WHAT TO EXPECT

What happens when someone is interested in participating?

The first step is that a staff member at the local research site provides a detailed description of the study. Each site is a little different. Before you could start as a participant, you would need to review and sign a form that indicates you understand the study, called “informed consent.” For those under 18 years old, parent participation in this process is required.

After you (and a parent if under 18) understands the study and agrees to participate, the assessments and other procedures begin. The following is a description to give you an idea about what would happen. However, the details would be somewhat different at each research site, and would be described during the informed consent procedure.

What happens in the study?

After someone agrees to be in this study, here are some examples of the things that happen:

You will be asked to provide medical and mental health history, your education, and your alcohol and drug use history. You may skip any questions that make you uncomfortable.

You will be asked to provide us with information to help us find you in case you move, like your driver’s license number, phone numbers, email, or phone numbers of relatives or friends. This information will be only be used to help find you for the follow-up study procedures. Relatives and friends are told only that this is a study of adolescent development; no other information about the study or about you is given.

You will be asked to not drink alcohol or use drugs for 72 hours before all study appointments. You will be asked questions about your recent alcohol, drug, tobacco, and caffeine use at each study appointment.

You will be asked to complete several questionnaires about how you think and feel and your personality. Remember - you may skip any questions that make you uncomfortable. You will be asked you to complete Puzzles & Games, either on paper or a computer, that measure how you think, your attention, and how well you remember things. In addition to interviewing you, we also interview your parent or legal guardian. We will ask him or her questions about things like your family background, childhood behaviors, mental and physical health, and alcohol and other drug use in the family.

Pictures of your brain will be obtained using a Magnetic Resonance Imaging (MRI) scanner. For this, you will be placed in a large donut-like MRI machine for about 1 hour and 10 minutes. Your head will be placed in a special helmet-like “head-holder” and you will be asked to hold still while we take pictures of your brain. We will put a finger-tip cuff on one finger to measure heart rate and a band around your chest to measure breathing rate. The MRI technician will position you in the scanner, provide hearing protection including ear plugs and headphones, ensure that you can view the display screen, and give you the response button box. Click here for more information about Magnetic Resonance Imaging.

While in the MRI, you will do both thinking tasks and resting tasks while we take pictures of your brain. You will be shown either scenery pictures, a blank screen, or colored words. You will be asked to press a button in response to seeing colored words and will be given instructions and time to practice the tasks outside of the scanner.

You will be asked not to eat heavily or drink a lot of fluids within two hours before your MRI appointment.

You will be asked to provide a urine sample that will be used for a confidential drug test, and we may do this at every study appointment. If you are a female and capable of child-bearing, we will ask you for verbal confirmation that you are not pregnant, and administer a urine pregnancy test before the MRI session. The test result must be negative for you to participate in the MRI session. You will be asked to provide a breath sample to test for recent alcohol use, and we may do this at every study appointment. Results are private, however, if you are under the influence of alcohol, you cannot be in the study.

You will be asked to provide a sample of your saliva at the beginning and end of one of your study appointments. With this saliva sample, we will measure your DNA (the genetic material inside your cells). Your saliva is collected by asking you to place a cotton-tipped swab into your mouth for 2-3 minutes or until it is wet.

After the MRI scan, you will be asked to complete questionnaires to measure your alertness and thoughts about the tasks.

About 6 months after finishing the study this year and each year, we will call you to complete a brief 15-minute telephone interview.

About 12 months after completing the study this year and each year, we will invite you to complete the study again, including an interview for you and your parent or guardian, MRI, and Games & Puzzles.

How much time will each study procedure take, what is my total time commitment, and how long will the study last?

It will take about 7 hours to complete all baseline study procedures. It will take the same amount of time to complete the follow-up study every 12 months. This study will last 4 years, including baseline and three annual follow-ups.

The baseline and follow-ups will include the following appointments:

Interviews (12 month and 6 month): 2 hours

Games & Puzzles: 2 hours

MRI scan: 3 hours, including 80 minutes in the scanner

Will I be paid to participate?

Yes! You will be paid for every interview and MRI session you complete. Contact your site coordinator for more information.

Overnight Sleep Study at SRI International and University of Pittsburgh

If you are a participant at SRI International or the University of Pittsburgh, you will also be asked to participate in overnight sleep recording sessions.You will be asked to sleep one to three separate nights in a sleep research laboratory. One of these nights may be replaced with monitoring of sleep at your home. You may be asked to wear a small activity monitor, similar to a wristwatch, to measure the amount of movement you make during the day and night, for a few days before each overnight recording.

In order to record information about the way you sleep in the laboratory, several electrodes (small disks which pick up body signals and brain activity) or an elastic lycra cap (like a swim cap) with electrodes attached will be worn. Electrodes will also be taped to the face, chest and arm. These electrodes will be used to monitor brain waves, heart and muscle activity during sleep. Small cuffs may also be placed around two fingers of one hand to allow measurement of blood pressure during the night. To monitor breathing on the first night, bands will be worn around the chest and abdomen, and small tubes placed near the nostrils. You will wear soft foam earplugs that sit comfortably in the ear canal. The earplugs are similar to iPod earphones that fit into the ears. Sound is delivered to the plugs via flexible plastic tubes, which run approximately 12 inches from small electronic amplifiers. You will go to sleep at your usual bedtime. Sounds will be played while you sleep. They are very brief and not loud enough to wake you up. You will be allowed to sleep until you naturally wake up.

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