The BRAIN Study

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"Studying different patterns of brain development in children"
Age:
24- 42 months
Gender:
Any
Healthy Volunteers:
Yes
Keywords:
Children, Autism Spectrum disorder (ASD)
Type:
Other
Investigator:
Description
Autism is a very complex disorder, and it is likely that various subtypes exist. For over 10 years, investigators at the MIND Institute have been trying to define different subtypes or “phenotypes” of autism in order to develop the best treatments for each type. As part of this effort, we have been examining the brains of children with autism and age matched typically developing kids to see if there are different patterns of development and organization.

In our previous work, we have found that about 15% of boys with ASD have a large brain form of autism. Besides a big brain, we have found that these kids have a different behavioral profile than other kids with ASD. On average, they showed fewer gains in IQ and language by age 5. However, some children with ASD and a big brain showed gains instead.

The primary goal of this project is to further study the large brain ASD children compared to other children with and without ASD.
This study requires

You and your child will be scheduled for 3-4 visits during the first year. We will also ask you to return for follow-up visits at timepoints one and two years after your first visit to see how your child has changed over time.

Study visits include: Behavioral & psychological assessments - looking at development, autism symptoms, and language

Medical exam - includes medical history and a brief physical exam

Blood draw - blood samples from child and one or both biological parents

MRI scan during natural sleep (without sedation) - looking at brain structure

EEG (electroencephalogram) - looking at brain activity

Questionnaires - evaluating various aspects of your child's behavior

Please contact for detailed information.

Who can participate

Inclusion criteria for all children: Age 24 and 42 months No contraindications for MRI (e.g., metal in body) Weigh at least 20 pounds At least one biological parent willing to participate in study (may be separate from legal guardian) Family speaks and understands English Ambulatory with no suspected motor, vision or hearing problems, and no chronic health conditions.

Exclusion criteria for all children: Fragile health condition that would prevent the child from participating in the study

Presence of any metal or electromagnetic implants that would prevent MRI testing

Additional criteria may apply. Please contact us for detailed information.

Benefits and risks of participating
We cannot promise any benefits to you or others from your taking part in this research. A brief summary of information about your child’s psychological functioning will be available to you and may be helpful in developing educational and behavioral interventions. The information gained from the MRI scan may be beneficial for future treatment and diagnosis of autism. You will receive a copy of the MRI scan for your medical records. The radiological report and other medical reports may be shared with your family physician (with your consent which will be obtained with a separate consent form). The information gained from the study may be beneficial for future treatments and diagnosis of neurodevelopmental disorders. The benefits of research using specimens include learning more about what causes diseases, how to prevent them, how to treat them, and how to cure them.

Risks and side effects related to the study include:

This is a low risk study with minimally invasive procedures. However, there are possible minor discomforts associated with the following procedures. At times your child may find the behavioral assessment to be boring or difficult. Every effort will be made to lessen any discomfort experienced during the tests.

There may be some discomfort, minor bruising or swelling associated with taking the blood sample. Sterile procedures will be followed but there is a very small chance of infection at the site where blood is taken.

There are also minimal risks to the MRI scanning procedures. You will be screened prior to participating in this study for any potential contraindications that might prohibit your child from participating in the MRI scanning. Your child may experience some anxiety when introduced and becoming familiar with the scanner.

If you tell your family doctor that you are participating in this study, or if you tell your family doctor about any specific aspects relating to your participation, this information may then become part of your medical record with this doctor. Insurance companies routinely have access to such records. We will not release information about you or your family to your doctor or anyone else unless you authorize us to do so.
Compensation
The study will compensate $50 for each of the completed visits that make up the study. Your child will choose a child-appropriate gift from a grab-bag at the end of each visit. Parking and mileage reimbursement will be provided. Compensation is based on visit and not on the ability to complete tasks during that visit. You will still receive compensation even if you only participate in part of the study.
Resources
Schedule
Study duration and period
You and your child will be in this study for approximately one to two months during the first year visits, and then you will return for follow-up visits two years later in which there will be additional tests of your child. After your behavioral assessment sessions are completed, the research team will send you a summary of how your child did on the tests.
Recruitment period
From Dec. 1, 2017
Location
UC Davis MIND Institute
2825 50th Street
Sacramento, CA 95817
Contact
Kellie Holley

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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