TITLE OF RESEARCH PROJECT

The effectiveness of expressive writing on mental health of mothers with long-stay infants in Neonatal Intensive Care

Dr. Deana Furr, College of Nursing and Health Innovation dfurr@uta.edu

The research team above is conducting a research study about the mental health of mothers with infants in NICU. Our study purposes are as follows: 1) to determine the association between maternal mental health and infant length of NICU stay and 2) to examine the effectiveness of expressive writing upon the mental health of mothers with infants currently in NICU or discharged from NICU within the last five years.

You can choose to participate in this research study if your baby is, or was ever in a NICU for a minimum of 7 days, is between 28 days and five years old, and if you are over 18  and read, write and speak English. This study recruits mothers and infants via an offline and online approach. If you are reading this consent at our website online, we will first need you to attest to the reading of a consent form (this document) and complete three surveys which assess your mental health. If you have received a packet of materials about our study and prefer offline participation, you must first read, sign, and mail the consent form (this document) to us. If online, you will automatically be directed to the surveys to complete. If offline, once we receive your signed consent, we will email you and then speak with you on the phone to continue with the completion of the surveys and further information. Whether on or offline, findings from these surveys determine if you can enroll into the study or not. If eligible to enroll in the study, you will be randomized into either an experimental writing group or a control group. Offline mothers will be randomly selected into a group over the phone and online participants will be randomized into groups by their zip codes. Those randomly selected into the writing group will be asked to complete three short writing tasks over three days and then retake two of the three surveys completed before. If you are selected to be a part of the writing group, you will have a chance to express your emotions in writing about your birth experience with an infant in NICU.  We would ask that you write for at least 5 minutes each time you write (or longer if you want) about the most traumatic aspect of your experience. You might not want to write because it might make you think of thoughts you’d prefer not to face and make you uncomfortable and anxious. Yet, we have found out from many other new mothers that sometimes writing your deepest feelings about a potentially traumatizing birth experience may help you feel better. You will have access to a listing of resources on depression and stress, including numbers for national crisis hotlines to call or text  regardless of whether you write or not. 

If you are selected into the non-writing group ("controls"), you will be asked to complete the three surveys that established your eligibility into the study at first, and then two surveys again in one month. All mothers will get the same resources and information. Online mothers receive a resources list here in this document below and also a message throughout participation. Offline participants receive information in the consent (this document) and several handouts in the study packet of materials.

This study has been reviewed and approved by an Institutional Review Board (IRB). An IRB is an ethics committee that reviews research with the goal of protecting the rights and welfare of human research subjects. Your most important right as a human subject is informed consent. You should take your time to consider the information provided by this form and the research team and ask questions about anything you do not fully understand before making your decision about participating. Online and offline participants can email the researchers with questions related to the study and consent.

Once you attest to the reading of this consent (or sign and return to researchers) and complete the first set of surveys for us, you will know if you are eligible to join our study either via an online message or a call from the researchers. Eligible online participants will be directed to the next task automatically ---then by zip code you will be enrolled in either the writing or non-writing (control) group, and offline participants will be called on the phone to be enrolled. Time commitment varies if writing or not. Mothers in the writing group will complete three sets of surveys, today, after you write all three writing tasks, and then four weeks after completion of all writings. Completion of survey sets will take about 15-30 minutes.  We will ask you to write for 5 minutes minimum, three times over the course of the next 7 days. So, the maximum total time for all surveys and writings would be around 105 minutes, spread out over five different days. Your time could be more if you choose to write for more than 5 minutes, and you can--that’s up to you! If you feel like writing more often or for more than 5 minutes at any of the three specified times, please do so, but please state this on the writing evaluation form. 

If eligible for the study and selected into the control group, you will complete a set of surveys now and another in 4 weeks. All together, you would complete two sets of surveys.

Completion of each set of surveys will take about 15-30 minutes, so total maximum time would be around 60 minutes spread over two time periods.

Thank you for your interest in our study  and reading this consent. The information below will take you step by step through the study and what you can expect, whether online or offline, writing or not. 

IF OFFLINE- Your packet of materials includes instructions on each procedure noted below, and once you have mailed us your signed consent, on the phone, we will go over each instruction sheet with you  for full understanding prior to continuing.

1. The first page you see on the left side of the packet is this page--the consent. You must contact us by the email at the bottom of this document so we can go over everything together in your packet, including this consent via a phone call.

2. Once you agree to participate and indicate understanding of all materials and sign the consent, complete the first set of surveys, then return to us in one of the stamped envelopes in your packet.

3. Once we receive these documents, we will contact you regarding your eligibility for the study and go over the next steps: randomization into groups, instructions if writing or not, and final surveys (see more information in online info as applies).

4. Upon our review of returned materials, at any time if you suggest extreme sadness/distress (on surveys or writings), we will call you on the phone and your participation will terminate. Additional resources with encouragement to seek, plus a connection to our licensed psychologist will be provided.

IF ONLINE--  Upon visiting our webpage, go to Link -1 (this is where you are now) for the consent (this document). Our email addresses are at end of the document if there are questions you may have about participation. 

THE FOLLOWING INFORMATION RELATES TO ALL STUDY PARTICIPANTS

POSSIBLE BENEFITS

Studies have shown that writing about one’s most traumatic aspect of the birth experience can be beneficial. After giving birth, many mothers have reported that the writings helped them gain insight and understanding about what they had been through and helped them to achieve closure. This may be true for mothers who are writing about the traumatic birth even if it happened several years before. Our study is exploring the trauma of a birth experience related to the infant's admission to a NICU.  These writing tasks can potentially guide you towards needed help and have been shown to be beneficial for mothers by reducing posttraumatic stress and depression. If you are randomly selected to the control group and wish to write, please let us know this, as you may do so AFTER the study is over. We will help you get started and talk to you more in detail about that process then as needed.

