Rømer Thomsen, Kristine
Vallentin-Holbech, Lotte
Xylander, Synnøve
Wellnitz, Kaare Bro
Tolstrup, Janne
Nielsen, Anette Søgaard
Ewing, Sarah W. Feldstein
Funding for this research was provided by:
Danish Foundation TrygFonden (ID: 155933, ID: 155933, ID: 155933, ID: 155933, ID: 155933, ID: 155933, ID: 155933)
Article History
Received: 26 August 2023
Accepted: 12 October 2023
First Online: 24 October 2023
Declarations
:
: This study is carried out in accordance with the study protocol, and the Helsinki Declaration. The study was approved by the Danish Data Protection Agency and the Research Ethics Committee at Aarhus University, Denmark (ID BSS-2023-039). Participants will receive written and verbal information about the study including that participation is voluntary and they are free to withdraw from the study at any time. Parents will receive the same written information and can contact the research team with any potential questions or concerns. Informed consent will be obtained from the students prior to the baseline survey (this will be done online for all students, a researcher from the team will be present in the class to answer potential questions). Additionally, written informed consent will be obtained for group MI, before initiation of the first group session (a researcher from the team will be present to answer potential questions). Informed consent will not be obtained from parents of participants aged 15–17 (or older). This is in accordance with Danish law (regarding this type of project) and has been approved by The Research Ethics Committee, Aarhus BSS, at Aarhus University. Informed consent will be obtained online from school staff prior to the qualitative interviews (a researcher from the team will be present to answer potential questions). Data will be stored on secure servers, in accordance with the Danish Data Protection Act (Law # 502 of May 12, 2018), and the European General Data Protection Regulation (2016/679) of the European Parliament and of the Council. The Danish Data Protection Agency has approved all data collection procedures and will continue to monitor the data collection and storage throughout the project. The trial was retrospectively registered at ClinicalTrials.gov on August 24th, 2023 (ID NCT06018389). In case of important protocol modifications, these will be reported to the Research Ethics Committee at Aarhus University, the Danish Data Protection Agency, and at ClinicalTrials.gov. The prevention interventions included in this trial do not entail risk of harm to the participants. However, if they experience any discomfort related to their participation, they are encouraged to contact members of the team, who will help or direct them to relevant services. Potential events will be reported in publications of main findings from the trial. Participants are informed that they are free to skip questions in the surveys and in the group MI sessions.
: No details, images or video material relating to an individual person, participant, or high school, will be published in relation to the study.
: The authors declare no competing interests.
: We follow the Vancouver authorship guidelines and will not use professional writers.
: Kristine Rømer Thomsen, Aarhus University, Denmark, e-mail: krt.crf@psy.au.dk.
: Our choice.
: A data monitoring committee is not needed because the prevention interventions included in this trial do not entail risk of harm to the participants.