Informed Consent Form
University of Miami
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Web-Based Relationship Enhancement
The following information describes the research study in which you are being asked to participate. Please read the information carefully. At the end, if you agree to participate, you will click on a box next to the statement “I consent to participate in this research study.”
PURPOSE OF STUDY:
You are being asked to participate in a research study to test self-help internet programs designed to strengthen your romantic relationship. These programs are NOT marriage counseling. We are interested in which program is more helpful to your relationship and whether one program is more helpful for certain types of people or relationships.
If you participate in this study, you will be asked to do the following:
- You will complete a 30-minute online questionnaire that asks about your relationship (e.g., satisfaction, behaviors) and you (e.g., demographics, personality, and physical and psychological symptoms). Both you and your partner need to complete this questionnaire to be eligible for the study.
- If you and your partner are eligible, you will complete a second 30-minute questionnaire – your answers to this questionnaire will be used to tailor the program to your specific relationship.
- Next, you and your partner will have a phone call with project staff, where you will have an opportunity to ask any remaining questions. If you continue to desire to participate, you will be randomly assigned (in other words, assigned by chance, like flipping a coin) to either the ePREP program, the OurRelationship program, or to a wait-list condition.
- If you are randomly assigned (like the flip of a coin) to complete one of the programs immediately:
- You will be assisted through the program by a staff “coach”. You and your partner will participate in four video calls (e.g., Skype, FaceTime) or phone calls (if you prefer) with your coach that will each last about 15 minutes. You should take care to conduct these calls in a location where you can maintain your privacy. If conducted via Skype or FaceTime, these calls will be encrypted; however, if using a wireless connection, you should ensure it is a secured network. There will be weekend, evening, and weekday times available for the calls.
- At the beginning of a call, your coach may request your permission to make an audio (not video) recording of that call. If you agree, these audio recordings will be used in training and ongoing supervision of the coach. These recordings will be erased after supervision (no later than the end of your participation in the study) and will not be used for any other purposes. This recording is optional; you can refuse to allow the recording without affecting your eligibility to participate in the study.
- During the programs, you will work on activities both separately and together with your partner.
- You will complete questionnaires: a) during the program, b) at the end of the program, and c) 2 and 4 months after you’ve completed the program; you will be paid for completing these questionnaires as described below.
- If your partner does not complete the program, you will be able to remain in the program and complete the relevant activities. Additionally, if you do not complete the program, we will still contact you and ask you to complete all remaining research questionnaires.
- If you are first assigned to the wait-list group:
- You will complete four questionnaires during the 6-month waiting period – at 1, 2, 4, and 6 months after beginning the waiting period. You will be paid for completing these questionnaires, as described below.
- Six months after initial randomization, you and your partner will be able to choose whether to start the ePREP or OurRelationship programs (you will not be randomly assigned to a program). If you choose to begin a program, you will be asked to complete an online survey at the end of the program that will take about 15 minutes to complete.
RISKS AND/OR DISCOMFORTS:
One potential risk is that participating in the programs could increase, rather than decrease your relationship distress. Additionally, completion of the questionnaires regarding personal and relationship functioning could also cause you some anxiety or emotional discomfort.
There may be uncommon or previously unknown risks. You should report any problems to the researcher.
No direct benefit can be promised to you and your partner. However, both programs have been found in previous research to be beneficial for the average couple. Therefore, it is possible that you will achieve a better understanding of relationship difficulties you’re experiencing and learn effective strategies to improve your relationship.
If you decide not to participate in this study, you could choose to see a marriage counselor, attend a relationship workshop, participate in another online program, or read a self-help book.
We will take several steps to protect your confidentiality, including:
- Use of a project-specific ID numbers: Your identifying information (e.g., name, address) will be separated from the rest of your responses after download. Your responses will be linked only to a project-specific ID number.
- Use of secure log-in IDs and passwords. You will create a unique user name and password upon entering the program.
- Security of electronic data. Data collected as part of this study will be stored on secure servers at Qualtrics.com, Kineo US (our website vendor in Chicago, IL), or Mathematica (a federal evaluation firm contracted by the sponsor).
Your information will be shared with the sponsor of this study (the Administration of Children and Families), and persons working with the sponsor to oversee and evaluate the study (including Mathematica, a federally-funded evaluation firm). The U.S Department of Health and Human Services (DHHS) may request to review and obtain copies of your records. Your records may also be reviewed for audit purposes by authorized University or other agents who will be bound by the same provisions of confidentiality.
Additionally, according to Florida laws, if you provide evidence of abuse of a child or vulnerable adult, we will be required to break confidentiality and report this abuse to the appropriate legal authorities. Additionally, if we determine you to be at risk for harming yourself or others, we may contact appropriate authorities or interested parties as permitted by Florida law.
There are no costs associated with your participation in this study.
You and your partner will each be paid separately for your participation in this study; therefore, all values that follow are per individual. If you are randomized to receive the program immediately, you will receive total payments of up to $115 ($230 per couple) in gift cards for completing program activities and research assessments on time. Specifically:
- $15 for completing online activities and coach calls on time
- $25 for the mid-program survey
- $25 for the post-program survey
- $25 for the questionnaire 2 months after the intervention
- $25 for the questionnaire 4 months after the intervention
If you are initially assigned to the wait-list control group, you will be eligible for a total of $200 ($400 per couple). Specifically:
- $50 for a survey 1 month from now
- $50 for a survey 2 months from now
- $50 for a survey 4 months from now
- $50 for a survey 6 months from now
All monetary rewards will be in the form of electronic gift codes from national vendors such as Amazon.com and Walmart. You will be able to choose your payment from one of these vendors. Gift codes will be sent to you via e-mail.
RIGHT TO DECLINE OR WITHDRAW:
Your participation in this study is voluntary. You are free to refuse to participate in the study or withdraw your consent at any time during the study. The investigator reserves the right to remove you without your consent at such time that they feel it is in the best interest for you.
Drs. Brian Doss and Andrew Christensen are the co-developers of the intellectual property associated with the Our Relationship program. If the program is commercialized in the future, they may gain royalties from this intellectual property.
Dr. Brian D. Doss, at (305) 284-1101 (“bdoss @ miami.edu”, make sure to remove the white spaces and quotes), will gladly answer any questions you may have concerning the purpose, procedures, and outcome of this project. If you have questions about your rights as a research subject you may contact Human Subjects Research Office at the University of Miami, at (305) 243-3195 (“eprost @ med.miami.edu”).