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Efficacy and acceptability of a blended intervention for emotion regulation (MAISHA) among young people in Kenya: study protocol for a cluster RCT

Crossref DOI link: https://doi.org/10.1186/s40359-025-03837-z

Published Online: 2025-12-20

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Rugendo, Esther https://orcid.org/0009-0004-1173-0575
Lyimo, Glorialoveness S. https://orcid.org/0009-0000-8225-1441
Daya, Rahim

Githinji, Moreen https://orcid.org/0009-0008-7265-9062
Kashamba, Kevin https://orcid.org/0009-0000-5023-468X
Njoki, Faith https://orcid.org/0009-0009-0091-288X
Yusufu, Innocent https://orcid.org/0000-0003-3080-1741
Osborn, Tom https://orcid.org/0000-0002-9092-1035
Chase, Rachel P. https://orcid.org/0000-0002-1503-4954
Sando, Mary https://orcid.org/0000-0002-8079-5960
Nyundo, Azan https://orcid.org/0000-0002-1433-2271
Bärnighausen, Till https://orcid.org/0000-0002-4182-4212
Reininghaus, Ulrich https://orcid.org/0000-0002-9227-5436
McMahon, Shannon A. https://orcid.org/0000-0002-8634-9283
Reinhold, Annika Stefanie https://orcid.org/0000-0002-7841-2270
Funding

Funding for this research was provided by:

Medizinische Fakultät Heidelberg der Universität Heidelberg
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Text and Data Mining valid from 2025-12-20

Version of Record valid from 2026-01-27
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Article History

Received: 18 August 2025

Accepted: 8 December 2025

First Online: 20 December 2025

Declarations

:

: Both phase 1 (the intervention adaptation) and phase 2 (the current trial) study protocols were approved by the institutional review board of the Medical Faculty, Heidelberg University, Heidelberg, Germany (Phase 1 - S-064/2024; Phase 2 - S-800/2024) as well as local (Phase 1 – PKU/2920/112943; Phase 2 – PKU/3115/E3039) and national (Phase 2 – NACOSTI/P/25/4175700) ethics review boards in Kenya. Protocol modifications will be communicated to all ethics committees. Given the low-risk nature of the intervention, no formal provisions for ancillary or post-trial medical care are deemed necessary. However, to ensure fairness, we will offer participants of the control arm a modified intervention after the trial.Study results will be disseminated through peer-reviewed publications, presentations at scientific conferences, and summaries shared with stakeholders in Kenya. This includes participating schools, community-based organizations, universities, other mental health stakeholders, and interested participants.

: Not applicable.

: The authors declare no competing interests.

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