Has Your Child Been Referred for an Evaluation of a Possible Developmental Disorder? Children 18 Months to 5 Years Needed for an Autism Research Study

What is the purpose of this study?

The purpose of this research study is to develop a blood test and demonstrate how accurate the test is in identifying children who are diagnosed with autism spectrum disorders (ASD). Researchers want to know if this type of blood test may be able to help doctors identify children who are more likely to be diagnosed with ASD.

ASD describes a category of childhood developmental disorders where children have difficulties with socialization, communication and repetitive behaviors.

Who can participate?

Children 18 months to 5 years old who have been referred to a pediatric developmental center for evaluation of a possible childhood developmental disorder, other than isolated motor problems, may be eligible for participation. Children must not already have an established diagnosis of Autism Spectrum Disorder.

The Division of Developmental and Behavioral Pediatrics at Cincinnati Children’s is an example of a pediatric developmental center.

What is involved?

Your child will take part in this research study for about 2 months and complete 1 or 2 study visits.

During the study, your child will be complete some tests and procedures, including:
• Review of medical and medication history
• Physical exam
• Autism Diagnostic Observation Schedule (ADOS) developmental evaluation
• Blood draw

A detailed list of procedures will be provided to anyone interested in knowing more about this study.

What are the benefits?

Your child will not receive a direct medical benefit from participating in this study. However, the information learned from this study may benefit other patients with suspected developmental disorders in the future.

Will I get all the facts about the study?

If interested in participating, you, as a parent of a participant, will be given a consent form that explains all of the details of the study. The form covers all of the procedures, risks, benefits, pay, whom to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the risks and discomforts of the study?

Any discomforts or risks will be discussed with you if you are interested in learning more about the study.

Do participants receive pay, compensation or reimbursement?

Participants will receive $50 for their time and travel during this study.

Who should I contact for more information?

Cincinnati Children’s Hospital Medical Center
Division of Child Psychiatry
3333 Burnet Ave., MLC 4002
Cincinnati, OH 45229-3039

Principal Investigator

Logan Wink, MD 
Division of Pediatric Psychiatry
Cincinnati Children’s Hospital Medical Center