Update 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 trial

The MYRIAD team

doi:10.1186/s13063-021-05213-9

Update 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 trial

The MYRIAD team

Research output: Contribution to journal › Article › peer-review

12 Citations (Scopus)

Abstract

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.

Original language	English
Article number	254
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05213-9
Publication status	Published - Dec 2021

Keywords

Adolescence
Depression
Mindfulness
Prevention
Protocol update
Resilience
Schools

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1186/s13063-021-05213-9

Cite this

@article{6a2f95814a184aec8760ab085bb2b6c0,

title = "Update 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 trial",

abstract = "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.",

keywords = "Adolescence, Depression, Mindfulness, Prevention, Protocol update, Resilience, Schools",

author = "{The MYRIAD team} and Jesus Montero-Marin and Elizabeth Nuthall and Sarah Byford and Catherine Crane and Tim Dalgleish and Tamsin Ford and Poushali Ganguli and Greenberg, {Mark T.} and Ukoumunne, {Obioha C.} and Viner, {Russell M.} and Williams, {J. Mark G.} and Saz Ahmed and Matthew Allwood and Louise Auckland and Ruth Baer and Susan Ball and Marc Bennett and Blakemore, {Sarah Jayne} and Daniel Brett and Triona Casey and {De Wilde}, Katherine and Darren Dunning and Farley, {Eleanor Rose} and Katie Fletcher and Lucy Foulkes and Cait Griffin and Kirsty Griffiths and Nils Kapplemann and Rachel Knight and Suzannah Laws and Jovita Leung and Liz Lord and Emma Medlicott and Lucy Palmer and Jenna Parker and Ariane Petit and Pi-Sunyer, {Blanca Piera} and Isobel Pryor-Nitsch and Lucy Radley and Anam Raja and Ashok Sakhardande and Jeremy Shackleford and Anna Sonley and Laura Taylor and Maris Vainre and Lucy Warriner and Brian Wainman and Willem Kuyken",

note = "Funding Information: MYRIAD acknowledges the support of the National Institute for Health Research Clinical Research Network (NIHR CRN). We would also like to thank all our participating schools, teachers and young people for giving their time so generously to participate in this project. Funding Information: This study was funded by the Wellcome Trust Grant WT104908/Z/14/Z and supported by the NIHR Oxford Health Biomedical Research Centre. OU is supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health in England. Funding Information: We would like to acknowledge the contribution of the wider MYRIAD project team to this work. The MYRIAD Team worked across the MYRIAD Strategic award {\textquoteleft}Promoting Mental health and Building Resilience in Adolescence: Investigating Mindfulness and Attentional Control{\textquoteright}. They are acknowledged as group authors in this paper for their substantial contributions to the project in accordance with the MYRIAD Dissemination Protocol. They are as follows: Saz Ahmed, Matthew Allwood, Louise Auckland, Ruth Baer, Susan Ball, Marc Bennett, Sarah-Jayne Blakemore, Daniel Brett, Triona Casey, Katherine De Wilde, Darren Dunning, Eleanor-Rose Farley, Katie Fletcher, Lucy Foulkes, Cait Griffin, Kirsty Griffiths, Nils Kapplemann, Rachel Knight, Suzannah Laws, Jovita Leung, Liz Lord, Emma Medlicott, Lucy Palmer, Jenna Parker, Ariane Petit, Blanca Piera Pi-Sunyer, Isobel Pryor-Nitsch, Lucy Radley, Anam Raja, Ashok Sakhardande, Jeremy Shackleford, Anna Sonley, Laura Taylor, Maris Vainre, Lucy Warriner and Brian Wainman. We are grateful to the members of the independent Trial Steering Committee: Nick Axford (Chair), Lucinda Powell, Sam Cartwright-Hatton, Steve Hollon, Paul Stallard, Chris Bonell and Una Sookun. Cathy Creswell was the Chair but she had to step down when she moved to Oxford. Paul Ramchandani was a member, but stepped down when he moved to Cambridge University. We are grateful to the members of the independent Data Monitoring and Ethics Committee: Mike Campbell (Chair), Sona Dimidjian, Judy Kidger and Jan Boehnke. Ruth Baer was also a member, but stepped down when she moved to Oxford. MYRIAD acknowledges the support of the National Institute for Health Research Clinical Research Network (NIHR CRN). We would also like to thank all our participating schools, teachers and young people for giving their time so generously to participate in this project. Publisher Copyright: {\textcopyright} 2021, The Author(s).",

year = "2021",

month = dec,

doi = "10.1186/s13063-021-05213-9",

language = "English",

volume = "22",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

}

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 - Funding Information: MYRIAD acknowledges the support of the National Institute for Health Research Clinical Research Network (NIHR CRN). We would also like to thank all our participating schools, teachers and young people for giving their time so generously to participate in this project. Funding Information: This study was funded by the Wellcome Trust Grant WT104908/Z/14/Z and supported by the NIHR Oxford Health Biomedical Research Centre. OU is supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health in England. Funding Information: We would like to acknowledge the contribution of the wider MYRIAD project team to this work. The MYRIAD Team worked across the MYRIAD Strategic award ‘Promoting Mental health and Building Resilience in Adolescence: Investigating Mindfulness and Attentional Control’. They are acknowledged as group authors in this paper for their substantial contributions to the project in accordance with the MYRIAD Dissemination Protocol. They are as follows: Saz Ahmed, Matthew Allwood, Louise Auckland, Ruth Baer, Susan Ball, Marc Bennett, Sarah-Jayne Blakemore, Daniel Brett, Triona Casey, Katherine De Wilde, Darren Dunning, Eleanor-Rose Farley, Katie Fletcher, Lucy Foulkes, Cait Griffin, Kirsty Griffiths, Nils Kapplemann, Rachel Knight, Suzannah Laws, Jovita Leung, Liz Lord, Emma Medlicott, Lucy Palmer, Jenna Parker, Ariane Petit, Blanca Piera Pi-Sunyer, Isobel Pryor-Nitsch, Lucy Radley, Anam Raja, Ashok Sakhardande, Jeremy Shackleford, Anna Sonley, Laura Taylor, Maris Vainre, Lucy Warriner and Brian Wainman. We are grateful to the members of the independent Trial Steering Committee: Nick Axford (Chair), Lucinda Powell, Sam Cartwright-Hatton, Steve Hollon, Paul Stallard, Chris Bonell and Una Sookun. Cathy Creswell was the Chair but she had to step down when she moved to Oxford. Paul Ramchandani was a member, but stepped down when he moved to Cambridge University. We are grateful to the members of the independent Data Monitoring and Ethics Committee: Mike Campbell (Chair), Sona Dimidjian, Judy Kidger and Jan Boehnke. Ruth Baer was also a member, but stepped down when she moved to Oxford. MYRIAD acknowledges the support of the National Institute for Health Research Clinical Research Network (NIHR CRN). We would also like to thank all our participating schools, teachers and young people for giving their time so generously to participate in this project. 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

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 -

Update 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 trial

Abstract

Keywords

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this