Learn More About Together We Grow
Study Title: Effects of enriched parent-infant interaction on health in early life
Research Study Summary:
● You and your baby are being invited to participate in a research study. Participation is completely voluntary.
● The purpose of this research study is to investigate how parent-infant daily experiences influence the health and wellbeing of both infants and parents.
● Study activities will include: (1) Reviewing weekly infant-parent online materials: You will receive access to study materials designed to support parent-infant engagement. These materials are accessible online, allowing you to review them at your convenience. (2) Completion of brief daily surveys on your smartphone throughout the study.
● Your involvement will require about 2-3 minutes each day to complete the survey and an additional 15 minutes every week to check out the online materials during the intervention period. The researcher will inform you of the planned duration of the study (e.g., 20 weeks).
● We anticipate no harm or risk to participants.
● By taking part in the intervention program, you may have the opportunity to acquire various techniques that can help enhance your interactions with your infant.
● Participation in this study is entirely your choice. You can choose to take part, or you can choose not to take part in this study. You also can change your mind at any time. Whatever choice you make will not have any effect on your relationship with Yale University.
● If you are interested in learning more about the study, please continue reading, or have someone read to you, the rest of this document. Ask the study staff questions about anything you do not understand. Once you understand the study, we will ask you if you wish to participate; if so, you will have to sign this form.
Why is this study being offered to me?
We are asking you to take part in a research study because you are a parent of an infant(s) aged between 0 and 4 months. You will be able to take part in this study if you (1) currently spend at least 50% of your daily hours with your infant, (2) can communicate and complete surveys in English, and (3) have a smartphone.
Who is paying for the study?
This research is funded by the the National Institutes of Health and the Meredith Wilson Pilot Research Program. Associated research with our international partners in New Zealand is supported by the University of Auckland Faculty of Science.
What is the study about?
The purpose of this study is to investigate how parent-infant daily experiences influence the health and wellbeing of both infants and parents.
What are you asking me to do and how long will it take?
If you agree to take part, your participation in this study will involve two primary tasks:
(1) Daily smartphone surveys: Over the course of the study, you will receive a notification on your smartphone, inviting you to complete a brief survey each day. The survey will focus on your infants’ mood and behavior, as well as your own mood. The survey will take about 3 minutes to complete. Examples of the survey questions are:
● Last night, how many times did your baby wake up after s/he fell asleep?
● In the last 2-3 hours, was your baby at all distressed or fussy?
Additionally, you will be asked to complete a more comprehensive survey several times during the study period, which should take around 10 minutes to finish.
(2) Weekly infant-parent online materials: During the intervention period, you will receive online materials introducing a variety of enrichment activities for you and your infant. These materials are designed to be brief and easily incorporated into your daily routines with your infant.
Are there any risks from participating in this research?
Typical and minor emotion reactions, such as mental fatigue, embarrassment, discomfort, or frustration may arise when responding to survey questions related to mood and depression; however, this study anticipates no harm or risk to participants.
How can the study possibly benefit me or others?
By taking part in the intervention program, you may have the opportunity to acquire various techniques that can help enhance your interactions with your infant. Furthermore, your involvement contributes to advancing our understanding of the effectiveness of infant-parent enrichment interventions, which has the potential to make significant contributions to both scientific research and particle parenting strategies.
Are there any costs to participation?
You will not have to pay for taking part in this study.
Will I be paid for participation?
You will receive various incentives as a token of appreciation. You will receive a total of $75 e-gift card (the digital gift card will be delivered via an online gift card service and you will be able to select a retailer of your choice to redeem the gift card on their website), along with enrichment resources you can enjoy with your infants. In case you decide to withdraw from this study before its completion, you will not be eligible to receive any remaining incentives.
How will you keep my data safe and private?
Your privacy and the security of your data are of utmost importance to us. All information you provide will be kept strictly confidential. Any identifiable personal information will be securely stored in a password-protected electronic database, accessible only to authorized members of the research team. This database will be used solely for the purpose of this study and will be securely destroyed once the study concludes. Access to your identifiable information will be limited to the researchers directly involved in this study and those responsible for research oversight (such as representatives of the Yale University Human Research Protection Program, the Yale University Institutional Review Boards, and others) will have access to any information that could identify you that you provide. We will share it with others if you agree to it or when we have to do it because U.S. or State law requires it. For example, we will tell somebody if we learn that you are hurting a child or an older person. When we publish the results of the research or talk about it in conferences, any information shared will be completely de-identified. We may share the data you provide with other researchers for future research but we will not use your name or other identifiers. We will not ask you for any additional permission for this.
What if I want to refuse or end participation before the study is over?
Taking part in this study is your choice. You can choose to take part, or you can choose not to take part in this study. You also can change your mind at any time. If you decide to withdraw from this study, you should notify the research team immediately. The research team may also end your participation in the study if you do not follow instructions, miss more than a half of the daily surveys, or if your safety and welfare are at risk. Whatever choice you make will not have any effect on your relationship with Yale University or the University of Auckland. If you choose to withdraw or are withdrawn from this study, data already collected may remain in the study database and could be used for the analysis of study data. We may also continue to use your data or share them with other researchers for future research studies, but any shared data will be fully de-identified to protect your privacy.
Certificate of Confidentiality
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.
There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.
Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.
ClinicalTrials.Gov Registration
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.
Who should I contact if I have questions?
Please feel free to ask about anything you don't understand. If you have questions later or if you have a research-related problem, you can reach the Principal Investigator at Dr. Samuel Mehr at samuel.mehr@yale.edu or Dr. Eun Cho at eun.cho@yale.edu. You may also email our lab at musiclab@yale.edu for additional assistance. If you have questions about your rights as a research participant, or you would like to speak with someone other than the Principal Investigator or study team to discuss problems, concerns, or questions, or to obtain information or offer suggestions, you can email hrpp@yale.edu.