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WELCOME TO THE SCREENING SURVEY!

When taking this research survey, if at any time you lose your Internet connection or need to stop, please use the same link to complete the survey.

You are free not to answer any question that you do not wish to answer, and can refuse to participate or withdraw from participation at any time without penalty.

THANK YOU FOR YOUR INTEREST!

Online Screening Consent Statement/Information Statement

Welcome to Project PATH!

This research is being conducted by Dr. Melissa Lewis from the School of Public Health at the University of North Texas Health Science Center located in Fort Worth, TX. This study has been approved by the North Texas Regional Institutional Review Board. If you would like to ask any questions about this information or about our confidential study, please call us at 817-735-2371 or e-mail PATH@unthsc.edu.

We would like to invite you to participate in a confidential research study. The purpose of our study is to explore health and risk behaviors, including alcohol and drug use, in adolescents and young adults. We are interested in recruiting people between the ages of 15 and 25, including both individuals who do not drink alcohol and who do drink alcohol. The information you provide for this study may help our research team to better understand who engages in certain types of health or risk behaviors and why.


Online screening survey and phone verification process:

  • You will be asked to complete demographic questions (e.g., age, birth sex, race, ethnicity, pregnancy status) and other knowledge-based questions to see if you fit our study needs and for your contact information. We will also ask you questions about how you learned of Project PATH. This short survey takes approximately 5 minutes. This information will be confidential. The overall purpose of this initial screening survey is to determine if you are eligible to participate in the main study.
  • If you are age 18 or older, we will ask health and risk behavior questions, such as alcohol or drug use, and sexual experiences.
  • If you are under the age of 18, we will ask for your parent/guardian contact information. Before we can give you additional information about the larger study and continue with the next step in verifying your eligibility, we need parental/guardian permission for your participation. Your parent/guardian will NEVER have access to any of your answers throughout the entire study should you choose to participate.
  • If a potential fit for our study, we will contact you by phone within approximately 3 business days to give you more information and to verify your eligibility (e.g., age, birth sex, residency, contact information).
  • If you are not a good fit for our study, you will receive an email following the completion of this initial screening survey or after the phone verification process notifying you that you are ineligible for the larger study.

Baseline/12-month survey and daily surveys:

