EMU Study

Your child may be eligible if he/she:

• Is 10 to 13 years old
• Does not wear braces, fixed retainers, or metallic prosthetics/implants

We will assess for other exclusion criteria by phone.

When can we come in? Do you have appointments on the weekends or weekday evenings?

We will work with you to accommodate your schedule, and have flexibility across weekdays, evenings and weekends for the interview and questionnaire parts of the study. For the parts of the study that are held at the imaging center (to take brain pictures with fMRI) and Nicklaus Children’s Hospital (to measure sleep with PSG), visits are typically scheduled over the weekend.

I will be out of town the weekend after the first fMRI (brain picture) visit — can we move the appointment for the following weekend?

We require your availability for two weekends in a row. The first weekend we will schedule the brain pictures with fMRI. If you are in the sleep group, we will also schedule the sleep study with PSG that weekend. The second weekend we will have the second set of brain pictures with fMRI on a Saturday or Sunday.

• If you know in advance that you will not make it to the second weekend and you did not complete the first fMRI session, we can reschedule for another time where you will be available for two weekends in a row.
• If for any reason you cannot make it to the second fMRI weekend but you had already completed the first fMRI session, unfortunately, we cannot reschedule for another day and you will not be compensated for that visit.

Can my husband/wife/sister/brother/neighbor bring the child to the appointments?

A parent or court-appointed legal guardian is required to attend the first visit, the MRI visits, and the overnight visit (if applicable). If the parent or legal guardian of the child cannot bring the child to the visits, we can reschedule the appointments for a time when the parent or legal guardian is available.

The reason that a parent or court-appointed legal guardian must be present at the first visit is because we will discuss the steps of the study in more depth, the risks and benefits of participating, and they will give us permission/consent for the child to participate in the study. We cannot move forward with the study if we do not have consent or permission from the parent or legal guardian.

In addition, in the MRI visit, the parent or legal guardian will be asked to fill out a screening form for the child asking about anything that might create a health risk or interfere with the brain pictures, such as: non-removable braces, cochlear ear implants, metal implants, body piercing, etc. The MRI technician will review the screening form and ask the parent or legal guardian the necessary questions to ensure your child’s safety and comfort.

Will I have access to the information collected from the questionnaires/interview/fMRI? Will I get results?

All the information we collect is for research purposes. Therefore, we do not obtain enough information to provide clinical diagnosis. However, if you have concerns about your child and/or if anything arises during the study, we will let you know that we recommend you follow up with a physician or other professional. We can provide you with a referral, if you wish.

I am still not sure about having my child participate. What should I do?

Participating in our study is completely voluntary, and you can always stop participating at any point. You can call us to learn more or ask us any questions that you have. If you talk with us on the phone and/or come in for a first meeting to learn more and decide you do not want to continue, that is perfectly ok! That being said, the study is approved by an institutional review board (IRB, which is a committee that assesses ethics and safety of research with human participants). The risks to participating in our research study are minimal. For example, some children may feel nervous about answering questions in the interview, or when the fMRI session begins. We do everything we can to help children to feel comfortable, and we remind them that they can stop at any time. We will discuss all the possible risks with you before you agree to participate in the study.

Some parents also wonder about the sleep part of the study. If your child is invited to the sleep group, our team, as well as the specialists at Nicklaus Children’s Hospital, will be there to make this experience as fun, memorable and comfortable as possible. Also, our kid-friendly room is ready with television and a comfortable bed. Kids tend to enjoy staying over, since they can bring their own sources of fun, such as favorite DVDs, books, and board games. Additionally, the child’s guardian will be asked to sleep in the room at Nicklaus with the child, to make this experience as enjoyable as possible.

Why should my child volunteer?

The volunteers who come to have us take pictures of their brain help us with our research. Without them, it would be incredibly hard to make any advances in our field. We simply wouldn’t know anything about the brain and how it works. Being part of research is often a memorable and enjoyable experience for families who participate, and we’ve heard a lot from families who were happy to contribute to science. Additionally, we hope that this work may increase our knowledge of how we can target treatments for children with anxiety.