University of Washington

Project Self 2.0

Study 1 Information Statement

Researchers:

Dr. Kristen Lindgren, Ph.D., Principal Investigator, Professor, Dept. of Psychiatry and Behavioral Sciences, University of Washington, 206-685-8083, KPL9716@uw.edu

Dr. Clayton Neighbors, Ph.D., Principal Investigator, Professor, Department of Psychology, University of Houston, 713-743-2616, cneighbors@uh.edu

Dr. Christine Lee, Ph.D., Co-Investigator, Research Professor, Dept. of Psychiatry and Behavioral Sciences, University of Washington 206-543-6574, leecm@uw.edu

Vyoma Shah, Research Coordinator, Dept. of Psychiatry and Behavioral Sciences, University of Washington, 206-543-7078, vyomas@uw.edu

24-hour crisis/emergency number: call or text 988 for the National Suicide Prevention Lifeline. The Lifeline can still be reached at (800) 273-8255 or (800) 273-TALK* 

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We are asking you to be in a research study. This form gives you information to help you decide whether or not to be in the study. Being in the study is voluntary. Please read this carefully. You may ask any questions about the study. Then you can decide whether or not you want to be in the study.

KEY INFORMATION ABOUT THIS STUDY

• We are providing this information so that you can decide whether you want to be in our research study. This process is called informed consent.

• Your participation is voluntary

• The purpose of the study is to test whether writing and thinking about your future self can change how people see themselves and help them to make healthy decisions about alcohol, including not drinking alcohol, during times of transition – like graduating high school. We think these writing tasks could be helpful for alcohol prevention or intervention.

• You need to have some interest in reducing or not increasing your drinking

• Participation in the study takes about 13 months.

• The main parts of the study are (1) a brief online screening survey, (2) three weekly meetings hosted on Zoom that include the writing task and surveys, and (3) follow up surveys 1 month, 3 month, 6 months, and 12 months after the last Zoom meeting.

• The most likely potential benefits to you are learning about yourself and your drinking.

• The risks of participating in the study that would be of most significance would be potential loss of privacy and feelings of discomfort due to questions that ask about alcohol use, which is illegal for individuals under age 21, or other substance use, which may be illegal at any age. 

• Alternative ways that you could learn about yourself and/or alcohol use include educational websites, mental health or substance use treatment. We can provide you with resources. You are allowed to be in treatment and be part of this study.

PURPOSE OF THE STUDY

The purpose of this study is to test how writing about one’s future self affects graduating high school seniors’ thoughts and beliefs about themselves and alcohol use. We want to evaluate whether doing so during a time of transition – like graduating high school – could be helpful for making adaptive, helpful decisions about drinking. If this kind of writing is helpful, it could ultimately be used in alcohol prevention or intervention programs.

STUDY PROCEDURES

Participation involves the following:

1. Three weekly Zoom meetings. We will provide you with a link to a scheduled Zoom meeting. An experimenter will be present to assist you for the full duration of the meeting. You will be required to have your video on for the first portion of the session. The experimenter will orient you to the session, get you started on the tasks, and answer any questions you have. They will also ask to see a copy of your school identification card or a government-issued identification card to verify your identity.

You will be asked to complete a series of questionnaires and computer-based tasks via an online survey. One type of task will measure how quickly you categorize words presented on the computer screen—this is called a reaction time task. Each session will include one or two reaction time tasks, and the words or statements will relate to alcohol or drinking. Questionnaires will ask about your personal characteristics (e.g., gender), health behaviors, including the use of alcohol and other substances, your family history, your future plans, your thoughts about who you want to be in the future, and your thoughts or feelings about yourself. Some of the most sensitive questions ask about whether you have used substances that may be illegal to use under age 21 or illegal to use at any age          . Additional examples include questions about whether you’ve experienced withdrawal symptoms from drinking alcohol or whether you have experienced any problems related to drinking.

You will also complete a writing exercise in which you will be asked to imagine yourself in a specific way and write about it for 20 minutes. You will be randomly assigned (like flipping a coin) to the writing exercise you receive. This task will follow with a brief set of questionnaires similar to those you completed earlier.