  • If you are eligible and agree to be in our study, you will be invited to an online baseline survey, which will take approximately 45 minutes to complete. You will be asked to read and sign an online assent form if you agree and choose to participate prior to engaging in the baseline survey and other research related activities. The confidential online survey asks about your basic demographics, including sexual orientation, personality, mood, social media use, social influences (including questions about your friends), health and risk behaviors (e.g., alcohol, marijuana, drug use, family history of alcohol use, sexual behavior), and your experience with COVID-19. You will be paid $25 on a Greenphire Mastercard to compensate for your time, which will be mailed to you after your online training session (see below).
  • Following the online survey, you will be invited to schedule for an online training session (hosted via Zoom Video Communications) regarding the daily survey portion of the study (see below). You will then be asked to download and install the Zoom application on your personal device. You will not be asked to sign up for a Zoom account nor agree to the Zoom Terms of Service in order to participate in the online training session. In order to download and run Zoom on your personal device, you will need an iPhone (iOS 7.0 or later), an Android cell phone (Android 4.0x or later), a PC/laptop (with Windows XP, Vista, 7, 8, or 10) or a Mac computer/laptop (MACOS 10.7 or later). You will need a stable internet connection during your participation in the online training session. The digital recording feature in Zoom will not be used by the facilitator and participants will not have access to it. Once you join the online session, the session will be locked and no one else will be allowed to join. During the online training session, you will review the consent/assent form with a trained facilitator and verify that you continue to agree to be in the study. You will be shown how survey links will be sent to you via text message and email and will be shown a test survey. Use of your phone during the entire study may contribute to your data use/data plan. The survey links have security features that ensure that all data is kept confidential. The session will last approximately 30 minutes and you will be paid $25 to compensate for your time. After your online session you will be mailed a Greenphire Mastercard. After you receive your card, you will be asked to contact us via email or phone so we can load your card with a total of $50 for the online baseline survey ($25) you previously completed and the online session ($25). You will also be provided with additional information about how the Greenphire Mastercard works during your online training session.
  • After the online training session, the next phase of the study includes daily surveys sent via links in text message and email. The survey links have security features to keep all data confidential. You will be asked to complete surveys for one year; within this year there will be four quarters that consist of 3 consecutive weeks of 5-7 minute surveys per quarter. Within each week, there will be 5 weekend assessments (i.e., 2 on Friday, 2 on Saturday, and 1 on Sunday morning), and 3 assessments during the week (i.e., 1 during a random weekday, 1 on the following morning, and 1 on Thursday afternoon) for a total of 8 weekly assessments. The first 3-week survey period will begin the Thursday after your online session. Each following quarter will begin the Thursday 90 days after day 1 of the previous quarter. The daily surveys will include questions about your current drug/alcohol use, situational factors, sexual behavior, and social influences. You will be paid $3 per AM survey and $3 per PM survey, which will be loaded onto your Greenphire Mastercard at the end of each quarter throughout the course of the study. You may receive a bonus of $10 per quarter if you complete 90% or more of the daily assessments.
  • You will also be asked to complete one web-based 45-minute survey at the end of the year. The confidential online survey will ask questions about your mood, social media use, and social influences (including questions about your friends). You will receive $25 loaded onto your Greenphire Mastercard for completing this survey.
  • You can receive a bonus of $5 on your Greenphire Mastercard if you provide contact information for individuals to contact for potential study enrollment and their provided referral contact information leads to the enrollment of one or more referred individuals. In total, you can earn up to $408 loaded onto your Greenphire Mastercard over the course of the one-year study.

Unless you withdraw from the research study, the researchers can continue to use or share your de-identified (no identifiers) information indefinitely. The researchers will be publishing articles and presenting data at conferences. Data will be de-identified (no identifiers) by the end of the study.

Participating in this study is voluntary. You may refuse to answer any question and still submit your survey without penalty or loss of benefits to which you are otherwise entitled. You are free to withdraw at any time without penalty or loss of benefits to which you are otherwise entitled.

Researchers will only retain your contact information if you are eligible for this study or if you are age 18 or older and agree (during the screening survey) to be contacted for future research studies. If you are ineligible for this study and you do not agree to be contacted for future research studies, your contact information will be deleted within 30 days and not be used in any way. If you are eligible for this study or if you are age 18 or older and agree to be contacted for future research studies, your contact information will only be used for the purposes of contacting you about the study or future research studies and we will retain your contact information indefinitely unless you request to no longer be contacted for future studies.

If you are 15-17 years old, you and your parent/guardian’s contact information will be deleted within 30 days in the event that your parent/guardian does not grant consent, or does not respond to the consent invitation or repeated consent reminders.

If you choose to “like” our Facebook Fan Page and/or “follow” our Instagram or Twitter, you may see more posts from us about our latest projects/activities, general updates, and other fun things.

The risks associated with participation in this short online survey are primarily related to the sensitivity of some of the questions. If you are age 18 or older, you will be asked about personal behaviors such as alcohol use, drug use, and sexual behavior. These questions may make you feel uncomfortable or may seem intrusive, or you may become concerned about your drinking or other health behaviors as you answer the questions. You are asked to report on illegal behaviors, such as drinking under the legal age, or using controlled substances. Answers to these questions could pose a risk if the information were known and linked to identifiable individuals. It is possible that you will feel uncomfortable while taking the survey, or feel as if you should share information that you don’t want to share. Additionally, there is informational risk since your contact information will be maintained for at least 30 days. However, we have taken steps to protect you from this risk. All of your data will be kept confidential and data will be identified only by a PIN (personalized identification number) randomly generated for research purposes, and will not be identified by participants’ names. The PIN is always embedded in survey links, meaning the link is specific to you and your survey data. Thus, you will not ever need to enter your PIN to complete study surveys.


