CONSENT FORM

Consent

TITLE OF RESEARCH PROJECT

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

RESEARCH TEAM

Dr. E. Stehling, College of Nursing and Health Innovation estehling@uta.edu

Dr. Cheryl Anderson, College of Nursing and Health Innovation c.anderson@uta.edu 

IMPORTANT INFORMATION ABOUT THIS RESEARCH PROJECT

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 and is between 28 days and five years old, and if you possess a telephone, are over 18 and read, write and speak English. If you wish to participate in this study, we will first need you to attest to the reading of a consent form (this document) and complete four short surveys. Findings from three of these surveys will determine if you can enroll into the study or not. Further participation for enrolled mothers would include retake of two of these same surveys mentioned above and perhaps three short writing tasks if you are randomly selected into the “writing group.” If you are selected to be a part of the “writing group,” you will have a chance to express your emotions in three 5-minute writings about your birth experience with an infant in NICU (past or present). We would ask that you write for at least 5 minutes each time but you can write 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. 

In this study there will be two groups of mothers like you, and, by zip code mothers will either be selected into the writing group or not, but all mothers will get the same resources and information. If you are selected into the non-writing group ("controls"), you will be asked to complete four surveys sets now, and two of the same surveys again in one month. For both groups, an elevated score on the stress or depression survey or report of harm/suicide intent will lead to ineligibility or disenrollment in the study.

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.

TIME COMMITMENT

Once you attest to the reading of this consent and then complete the first survey set of questionnaires for us, you will know if you are eligible to join our study---then by zip code you will be automatically enrolled in either the writing or non-writing (control) group. 

If eligible for the study and selected into the writing group, you will be asked to complete three writing tasks over a period of one week, and then complete a second set of surveys (two of the same four surveys you already did) and a quick evaluation form about the writing task- all in that one week, then in four weeks we will ask you to complete the third and final set of surveys one last time. All together there are four sets of surveys. Initial completion of all sets of surveys 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 45 minutes, spread out over five time periods. 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. 

If eligible for the study and selected into the control group, you will initially complete four surveys and at 4 weeks two of the four surveys (completed initially today). Altogether, you would complete two sets of surveys now and in one month. Completion of both sets of surveys will take about 15-30 minutes, spread over two time periods.

Following consent, all mothers (writers and non-writers) are requested to consider taking a short 5-minute survey called the Childbirth Trauma Index- 7(CTI-7) located on our homepage assessing your perception of the birth experience. Findings from mothers like you can help healthcare providers to understand and help mothers who experience perceived and real trauma at birth. As you reflect on some of the questions in this short survey, you may gain insight into your birth experience and feel content or feel the need to talk with someone about feelings perhaps related to your birth. The findings for this survey are not related to your eligibility into the study.

RESEARCH PROCEDURES

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. In summary, this is the procedure for the study in several steps:

1.      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. 

2.      Following your reading of the consent form, move to LINK-2 for our "Hello" letter which will further provide study instructions. Confirm here reading/understanding of the consent and meeting of all eligibility criteria. Please make sure that if you have any questions about the study unanswered, please email us-- before you make your choice about whether to participate. Without confirmation of having read the consent, you cannot be in the study.

3.      Once confirmation of reading of consent and meeting of eligibility criteria, you will be automatically directed to our surveys (the Demographics Sheet (EWOB), Edinburgh Postnatal Depression Inventory, and the PCL-5) [LINK-2; LINK -6] to tell us something about you, your baby/child and how you are feeling.  At any time you can return to the homepage and complete the short childbirth survey childbirth (CTI-7). The CTI-7 survey is optional and is not required to participate in this study. We ask you to please do this first set of four surveys today or within the next 7 days.

4.      While not anticipated, if doing these surveys causes you extreme distress, please call or text the hot line numbers provided here in this document (below) to speak to a hot-line counselor or email us if needed. If you are out of this area, please also contact your local provider or local help agency. As you are completing these surveys there are few places that ask about severe mental health symptoms and if you answer positive to these questions, you will be directed to resources and your study participation will be terminated. Please connect with these provided resources if you feel extremely sad or stressed; please call 911 for immediate needs. (Resources automatically appear in LiNKS-2-6 after all writings and after completion of surveys.)

