After completing a phone interview, one or two visits for the purpose of determining eligibility are scheduled. We refer to this as the "screen." Screen #1 will include an interview with a medical provider [this wouldn’t be with a psychiatrist in Rochester] (separately with parent and child), an assessment of IQ, and a detailed clinical interview by another staff member with the parent to review the child's development in detail. If the study is a good match for the child (all inclusion criteria are met), Screen 2 will consist of a blood draw, an electrocardiogram (EKG) reading, a physical examination, a urine sample, and further evaluations by a psychologist. (If a family lives a long way from our clinic, there is a chance that we would try to fit all screen procedures into one visit.)
We will conduct brief assessments at each weekly clinic visit to rate progress toward meeting your goals and changes in your child’s behavior.
After 10 weeks of clinic visits, all of the questionnaires, interviews, and tests from the Screen visits will be repeated. The blood draw, EKG, urine sample, and physical and psychological examinations also will be repeated.
If your child has a good response in "Study 1" (Screens + 10 weeks; first part of this investigation), monthly visits can be scheduled for "Study 2" (second part of the investigation). If your child does not have a satisfactory response in "Study 1," we would look at a variety of medication options with you, the parents, and continue to follow your child in "Study 2." Depending on the medication response (end of "Study 1) and choice of medicine in "Study 2," we would see you and your child weekly or monthly (or a mix of weekly and monthly) in the second part of the investigation. Naturally, if we are evaluating a new medicine, then we would want to see your child more frequently.