Trial Information

Summary: Pediatric ADHD Study

What is the purpose of this study?
This is research to study behavioral performance on computer tasks in children with attention problems.

Who will be included in this study?
Children 7 to 11 years old may participate who:

• Have been diagnosed with ADHD and have not previously taken medications for ADHD.
  OR
  
• Have ADHD symptoms including: short attention span for age, difficulty listening to others, easily distracted, excessive fidgeting and/or talking, or often interrupts others.
  OR
  
• Have not been diagnosed with ADHD.

What is involved?

• For children with ADHD, this study lasts for 1-2 months and includes 7 visits.
• For children without ADHD, this study will include 3 visits.

Some procedures that will take place during the study include:

• An evaluation to determine if your child has ADHD.
• Your child will complete tests, some of them on the computer.
• Complete questionnaires

What are the benefits?
Your child may receive no direct benefit from participating in this study. Potential benefits for study participants taking the research drug may include the possibility that the medications used in this study will improve your child’s ADHD symptoms. If there are any psychological problems discovered about your child during the evaluation, a professional will be available to discuss these results with you and refer you to the appropriate provider for additional assessment or treatment. The information learned from this research study may benefit patients with ADHD in the future.

Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns, and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
For study participants taking the research drug, mythelphenidate, potential risks in this study are possible side effects from the drugs. Risks associated with methylphenidate include the following: nervousness, insomnia (trouble sleeping), skin rash, appetite loss, nausea, dizziness, abnormal heartbeat, headache, drowsiness, blood pressure and pulse changes (both up and down), increased heart rate, chest pain, abdominal pain, and weight loss. Other rare side effects have been reported and include tics and psychotic behavior. There may be other risks involved with participation in the study that are not known at the present time.

For study participants without ADHD, there are no known risks to participation in this research study. However, there may be other risks associated with participating in the study that are not known at the present time.

What is the compensation?
You will be paid for the study on a per visit basis. Payment opportunities will total $100 for children without ADHD and $240 for those diagnoses with ADHD. Participants will not be paid for the screening visit.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.