Family Outcomes Scale

Title of study: Pilot Testing of a Measure of Family Outcomes after Newborn Screening: The Family Outcome Scale 

Principal Investigators: Don Bailey, PhD, and Melissa Raspa, PhD, RTI International  

Study Sponsor: Health Resources and Services Administration (HRSA) 

What Is the Research About? 

Researchers at RTI International have developed a scale (i.e., survey) that may be used in the future to study and understand the experiences of families after a child in the family is diagnosed with a condition through newborn screening. It is called the Family Outcomes Scale. We got input from interest-holders in the newborn screening system (including parents and caregivers) to develop a draft of the scale. Now we are asking parents and legal guardians to complete the Family Outcomes Scale as an online survey. The information we collect will help us learn about families’ experiences after getting a diagnosis through newborn screening. It will also help us understand if there are ways the scale needs to be changed before it is finalized for broader use.  

If you take part in this study, you will be one of up to 500 people to do so. You are being invited to participate in this study because you are the adult parent or legal guardian of a child less than 18-years-old who was diagnosed with a condition that is part of a state newborn screening panel in the United States. 

Who Is Leading the Study? 

The people in charge of this study are Don Bailey and Melissa Raspa of RTI International. This research is being funded by the Health Resources and Services Administration (HRSA).   

What Is the Purpose of This Study? 

By doing this study we hope to collect data from a large number of parents/guardians, representing different states and newborn screening conditions, to learn about family outcomes after newborn screening. We will do statistical analyses of the data from this survey to help us finalize the Family Outcomes Scale (for example, by dropping items or grouping items together in a certain way). Once the Family Outcomes Scale is finalized, we will share it with clinicians, researchers, and other newborn screening interest-holders who are interested in measuring family outcomes of newborn screening.     

Do I Have to Take Part in this Study? 

If you decide to take part in the study, it should be because you really want to. There will be no penalty and you will not lose any benefits or rights you would normally have if you choose not to take the survey.  

Where Is the Study Going to Take Place and How Long Will It Last? 

This is an online survey that will take about 15-minutes to complete. We ask that you only take the survey one time, and there are no additional follow-up activities after submitting your responses.  

What Will I Be Asked to Do? 

You will be asked to take an online survey in English. Before taking the survey, you will be asked to confirm that you are at least18 years-old and that you are the parent/guardian of a child less than 18 years-old who was diagnosed with a condition through newborn screening in the United States. The survey includes some questions about demographic information so that we can understand characteristics of the survey participants and their families. Following demographic questions, the Family Outcomes Scale will ask you to consider approximately 50 statements and choose from 5 specific answer choices (i.e., “multiple choice”) to describe the degree to which the statement applies to your family right now. The survey items are categorized by 8 overarching outcomes that families may experience after a child in the family is diagnosed with a condition through newborn screening. Each outcome has multiple items that measure it. The Family Outcomes Scale is meant to pertain to families broadly. You will not be asked to provide specific or identifiable information about your child or family. The only personal information you will be asked to provide is your name and email address for the purposes of sending you a gift card for completing the survey and/or contacting you about future research opportunities. Providing your contact information for either purpose is optional. 

What Are the Possible Risks and Discomforts? 

To the best of our knowledge, the things you will be doing have no more risk of harm than you would experience in everyday life.  

Will I Benefit from Taking Part in This Study? 

By participating in this research study, you are helping the study team learn more about the experiences of families after newborn screening and improve the Family Outcomes Scale so that it can be used in future research. There are no personal benefits to you from taking part in this study.  

What Will It Cost to Participate? 

There are no costs associated with taking part in this study.  

Will I Receive Any Payment or Reward for Taking Part in this Study? 

You will receive a $15 gift card for completion of the survey. To receive a gift card, you must complete the required survey questions, select “yes” to desire to receive a gift card at the end of the survey, and provide your name and email address. The study team reserves the right to withhold the incentive for fraudulent or invalid responses, and the team may follow up via email if fraudulent data is suspected.    

Who Will See the Information I Give? 

The information that you provide in the study will be handled confidentially. When we analyze the results, your survey responses will be separated from the information that identifies you and combined with information from other people taking part in the study. Specifically, we will remove your name and email address from your survey responses. We will replace this information with a code number. We will maintain a master list linking code numbers to names. We will keep this list separate from your survey responses, and we have procedures in place that are designed to ensure that only authorized staff can connect your name to your survey responses.  

Please note that the survey is being conducted with the help of Alchemer, a company not affiliated with RTI and with its own privacy and security policies that you can find at its website. We anticipate that your participation in this anonymous survey presents no greater risk than everyday use of the Internet. Survey data will be downloaded to RTI’s secure servers for long-term storage and deleted from Alchemer.  

We only store your contact information for the purposes sending you a gift card for participating. We plan to destroy files containing your contact information within three years of the study’s end unless you indicate interest in being contacted about future research studies.

Can My Data Be Kept and Used for Other Research Studies? 

Sometimes there are opportunities for researchers to use data from previous studies or to share data with each other if they are conducting similar research. For these reasons, we may use your de-identified survey responses for future research. We may also share your de-identified survey data with other researchers at RTI International, at other institutions in the United States, or around the world. “De-identified” means that we will have removed any information that connects your identity to your responses (e.g., name, email address). If you indicate in your survey responses that you are willing to be contacted about future research, we will save your contact information for the purposes of inviting you to participate in future studies.   

What If I Have Questions? 

Before you decide whether or not to participate in the study, please ask any questions that come to mind. You can contact Sara Andrews, a research coordinator on this study, via email (sandrews@rti.org) or phone (919-699-2556). Later, if you have questions about the study, you can contact the investigator, Melissa Raspa (PI) at 919-541-8736.