If you would like to participate, please indicate your consent/assent below.
Melissa Lewis - Signature
Melissa A. Lewis, Ph.D., Principal Investigator
melissa.lewis@unthsc.edu, 817-735-5136

Please answer the question below and hit NEXT (regardless of your answer).


PARTICIPANT’S STATEMENT

This study has been explained to me. I have had a chance to ask questions. If I have questions later about the research, I can ask one of the researchers listed above. If I have questions about my rights as a research subject, I can call the North Texas Regional Institutional Review Board at (817) 735-0409.

Your research records will be kept as confidential as possible under current local, state, and federal law. However, federal regulatory agencies and the North Texas Regional Institutional Review Board may examine your records.


Please click the box indicating whether or not you would like to participate.

(Note: by checking YES you are only consenting to this initial screening phase of the project and not the entire research study. You will also be asked to provide a drawn e-signature and asked to type your full name.)

Please indicate whether you would like to participate or not.

Please sign and complete the information below if you checked the “YES” box above. This information will document your consent for this initial screening survey. All of your responses will be kept confidential.


Electronic Signature: (click or tap to sign)

To be eligible for this study your signature is required.

Typed Full Name:

To be eligible for this study your full name is required.

Please enter your email to receive a copy of this signed consent form for your records.

Email (e.g. PATH@unthsc.edu)

To be eligible for this study your email is required.

Please submit your completed consent form by pressing the ‘Next’ button below.


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You indicated that you DO NOT want to participate in Project PATH at this time.


If this is INCORRECT, and you DO want to participate, please press [Back] and change your response.


If this is CORRECT, please confirm:

Please provide a response.

Thank You.


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Study Title:
A Longitudinal, Measurement Burst Study to Examine the Ecological Validity of the Prototype Willingness Model of Hazardous Adolescent and Young Adults Alcohol Use (Project PATH)

Principal Investigator Name:
Melissa A. Lewis


A. What is the purpose of this form?

The purpose of this form is to give your permission to the research team at the University of North Texas Health Science Center (“UNTHSC”) to obtain, use or share your protected health information (PHI). This protected health information will be used to do the research named above. UNTHSC understands that information about you and your health is personal and we are committed to protecting the privacy of that information in accordance with state and federal privacy laws. Because of this commitment, we must obtain your written authorization before we may collect, use or share your protected health information for the research study listed above. This form provides authorization and helps us make sure you are properly informed of how this information will be used or disclosed. You do not have to sign this permission form. If you do not sign, UNTHSC will not obtain, use or share your protected health information for research. Please note though that you will not be able to participate in the research study. Your decision to not sign this permission will not affect any treatment, health care, enrollment in health plans or eligibility for benefits.

"This document is also used for parents to provide permission to obtain the individual health information of their minor children, and for legally-authorized representatives of subjects (such as an appropriate family member) to provide permission to obtain individual health information of individuals who are not capable themselves of providing permission. In such cases, the terms “you” and “your health information” refer to the subject rather than the person providing permission.

A minor’s signature is required to release the following information about the minor: 1. Age 14 and older – information relating to reproductive care, including but not limited, to birth control and pregnancy-related services and sexually-transmitted diseases, including HIV/AIDS and 2. Age 13 and older – substance abuse diagnosis or treatment, and mental health information."


