Report of an Initial Pilot Study on the Feasibility of Using the MacArthur Competence Assessment Tool for Clinical Research in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

Koelch, Michael; Prestel, Anja; Singer, Hanneke; Schulze, Ulrike; Fegert, Jöerg M.

doi:10.1089/cap.2008.0114

Cited by 15 publications

(17 citation statements)

References 36 publications

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“…Turrell and colleagues, using MacArthur Competence Assessment Tool for Treatment (MacCAT-T), conducted a comparative study on competence to consent in adolescents with anorexia nervosa and in adolescents considered healthy (in medicine known as healthy controls); that is, uncompromised by any disorders or illness, and found group differences: adolescents with anorexia nervosa tend to experience more problems in reasoning about treatment than healthy controls [ 23 ]. Koelch and colleagues examined the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) on a small sample of children and adolescents aged 7 to 12 diagnosed with Attention Deficit Hyperactivity Disorder and concluded that the tool was feasible and offered a detailed assessment, recommending further research on the validity of the tool [ 24 ]. Other studies directed at assessing children’s competence in medical decision-making vary widely; while often making use of both hypothetical and actual decision-making scenarios, these studies mostly measure only one dimension of competence, disregarding validity and reliability altogether [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

Why is it hard to make progress in assessing children’s decision-making competence?

et al. 2015

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BackgroundFor decades, the discussion on children’s competence to consent to medical issues has concentrated around normative concerns, with little progress in clinical practices. Decision-making competence is an important condition in the informed consent model. In pediatrics, clinicians need to strike a proper balance in order to both protect children’s interests when they are not fully able to do so themselves and to respect their autonomy when they are. Children’s competence to consent, however, is currently not assessed in a standardized way. Moreover, the correlation between competence to give informed consent and age in children has never been systematically investigated, nor do we know which factors exactly contribute to children’s competence.This article aims at identifying these gaps in knowledge and suggests options for dealing with the obstacles in empirical research in order to advance policies and practices regarding children’s medical decision-making competence.DiscussionUnderstanding children’s competency is hampered by the law. Legislative regulations concerning competency are established on a strong presumption that persons older than a certain age are competent, whereas younger persons are not. Furthermore, a number of contextual factors are believed to be of influence on a child’s decision-making competence: the developmental stage of children, the influence of parents and peers, the quality of information provision, life experience, the type of medical decision, and so on. Ostensibly, these diverse and extensive barriers hinder any form of advancement in this conflicted area. Addressing these obstacles encourages the discussion on children’s competency, in which the most prominent question concerns the lack of a clear operationalization of children’s competence to consent. Empirical data are needed to substantiate the discussion.SummaryThe empirical approach offers an opportunity to give direction to the debate. Recommendations for future research include: studying a standardized assessment instrument covering all four relevant dimensions of competence (understanding, reasoning, appreciation, expressing a choice), including a study population of children covering the full age range of 7 to 18 years, improving information provision, and assessing relevant contextual data.

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Section: Discussionmentioning

confidence: 99%

Why is it hard to make progress in assessing children’s decision-making competence?

et al. 2015

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“…Koelch [22] used an adapted MacCAT-CR to study the decision-making process in 19 children aged 7 to 15 with psychiatric diagnoses; Tan [23] used the MacCAT-T to study thinking processes in 10 adolescents aged 13 to 21 with anorexia nervosa. Both studies confirmed the feasibility of using the MacCAT scales for children, but neither tested their validity and reliability More rigorous research is needed on the applicability of the MacCAT instruments for children.…”

Section: Introductionmentioning

confidence: 99%

Assessing children’s competence to consent in research by a standardized tool: a validity study

et al. 2012

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BackgroundCurrently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents.Methods/designIn this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment.DiscussionA validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish a reference standard of children’s competence to consent, combined with validation of an assessment instrument. Results can facilitate responsible involvement of children in clinical trials by further development of guidelines, health-care policies and legal policies.

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“…Research on this topic shows that understanding is not the only relevant issue, but also the provision of information and involvement in decision making are a value which is essential for children in this context (Tan, Hope, & Stewart, 2003;Vitiello, Kratochvil, & Silva, 2007). How to examine whether a child can give assent in a meaningful way has been discussed, but no simple solution has been available up to now Koelch, Prestel, & Singer, 2010).…”

Section: Pediatric Assentmentioning

confidence: 99%

Ethics in child and adolescent psychiatric care: An international perspective

Koelch

Fegert

2010

International Review of Psychiatry

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In the treatment of children with psychiatric disorders as a vulnerable population, ethical issues arise that seldom come into play with adults. The UN Conventions on the Rights of the Child and the Rights of Persons with Disabilities set out rights to be respected in child and adolescent psychiatric treatment. Rights of participation and inclusion (minimizing of barriers to the involvement of disabled people) can create complex problems in cases of restraint or deprivation of liberty. This paper analyses the consequences of these conventions and other ethics guidelines on child and adolescent psychiatric treatment and research. Beneficence, justice and autonomy are core principles that are mirrored in the problems of inclusion and protection, confidentiality, and the safety of psychopharmacological interventions. Factors of inclusion are involved in the areas of availability of care, participation in best evidence-based treatment, and research. The right of the child to protection, the right of inclusion, and parents' rights and duties to safeguard their child's wellbeing form a triangle. National laws to regulate the treatment of psychiatrically ill children should be created and implemented and these should be non-discriminatory but at the same time safeguard the developing human being.

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Report of an Initial Pilot Study on the Feasibility of Using the MacArthur Competence Assessment Tool for Clinical Research in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

Cited by 15 publications

References 36 publications

Why is it hard to make progress in assessing children’s decision-making competence?

Why is it hard to make progress in assessing children’s decision-making competence?

Assessing children’s competence to consent in research by a standardized tool: a validity study

Ethics in child and adolescent psychiatric care: An international perspective

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