Depending on what condition you are assigned to, you will complete the writing exercise only at the third meeting or at each of the three meetings. Every meeting will include questionnaires.

a. The first session is expected to last between 60 and 75 minutes.

b. Sessions 2 and 3 are expected to last between 35 to 45 minutes.

c. You will be compensated with Amazon gift cards for completing the assessment at each session. $30 for the first session, $15 for the second, and $20 for the third.

2. Four web-based follow-up surveys. There will be four web-based surveys to check in on you and see how you’re doing. These will include questionnaires and reaction time tasks very similar to those completed previously.

a. These will take place 1 month, 3 months, 6 months, and 12 months after your final Zoom meeting.

b. We will remind you about these surveys in a variety of ways, which may include email, text message, telephone, and mail. If you opt-in to receive text messages, standard message and data rates apply. You may opt-out anytime.

c. Each assessment will be completed online on the laptop or desktop of your choice and will take approximately 25 to 30 minutes.

d. You will be compensated with Amazon gift cards in the following amounts for completing the follow-up assessments:  $25 for completing the 1-month follow-up, $30 for the 3-month follow-up, $35 for the 6 months, and $45 for the 12-month follow-up.

e. If you complete all 4 of the assessments, you will receive a bonus $45 gift card. If you complete 3 of the 4 assessments, you will receive a bonus $30 gift card.  

f. We will email you your gift cards within 5 business days of the date you complete a given survey.

You are free not to answer any question you do not want to answer, except for a few questions that don’t give you the option to decline.

RISKS, STRESS, OR DISCOMFORT

• The risks associated with participation in this study are primarily related to the loss of privacy and the unintentional release of private information. This could occur if data from a participant, or the information that they were participating in a study of alcohol use, were to be released to anyone outside the study.

• Should the data be breached, this could potentially include parents, friends, current or future teachers, and current or future employers being aware of a participant’s reported alcohol (or other drug) use, which could result in negative consequences. For example, a future employer could hold this information against you when making a hiring decision about you.

• These risks are unlikely and have not occurred in the many years that our research team has been doing research at the University of Washington and at the University of Houston.

• We, the research team, will do our best to protect your confidentiality, but we cannot guarantee it.

• Additionally, the potentially sensitive nature of some of the survey questions may make you feel uncomfortable or feel as if you should share information you may not want to share.

ALTERNATIVES TO TAKING PART IN THIS STUDY 

If you choose not to participate in this study but still have questions about alcohol use, we can provide you with a list of information available in the community and nationwide. 

BENEFITS OF THE STUDY

• There may be no direct benefit to you for participating in this study. It is possible you could learn more about yourself and drinking as you go through the study, which may be beneficial. You may think about yourself and your future differently, which could help you make healthy decisions about alcohol during a time of transition (high school graduation).

• Benefits to society include the opportunity to better understand whether writing tasks about one’s future self can help graduating seniors make healthy decisions about alcohol use. Ultimately, those tasks might become part of programs that seek to improve high school students’ health behaviors.

SOURCE OF FUNDING

The study team, the University of Washington, and the University of Houston are receiving financial support from The National Institute of Alcohol Abuse and Alcoholism.

CONFIDENTIALITY OF RESEARCH INFORMATION

• We have taken steps to protect you from the risks mentioned above.

• Participation in this research is voluntary, and with the exception of a few required questions, you are free not to answer any survey questions you do not want to answer or to stop participating at any time without any penalty or loss of benefits.

• All of the information collected from the online survey assessments and writing tasks will be kept confidential to the best of our abilities.

• However, if we learn that you intend to harm yourself or others, we must report that to the authorities.

• In addition, government or university staff sometimes review studies such as this one to make sure they are being done safely and legally. 

• If a review of this study takes place, your data may be examined. The reviewers will protect your privacy. The study data will not be used to put you at legal risk of harm.

• Your answers to the assessment questions and your contact information will be linked together on our survey platform, Qualtrics (www.Qualtrics.com). This is done so that we can send you personalized study links after you’ve enrolled. It allows us to track your participation over time so we can link your responses together over the course of the study.

