The indication for antipsychotics was mostly behavioral symptomatology, while antidepressants were used for a wide variety of symptoms. The high proportion of children and adolescents using psychotropic medication with normal scores in the emotional and behavioral screening was remarkable. It cannot be determined whether in these cases low scores were related to improvement in symptoms or whether medication was being misused.
The practicability and the interrater reliability suggest that the MacCAT-CR is feasible in children, but the question of whether competence is assessed validly remains unsolved in the absence of external validation. The differences between assessment by clinicians and the low scores obtained in the MacCAT-CR suggest that children may give assent even if they do not understand completely. The results of this initial pilot study may help in the planning of further investigations intended to improve information about studies and assessment of assent/consent.
BackgroundThe aim of this study is to assess and evaluate the capacities for understanding, appreciation and reasoning of legal minors with psychiatric disorders and their parents and their competence to consent or assent to participation in clinical trials. The beliefs, fears, motivation and influencing factors for decision-making of legal minors and parents were also examined.MethodsUsing the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), an instrument developed for adults whose capacities to consent are unclear, we provided information about clinical trials and assessed understanding, appreciation and reasoning. We adapted this tool for legal minors and examined 19 children and adolescents between the ages of 7 and 15 with attention deficit/hyperactivity disorder (ADHD) or ADHD combined with oppositional defiant disorder (DSM-IV 314.00/314.01/312.8) enrolled in clinical trials. Parents were also examined using the MacCAT-CR.ResultsFacts such as the procedures involved in trials or their duration were well understood by legal minors, but more abstract issues like the primary purpose of the trial were not understood by children and adolescents or by many parents. Legal minors also had difficulties understanding the nature of placebo and the probability of receiving placebo. Children's and adolescents' decisions were influenced by fears about their disorder worsening and by problems in their relationship with their parents. Parents wanted the best therapy for their children in order to minimize problems in school.ConclusionLegal minors and parents need to be informed more precisely about specific issues like placebo and the primary purpose of trials. In general, the reasoning of children and adolescents was influenced by their experience with their disorder and decision making was based on reasonable arguments. Their fears were based on everyday experiences such as school performance or family relationships.
In youth welfare quality management increasingly gains in importance over the last decades. Tools used for quality assurance have to be broadly acceptable in everyday practical work. To meet that precondition it is essential that everyday practice and the diferent problem situations of children and adolescents are accordingly represented by these assessment scales. On the other hand they also require good methodical quality and generalization, thus, allowing to provide information about the efectiveness in a multiplicity of diferent residential institutions. herefore, goal attainment scales have to be adapted to speciic pedagogic settings as well as to the particular clientele. However, universal goals of pedagogic processes should be assessed as well. At the university hospital of Ulm, department child and adolescent psychiatry and psychotherapy, a scale was developed to measure the attainment of social competence and individual goals (PädZi). With the intention of an application of these scales in youth forensic context within a project (MAZ) in Switzerland the scales were adapted and expanded based on qualitative interviews with experts from the forensic and educational ields. Interrater agreement was shown to be good.
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