Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to look at how children with attention deficit hyperactivity disorder (ADHD) respond to medication.
Children will have a full diagnostic evaluation for ADHD, as part of this study.
Who can participate?
Children 7 to 11 years old who:
- Have been diagnosed with ADHD and have not previously taken medication for ADHD
- Have ADHD symptoms including: short attention span for age, difficulty listening to others, easily distracted, excessive fidgeting and/or talking, or often interrupting others
What will happen in the study?
This study involves 10 study visits during a 14-week period.
In the screening visit, we will collect information about your child to see if he/she is healthy and able to take the study medication. If your child qualifies for this study, we will provide you with a detailed list of study procedures.
Here are some of the things that will happen during the study:
Your child will:
- Take psychological (thinking) tests, some of which are on a computer
- Complete academic tasks including math worksheets
- Have a physical exam, and submit urine and saliva samples
As the parent or guardian, you will:
- Complete questionnaires about your child’s ADHD symptoms, his/her medications, etc.
- Be asked to have your child’s teacher complete questionnaires about your child’s behavior at school
- Be given an app to use on your smart phone, or we will provide you with a personal data assistant (PDA) to use for 1 week to record your child’s behavior and mood
Children who are determined to be eligible to take part in this study will be given 3 different doses of the study medication for 4 weeks, to determine the dose that works best for them. This medication is called methylphenidate, a medication approved by the United States Food and Drug Administration (FDA) for the treatment of ADHD.
Your child will also take placebo (a pill that is not medication) for 1 of the 4 weeks, to find out if your child is better taking medication compared to not taking medication. The study visits during the time your child is taking medication will include answering questions about side effects, how your child is doing, and measures such as heart rate and blood pressure.
A detailed list and explanation of other things that will happen in the study will be given to parents, as a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
Being in this study may not help your child right now. However, when we finish with the study, we hope that we will know more about whether the study medication methylphenidate is a good treatment option for your child and if so, what the best dose is for him/her.
Also, if your child’s evaluation points to possible new conditions, the study doctor will be available to discuss these results with you and refer you to the appropriate provider for further assessment or treatment.
What are the bad things that can happen from this research?
Possible risks and discomforts will be discussed with parents or
guardians interested in learning more about the study.
Will you/your child be paid to be in this research study?
Families may receive up to $310 for time and effort.