Understanding Minors' Participation in Clinical Trials
Author Information
Author(s): Koelch Michael, Singer Hanneke, Prestel Anja, Burkert Jessica, Schulze Ulrike, Fegert Jörg M
Primary Institution: Department of Child and Adolescent Psychiatry/Psychotherapy, University Hospital of Ulm
Hypothesis
How well do children and parents understand the information provided about clinical trials in child and adolescent psychiatry?
Conclusion
Legal minors and parents need clearer information about clinical trials, especially regarding placebo and the primary purpose of the trials.
Supporting Evidence
- Children understood concrete procedures of clinical trials well but struggled with abstract concepts like the purpose of the trial.
- Many children believed they would benefit personally from participating in the trial.
- Parents showed a strong desire to discuss their child's issues during the consent process.
Takeaway
Kids and their parents need to know more about what happens in clinical trials, especially about things like placebos, so they can make better choices.
Methodology
The study used the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) to assess understanding, appreciation, and reasoning in 19 children and adolescents aged 7 to 15 with ADHD or ADHD combined with ODD.
Potential Biases
Potential therapeutic misconceptions among children and parents regarding the nature of clinical trials.
Limitations
The sample size was small and results may differ in studies with children having other psychiatric disorders.
Participant Demographics
19 children and adolescents aged 7 to 15, with ADHD or ADHD combined with ODD; parents from various social strata.
Digital Object Identifier (DOI)
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