Development of a Child Psychopharmacology Trial Scale

Abstract

Psychotropic prescriptions for children and adolescents are on the rise. Until recently, pediatric psychopharmacology practice was extrapolated from adult data. While over 70% of pediatric psychopharmacology prescriptions were “off label”, evidence grew of differences between pediatric and adult biological properties and psychosocial factors. Spurred by recent U.S. Congressional legislation, there have been many newly published studies on safety, tolerability, and efficacy for medications in children and adolescents. Traditional methods for clinicians to evaluate these trials are qualitative, confusing to many, difficult to use as a comparison between studies, and do not account for important issues specific to the pediatric population. This paper describes the initial development of the Child Psychopharmacology Trial Scale (CPTS). A Medline review of the past 20 years on scale development along with interviews with expert psychopharmacologists and scale developers were conducted. A thorough yet concise scale was developed and tested in a pilot study to assess for feasibility. This one-page scale is presented. The CPTS provides 1) a standard evaluation of appropriate study design, 2) a confidence index for the clinician who wants to base his/her drug selection from available pediatric studies, 3) a standard to compare among studies, and 4) an effort to promote better science in pediatric trials. The CPTS has good face validity. Results will aid further development. It is to our knowledge the first attempt to quantify the quality of studies in the field of pediatric psychopharmacology. Keywords: Evaluation, medication, pediatrics, psychopharmacology, scale, trial, randomization, Extensions, Child Psychopharmacology, Anxiety, Hyperactivity, Mental Health, suicidal, tolerability, filtration