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Article History

Received: 10 October 2025

Accepted: 28 October 2025

First Online: 22 January 2026

Declarations

:

: This study was approved by the Institutional Review Board of the Balearic Islands Health Service Research Ethics (CEI-IB Ref No: IB 4837/22 PI) and follows the Declaration of Helsinki ethical standards. Written consent from all participants will be obtained, and all data collected will be kept anonymous and confidential. Participants will be able to voluntarily withdraw their informed consent at any time during the study.

: Compensation for Harm: Given the low-to-moderate risk, non-pharmacological nature of the SOM-RIU intervention, the study is covered by the standard institutional liability insurance of the Health Research Institute of the Balearic Islands (IDISBa) for all participants. Post-Trial Care: All participants identified as requiring support due to suicidal ideation or related distress during the trial will receive immediate support via the predefined emotional safety protocol and subsequent referral to the school counselling team. These referrals ensure linkage to the public mental health services network, guaranteeing continuity of care beyond the six-month follow-up period of the trial. Post-Trial Availability and Sustainability: If the results of this cluster-RCT demonstrate the effectiveness of the SOM-RIU program in reducing suicidal ideation and improving mental health outcomes, the intervention materials, curriculum, and training resources will be made available for use by all educational centres in the Balearic Islands that wish to adopt the program. Future large-scale implementation will be coordinated through established collaboration channels and will be subject to the formal approval and authorization of the Balearic Islands Department of Education (Conselleria d’Educació de les Illes Balears), ensuring the sustainable integration of the intervention into the regional educational system.

: The definitive results of the trial will be submitted for publication in a peer-reviewed academic journal, reporting findings in accordance with the CONSORT 2025 guidelines. To ensure that the findings are accessible to all stakeholders, a plain-language summary of the results will be developed in both Spanish and Catalan. This summary will be actively disseminated through our collaborators, including the Balearic Islands Department of Education, and via all participating school networks (through newsletters, circulars, or dedicated public meetings) to reach students, parents, and teachers directly. Furthermore, results will be presented at relevant professional conferences and communicated directly to policymakers and the funding body to inform future public health planning and potential large-scale implementation.

: Any major modifications to the protocol that affect the study design, participant eligibility criteria, interventions, outcomes, or statistical analysis plan will be formally documented. These important protocol modifications will be promptly communicated to the Institutional Review Board of the Balearic Islands Health Service Research Ethics (CEI-IB) for formal approval. Once approved, the trial registration (NCT06996054) on clinicaltrials.gov will be updated accordingly. Researchers and participating school staff will be notified of any changes relevant to the conduct of the trial, and participants will be informed if the amendments directly affect their rights, well-being, or willingness to continue participation.

: Not applicable.

: The authors declare no competing interests.