 
have to give your information if the study is audited, or if the information is required by the 
Food and Drug Administration (FDA).  
 
The researchers may share information about you or your participation, or your child, in the 
research study without your consent if a disclosure is made, such as child or elder abuse or 
neglect, or harm to self or others.  
 
The researchers cannot prevent you or others, for example a member of your family, from 
sharing information about you or your involvement in this research. If you give an insurer, 
employer, or other person permission to receive research information, then the researchers 
may not use the Certificate to withhold that information. .  
 
HOW WILL MY CHILD’S HEALTH INFORMATION BE USED AND SHARED DURING THIS 
STUDY? 
As part of this research study, we will ask you to share your child’s identifiable health 
information with us and/or permit us to access existing information from your child’s 
healthcare records. New health information may also be created from study-related tests, 
procedures, visits, and/or questionnaires and added to your healthcare records. This type of 
information is considered “Protected Health Information” that is protected by federal law.  
 
What type of health information will be used or shared with others during this research? 
The following types of information may be used for the conduct of this research:  

Virginia Commonwealth University (VCU) 
Page 6 of 8   
 
Nicholas Thomson, PhD 
Advarra IRB Approved Version 17 Apr 2024 
 
 
• Information about mental health  
 
Who will use or share protected health information about me?  
VCU and VCU Health are required by law to protect your identifiable health information. By 
consenting to this study, you authorize VCU/VCU Health to use and/or share your health 
information for this research. The health information listed above may be used by and/or 
shared with the following people and groups to conduct, monitor, and oversee the research:  
• 
Principal Investigator, and research and study staff  
• 
Health Care Providers at VCU Health  
• 
Institutional Review Boards  
• 
Government/Health Agencies  
• 
Others as Required by Law  
• 
Research Collaborators  
• 
Study Sponsor  
 
Once your health information has been disclosed to anyone outside of this study, the 
information may no longer be protected under this authorization.  
 
When will this authorization (permission) to use my protected health information expire?  
This authorization will expire when the research study is closed, or there is no need to review, 
analyze and consider the data generated by the research study, whichever is later.  
 
Statement of Privacy Rights  
You may change your mind and revoke (take back) the right to use your protected health 
information at any time. However, even if you revoke this authorization, the researchers may 
still use or disclose health information they have already collected about you for this study. If 
you revoke this Authorization, you may no longer be allowed to participate in the research 
study. To revoke this Authorization, you must write to the Principal Investigator at the address 
listed on page one of this form. 
 
If you decide not to sign this form, you will not be able to take part in the study. 
 
WHOM TO CONTACT ABOUT THIS STUDY 
During the study, if you experience any medical problems, suffer a research-related injury, or 
have questions, concerns or complaints about the study such as: 
 
• Whom to contact in the case of a research-related injury or illness; 
• Payment or compensation for being in the study, if any; 
• Your responsibilities as a research participant; 
• Eligibility to participate in the study; 
• The investigator’s or study site’s decision to withdraw you from participation; 
• Results of tests and/or procedures; 
 

Virginia Commonwealth University (VCU) 
Page 7 of 8   
 
Nicholas Thomson, PhD 
Advarra IRB Approved Version 17 Apr 2024 
 
 
Please contact the investigator at the telephone number listed on the first page of this 
consent document.  
 
If you seek emergency care, or hospitalization is required, alert the treating physician that you 
are participating in this research study.  
 
An institutional review board (IRB) is an independent committee established to help protect the 
rights of research participants. If you have any questions about your rights as a research 
participant, contact: 
 
• By mail: 
Study Subject Adviser 
Advarra IRB 
6100 Merriweather Dr., Suite 600 
Columbia, MD 21044 
• or call toll free:    877-992-4724 
• or by email:          adviser@advarra.com 
 
Please reference the following number when contacting the Study Subject Adviser: 
Pro00069982. 
 
 

Virginia Commonwealth University (VCU) 
Page 8 of 8   
 
Nicholas Thomson, PhD 
Advarra IRB Approved Version 17 Apr 2024 
 
 
STATEMENT OF CONSENT AND PARENT/LEGAL GUARDIAN PERMISSION  
I have been provided with an opportunity to read this consent form carefully. All of the 
questions that I wish to raise concerning this study have been answered. By signing this consent 
form, I have not waived any of the legal rights or benefits to which I and my child otherwise 
would be entitled. My signature indicates that I freely consent to participate and give 
permission for my child to participate in this research study. I will receive a copy of the consent 
form for my records. 
 
Signature Block for Enrolling Adult Participants  
 
Adult Participant Name (Printed):________________________________________________  
 
Adult Participant’s Signature Date:________________________________________________ 
 
Name of Person Conducting Consent Discussion (Printed):____________________________________  
 
Signature of Person Conducting Consent Discussion Date:_____________________________________ 
 
Investigator Signature (if different from above) 
________________________________________________ Date________________ 
 
Signature Block for Enrolling Child Participants – Parent/Legal Guardian Permission  
 
________________________________________________  
Name of Child/Youth Participant  
 
________________________________________________ 
Name of First Parent/Legal Guardian (Printed) 
Study staff – verify that this individual is the child’s parent or legal guardian.  
 
________________________________________________ 
Required First Parent/Legal Guardian Signature Date