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
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
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:
- Review of medical and
developmental history, including medication/supplement use
- Family medical
- Questionnaires and
- Interview about
adaptive functioning skills
- Eye tracking
- Developmental/IQ testing
(optional for healthy control subjects)
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
Autism Diagnostic Observation Schedule (ADOS)
- Aberrant Behavior
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
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?
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