Course catalogue doctoral education - VT21

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Title Clinical Research in Child and Adolescent Psychiatry: Methods and Practice
Course number 5287
Programme Neurovetenskap
Language English
Credits 1.5
Date 2021-03-15 -- 2021-03-26
Responsible KI department Institutionen för klinisk neurovetenskap
Specific entry requirements
Purpose of the course To provide broad as well as in-depth knowledge about methodological and practical aspects of clinical psychiatric research focusing on children and adolescents. The course aims to cover a range of methodological factors in clinical trials on youths with psychiatric disorders, including psychiatric assessment and psychological as well as pharmacological treatment. The course also addresses rules and laws relevant to clinical research involving young individuals.
Intended learning outcomes After completing the course, participants should:
- Be able to account for ethical issues related to having children and adolescents as research subjects
- Be able to describe preparatory groundwork for clinical trials in psychiatric research, including development of a study protocol, ethical application and trial registration
- Have knowledge about study monitoring and study documentation routines in child psychiatric research
- Be able to account for Good Clinical Practice (GCP)
- Be able to explain the implications of different forms of control conditions in randomized controlled trials with children and adolescents
- Know how to register and report adverse events and side effects in studies with children and adolescents
- Be able to account for relevant considerations in the choice of assessment method (e.g., child-adapted diagnostic interviews) and explain the implications of having multiple informants (children, parents and clinicians) in clinical trials with youths
- Know the procedures for blind assessments with children and adolescents
- Be aware of precautions ensuring children's health and safety in research conducted in regular psychiatric care
Contents of the course During the course participants will:
- Participate in lectures about ethical and methodological aspects of clinical trials with children and adolescents in psychiatric research
- Participate in seminars where participants will discuss published papers relating to psychiatric assessments and psychological as well as pharmacological treatments
- Read scientific articles about methodological considerations in clinical trials with children and adolescents
- Practice writing ethical applications as well as research information and informed consents for children and adolescents
- Conduct group presentations where they present their analyses and conclusions about various aspects of conducting research in child psychiatric settings
Teaching and learning activities Lectures, seminars, group presentations.
Compulsory elements Compulsory attendance at lectures and seminars. Absence can be compensated for by written assignments.
Examination Examination seminar with group presentations and discussions. All students are assessed individually on their ability to present, discuss and reason about clinical research in child and adolescent psychiatric research.
Literature and other teaching material Mandatory literature:

Christensen, P., & James, A. (Eds.). (2008). Research with children: Perspectives and practices. Routledge (selected chapters).

Fargas-Malet, M., McSherry, D., Larkin, E., & Robinson, C. (2010). Research with children: methodological issues and innovative techniques. Journal of Early Childhood Research: ECR, 8(2), 175–192.

Mohammadi, M. R., & Mostafavi, S. A. (2017). Good Clinical Practice in Children and Adolescents. In Clinical Trials in Vulnerable Populations. IntechOpen.

Creswell, C., Nauta, M., Hudson, J., March, S., Reardon, T., Arendt, K., Bodden, D., Cobham, V., Donovan, C., Halldorsson, B., In-Albon, T., Ishikawa, S., Johnsen, D., Jolstedt, M., Jong, R., Kreuze, L., Mobach, L., Rapee, R., Spence, S., … Kendall, P. (2020). Research Review: Recommendations for reporting on treatment trials for child and adolescent anxiety disorders - an international consensus statement. Journal of Child Psychology and Psychiatry.

Kirk, S. (2007). Methodological and ethical issues in conducting qualitative research with children and young people: A literature review. International Journal of Nursing Studies, 44(7), 1250–1260.

De Los Reyes, A., & Kazdin, A. (2005). Informant Discrepancies in the Assessment of Childhood Psychopathology: A Critical Review, Theoretical Framework, and Recommendations for Further Study. Psychological Bulletin, 131(4), 483–509.

Reference literature:

Guideline for Good Clinical Practice integrated addendum to ICH (ICH GCP 4.8.13. Finns på: https://ichgcp.net/4-investigator.

Chan, A., Tetzlaff, J., Gøtzsche, P., Altman, D., Mann, H., Berlin, J., Dickersin, K., Hróbjartsson, A., Schulz, K., Parulekar, W., Krleža-Jeric, K., Laupacis, A., & Moher, D. (2013). SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ: British Medical Journal, 346 (jan08 15), e7586–e7586. https://doi.org/10.1136/bmj.e7586

Grills, A., & Ollendick, T. (2003). Multiple Informant Agreement and the Anxiety Disorders Interview Schedule for Parents and Children. Journal of the American Academy of Child and Adolescent Psychiatry, 42(1), 30–40.

Hróbjartsson A, Thomsen AS, Emanuelsson F, Tendal B, Hilden J, Boutron I, et al. Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and nonblinded outcome assessors. BMJ 2012 ; 344 : e1119

Freedland, K., Mohr, D., Davidson, K., & Schwartz, J. (2011). Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosomatic Medicine, 73(4), 323–335.

Lancaster, G. A., Dodd, S., & Williamson, P. R. (2004). Design and analysis of pilot studies: recommendations for good practice. Journal of evaluation in clinical practice, 10(2), 307-312
Number of students 8 - 25
Selection of students Selection will be based on 1) the relevance of the course syllabus for the applicants doctoral project (according to written motivation), 2) date for registration as a doctoral student (priority given to earlier registration date).
More information This course runs at half-time pace (50%) over two weeks and will be held at Campus Solna. The schedule with all details will be sent out after admission to the course.
Additional course leader Course leaders are Jens Högström, associate professor and clinical psychologist. Eva Serlachius, associate professor, MD, specialist in child psychiatry.
Latest course evaluation Not available
Course responsible Jens Högström
Institutionen för klinisk neurovetenskap

jens.hogstrom@ki.se

Gävlegatan 22



Contact person Eva Serlachius
Institutionen för klinisk neurovetenskap

eva.serlachius@ki.se


Kristina Aspvall
Institutionen för klinisk neurovetenskap

kristina.aspvall@ki.se


Martina Nord
Institutionen för klinisk neurovetenskap

martina.nord@ki.se


Rebecca Grudin
Institutionen för klinisk neurovetenskap

rebecca.grudin@ki.se