When completing the surveys or writing about your birth, there is nothing that puts you in physical danger. Although it is unlikely that completion of surveys will increase your stress, please remember you can decide to not answer a specific survey question or stop the writing or the study at any time if you become too uncomfortable or anxious. Once you begin writing, emotions and feelings regarding your most traumatic experience may become uncomfortable for you and bring up memories of other past traumas or another past traumatic birth. If this occurs, stop writing, or if comfortable doing so, shift to a lesser traumatic experience related to your birth. If symptoms are extremely severe, call 911 immediately. Also the MHMR crisis hot line number is available 24-7  where counselors and referrals can be accessed immediately. Please see resources listed below for local and national agencies:

1.  NICU Helping Hands is a support group for mothers of premature infants (817-668- 5191). [Fort Worth, Texas]

2. Depression- Postpartum Depression hotline at 1-800-944- 4773. At the local Fort Worth chapter of Postpartum Support International (PSI), you can speak with a licensed perinatal mental health counselor at 817-676-8858. Additional local agencies offer free or low-cost counseling such as  Catholic Charities (817- 534-0814) and Family Resource Center (817-815-2850).

The I Care crisis line for Tarrant County is available through MHMR of Tarrant County 24 hours a day 365 days a year 817-335-3022 or toll free 1-800-866-2465. This is for emergency mental health support, information and referrals.

Outside the local area, contact the National Suicide Prevention hotline at 1-800-273-talk or the Crisis Text Line- text on phone 741741 for immediate counseling needs

3. Posttraumatic stress- National Alliance of Mental Illness at 1-800-950-6264. Postpartum mothers may experience PTSD from birth trauma, such as admission of an infant into NICU; yet, no specific agency exists for PTSD related childbirth trauma. Cognitive Behavioral Therapy (CBT) has been used with some positive results for birth related PTSD as well as PTSD due to other reasons and numerous CBT therapists/counselors are located nationally. In our local area, Dallas Counseling & Psychotherapy and Dallas CBT provide this service.

4. Other helpful agencies- National Domestic Violence hotline at 1-800-799-SAFE. Calling 211 connects individuals to community services by phone.

There is no monetary compensation for study participation; however, benefit from the intervention and/or the information you provide for researchers can possibly help many mothers faced with traumatic birth experiences.

There are no alternative options for the study, but you have the choice to decline the study, study group, or intervention with no change in your infant’s care (if still in the NICU). However, if selected for the writing group, you do have an option of writing more than five minutes if you so desire, at one, or all three sessions. If you find writing to be beneficial to you, you may choose to write more than three times as well. On the evaluation form (in study packets or at LINK-5) please record this information for us so we may know. If you are a mother selected into the control group, you may request to write after the study has been completed or receive instructions for writing at home in your own journal. If you are a control mother, please wait to do your writings until after you have completed the 4 week data surveys (labeled in packets or online at Link -6).

The research team is committed to protecting your rights and privacy as a research subject. All paper and electronic data collected from this study will be stored in a secure location on the UTA campus and/or a secure UTA server for at least three (3) years after the end of this research. Any hard-copy materials obtained are under lock and key in the (PI) researcher’s file cabinet on campus. If your initial surveys determine ineligibility to the study, these surveys will be maintained in the files but not used for analysis. In general, only the researchers will read your surveys or writings. If later surveys should show distress, resources are listed (automatically appearing online); local participants have referrals to community agencies and a psychologist to talk with, if requested. All mothers are strongly encouraged to consult their local providers if distressed. All writings will be reviewed, but we will only briefly review them to know that you were able to write about your birth experience as relates to NICU and that you are feeling OK without need for seeking referrals or resources. If you write about feeling really sad, or if your writing shows extreme sadness (suicide ideation), you will be terminated from the study and use of resources is highly encouraged.  If child or elder abuse is expressed in writing, as healthcare providers, we are required by law to report actions to a law enforcement agency.

The results of this study may be published and/or presented but without naming you as a participant. The data collected about you for this study may be used for future research studies that are not described in this consent form. If that occurs, an IRB would first evaluate the use of any information that is identifiable to you, and confidentiality protection would be maintained. The security of our webpage for all personal identifiers and written information is maintained. In addition to the research team, the following entities may have access to your records, but only on a need-to-know basis: the U.S. Department of Health and Human Services and the FDA (federal regulating agencies), the reviewing IRB, and sponsors of the study.

Questions about this research study or reports regarding an injury or other problem may be directed to

UT Arlington Principal Investigator (PI)

Dr. Deana Furr [Phone: 817-272-2776/ Email: dfurr@ uta.edu]  or

Co-PI- Dr. Cheryl Anderson [Phone: 817-272-2776/ Email: c.anderson@uta.edu (text 817-688-3995)

Any questions you may have concerning your rights as a research subject, or complaints about the research, may be directed to the Office of Research Administration: Regulatory Services at 817- 272-3723 or regulatoryservices@uta.edu.

You are confirming that you have read this form and understand the study’s purpose, procedures, potential risks, and your rights as a research subject. By agreeing to participate, you are not waiving any of your legal rights. You can refuse to participate or discontinue participation at any time, with no penalty or loss of benefits that you would ordinarily have. 

We require an email address for all study participants in case of distress. (For offline participants, provide at bottom of consent when sign and return)

For online participants: Below we ask that you please provide your email in case we should need to contact you for any reason, such as follow-up survey reminders or needed resources.

  

You can include any apps used for messaging such as whatapps etc here in case of needed contact: