TY - JOUR
T1 - Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD)
T2 - study protocol for a randomised controlled trial
AU - The MYRIAD team
AU - Montero-Marin, Jesus
AU - Nuthall, Elizabeth
AU - Byford, Sarah
AU - Crane, Catherine
AU - Dalgleish, Tim
AU - Ford, Tamsin
AU - Ganguli, Poushali
AU - Greenberg, Mark T.
AU - Ukoumunne, Obioha C.
AU - Viner, Russell M.
AU - Williams, J. Mark G.
AU - Ahmed, Saz
AU - Allwood, Matthew
AU - Auckland, Louise
AU - Baer, Ruth
AU - Ball, Susan
AU - Bennett, Marc
AU - Blakemore, Sarah Jayne
AU - Brett, Daniel
AU - Casey, Triona
AU - De Wilde, Katherine
AU - Dunning, Darren
AU - Farley, Eleanor Rose
AU - Fletcher, Katie
AU - Foulkes, Lucy
AU - Griffin, Cait
AU - Griffiths, Kirsty
AU - Kapplemann, Nils
AU - Knight, Rachel
AU - Laws, Suzannah
AU - Leung, Jovita
AU - Lord, Liz
AU - Medlicott, Emma
AU - Palmer, Lucy
AU - Parker, Jenna
AU - Petit, Ariane
AU - Pi-Sunyer, Blanca Piera
AU - Pryor-Nitsch, Isobel
AU - Radley, Lucy
AU - Raja, Anam
AU - Sakhardande, Ashok
AU - Shackleford, Jeremy
AU - Sonley, Anna
AU - Taylor, Laura
AU - Vainre, Maris
AU - Warriner, Lucy
AU - Wainman, Brian
AU - Kuyken, Willem
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: 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.
AB - Background: 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.
KW - Adolescence
KW - Depression
KW - Mindfulness
KW - Prevention
KW - Protocol update
KW - Resilience
KW - Schools
UR - http://www.scopus.com/inward/record.url?scp=85103994843&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85103994843&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05213-9
DO - 10.1186/s13063-021-05213-9
M3 - Article
C2 - 33827652
AN - SCOPUS:85103994843
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 254
ER -