Autism risk and exposures/biomarkers measured during the pre-, peri-, and neonatal periods: 
a baby sibs pilot investigation

• 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 an autism spectrum disorder.

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 in their 22^nd week of pregnancy or earlier
• Have a previous child with an autism spectrum 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 autism spectrum 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 an autism spectrum disorder, 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 your placenta
• 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 an autism spectrum disorder

If you are interested, when your newborn reaches age two, he or she will be evaluated at CARD.  You do not have to agree to the 2-year developmental evaluation to enroll in the study.

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

Do I have to be in the study?

• Your participation in this research project is completely up to you 
• You can change your mind and stop participating at any time  

Who can I call if I have any questions?

• If you are interested in participating or have any questions about this study you may contact: