Funding for this research was provided by:
Norges Forskningsråd (238081/H20)
The Norwegian Directorate of Health
Gidske og Peter Jacob Sørensens fond
Received: 31 May 2018
Accepted: 30 April 2019
First Online: 22 May 2019
Ethics approval and consent to participate
: This investigation has been performed in accordance with the Declaration of Helsinki, and has been approved by The Norwegian Regional Committee for Medical and Health Research Ethics (South East). Approval reference: 2015/1027 Depresjonsmestring for ungdom.Adolescents who had a BDI score > 10, and who were between 16 and 20 years old could be included in the study. (On rare occasions students in 1st grade in upper secondary school could be 15 years old. If this happened in our recruitment, parents had to sign the informed consent form). The course leader and the student went through the written information about the investigation together. General information about the background and purpose of the study was given first. It was explained that there are different treatments for young people who have depressive symptoms, and that the Norwegian Center for Child Behavioral Development was comparing a new treatment “DU – Adolescent Coping with Depression Course” with more traditional treatments. Therefore, adolescents from the 1st and 2nd grade of junior high school who were struggling with sadness and depression were invited to join the study. The purpose was to compare how these treatments could affect sadness, the way students were with friends and in school, and in the long term how they might affect school attendance and dropout.Then participants were given information about study procedures. First the students were informed that they would have to fill in a questionnaire after they signed the consent form. The questions were about sadness and thoughts associated with this, and how they were in school and with friends. Then the students were informed that they would be randomly assigned either to the DU course or to usual care, and that usual care may vary depending on where they live and local routines and preferences. They were told when and how (by mail) they would be informed about the outcome of the randomization, and when the treatment should start. They were also told that they would have to answer a few questions via a link in an email that we would send to them right at the start of the course. After 14 weeks they would answer some more questions, and again six and 12 months later. Participants would receive a gift certificate with a value of NOK 300, − (about GBP 25). after answering the questionnaire for the last time. The adolescents were also informed that information about grades and possible drop out from school would be gathered from schools/public registries.We also gave information about the general need for more knowledge about child and adolescent mental health, and how this has been emphasized in public documents. Participating in the study would provide more knowledge and better understanding about ways to help. It was explained that joining the study involved little effort, and that it would probably not cause any great discomfort.Following this there was information about how data would be used. This included the duty of confidentiality, also for the database where the responses are recorded. All information would be treated without name, personal/id number or other directly recognizable information, and that a code would connect personal information to data. Furthermore, only a few authorized administrative personnel associated with the project would have access to the list of names so that data from different tests can be merged. The data would be de-identified when all the data was obtained, and the name lists would be cleared.Finally, the young people were informed that participating in the study was voluntary and that participants could at any time and without any given reason withdraw their consent to participate. This would not affect their further participation on the course or in the usual care treatment. Contact information was provided for these issues.
: Non applicable. No details, images, or videos relating to individual participants will be published.
: The authors declare that they have no competing interests.
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