• We will use an online scheduling program, SuperSaas (www.supersaas.com), to schedule sessions and send reminders to you if you agree. The information stored in SuperSaaS will be password protected and will be accessible only to research staff for the purposes of sending you reminders of your scheduled lab sessions. We will store your name, email, and phone number in SuperSaas if you agree. You will only receive reminders if you agree to enter this information into SuperSaas. . You do not have to agree to receive reminders in order to participate in the study.

• Your name and contact information will be accessible only to research staff for the purposes of contacting you to complete the study and to compensate you for your participation. We will retain your name and contact information until the record retention period for this study (6 years) has ended. 

• You will not be identified in any research reports or presentations of this research. Data identified only by a randomly-generated non-identifying ID may be shared with other researchers doing similar work on other campuses, be combined with data from other campuses in some research reports, and/or may be used to develop procedures used in future studies. These data will be retained indefinitely, identified only by the ID.

• A description of this clinical trial will be available on https://www.clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Certificate of Confidentiality

• We have a Certificate of Confidentiality from the federal National Institute on Alcohol Abuse and Alcoholism (NIAAA).

• The Certificate helps us protect your privacy. 

• The Certificate means that we do not have to give out identifying information about you even if we are asked to by a court of law. 

• We will use the Certificate to resist any requests for identifying information.

• We can’t use the Certificate to withhold your research information if you give your written consent to give it to an insurer, employer, or another person.  Also, you or a member of your family can share information about yourself or your part in this research if you wish.

• There are some limits to this protection. We will provide the information to:

  • A member of the federal government who needs it in order to evaluate the research

  • Individuals at the institutions conducting the research, the NIAAA, and other groups involved in the research, if they need the information to make sure the research is being done correctly

  • Proper authorities, if we learn of child abuse, elder abuse, or your plans to harm yourself or others

  • Individuals who want to conduct secondary research if allowed by federal regulations and according to your consent for future research use as described in this form

• The Certificate expires when the NIAAA funding for this study ends. Currently this is March 30, 2028.  Any data collected after expiration is not protected as described above. Data collected prior to expiration will continue to be protected

OTHER INFORMATION

• You may refuse to participate and you are free to stop participating in this study at any time without punishment or loss of benefits which you otherwise would receive.

• Research staff may also remove you from participating in the study at any point for any reason.

• If you become concerned about your alcohol use or other drug use, or experience discomfort as a result of participation, you can contact one of the investigators listed above to discuss this. 

• Just in case you might have concerns, we will provide you with information about local and national substance use and mental health counseling services

• In addition, you are free to participate in mental health, alcohol or drug-related programs such as support groups, treatment, therapy, etc. while involved in the study.

• We may contact you by email and phone if we become concerned about your alcohol use and inform you about services in the local community.

• The information that we obtain from you for this study might be used for future studies. We may remove anything that might identify you from the information. If we do so, that information may then be used for future research studies or given to another investigator without getting additional permission from you. It is also possible that in the future we may want to use or share study information that might identify you. If we do, a review board will decide whether or not we need to get additional permission from you.

NIAAA Data Archive (NIAAADA) Informed Consent 

Data from this study will be submitted to the National Institute on Alcohol Abuse and Alcoholism Database (NIAAADA) at the National Institutes of Health (NIH). NIAAADA is a large database where de-identified study data from many NIAAA studies is stored and managed. NIAAA will store your de-identified information in this data banks for other researchers to use in future studies on any topic. The researchers could be from government, academic, or commercial institutions.

Deidentified study data means that all personal information about you (such as name, address, birthdate and phone number) is removed and replaced with a code number. Sharing your de-identified study data helps researchers learn new and important things about alcohol problems more quickly than before.  

During and after the study, the study researchers will send de-identified study data about your health and behavior to the NIAAADA. Other researchers across the world can then request your de-identified study data for other research. Every researcher (and institutions to which they belong) who requests your de-identified study data must promise to keep your data safe and promise not to try to learn your identity. Experts at the NIH will review each request carefully to reduce risks to your privacy.  

