Frequently asked questions about clinical studies
Q: I want my child to be seen at a M.I.N.D. Institute clinic. What is the difference between the evaluation clinic and the research clinic?
A: All potential evaluation clinic patients must be referred by their primary care physician. Referrals are reviewed by M.I.N.D. Institute clinicians and accepted or denied based on current criteria. If the referral is accepted, appointments for evaluations are usually scheduled based on availability. At times, it can take up to nine months. Appointments with a neurologist are scheduled within two months. The family receives a detailed report of assessment results and referrals to appropriate providers, if necessary.
Families interested in the Research Clinic do not need a referral from their primary care physician; they simply search our clinical research studies for studies currently recruiting participants. Study participation does not require insurance authorization or charges to the family unless otherwise noted. Research appointments are usually scheduled within a few weeks. The family receives a brief report of assessment outcomes. If you have questions about this process, please call Taylor Rios at (916) 703-0320.
Q: Why should my family participate in research?
A: By participating in research, you help expand our knowledge of autism and other neurodevelopmental disorders. This information moves us closer to understanding causes, developing better treatments and, ultimately, identifying cures. Your family may directly benefit by going through the clinical assessments that are part of the study’s protocol, since most families are provided with results of their child's clinical assessments. Families will learn how their child is developing compared to other children who are the same age and can share this information with their child’s school, doctor, service provider or other agency. Children may also receive gift certificates or toys to thank them for their participation. Depending on the type of study, some participants may receive treatment in accordance with research protocols.
Q: Why do studies only include children of a certain age or with certain diagnoses?
A: All studies have guidelines about who can participate. Inclusion and exclusion criteria – including age, diagnosis and gender – determine who is eligible and ineligible to participate. The inclusion and exclusion criteria are determined by the investigator and/or study sponsor based on the subject of the study and how the investigator can show meaningful results. Studies have to explicitly define these criteria then have them approved by the UC Davis Institutional Review Board (IRB). Once approved, investigators must continue to use the established criteria.
Q: My child doesn’t have autism. Can he/she still be involved in research?
A: Yes! The M.I.N.D. Institute is conducting research on a number of neurodevelopmental disorders, including developmental delay (speech delay or cognitive impairment), Down syndrome, fragile X syndrome, 22q11.2 deletion syndrome and Tourette syndrome. Some studies also need children who are typically developing for comparison purposes.
Q: My child doesn’t have any developmental problems. Can he/she can be involved in research?
A: Yes! Many studies need children who are typically developing to serve as a comparison group.
Q: What types of studies are currently under way at the M.I.N.D. Institute?
A: Our studies fall under three categories: biological, behavioral and intervention. Biological studies are building our understanding of the body such as how the brain works when completing certain tasks and why people respond a certain way to medication. Behavioral studies look at various aspects of behavior such as how sleepiness changes behavior and how children imitate other people's actions. Intervention studies address different types of treatments such as vitamins, medications and social skills groups.
Q: I don’t see a current study that my child can participate in. Can we be notified if a new study becomes available?
A: Yes! If you complete and submit the sign up form for clinical studies, we will mail you an information packet for our “subject tracking system.” Information about your child will be added to the system. When we need subjects for a study, we search the database for families who might be eligible. If we call you about a study, you are not obligated to participate.
Q: What should I consider before participating in a study?
A: You should know as much as possible and feel comfortable asking the research team any questions you have about the study. The following questions might be help you start this discussion:
- What is the purpose of the study?
- Who is going to participate?
- What kinds of tests and/or treatments are involved?
- How do the possible risks, side effects and benefits of the study compare with your current treatments?
- How will the study affect my daily life or routine?
- What is the expected time commitment?
- Will I be compensated for participating?
- Why do researchers think their approach will be effective?
Q: What are the potential risks of participating in a study?
A: Each study has potential risks depending on the procedures involved. Some participants might feel tired or stressed by completing clinical assessments. Others may have side effects from medication. All studies will identify any potential risks to help you decide if you should participate.
Q: My family does not live near the M.I.N.D. Institute. Can we still participate in research?
A: Yes! However, some studies require frequent visits that make participation more difficult for out-of-town families. Some studies may be able to help families with transportation and/or lodging expenses. Low-cost accommodations are also available through Kiwanis House and Ronald McDonald House Charities.