Father’s Feelings Infant Safety Sub-Study Consent Form

Introduction

You are being asked to participate in a research study at OhioGuidestone called "Father's Feelings: Infant Safety Sub-Study." The word "you" in this document refers to you as the possible participant or to your minor child if the person who will sign this consent form is the parent/guardian of a possible participant under 18 years of age.

You are being asked to participate in this study because you are:

• A male 14 years and older;
• A father of an unborn child (partner/spouse still pregnant) OR a child between 0-12 months old;
• Have not been diagnosed or treated for any serious mental health illnesses.

AND

• You are eligible to receive free infant safety items based on your monthly income and family size.

Your participation in this study is voluntary and is not required. If you or your family members get services, benefits or are in any programs at OhioGuidestone or with a participating location, you will not be affected if you do or do not choose to participate.

If you are a minor (under 18 years of age), your parent or legal guardian must sign this consent form. In addition, your "assent" (agreement) will be obtained by the researcher before you may participate in this study. You must sign the assent form. You and your parent/guardian will be given a copy of the signed consent and assent forms to keep.

Please read the information below and ask questions to better understand this research study.

Purpose of the Study

OhioGuidestone wants to create and study a short questionnaire (or survey) created for male fathers. The months before a baby is born is known as the prenatal period and the 12 months after the birth of a baby is known as the post-partum period. These two periods, prenatal and post-partum, are a part of what is known as the perinatal period.

The perinatal period is sometimes a mixture of good and bad experiences, situations and feelings. Sometimes sadness or even depression can happen during the prenatal and or post-partum time for both mothers and fathers. We have created a special questionnaire that is made for male fathers’ feelings during the perinatal period. There are other questionnaires that ask about feelings in the prenatal or post-partum time, but they were created for female mothers. We believe that men’s feelings can be different, and different questions should be written differently, too. Sometimes these other questionnaires do not help men, their families and healthcare providers understand if dads need extra support.

The main part of the Father’s Feelings Study does study visits with fathers who are not eligible to receive free infant safety items from the study. This sub-study wants to understand the possible effects of providing these needed items to fathers like you.

Procedures

You may have learned about the research study after seeing a flyer or being told about the study. If you are interested in participating, study staff will contact you to schedule several appointments. Each appointment is a one-on-one, individual session with a member of the study staff and lasts about 60-90 minutes. To make it easier for you, the appointments will take place in your home, or a similar quiet and personal location (for example, a private room in a library near your home or work). Appointments can also take place through video conferencing. Video conferencing is a face-to-face meeting over the internet using a device that has both video (see) and audio (hear). We will use a safe and secure video conferencing platform like Zoom or Lifesize. To participate in video conferencing sessions, you will need a device that has a camera, audio (speakers), and can connect to the internet. Research staff will help with connecting to the video conferencing platform. (NOTE: During the COVID-19 pandemic, all study visits will be done remotely via video conferencing.)

If you agree to participate in the study you will sign an informed consent form (this document) and complete study appointments. You will participate in five (5) study appointments (completing about one visit per week).

Each Study Visit

During each one-on-one appointment, you and a study staff member will fill out study paperwork and will have a conversation about your feelings around being a father. The conversation about your feelings is called an “interview” or "consultation" but is more like a supportive conversation using questionnaires to better understand your feelings and experiences during the post-partum time (your baby’s first year). Study staff are trained mental health specialists, so if you have strong or negative feelings during or after the study appointment, study staff will support and help you deal with these thoughts or feelings. Study staff will also provide emergency contact numbers that you can call 24 hours a day, 7 days a week, if you need to talk to someone or need more help for your thoughts or feelings.

At the end of your study appointment, study staff will inform you if your results suggest that you might be depressed. If this happens, they will suggest that you make an appointment with a local mental health service provider. OhioGuidestone will not be providing counseling or mental health services to you during the study session. If your results from the study questionnaires (surveys) suggest that you might be depressed, study staff will give you a form called a referral to take with you to your appointment with a mental health provider.

After you complete your final study appointment, you will receive a follow-up call from study staff in about 1 week. This follow-up call is to see if you have any questions, need more information, or need help contacting a local mental health provider. More follow-up calls, letters, or emails will be sent 2 weeks and 1 month after you complete the study if you need more help.