You will not receive any results from allowing your data to be placed in the NIAAADA data bank.

You can withdraw your consent any time you don't want your data in the NIAAADA data bank.  There will be no consequences for withdrawing consent.  However, data that has already been sent to researchers cannot be retrieved.

Risks associated with sharing information through the NIAAADA data bank includes:

• It is possible that your information could be used to identify you when combined with information from other public sources.

• Others may be able to trace this information back to you or close biological relatives. The current risk of this happening is small but may grow in the future as new technologies are developed.

• There is a risk that your information could become known to the public, employers, or law enforcement agencies. The information may be used to enforce negative stereotypes.

• There may be other risks that are not yet known.

You may not benefit directly from allowing your study data to be shared with NIAAADA. The study data provided to NIAAADA may help researchers around the world learn more about alcohol problems and how to help others who have problems with alcohol. NIAAA will also report to Congress and on its website about the different studies using NIAAADA data. You will not be contacted directly about the study data you contributed to NIAAADA.  

You may decide now or later that you do not want your study data to be added to the NIAAADA. You can still participate in this research study even if you decide that you do not want your data to be added to the NIAAADA.

If you decide any time after today that you do not want your data to be added to the NIAAADA, call or email the study staff who conducted this study, and they will tell NIAAADA to stop sharing your study data. Once your data is part of the NIAAADA, the study researchers cannot take back the study data that was shared before they were notified that you changed your mind. If you would like more information about NIAAADA, this is available online at https://nda.nih.gov/niaaa. 

RECAP OF KEY INFORMATION ABOUT THIS STUDY

• You can decide whether you want to be in our research study.

• We are studying whether writing and thinking about your future self can change how people see themselves and help them to make healthy decisions about alcohol, including not drinking alcohol, during times of transition – like graduating high school. We think these writing tasks could be helpful for alcohol prevention or intervention.

• You need to have some interest in reducing or not increasing your drinking

• Participation in the study takes about 13 months.

• The main things the study consists of are (1) a brief online screening survey, (2) three weekly meetings hosted on Zoom that include the writing task and surveys to complete, and (3) follow up surveys 1 month, 3 month, 6 months, and 12 months after the last Zoom meeting.

• The most likely potential benefits to you are learning about yourself and your drinking.

• The risks of participating in the study that would be of most significance would be potential loss of privacy and feelings of discomfort due to questions that ask about drinking, which is illegal for individuals under age 21, or substance use, which may be illegal at any age.

• Alternative ways that you could learn about yourself and/or alcohol use include educational websites, mental health or substance use treatment. We can provide you with resources. You are allowed to be in treatment and be part of this study.

Kristen P. Lindgren, Ph.D., ABPP                                             Clayton Neighbors, Ph.D.       
University of Washington                                                       University of Houston

Principal Investigator                                                              Principal Investigator
Telephone: 206-685-8083                                                      Telephone: 713-743-2616     

 If you have questions about the research later on, you can call Dr. Lindgren at the number listed above, and if you have questions about your rights as a research subject, you can call the University of Washington Human Subjects Division at (206) 543-0098. 

Subject’s statement

This study has been explained to me. I volunteer to take part in this research. I have had a chance to ask questions. If I have questions later about the research or if I have been harmed by participating in this study, I can contact one of the researchers listed on the first page of this consent form. If I have questions about my rights as a research subject, I can call the University of Washington Human Subjects Division at (206) 543-0098 or call collect at (206) 221-5940. 

As a reminder, we will send de-identified data to the NIAAADA for their data repository, but only for those that consent to have their data used in this way. You can still participate in the study even if you do not want share your de-identified data to the NIAAADA.

 You may decide now or later that you do not want your study data to be added to the NIAAADA. You can still participate in this research study even if you decide that you do not want your data to be added to the NIAAADA.

You may print a copy of this information statement for your personal records by visiting our website or following this link: Project SELF Information Statement | Project SELF (uw.edu). You can do this any time you'd like.