Development of a Multimethod Clinical Protocol for Assessing Stimulant Drug Response in Children With Attention Deficit Disorder

Abstract

We developed a protocol for clinical assessment of stimulant drug response in children with attention deficit disorders (ADD) and used a triple-blind, placebo-controlled crossover design to assess the effects of two doses of Ritalin (.3 mg/kg and .5 mg/kg BID) and a placebo. The 1-hr assessment battery, administered at the end of each 1-week drug condition, consisted of parent and teacher ratings of ADD behaviors, problem settings, drug side effects, laboratory tests of vigilance and impulse control, and clinic playroom observations of ADD behaviors during academic performance. Twenty-three of twenty-eight 5- to 12-year-olds completed the entire study. Results demonstrated that most measures in the protocol were sensitive to both doses of medication. Eighty percent of the children were judged positive responders to medication. This quantitative, objective protocol for the clinical evaluation of stimulant drug response is feasible and cost-effective. It should represent a substantial improvement over the use of subjective impressions now commonplace in clinical practice.