What hypothesis was being tested and what concepts that were applied for the article, "Cognitive Effects of Risperidone in Children with Autism and Irritable Behavior" by Aman, M. G., Hollway, J. A., McDougle, C. J., Scahill, L., Tierney, E., McCracken, J. T., . . . Posey, D. J. (2008)?
One of the concepts present in the trial was to examine a reality that had not been given extensive treatment in the literature. The ability to run trials for an aspect not covered in literature is one of the concepts being tested in the experiment: “Literature focusing on the cognitive effects of atypical antipsychotics in children and adolescents is exceptionally sparse.” Another concept is the effect of a drug primarily seen in one context placed in another. The trials sought to examine the effects of Risperidone in children with autism throughout different time frames of the treatment process and phase. A similar concept resided in expanding the potential uses of Risperidone. The study sought to examine the cognitive effects for children with severe emotional disturbances.
The study was focused on expanding the discourse triggered by other studies. This becomes another concept that was applied in the article. Some data in the form of previous studies by Aman in 2007 and Troost in 2006 reflected that some cognitive improvements were present with Risperidone, thus enhancing the potential for its use in a field apart from its antipsychotic usage.
These become some of the overriding concepts in examining the effect of Risperidone on children with severe behavior problems caused by the onset of autism. The hypothesis offered was that there would be no difference between patients who took the placebo and those who took the Risperidone.
The present study was designed to test whether Risperidone has an effect on cognitive performance in children with autism accompanied by serious behavior problems. This was an exploratory comparison, as no data were available with AAPs in children with autism at the time of the trial. The null hypothesis is that there would be no differences between placebo and Risperidone.
In the final analysis, the results of the study suggested that there was no “detrimental effect on cognitive performance” in children when Risperidone is given in low doses (no more 3.5 mg) over an extended period of time (up to 8 weeks.)