B. What is considered Protected Health Information (PHI)?

In this form, “protected health information” (PHI) refers to any health information that identifies you, such as:

  • Your past, present, or future physical or mental health or condition (e.g., responses to surveys)

C. What Protected Health Information will be obtained, used or shared?

If you sign this form, you give UNTHSC permission to obtain, use or share the following health information as part of this research study:

  • Alcohol and drug use information collected from surveys
  • Health information, including mental health, collected from surveys
  • Sexual behavior information collected from surveys
  • Family substance use history collected from surveys

UNTHSC is required by law to protect your health information. By signing this form you authorize UNTHSC to obtain, use or share your health information for this research. Those persons who receive your health information may not be required by Federal privacy laws to protect it and may share your information with others without your permission, if permitted by laws governing them.


D. From whom, or where will you obtain my Protected Health Information?

Health information about you created or generated during the course of this research study.


E. Who may obtain, use or share my Protected Health Information?

Your protected health information may be obtained, used, or shared with these individuals or organizations for the following purposes:

  1. To the research team for the research described in the Research Consent Form
  2. To others with authority to oversee the research (i.e., Institutional Review Board (IRB), safety monitoring committee, oversight board, etc.)
  3. To others who are required by law to review the quality and safety of the research, including: U.S. government agencies, such as the Food and Drug Administration or the Office of Human Research Protections, the research sponsor National Institutes of Health, or the sponsor’s representatives including but not limited to the National Institutes on Alcohol Abuse and Alcoholism, other federal or state agencies, and government agencies in other countries.

Any protected health information disclosed pursuant to the authorization may be subject to re-disclosure by the recipient and is no longer protected.


F. How will my Protected Health Information be used or shared for the research?

If you agree to be in this study, the research team may use or share your protected health information in the following ways:

  1. To perform the research
  2. Share it with researchers in the U.S. or other countries
  3. Use it to improve the design of future studies

G. Am I required to sign this document?

No, you are not required to sign this document. If you decide not to sign this document, you will still receive the same clinical care, or any services you were already entitled to receive. However, if you do not sign the document, you will not be able to participate in this research study.


H. Does my permission expire?

This permission to release your Protected Health Information expires when the research ends and all required study monitoring is over.


I. Can I cancel my permission?

You can cancel your permission at any time.

You can do this by writing to the researcher. Please send your written request to:

Project PATH Staff
Department of Health Behavior and Health Systems
School of Public Health
3500 Camp Bowie Blvd; EAD suite 708
Fort Worth, TX 76107-2699
Telephone: 817-735-2371
Email: path@unthsc.edu

You have the right to take back your permission at any time, except to the extent that the research team has already taken action in reliance on your permission. If you cancel your permission, you may no longer be in the research study.

If you cancel, no more health information about you will be collected. However, information that has already been collected and disclosed about you may continue to be used as necessary to maintain the integrity of the study (i.e., complete the research). Also, if the law requires it, the sponsor and government agencies may continue to look at your protected health information to review the quality or safety of the study.


J. QUESTIONS CONCERNING YOUR PRIVACY RIGHTS?

Please call us at 817-735-2371 with any questions.


K. Authorization

If you agree to the use and release of your Protected Health Information, please sign using your electronic signature below.


Consent for Specific Health Information and Use

The following information will only be released if you give your specific permission, which is required by Federal and state laws, by putting your initials on the line(s). The federal rules bar any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient.


I agree to the release of information pertaining to drug and alcohol abuse.

Initials
To be eligible for this study your initials are required.

I agree to the release of information pertaining to mental health.

Initials
To be eligible for this study your initials are required.

Required Signature for HIPAA Authorization:


Subject Typed Full Name:

Full Name
To be eligible for this study your full name is required.

Subject Electronic Signature: (click or tap to sign)

To be eligible for this study your signature is required.

Witness
If this form is being read to the subject because s/he cannot read the form, a witness must be present and is required to type his/her name and sign here.


Witness Typed Full Name:

Full name
Please use only alphabetical characters. Ex: James.

Witness Electronic Signature: (click or tap to sign)

Please provide a response.

If you provided your email, you will receive a copy of this statement for your records.


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Please click below to proceed.