Promoting mental health and well-being in schools: examining mindfulness, relaxation and strategies for safety and well-being in English primary and secondary schools-study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)

Daniel Hayes; Anna Moore; Emily Stapley; Neil Humphrey; Rosie Mansfield; Joao Santos; Emma Ashworth; Praveetha Patalay; Eva-Maria Bonin; Sara Evans-Lacko; Bettina Moltrecht; Kirsty Nisbet; Emma Thornton; Aurelie Lange; Paul Stallard; Abigail Thompson; Jan Rasmus Boehnke; Jessica Deighton

doi:10.1186/s13063-023-07238-8

Promoting mental health and well-being in schools: examining mindfulness, relaxation and strategies for safety and well-being in English primary and secondary schools-study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)

Trials. 2023 Mar 23;24(1):220. doi: 10.1186/s13063-023-07238-8.

Authors

Daniel Hayes¹, Anna Moore¹, Emily Stapley¹, Neil Humphrey², Rosie Mansfield², Joao Santos², Emma Ashworth², Praveetha Patalay³, Eva-Maria Bonin⁴, Sara Evans-Lacko⁵, Bettina Moltrecht¹, Kirsty Nisbet¹, Emma Thornton⁶, Aurelie Lange¹, Paul Stallard⁷, Abigail Thompson¹, Jan Rasmus Boehnke⁸, Jessica Deighton⁹

Affiliations

¹ Evidence Based Practice Unit (EBPU), University College London and Anna Freud National Centre for Children and Families (AFNCCF), London, UK.
² Institute of Education, The University of Manchester, Manchester, UK.
³ MRC Unit for Lifelong Health and Ageing and the Centre for Longitudinal Studies, University College London, London, UK.
⁴ Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.
⁵ Care Policy and Evaluation Centre (CPEC), London School of Economics and Political Science, London, UK.
⁶ Manchester Institute of Education, The University of Manchester, Manchester, UK.
⁷ Department for Health, University of Bath, Bath, UK.
⁸ School of Nursing and Health Sciences, University of Dundee, Dundee, UK.
⁹ Evidence Based Practice Unit (EBPU), University College London and Anna Freud National Centre for Children and Families (AFNCCF), London, UK. EBPU@annafreud.org.

Abstract

There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based universal prevention programmes are thought to be one way of helping tackle such difficulties. This paper describes an update to a four-arm cluster randomised controlled trial ( http://www.isrctn.com/ISRCTN16386254 ), investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. Due to the COVID-19 pandemic, the trial was put on hold and subsequently prolonged. Data collection will now run until 2024. The key changes to the trial outlined here include clarification of the inclusion and exclusion criteria, an amended timeline reflecting changes to the recruitment period of the trial due to the COVID-19 pandemic and clarification of the data that will be included in the statistical analysis, since the second wave of the trial was disrupted due to COVID-19.Trial registration ISRCTN Registry ISRCTN16386254. Registered on 30 August 2018.

Keywords: Adolescent; Children; Cluster randomised controlled trial; Mental health; School-based; Well-being; Young person.

Publication types

Clinical Trial Protocol

MeSH terms

Adolescent
COVID-19*
Child
Humans
Mental Health
Mindfulness*
Pandemics / prevention & control
Randomized Controlled Trials as Topic
Schools