ADD Medication Study

What is the purpose of this study?

Researchers at Cincinnati Children’s Hospital Medical Center are conducting a research study, sometimes known as a clinical trial or clinical study, to study response to medication in children with Attention Deficit Disorder (ADD). During the study, children undergo a full diagnostic evaluation for ADD.

Who can participate?

Children 7 to 11 years old who:

  • Have ADD symptoms including short attention span for age, difficulty listening to others, and/or being easily distracted
  • Have been diagnosed with ADD and have not previously taken medications for ADD

Conditions

  • ADD/ADHD
  • Disabilities: Intellectual
  • Medications

What is involved?

The study will last for approximately 1 year and includes 1 screening visit and 6 study visits. The study includes the following:

You will:

  • Be asked about your child’s development, his/her medications and medical history
  • Complete questionnaires about your child’s ADD symptoms and how the symptoms affect them
  • Be asked to have your child’s teacher complete ADD questionnaires throughout the study
  • Bring in your child for doctor visits
  • Meet with the doctor to evaluate how well your child is responding to the medication and to report any side effects
  • Be given a report that summarizes your child’s screening tests and study results including his/her response to the study medication, the study team’s treatment recommendations, etc.
  • Be contacted to complete follow-up surveys after the study visits

Your child will:

  • Complete screening tests for intelligence and learning problems
  • Have a routine medical exam
  • Have his/her vital signs measured (blood pressure, heart rate, etc.)
  • Be given different dosages of the study medication over four weeks
  • Be asked about how their ADD symptoms affect them
  • Submit two saliva samples
  • Submit a hair sample

What are the benefits?

Although there are potential benefits from participating in this research study, your child may not receive a direct medical benefit. Potential benefits for your child include the possibility that the study medication will improve his/her ADD symptoms. Also, the process might identify what the best dose of the study medication is for your child. The information learned from this research study may benefit other patients with ADD in the future.  

Will I get all the facts about the study?

You will be given a consent form that thoroughly explains all of the details of the study. The form covers 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 or guardian has signed this form and, if of age, the child has given, at minimum, his/her verbal agreement.

What are the risks and discomforts of the study?

Potential risks in this study are possible side effects from the study medication methylphenidate. Side effects include nervousness, trouble sleeping, skin rash, appetite loss, nausea, dizziness, etc. A detailed list of risks and discomforts will be provided to those parents interested in knowing more about this study.

Do participants receive pay, compensation or reimbursement?

Study participants will be paid for time and travel, up to a total of $120 depending on how many visits your family attends.

Who should I contact for more information?

Heather Matheson 
513-636-6632
Cincinnati Children’s Hospital Medical Center

Principal Investigator

Tanya Froehlich, MD
Division of Developmental & Behavioral Pediatrics
Cincinnati Children’s Hospital Medical Center

Date

Ongoing