Has Your Child or Teen Had a Moderate to Severe Head Injury? Do They Have Trouble with Concentration or Staying Focused?
What is the purpose of this study?
Cincinnati Children’s is conducting a research study called the Focus On Concerta® Study (or FOCuS) to learn more about how a medication that helps with attention problems can help children who have had a moderate to severe head injury.
Who can participate?
Children and teens, 6 to 17 years old, who have had a moderate to severe head injury (6 months to 4 years ago) and now have attention difficulties may be eligible for participation in the FOCuS research study.
What is involved?
If your child qualifies, and you agree to participate, you and your child will take part in the FOCuS study for about 3 months.
During the study, your child will take Concerta® for 4 weeks (approved by the United States Food and Drug Administration, or FDA, for the treatment of attention problems) and a placebo (sugar pill) for 4 weeks. All of the pills will look the same so you, your child and the study doctor will not know which kind of pill (Concerta® or placebo) your child is receiving. Comparing the results when your child takes Concerta® to when your child takes placebo helps us know if your child does better on medication compared to no medication.
During the study you and your child will have 3 full assessments (1 at the beginning, 1 at the middle, and 1 at the end) and 6 check-up visits with the study team. Between the 1st and 2nd assessment you will take one kind of pill (Concerta® or placebo) and come in for 3 check-up visits. Between the 2nd and 3rd assessment you will take the other kind of pill and come in for 3 check-up visits.
| ||Study at a Glance || |
|1st assessment ||3 weekly check-ups ||2nd assessment ||3 weekly check-ups ||3rd assessment |
|Concerta® or Placebo ||Placebo or Concerta® |
At each check-up (lasting about 25 minutes), you and your child will do brief questionnaires and meet with the study team to discuss changes in ADHD symptoms and to report any side effects. The study physician may use this information to adjust the dose. If your child is tolerating the medication well, the physician may increase the dose. It is possible that your child may not show improvement. If your child is having severe side effects, the physician may decrease or stop the dose. Our goal is to find the best dose for your child.
At each full assessment we will collect the same kind of information. Comparing that information over time is how we learn how effective the medication is. At the assessments, you will be asked to complete questionnaires about your family background, your child and your child’s behavior. Your child will be asked to complete game-like tests that measure his or her attention, memory and thinking skills. You and your child will also meet with the study physician who will conduct a routine physical exam and collect vital signs on your child.Because these assessments are so thorough they will take approximately 2 ½ hours.
We will also ask one of your child’s teachers to complete brief questionnaires each week of the study, either online or by mail.
More details about participation will be provided to anyone interested in knowing more about this study.
What are the benefits?
There are potential benefits for your child beyond those of usual care such as a full diagnostic evaluation and a report on attention problems after traumatic brain injury, including feedback on the best dosage for your child.
It is possible that the study may help health care providers understand how to help other children who have attention problems related to head injury.
Will I get all the facts about the study?
You, as the parent or guardian, will be given a consent form that thoroughly explains all of the details of the study including 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.
What are the risks and discomforts of the study?
A detailed list of possible risks and side effects will be provided to those participants, parents or guardians interested in knowing more about this study.
Do participants receive pay, compensation or reimbursement?
Participants will be paid up to $125 for their time and travel. Your child’s teacher will be paid $10 for their participation in the study.
Who should I contact for more information?
Cincinnati Children’s Hospital Medical Center
Division of Physical Medicine and Rehabilitation
3333 Burnet Avenue, MLC 4009
Cincinnati, OH 45229-3039
Where can I find additional information?
Brad Kurowski, MD, MS
Division of Pediatric Physical Medicine and Rehabilitation
Cincinnati Children’s Hospital Medical Center