Infant Sleep and Digestion and Early Markers for Developmental Disorders
You and your child (or children) are invited to take part in a research study about sleeping, eating, and digestion in healthy babies and babies who may later be diagnosed with developmental disorders. This study will be conducted by Dr. David J. Heeger, of the Department of Psychology and Center for Neural Science at New York University, and by designated members of his research staff.
We know that older children with autism and other development disorders have trouble with sleep and digestion, but very little is known about sleeping, eating, and digestion cycles in infants and we do not know if sleep and digestion problems are evident in babies who will later be diagnosed with developmental disorders. This study will assess sleeping, eating, and digestion in healthy babies and babies who may later be diagnosed with developmental disorders. We plan to enroll thousands of babies in this study. With your help, we hope to recognize early signs of developmental disorders so that infants can get help early. We will also amass a large database (without any identifying information about individual babies) about the development of sleeping, eating, and digestion so that parents will have better (scientifically-informed) advice about how to manage their baby's sleeping and eating schedule.
You can enroll your baby in this study if she or he is under 2 years of age, or if your child is older and you used the Baby Connect app when she or he was an infant (by enrolling, we can recover the Baby Connect data retrospectively). We are particularly interested in enrolling younger siblings of children who have been diagnosed with autism or other developmental disorders.
If you agree to be in this study, you will be asked to do the following:
- Purchase the Baby Connect app ($4.99), a popular baby tracking app for Android, iPhone, iPad, and Windows Phone. Baby Connect allows multiple caregivers to track daily information about feeding, diapers, sleep, mood, activities, and medications.
- Add [email protected] as a caretaker on Baby Connect (instructions will be provided).
- After clicking “I Agree” at the bottom of this consent form, a confirmation will be sent to your email address with a link to the registration and questionnaire.
- Register your baby for the study by providing your baby’s birthdate and gender on our web site, and by providing an identification number from the Baby Connect web site.
- Complete an online questionnaire about your baby (race, ethnicity, birth order, birth weight, etc.), about your baby’s health (whether your baby has been diagnosed with a developmental disorder like autism or medical problem like diabetes, etc.), about you (age, gender, race, ethnicity, email address, home zip code, etc.), and about your family (whether anyone in your immediate family has been diagnosed with autism, ADHD, schizophrenia, etc.).
- Use Baby Connect to log your baby's sleeping, eating, and diaper changes.
Participation in this study will take a few seconds at various times each day. You can log for a week, for a month, or until your baby is 2 years old. You may participate if you are already using Baby Connect or if you have an older child for whom you used Baby Connect in the past. As soon as you agree to participate, the researchers at NYU will get all of the information that you have already logged.
To enroll in this study, you must be the baby's parent or legal guardian.
If you agree to participate in this study, then the developers of the Baby Connect app have agreed to make your baby's data available to Dr. Heeger and his research staff. But neither New York University nor any of the researchers at NYU involved in this project have any financial interest in Baby Connect.
There are no known risks associated with your participation in this research beyond those of everyday life. Although you and your baby will receive no direct benefits, many people find it rewarding to contribute to a scientific study that may help us gain understanding of human development. This research will contribute to understanding normal human development of sleep and digestion as well as possible links to developmental disorders. We will distribute findings from this research to assist parents, doctors, specialists, and teachers in their future care of young children. We hope to recognize early signs of developmental disorders so that infants can get help early.
Confidentiality of your research records will be strictly maintained by assigning code numbers to each participant. Only Dr. Heeger or designated members of his research staff will have access to the code book that could be used to link the data with your identity. We will share the data that we gather about your baby with other researchers, but only after removing information that could be used to identify you or your baby. In particular, your name and email address, your baby's name, and the names of your family members will always remain confidential.
Your responses will be kept confidential with the following exception: the researcher is required by law to report to the appropriate authorities, suspicion of harm to yourself, to children, or to others.
Participation in this study is voluntary. You may refuse to participate or withdraw at anytime without penalty. For interviews, questionnaires, or surveys, you have the right to skip or not answer any questions you prefer not to answer. If you withdraw from the study, we will keep the information that has already been obtained from you about your baby's sleep and digestion, but we will stop collecting any additional information.
If there is anything about the study or your participation that is unclear or that you do not understand, or if you have questions or wish to report a research-related problem, you may contact Dr. Heeger at [email protected], 4 Washington Place, room 809, New York, NY 10003. For questions about your rights as a research participant, you may contact the University Committee on Activities Involving Human Subjects, New York University, 665 Broadway, Suite 804, New York, New York, 10012, at [email protected] or (212) 998-4808.
Agreement to Participate