Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (FKZ 01GL1740D)
Text and Data Mining valid from 2018-11-14
Received: 5 May 2018
Accepted: 16 October 2018
First Online: 14 November 2018
Ethics approval and consent to participate
: The study will be conducted in accordance with the principles of good clinical practice, the Declaration of Helsinki [CitationRef removed] and all current ethical standards. Written informed consent will be obtained from study participants and their legal representatives or guardians prior to enrolment. Consent can be withdrawn at any time during the trial without giving reasons. The study protocols have been approved by the ethics committee of the University of Düsseldorf (COACH-MI study, reference 6244R). The ethics committee, trial registry and trial participants will be informed of any protocol modifications. The COACH consortium will be advised by an external data and safety monitoring board. We will report the progress of the project to the Federal Ministry of Education and Research (BMBF). No physical risks are anticipated with study participation; however, participants and parents will be provided travel insurance for the second counselling appointment with MI-educated physicians.The study intervention is considered safe and will be monitored using the SAE reporting system. All ongoing or newly developed SAEs will be immediately reported to the principal investigator and to the data safety and monitoring board, and routine reports will be delivered at 6-month intervals. The most likely patient safety concern is that a former unknown suicidality or severe depression may be uncovered by the screening or subsequent advice (during a TAU or MI session). As a standard procedure for responding to suicidal ideations (PHQ-9 question 9), physicians are advised to use the Columbia Suicide Severity Rating Scale (C-SSRS) [CitationRef removed] as a standard tool for evaluating suicidality. Red flags (see above) will trigger an immediate psychological evaluation. If a substantiated concern arises for active suicidal thoughts or major depression, the patient will be referred to the psychiatric unit for immediate evaluation or treatment. These participants will be dropped from the study.
: Not applicable.
: The authors declare that they have no competing interests.
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