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Article History

Received: 27 August 2025

Accepted: 20 October 2025

First Online: 18 November 2025

Declarations

:

: The ELIPSE trials are in accordance with the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines and the World Medical Association Declaration of Helsinki, with data processing compliant with the Swiss Federal Act on Data Protection (FADP) [ – ]. Ethics approval for ELIPSE I was first obtained on 25 July 2023 (current version 2.2 approved on 9 October 2025), and for ELIPSE II on 1 November 2023 (current version 2.2 approved on 3 May 2025), from the Ethics Committee of the Canton of Bern, Switzerland (see Additional file 4). Both trials were registered in the Business Administration System for Ethics Committees (BASEC ID 2023–01136 for ELIPSE I and BASEC ID 2023–01615 for ELIPSE II). All protocol amendments will be discussed and approved by the study team, with final approval from the sponsor-investigator, prior to submission to the Ethics Committee for review and approval. Upon approval, amendments will be communicated to referring centres and practices as applicable. Any protocol deviations will be fully documented using a breach report form. Additionally, the clinical trial registries will be promptly updated to reflect any protocol changes. Informed written consent will be required from participating parents/legal guardians before conducting this study, and all children will be asked to assent prior to their participation in data collection. For ELIPSE I, children aged 11–12 years will receive an information sheet about the study in simplified language. Independent monitoring and audit procedures are planned after the inclusion of the first 5 participants, and following the inclusion of 50% and 100% of participants in both trials, to ensure compliance with the study protocol and GCP guidelines. Given the study design, minimal risk profile, and robust internal oversight by the sponsor-investigator, one investigator, three sub-investigators, one study coordinator, three study nurses, and three PhD students at the two participating sites (University Children’s Hospital Bern and University Hospital of Child and Adolescent Psychiatry and Psychotherapy Bern), a formal Data Monitoring Committee was not established nor deemed necessary. Data monitoring and analyses are conducted by the study team. The study team meets regularly to review trial conduct and ensure adherence to regulatory and ethical standards: sub-investigators, study coordinator, study nurse, and PhD students meet weekly to biweekly; meetings with the sponsor-investigator are held monthly at the University Children’s Hospital Bern; and the entire study team from both sites gathers every 3 to 6 months.

: Not applicable.

: The authors declare no competing interests.