ArticleChild and adolescent psychiatry and mental health2009
"...because I am something special" or "I think I will be something like a guinea pig": information and assent of legal minors in clinical trials--assessment of understanding, appreciation and reasoning.
Article in Child and adolescent psychiatry and mental health, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Experiences and perspectives of children and adolescents participating in pediatric clinical trials: a qualitative evidence synthesis.Archives of public health = Archives belges de sante publique · 2026Pooled it
- Motivations of children and their parents to participate in drug research: a systematic review.European journal of pediatrics · 2016Pooled it
- Out of the black box: treatment of resistant depression in adolescents and the antidepressant controversy.Journal of child and adolescent psychopharmacology · 2012Trial
- Standardised capacity measures and cognition in the assessment of capacity in children and adolescents: a systematic review.Psychiatry, psychology, and law : an interdisciplinary journal of the Australian and New Zealand Association of Psychiatry, Psychology and Law · 2025Article
- Childhood ADHD and Early-Onset Bipolar Disorder Comorbidity: A Case Report.Brain sciences · 2020Article
- Challenges in recruiting and retaining adolescents with abuse-related posttraumatic stress disorder: lessons learned from a randomized controlled trial.Child and adolescent psychiatry and mental health · 2020Article
- Banking the Future: Adolescent Capacity to Consent to Biobank Research.Ethics & human research · 2019Article
- "I Won't Out Myself Just to Do a Survey": Sexual and Gender Minority Adolescents' Perspectives on the Risks and Benefits of Sex Research.Archives of sexual behavior · 2017Article
- Contrasting views of risk perception and influence of financial compensation between adolescent research participants and their parents.Journal of empirical research on human research ethics : JERHRE · 2015Article
- Is Guardian Permission a Barrier to Online Sexual Health Research Among Adolescent Males Interested in Sex With Males?Journal of sex researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.