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Title of research study: A Community-Based Approach to Developing a Brief Couples Intervention for Co-occurring Alcohol Use Disorder and Intimate Partner Violence

Principal Investigator: Meagan Brem, Ph.D., Phone: (540) 231-5701, E-mail: mbrem@vt.edu

Other study contact(s): Donna Sedgwick, Ph.D., 540-231-8965, E-mail: Sedgwick@vt.edu

Key Information: The following is a short summary of this study to help you decide whether or not to be a part of this study. More detailed information is listed later on in this form.

Why am I being invited to take part in a research study?
We invite you to take part in a research study because you are at least 18 years old and are in a romantic relationship that is not characterized by severe intimate partner violence. Additionally, your romantic relationship may have been impacted by some physical aggression or alcohol use.

What should I know about being in a research study?
Someone will explain this research study to you Whether or not you take part in this research study is up to you You can choose not to take part in this research study You can agree to take part in this research study and later change your mind Your decision will not be held against you You can ask all the questions you want before you decide

Why is this research being done?
The aim of the study is to learn about rural couples’ treatment needs and preferences, and gaining a better understanding of barriers that keep them from accessing or benefitting from treatment that could reduce problems associated with alcohol use and/or partner conflict. As a result of this information, the research team will work with community partners to develop a brief intervention that could better serve couples in Virginia. This study will take between 60 and 90 minutes of your time. About 60 participants will be enrolled in this study. More detailed information about the study’s procedures can be found in the “What happens if I say yes, I want to be in this research?” section below.

Detailed Information: The following is more detailed information about this study in addition to the information listed above.

Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research team by contacting:
Dr. Meagan Brem, Office: (540) 231-570, E-mail: mbrem@vt.edu

This research has been reviewed and approved by the Virginia Tech Institutional Review Board (IRB). You may communicate with them at 540-231-3732 or irb@vt.edu if:

You have questions about your rights as a research subject Your questions, concerns, or complaints are not being answered by the research team
You cannot reach the research team
You want to talk to someone besides the research team to provide feedback about this research

How many people will be studied?
We plan to include about 60 people in this research study.

What happens if I say yes, I want to be in this research?
You will interact with one trained research staff for 60-90 minutes who will interview you at the site you and your interviewer agreed upon. This may include either room 237 or 241 in Williams Hall at Virginia Tech’s Blacksburg campus. The entire study could take between 60 and 90 minutes. You will be compensated with a $100 Clincard for participating, which can be used as a debit card. You will be asked about your thoughts on you/your partner’s treatment needs and preferences, barriers that keep you/your partner from accessing or benefitting from treatment that could reduce problems associated with alcohol use and/or partner conflict, and whether you think a couples treatment would be possible, helpful, and appropriate for reducing alcohol use and relationship conflict. You will answer these questions in a private room, and your responses will be audio recorded. You will be compensated $100 after the interview is complete, and provided with a list of mental health, substance use, and relationship health resources. If other participants are referred to our study by you, your name will be entered into a drawing for 4 movie tickets (1 entry per referral).

What happens if I say yes, but I change my mind later?
You can leave the research at any time, for any reason, and it will not be held against you. You will still be compensated $100.
If you decide to end the interview before all questions have been asked (i.e., you choose to end your participation early), data you previously submitted with be kept as part of the research team’s final data set, but you will not be asked to provide additional data. Audio data will not be linked to your name, phone number, address, birthdate, or any other identifiable information; if you disclose identifiable information during the interview, that information will be deleted when research staff type the transcript of your interview. Specifically, we will replace your identifiers with the word “MASKED.”

Is there any way being in this study could be bad for me? (Detailed Risks)
There is the possibility that responding to some questions may cause you to experience some distress. You may skip questions at any time without penalty, and you may provide as much or as little information as you feel comfortable with during the interview. You may also withdraw from the study at any time without penalty. Research staff will provide you with referrals to medical and mental health services at the end of the study. Appropriate authorities may be contacted should you report any plan, intent, or threat to harm another person or yourself during the study, or if you give researcher staff reason to suspect abuse of a child, elderly person, or vulnerable population (e.g., person with a disability). Dr. Meagan Brem and her trained research staff will have access to the information you provide. Information may also be shared with those who make sure the study is done correctly (Virginia Tech Institutional Review Board). The paper information you provide will be stored in locked cabinets, and electronic data you provide will be stored on password- and firewall protected computers in locked laboratory rooms. We will use a code number rather than your name on all data (other than the consent forms) collected today. After today, personal identifying information used to contact you and schedule your study session will be deleted from electronic records. Despite all of our efforts to protect your privacy, confidentiality breaches may still occur. Taking part in this research study might lead to added costs to you. Examples might include child care costs you and your partner may experience for participating in this study, travel expenses, etc. You will not be reimbursed for these costs. The only financial payment you will receive is $100.

What happens to the information collected for the research?
We will make every effort to limit the use and disclosure of your personal information, including research study and medical records, only to people who have a need to review this information. We cannot promise complete confidentiality. Organizations that may inspect and copy your information include the IRB, Human Research Protection Program, and other authorized representatives of Virginia Tech.
Appropriate authorities may be contacted should you report any plan, intent, or threat to harm yourself or another person during the interview, or if you give researcher staff reason to suspect abuse of a child, elderly person, or vulnerable population (e.g., a person with a disability).
Participants who complete the study will be given ID numbers, which will be used to track their data in future analyses. Though identifying information will initially be obtained to schedule participants for this study, no names will be kept; the audio file and transcription of the audio file will be stored and analyzed with the ID numbers, alone. The audio file will be permanently deleted from all devices once it is transcribed to text, which will occur no more than 3 months after the interview is completed. Only the principal investigator and authorized co-investigators will have access to these data sets, which will be stored on Dr. Brem’s password-protected computers and backed up on a password-protected hard drive and a password-protected and encrypted server. At no time will the researchers release identifiable results of the study to anyone. The Virginia Tech (VT) Institutional Review Board (IRB) may view the study’s data for auditing purposes. The IRB is responsible for the oversight of the protection of human subjects involved in research.

Following the study, the de-identified data will be retained for three years after the study is completed or the last of secondary analyses are published, whichever is longer. Signed consent forms will be stored in a locked filing cabinet in Dr. Brem’s locked office for three years after the study ends after which signed consent forms will be destroyed.

If identifiers are removed from your private information or samples that are collected during this research, that information or those samples could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent.
Results of this research study may be presented in summary form at conferences, in presentations, reports to the sponsor, academic papers, and as part of a thesis/dissertation.

Can I be removed from the research without my OK?
The person in charge of the research study or the sponsor can remove you from the research study without your approval. Possible reasons for removal include:
Medical emergencies that occur on site Technology difficulties (during which we would attempt to reschedule your study appointment)
We will tell you about any new information that might affect your health, welfare, or choice to stay in the research.

What else do I need to know?

All participants, regardless of what information they provide during this study, will receive a list of local and national resources.
Any expenses accrued for seeking or receiving medical or mental health treatment will be your responsibility and not that of the research project, research team, or Virginia Tech.
If you agree to take part in this research study, you will receive $100.