Mental health disorders are prevalent in paediatric ages. Although involving young patients and parents through the whole research process can create improvements not only in research participation but also in the mental health setting, this is not common practice. c4c has a group of experts in mental health conditions and a patient and public involvement group to support involving children and young people in this therapeutic area.
If interested in more information and to sign-up, click here.
Mental health disorders are prevalent in paediatric ages. Population estimates suggest that around 20% of children and adolescents will suffer from a mental health disorder. Around 50% of all mental health disorders start prior to age 18, meaning that involving young patients in research is vital for the development of medicines that prevent the effects of untreated mental health illness in this population. Despite this, the number of clinical trials addressed to the paediatric population living with these conditions is few, and including children and adolescents in psychiatric clinical trials remain challenging.
There are different areas in clinical trials in which the involvement of children and adolescents with mental health disorders can be meaningful. This includes supporting the design of trials, as currently trials frequently mirror adult developments meaning very specific populations are recruited which are not always representative of needs of patients in clinical settings. In children and adolescents, whilst the mental health disorder classification systems are the same in adults, clinical expression of psychopathology present certain particularities. In addition, mental health disorders manifest with a different comorbidity pattern, that frequently constitutes trial exclusion criteria. There are some clinical characteristics, very prevalent in children and adolescents in different psychiatric disorders and associated with functional impairment, such as irritability, that are frequently treated with off-label medications in clinical practice that would benefit from being studied across disorders.
There are other contributing factors present in young patients with mental illnesses and their parents. Some of them are the stigma around diagnosis, issues with confidentiality and trust, lack of perceived need of help or economic impact of trial participation. On the contrary, perceived support or encouragement from others, and education and awareness, may enhance trial participation and satisfaction. To address these factors, it is critical to start involving young people with mental health diseases and their parents in the research process, from the definition of the unmet medical needs, the clinical trial design, the patient’s information and consent documents, and also in the interpretation of results and dissemination. Adapting protocols to the perceived needs of patients and parents will very likely increase their interest in participating and will increase useful results that may improve the lives of our patients. Involving young people with experience with mental health problems to develop specific materials to raise awareness on the benefits of clinical trials, will also enhance the impact on education on society and help decrease stigma related to mental health.
Despite the benefits of involving young patients and parents in the mental health setting, this is not common practice. c4c has a group of experts in mental health conditions and in patient and public involvement to support the process of involving children and young people in this therapeutic area. Young adult patients, parents and patients organizations are welcome to join our expert patient database if they are interested in being involved in future advisory activities organized by c4c.
For more information and to sign-up to the database, click here.