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dc.contributor.authorMontero-Marin, J
dc.contributor.authorNuthall, E
dc.contributor.authorByford, S
dc.contributor.authorCrane, C
dc.contributor.authorDalgleish, T
dc.contributor.authorFord, T
dc.contributor.authorGanguli, P
dc.contributor.authorGreenberg, MT
dc.contributor.authorUkoumunne, OC
dc.contributor.authorViner, RM
dc.contributor.authorWilliams, JMG
dc.contributor.authorAhmed, S
dc.contributor.authorAllwood, M
dc.contributor.authorAuckland, L
dc.contributor.authorBaer, R
dc.contributor.authorBall, S
dc.contributor.authorBennett, M
dc.contributor.authorBlakemore, SJ
dc.contributor.authorBrett, D
dc.contributor.authorCasey, T
dc.contributor.authorDe Wilde, K
dc.contributor.authorDunning, D
dc.contributor.authorFarley, ER
dc.contributor.authorFletcher, K
dc.contributor.authorFoulkes, L
dc.contributor.authorGriffin, C
dc.contributor.authorGriffiths, K
dc.contributor.authorKapplemann, N
dc.contributor.authorKnight, R
dc.contributor.authorLaws, S
dc.contributor.authorLeung, J
dc.contributor.authorLord, L
dc.contributor.authorMedlicott, E
dc.contributor.authorPalmer, L
dc.contributor.authorParker, J
dc.contributor.authorPetit, A
dc.contributor.authorPi-Sunyer, BP
dc.contributor.authorPryor-Nitsch, I
dc.contributor.authorRadley, L
dc.contributor.authorRaja, A
dc.contributor.authorSakhardande, A
dc.contributor.authorShackleford, J
dc.contributor.authorSonley, A
dc.contributor.authorTaylor, L
dc.contributor.authorVainre, M
dc.contributor.authorWarriner, L
dc.contributor.authorWainman, B
dc.contributor.authorKuyken, W
dc.date.accessioned2021-07-13T08:30:56Z
dc.date.issued2021-04-07
dc.description.abstractBackground: MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-017-1917-4). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. Methods: Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. Discussion: These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. Trial registration: International Standard Randomised Controlled Trials ISRCTN86619085. Registered on 3 June 2016.en_GB
dc.description.sponsorshipWellcome Trusten_GB
dc.description.sponsorshipNational Institute for Health Research (NIHR)en_GB
dc.identifier.citationVol. 22, article 254en_GB
dc.identifier.doi10.1186/s13063-021-05213-9
dc.identifier.grantnumberWT104908/Z/14/Zen_GB
dc.identifier.urihttp://hdl.handle.net/10871/126383
dc.language.isoenen_GB
dc.publisherBMCen_GB
dc.rights© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.en_GB
dc.subjectadolescenceen_GB
dc.subjectschoolsen_GB
dc.subjectresilienceen_GB
dc.subjectmindfulnessen_GB
dc.subjectdepressionen_GB
dc.subjectpreventionen_GB
dc.subjectprotocol updateen_GB
dc.titleUpdate to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trialen_GB
dc.typeArticleen_GB
dc.date.available2021-07-13T08:30:56Z
dc.descriptionThis is the final version. Available on open access from BMC via the DOI in this recorden_GB
dc.descriptionAvailability of data and materials: Data and materials (codebook, statistical analysis plan, protocols, etc.) are available from Prof. Kuyken (willem.kuyken@psych.ox.ac.uk) upon request (release of data will be subject to an approved proposal and a signed data access agreement).en_GB
dc.identifier.eissn1745-6215
dc.identifier.journalTrialsen_GB
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en_GB
dcterms.dateAccepted2021-03-20
exeter.funder::Wellcome Trusten_GB
rioxxterms.versionVoRen_GB
rioxxterms.licenseref.startdate2021-04-07
rioxxterms.typeJournal Article/Reviewen_GB
refterms.dateFCD2021-07-13T08:29:01Z
refterms.versionFCDVoR
refterms.dateFOA2021-07-13T08:31:18Z
refterms.panelAen_GB


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© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,
which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give
appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if
changes were made. The images or other third party material in this article are included in the article's Creative Commons
licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons
licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain
permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the
data made available in this article, unless otherwise stated in a credit line to the data.
Except where otherwise noted, this item's licence is described as © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.