1.      What is the purpose of this study?

The purpose of this study is to learn what causes autism. We collect environmental and biological data on mothers and their children with an Autism Spectrum Disorder diagnosis. Researchers in the EARLI Network study possible risk factors and biological indicators for autism during the prenatal, neonatal, and early postnatal periods. The researchers aim to follow a large group of mothers of children with Autism Spectrum Disorders at the start of a new pregnancy. The development of the newborn sibling will be followed through age 3. This study provides a unique opportunity for studying possible Autism Spectrum Disorder environmental risk factors and biomarkers during different developmental windows as well as an opportunity to investigate the interplay of genetic susceptibility and environmental exposure.

 

2.      Who is being studied?

Mothers of children with Autism Spectrum Disoders, their child with an Autism Spectrum Disorder, and the baby born during the study. Additionally, some information is collected from the father and any other siblings in the family.

 

3.      What is the chance that a younger brother or sister of a child with Autism Spectrum Disorder (ASD) will also have an ASD?

Studies show that families who have a child with ASD are at increased risk for having subsequent children with ASD. However, estimates of how likely this is, known as recurrence, vary widely. The EARLI Study plans to learn more about this with the data collected. For information on this, please see our Recurrence Fact Sheet.

 

4.      What is expected of study participants?

Families enrolled in the EARLI Study complete a series of clinic visits, home visits, and telephone interviews. They complete questionnaires and diaries at home throughout the study. Biosamples such as blood, hair, and urine are collected during the mother's pregnancy and after the baby is born. Families  participate from early in pregnancy until the baby is three years old and are compensated for time, travel, and meal expenses.

 

5.      How much time does this take?

The EARLI Study follows families at the start of a pregnancy and stays with them until the baby’s third birthday. The length of study home and clinic visits will vary. The study requires approximately 15 hours of time at home either through completing questionnaires, assessments, and diaries or through home or telephone visits. Clinic visits will take between 8 and 13 hours over the course of 2 visits, depending on the assessments required for individual families.

 

Families are compensated for time and reimbursed for travel and meals.

 

 

7.      Can I/my child be in this study?

EARLI is currently in an enrollment pause.  We hope to start enrolling again soon.  Please contact us if you are interested in keeping in touch with us.  We would love to hear from you! Should our enrollment resume and your family meets the EARLI Network's criteria for enrollment then you may be eligible.

 

8.      What safeguards are in place to ensure that the study is conducted ethically and the families who participate in the study are not harmed in any way?

Each university and institution in the EARLI Network has received a thorough review by their respective review boards to ensure that the study is carried out with the highest standards. Additionally, all National Institutes of Health (NIH) guidelines and standards are upheld throughout the EARLI Network. For more information, please contact us.

 

9.      Who is funding the study?

The EARLI Network is funded by a National Institutes of Health Autism Center of Excellence (ACE). EARLI has also received supplemental funding from Autism Speaks.

 

10.      What other universities/institutions are conducting this study?

The EARLI Network has four sites across the United States:

11.      Who are the members of the research team conducting this study?

Information about the research team can be found here on the EARLI Investigators page.

 

12.      How can I get further information?

You can contact the EARLI Network here.

Or click on one of the below links for that site's contact information:

Southeast Pennsylvania Site

Northeast Maryland Site

Northern California - UC Davis Site

Northern California - Kaiser Permanente Site

 

13.      What is an epidemiological study?

Epidemiology is the branch of medicine that deals with the study of the causes, distribution, and control of disease in populations. In the case of the EARLI Network’s epidemiological study, we seek to learn about the causes of Autism Spectrum Disorders in a population of families that are at increased risk of having a child with autism.

 

Citation of definition:

epidemiology. Dictionary.com. The American Heritage® Dictionary of the English Language, Fourth Edition. Houghton Mifflin Company, 2004. http://dictionary.reference.com/browse/epidemiology (accessed: June 16, 2008).

 

14.      What is a longitudinal study?

A longitudinal study means that we are studying families over a period of time (approximately 3.5 years) as opposed to studying families at one point in time. 

 

15.      Is there any risk to my family by participating?

The EARLI Network takes every measure to ensure that families will be safe and that no harm will come to families who participate.  If enrollment resumes and you enroll in the EARLI study you will receive an Informed Consent Form. This document will go over in detail the risks and benefits of participating in the study. Study staff will make sure that you understand everything in the Informed Consent and will be happy to answer any questions you have about study risks and benefits at the time you receive the form or any time after that.