Needed: Babies Under 18 Months Old Who Have an Older Sibling with an Autism Spectrum Disorder

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to create a repository, or storage area, of biological samples (such as blood or urine) and matching data from people who have developmental disorders as well as from healthy controls.  Examples of developmental disorders include, but are not limited to, autism spectrum disorders (ASD), Fragile X Syndrome, Angelman Syndrome, Rett Syndrome, and Down syndrome.

The repository and data will be used by researchers at Cincinnati Children’s to ensure they have the samples they need to understand the causes of developmental disorders and to identify suitable traits of the diseases.

Who can participate?

Babies under 18 months old who have an older sibling with an ASD may be eligible for participation. Other family members may also be eligible to participate in this study.

Younger siblings of children with an ASD have an increased chance of developing ASDs themselves. One of the goals of this research study is to follow younger siblings of children with ASD in the hopes of being able to intervene at the earliest signs of any ASD.

The earlier treatment and therapy can begin in ASD, the better the developmental outcome.

What will happen in the study?

You or your child can take part in this research study.  Both you and your child are able to participate.  You can complete up to 4 study visits each year. 

During the study, all participants will be asked to complete some tests and procedures, including:

  • Demographic questionnaire
  • Review of medical and developmental history, including medication/supplement use
  • Family medical history
  • Questionnaires and checklists
  • Interview about adaptive functioning skills
  • Eye tracking
  • Developmental/IQ testing (optional for healthy control subjects)
  • Neurocognitive testing using computer based programming
  • Blood draw, urine sample, and/or cheek swab (for those under 24 months and/or those unable to provide a blood sample)
  • Maternal Pregnancy questionnaire and consent to release medical records of mother’s pregnancy care/course (optional, will be collected when participants enroll with their biological mother present during the visit)

Developmental disorder participants will also be asked to complete the following:

Autism Diagnostic Observation Schedule (ADOS)

  • Aberrant Behavior Checklist (ABC)

Additional tests may be completed for those 18 and under including:

  • Child Behavior Checklist  or CBCL (completed for participants ages 1.5 to 18 years)
  • Pediatric Quality of Life Scale (completed for participants ages 2 to 18 years)

Many checklists and questionnaires can be completed at home and mailed back to the hospital, or completed over the phone with a member of the study team.

Anyone interested in participating will be given a consent form that thoroughly explains all of the details of the study. 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 good things that can happen from this research?

You or 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 developmental disorders in the future.

What are the bad things that can happen from this research?

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

Will you/your child be paid to be in this research study?

Participants may receive $10 per study visit for their time and travel. Participants will also receive free diagnostic testing and be followed by a physician and researcher during the duration of the research study, if needed.

Who should I contact for more information?

autism@cchmc.org

513-636-0523 Cincinnati Children’s Hospital Medical Center

Division of Child Psychiatry

3333 Burnet Ave., MLC 4002

Cincinnati, OH  45229-3039

Study Doctor:

Craig Erickson, MD

Division of Child Psychiatry

Cincinnati Children’s Hospital Medical Center