Infant Safety Items

During the study screening process, study staff identified you as eligible to receive free infant safety items for your baby. These items are intended to assist with caring for your child and promoting child safety. For example, some of these items may include, but are not limited to: car seat; play yard or pack and play; diaper bag; high chair; stroller; feeding kit; bath tub; baby gate; baby monitor; outlet covers; and other items selected by staff, based on your needs.

These items are provided through a program called Temporary Assistance for Needy Families (TANF). Funding is provided by the Ohio Children’s Trust Fund (OCTF), a part of the Ohio Department of Jobs and Family Services. As part of this service, the U.S. federal government requires that fathers who receive these items provide identifying information about themselves in a TANF eligibility form. This includes fathers under 18 years old.

The information provided in the TANF eligibility form is maintained by the OhioGuidestone research team. These forms will only be shared with OCTF and federal auditors in the event of an audit. An audit is a review to make sure that funds were spent correctly. The information you will need to provide includes:

• Your name, social security number, and address;
• Your citizenship/qualified non-citizenship status;
• Your family household income and family size;
• The names and ages of your minor children;
• Your relationship to your children (custodial parent, non-custodial parent, or blood relative).

To receive items, you must complete study appointments and all necessary study documents and forms. You also will receive education and information on child development and safety from study staff. Qualified participants who complete the study are eligible to receive up to $400 in infant safety items.

Study staff will ship these items to you directly at the address of your choice. Items will be shipped once you have completed the study.

Potential Risks

There are minor risks you may experience, such as thoughts or feelings that are upsetting to you. Study staff are trained mental health specialists, so if this happens, they will support you and help you deal with these thoughts or feelings during your study appointment.

Study staff will also provide the name and contact information for local mental health services, programs or providers. If you express thoughts and feelings that you are depressed; or if your interview results suggest that you might be depressed study staff will help you make a follow-up appointment with a mental health service provider. Even if your results do not suggest that you might be depressed, you will still be provided information if you want to reach out to schedule an appointment with a mental health service provider. If you receive a referral, study staff will call you about 1 week, 2 weeks and 1 month after to see if you were able to make an appointment with a mental health service provider.

Anticipated Benefits

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

• Learning more about your own feelings and thoughts
• Opportunity to be informed about more mental health supportive services
• Information specifically for fathers
• Free, short clinical interventions
• $25 gift card after participating in the study appointments
• Up to $400 worth of infant safety items
• Information learned from this research study may also benefit other men, fathers, children and families
• Better relationship between you and your baby
• Better relationship between you and your baby's mother (or other co-parent)
• Increased fun and play in your relationships with you and your baby
• Increased positive emotions and feelings in you and your baby
• Increased confidence as a father

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. The only exceptions would be:

• In the event of a referral to a mental health provider: With your permission, we would share some information with the provider in this situation.
• After you receive any infant safety items: We are required to share some of your basic demographic information (but not your name) with the Ohio Children’s Trust Fund (OCTF). This is the government agency that is providing funding for the safety items.
• In the event of a TANF audit: We would be required by law to disclose your name, social security number, and other information provided in the TANF eligibility form to OCTF and federal auditors.

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.

If your study results suggest that you might be depressed, you will receive information for a local mental health provider, and a referral form to take with you to your appointment. This referral form will show that you were a participant in this study and completed surveys to see if you might be depressed. The form will include the scores from the study questionnaires you completed, your contact information, and current medications. It also is possible that the referral may 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 a mental health provider cannot happen without your permission.

Voluntary Participation and Withdrawal

Your participation in this study is completely voluntary. If you choose not to participate, it will not affect your relationship with OhioGuidestone or any other organization, program or service. You will still have the right to services that you are eligible for at OhioGuidestone or any other organization, program or service. You will not be treated differently 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 if you decide to withdraw from the study. If you withdraw from the study, your services or relationship with OhioGuidestone or any other organization, program or service will still continue.

If you do participate in this study, your access to current and future services and client rights will not be changed or different. There is no cost to participate in this research study.

Contacts and Questions

If you have any questions about this study, you can contact the study doctor:
Dr. Ben Kearney at Benjamin.Kearney@ohioguidestone.org or 440.260.8304.

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 your program staff any questions that you have now, or during any part of the research study.

Signature of Research Subject or Parent/Guardian

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 or your minor child volunteer to participate in the study and understand that you or your minor child can withdraw from the study at any time.

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