CADDE Baby Sibs Pilot Study

CADDE Baby Sibs Pilot Study

KENNEDY KREIGER INSTITUTE RESEARCH STUDY

Do you have a child with autism? Are you currently pregnant?

Then this study might be right for you!

Autism Risk and Exposures/Biomarkers Measured During the Pre-, Peri-, and Neonatal Periods: A Baby Sibs Pilot Investigation

What is the purpose of the study?

To learn more about early signs of autism and its potential causes by collecting data on exposures and biological markers in pregnant women who have a previous child with autism.

Who is conducting the study?

	The Center for Autism and Developmental Disabilities Epidemiology (CADDE) at the Johns Hopkins Bloomberg School of Public Health
	The Center for Autism and Related Disorders (CARD) at the Kennedy Krieger Institute

Who is potentially eligible for this study?

Women who meet the following two criteria:

	Are no more than 22 weeks pregnant
	Have a previous child with an autistic disorder

What will my child and I have to do to be in the study?

To determine if you are eligible:

	Your child with symptoms of autistic disorder will complete one-hour of play-based testing
	You will complete a parent interview that lasts approximately 2 hours

If your child meets criteria for autism, we will also ask you to do the following:

	Allow us to collect your blood, hair, and saliva once per trimester
	Allow us to collect blood from the umbilical cord and blood from the newborn heel stick that all newborns get
	Allow us to take photos of the placenta as well as a biopsy
	Complete a fetal neurobehavioral assessment, lasting 50 minutes (includes monitoring of the baby’s heart rate and activity. Your heart rate and breathing will also be monitored
	Complete a telephone interview and short questionnaires asking about you and your child
	Fill out a pregnancy diary throughout your pregnancy
	Fill out food frequency questionnaires and food records
	Allow us to review medical records for you and your child with autism

Are there any risks involved with the study?

	There is a small risk to your privacy associated with completing the questionnaires and interviews
	You may feel a little discomfort when having blood drawn
	You or your child may become fatigued during testing
	There is a small risk to your privacy associated with the medical record review

What will be done to minimize the risks?

	Should any question make you uncomfortable, you can skip it and all the information you give us over the course of the study will remain confidential
	An experienced phlebotomist will draw your blood following standard safety guidelines
	If you or your child should become fatigued, we will take a break or stop
	Your and your child’s medical records will remain confidential and your privacy will be protected to the best of our ability

Why should I be in the study?

	Your participation may help researchers learn more about autism
	There are no direct, personal benefits for you or your child

Will the information I give be kept private?

	The information you provide will be seen only by authorized researchers from the study
	A study ID number will be assigned to you and used on the biosample
	The link between your ID and your identifying information will be kept by a study coordinator on a computer file that is password protected
	The medical records will be kept in locked file cabinets
	At the end of the study, the link and the data we collected from you and your child will be destroyed unless you give permission otherwise