5.    If severe symptoms are not noted in this first set of surveys, you are eligible for continued participation in the study.  

At any time if you suggest extreme sadness/distress on any materials, the study will terminate, and you will receive the "Resources" page.  Your completed information will be maintained for our files but not used in analysis per university policy. If at any time you feel severely distressed, please call 911 as needed or connect with local or national hotline numbers to speak immediately with a counselor in your area of residence. Local participants may use local resources provided in this document. For any mother reporting harm/suicide intention additional resources through our collaborating agency, MHMR, is also provided to all local mothers

6.   Next, you will go into LINK-3 "Randomization." By zip code, you will be automatically placed randomly into either the writing or non-writing (control) group of mothers. 

         If your zip code ends in an even number, you will be in the writing (experimental) group and you will be automatically directed to a place to write for 5 minutes minimum about your birth/NICU experience (considered your first of three writing tasks). 

         If your zip code ends in an odd number, you will be designated as a control mother and automatically directed to end the study for now and complete the surveys again one last time in one month. One- month surveys are found in LINK-6. 

7.  Next, for the writing group of mothers ONLY, go to LINK-4 to complete your 2nd writing task. Please do this another day than when you did the first writing task.

8.  Next, for the writing group of mothers ONLY, within the next few days, please go to LINK-5 for the final and third writing task, completion of a writing task evaluation form, and completion of the same two surveys (EPDS and PCL-5) you completed before.    

9.  Last, for ALL mothers, at one month, please go to LiNK-6 to complete your final set of surveys. (For control mothers, one month is 4 weeks from when you first were online and competed the first surveys. For writing mothers, one month is 4 weeks after you completed the surveys the second time—or after you had completed your third writing task.)

If your initial symptoms are not severe and you decide to join our study but later change your mind and withdraw from the study, we will keep the information you gave us on your surveys for analysis, but no one except the researchers will know it was yours. If symptoms show up as severe when you complete the surveys at any time, the "Resources" page will appear and you will be terminated from the study. Please seek help at your local establishments.   If distressed at any time-- please call or text the national hotline numbers . If you become distressed when completing the surveys, stop, or if distress is not major, omit the stressful question as needed and continue. You have the right to withdraw from the study at anytime. If you feel uncomfortable when writing, please quit, or if distress is not major, shift to another less distressing aspect of what you were writing about. Your writings will not be analyzed but we will look at them; however, our review may not be immediate. If harmful intent is expressed, please call 911 and seek help from local resources. Writing about severe symptoms (harm/suicide intent) will also disqualify you from continuing the study. We care about you and will endeavor to contact you if such distress is severe, an attempt to call you on the telephone will also be made.

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 an 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 symptoms. 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.

POSSIBLE RISKS/DISCOMFORTS

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. However, if severe symptoms such as harm/suicide intent are disclosed, we will contact you. For local mothers 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. PSI offers the same resource for non-local mothers. 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.

COMPENSATION

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.

ALTERNATIVE OPTIONS

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 please record this information for us so we may know. 

If you are a mother selected into the control group, you may reenter the webpage link (Link 3-5) 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 (Link -6).

CONFIDENTIALITY

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. If your initial surveys determine ineligibility to the study, these surveys will be maintained in the files but not used. In general, only the researchers will read your surveys or writings. If later surveys should show distress, a resources page automatically appears; participants have referrals to local/national resources. All mothers are strongly encouraged to consult their local providers. 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 additional encouragement for seeking referrals or resources. If you write about feeling extreme sadness (harm/suicide intent), you will be terminated from the study and use of resources is highly encouraged.  We will also personally email you and offer conversation. 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 agent would first evaluate the use of any information that is identifiable to you, and confidentiality protection would be maintained.

The security of this 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.

CONTACT FOR QUESTIONS

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

UT Arlington Principal Investigator (PI)

Dr. Elisa Stehling [Phone: 817-272-2776/ Email: elisa.stehling@ uta.edu (text 817-907-5892)]  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.

CONSENT

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. 

  

In case of needed contact please email us.