Maternal Vitality Study Informed Consent

INTRODUCTION

You are being asked to participate in a research study at OhioGuidestone called “The Maternal Vitality Study”. This study intends to create a research-based therapy screening protocol developed with Black women for Black women to empower them with strategies to boost their overall health and wellness for themselves and their families. We want more than survival - we want vitality! Currently, we believe mental health screenings for Maternal Depression in the United States is not inclusive and/or culturally responsive to the needs of Black women. For this reason, we want to remodel a screening tool that is culturally responsive and inclusive to the needs of Black women. The word “you” in this document refers to the participant. You are being asked to participate in this study because you identify as a Black, perinatal woman, residing in Cuyahoga County who has been pregnant in the last twelve months no matter how the pregnancy ended (miscarriage, abortion, stillbirth, or live birth). (Perinatal means the time right before, during, and after a pregnancy.) Your participation in this study is voluntary and it is not required to receive services from OhioGuidestone.  Please read the information below and ask questions to better understand this research study.   

WHAT IS MATERNAL DEPRESSION
Maternal depression is a complex condition that includes physical and psychological symptoms for women during and after pregnancy. It can include symptoms related to general depression and anxiety, but also "Baby Blues", anger, and even chronic stress.

PURPOSE OF THE STUDY 
Create a research-based therapy screening protocol developed with Black women for Black women to empower them with strategies to boost their overall health and wellness for themselves that will also positively impact their families.  Maternal depression is a contributor to the current maternal and infant mortality crisis in the United States, especially among Black Americans. The “interview-style” format of the study invites Black women to contribute strategies to identify and combat not only maternal depression, but also race related stressors during therapy to increase healthcare options that focus on cross-generational thriving- not just surviving. This study will include completing a basic eligibility form and consent form for enrollment into the study, completing four “current” screening forms for anxiety, depression, and race-related stress, a ~20-30-minute interview that will help to provide input on the final protocol, and a family needs resource conversation to end your visit. Approximately 5-15 Black perinatal women residing in Cuyahoga County will participate in this study.

There are (4) components/phases of the Maternal Vitality Study Enrollment/Sign-Up Appointment Depression and Anxiety Screenings as well as a Race-Related Stress Screening Conversation Style Interview on Screening Surveys & Participant Feedback Family Needs & Resource Follow-Up with Warm Hand Off Flyer All phases can be completed in 1, 60–90-minute session, or broken down into 2, 30–45-minute sessions. Appointments can be completed on the computer using teleconferencing (like Zoom or Teams) or in-person at your home or another community location (like a local library). Once you are done with the study, you will be able to receive a referral to continue therapy if you desire.

POTENTIAL RISKS  

There are minor risks you may experience, such as thoughts or feelings that are upsetting to you. This is expected during the study visit, and study staff are trained to support you and help you deal with these thoughts or feelings during your appointment if needed. Study staff will also provide the name and contact information for local emergency or healthcare services, programs or providers if needed. If you receive a referral during or at the end of this study, study staff will call you between 1-6 weeks (about 1 and a half months) after to see if you were able to make an appointment with a healthcare or service provider.

ANTICIPATED (POTENTIAL) BENEFITS  

You may or may not benefit from this study. Possible benefits may include: 

• Improved mental health and well-being.
• A sense of validation from being able to directly speak to your experiences as a Black, perinatal mother.
• Strategies to meet your mental health needs.
• Strategies to lower stress, including race related stress.
• On-sight screening for depression and anxiety as well as race-related stress.
• A referral to begin mental health appointments with a licensed mental health specialist (as needed/desired).
Information learned from this research study may also benefit other black mothers and families

INCENTIVES

Thank You Gift- A one time, $25.00 gift card will be mailed to your home address (or desired address) upon completion of study visits as a “thank you” for your time. This gift card can be to the retailer, Amazon, Target, or Walmart.

Maternal Vitality E-Journal- Our research team created a special electronic journal specifically for participants of this study. This self-care workbook is meant to be used by perinatal mothers coping with the symptoms of Maternal Depression. This journal is filled with a series of prompts and journal spaces to allow perinatal women to identify key emotions and practices that may be intensifying or relieving symptoms of Maternal anxiety, anger, or depression, and is a great addition or starting place for routine self-care.

Warm-Hand Off/Community Resources Flyer- Our desire is to support maternal “thriving” even after the study is completed! After you have completed your “Maternal Vitality” study visit, our research team will email you a flyer containing the names and contact information of organizations around Northeast Ohio who are working to help African American, perinatal mothers... THRIVE!

Research Team Contact Information- Our work does not stop after your visits are completed. Feel free to contact our research team for any perinatal or maternal health needs!

Confidentiality 

Your information will be kept confidential and only used for this research study. Only people working on this research study will have access to your study information. We will collect your demographic information, but a unique number (study ID number) instead of your name or other identifying information will be used on study documents. If you submit study forms through our Research Portal, your IP address will be collected along with the form, for verification purposes only, and will be treated by study staff as identifying information. Your name or anything else that could identify you will not be included in reports, presentations or publications from this study. Your information will be kept in a locked file cabinet in a locked room, and computer files will only be opened on password protected computers. All documentation with identifying information will be destroyed once the study has ended.

Confidentiality and Referrals

If your conversations with study staff suggest that you might need additional health care, or if at the end of the study you want to continue therapy, or for any reason you tell us: you will receive information for a local emergency healthcare provider (such as a crisis number), for a mental health provider, and a referral form to sign-up for any additional healthcare you want to receive during or after the study. This referral form will show that you were a participant in this study and completed surveys to see if you might be experiencing maternal depression, anxiety, high stress, or another mental health need. The form will include the scores from the study questionnaires you completed, your contact information, and current medications. The referral may also include any responses you gave to study questions. Observations and notes from study staff would be included, too. These would be shared only with the mental health provider, since they might be relevant to any mental health care you might receive. A referral to any other healthcare provider, unless it is an emergency or crisis, cannot happen without your permission.

Voluntary Participation and Withdrawal 

Your participation in this study is completely voluntary. Currently, participating in this study is the only way to participate in the activities for this study, but OhioGuidestone does offer maternal depression therapy that you can sign-up for (our staff can help you). If you choose not to participate, it will not affect your relationship with OhioGuidestone.  You will still have the right to services that you are eligible for at OhioGuidestone. You will not be treated inappropriately differently, or negatively if you decide not to participate. If you decide to participate, you are free to withdraw your consent and stop at any time.  You will not be treated any differently by OhioGuidestone if you decide to withdraw from the study. If you decide to withdraw from the study, we will still help you if you want services at OhioGuidestone or another location for your mental healthcare. If you do participate in this study, your access to current and future services and client rights with OhioGuidestone will not be changed or different. There is no cost to participate in any part of this research study

Contacts and Questions 

If you have any questions about this study, you can contact the study team at: research@ohioguidestone.org or 216-562-8543.  If you have any questions about OhioGuidestone’s services, including client rights, you can contact the agency’s Client Advocate at 440-260-8308.  You may also ask research staff any questions that you have now, or at any point during the research study.  

Informed consent to participate in research is very important.  

By signing below, you agree :

That you have read the information about this research study. 

You have been given the chance to answer questions and they have been answered. 

You can participate in the study and do not agree to record play sessions. 

You volunteer to participate in the study and understand that you can withdraw from the study at any time. 

A copy of this consent form will be provided to you.