Currently, doctors diagnose autism based only on behavioral testing. NeuroPointDX, in partnership with nine hospitals and medical centers across the United States, is conducting a research study to evaluate a blood test that is being developed to diagnose children with autism spectrum disorder (ASD).
The CAMP study aims to develop diagnostic tests for autism spectrum disorder that could be used with very young children. The earlier a child can be diagnosed, the sooner he or she can receive helpful intervention.
Researchers want to know whether these blood tests (performed from a single blood sample) will differentiate children with ASD from children with development delays and/or children who are developing typically.
This study consists of two main parts:
- Laboratory tests performed on a blood sample (and a voluntary urine sample, if applicable)
- Standard behavioral testing by a trained professional
This study is sponsored by NeuroPointDX, a division of Stemina Biomarker Discovery.
We are recruiting children 18-48 months old.
The study requires 1-2 visit(s) to one of the sites listed below. Participants and their families may be contacted to return for an additional visit about two months after the initial visit; you may also be contacted by study management personnel up to two years after the initial visit to answer more detailed question and otherwise follow up on your child’s developmental status.
In short, the study will require a blood draw and psychological and behavioral testing. What to expect:
- 1-2 visit(s) to one of the study sites. (Additional visits are optional.)
- Behavioral and psychological assessments: As part of this research, your child will receive behavioral and psychological testing at no charge to you. At your request, the site will provide your child’s test results for your records; you may share these results with anyone you choose. For example, documentation of behavioral and psychological testing may be used to request accommodations from schools or other institutions/support services.
- A physical examination: A doctor will conduct a short physical exam of your child. Each site is a child-friendly environment; the staff is highly qualified and trained to work with children in a medical facility. The site’s staff will make every effort to make you and your child comfortable during your appointment.
- A medical history review: A doctor will collect medical history. Study professionals will also review the medical history of both parents and ask questions about his or her mother’s pregnancy, if available.
- A fasting blood draw: The CAMP study involves a 12-hour fasting blood draw; this means we ask that your child have nothing to eat or drink (except water) for 12 hours prior to the blood draw. To make this as easy as possible for families, visits are scheduled early in the day. Following the blood draw, your child will have an opportunity to eat. The site will provide snacks, but if your child has specific dietary preferences or considerations, you are welcome to bring food and drinks from home.
- Urine sample (optional): A urine sample is not required to participate in the CAMP study, but the site will try to collect a sample whenever possible to provide a variety of metabolic measures that can be used for research.
How many visits are required for the CAMP study?
The study requires 1-2 visit(s) to one of the sites. You may be contacted to return for an optional second visit within two months of the initial visit. You may also be contacted by study management personnel up to two years after the initial visit to follow up on your child’s developmental status.
What do I need to bring with me?
If possible, please bring your child’s immunization records, as well as any recent medical records you have available to the site. Please let the study personnel know if your child’s medical provider is a physician who practices at the site. If your child has special dietary restrictions or preferences, please bring along food and drink that he or she can enjoy after the blood draw.
Do I need to sign, scan, or email any documents prior to my visit?
No. When you arrive for the first visit, the site will provide any documentation that needs to be signed, as well as copies for you to take home.
Can I have more information before deciding whether to enroll my child?
Yes. For access to the consent forms and to answer any questions you may have, please contact the principal investigator for your site.
- Families can receive feedback from expert clinicians about their child’s development.
- Participants will receive compensation for their time, effort, and travel for this study. Contact the site for further details.
Results from this study will have the potential to positively influence the diagnostic process of ASD.
For complete details, visit clinicaltrials.gov and search for Children’s Autism Metabolome Project.