A new study of families participating in a clinical trial to treat children with severe physical aggression explored the factors affecting parent satisfaction with the research study. Parents' overall satisfaction with the clinical trial experience and the relationship between the parent satisfaction and their child's treatment group or response to therapy are reported in an article in Journal of Child and Adolescent Psychopharmacology.
The Treatment of Severe Childhood Aggression (TOSCA) study included behavioral management training for parents of children with severe physical aggression, disruptive behavior disorder, or attention-deficit/hyperactivity disorder. The children all received a psychostimulant and either a placebo or the antipsychotic drug risperidone.
"These findings indicate high levels of satisfaction with TOSCA study involvement and, taken together with previous pediatric psychopharmacology social validity studies, suggest high levels of support for the research experience," according to the authors. "These findings may inform research bioethics and may have implications for the deliberations of institutional review boards."
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E.V. Rundberg-Rivera, L.D. Townsend, J. Schneider, C.A. Farmer, B. Molina, R.L. Findling, K.D. Gadow, O.G. Bukstein, L.E. Arnold, D.J. Kolko, K.A. Buchan-Page, N.K. McNamara, C. Michel, A. Austin, H. Kipp, R.R. Rice, M.G. Aman. Participant Satisfaction in a Study of Stimulant, Parent Training, and Risperidone in Children with Severe Physical Aggression. Journal of Child and Adolescent Psychopharmacology, Published April 17 2015. doi: 10.1089/cap.2014.0097