Condition category
Mental and Behavioural Disorders
Date applied
30/08/2018
Date assigned
04/09/2018
Last edited
13/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background aims.
The majority of mental health difficulties start before adulthood, and there is evidence to suggest these difficulties may be increasing. Schools are ideally situated to provide support; most young people attend school and there are opportunities for support without attending specialist mental health services. The Department for Education has commissioned the Evidence Based Practice Unit and partners (University of Manchester, the University of Dundee, and London School of Economics) to evaluate the effectiveness of three programmes, Mindfulness, Relaxation and Strategies for Safety and Wellbeing, on mental health and wellbeing outcomes in schools.

Who can participate?
Primary or secondary schools in either London, Manchester, Durham and the North East, Bath, Bristol and Somerset or Birmingham and the Midlands.
Primary schools must be able to deliver an intervention to at least one or two year 4 classes, and one or two year 5 classes. Secondary schools must be able to deliver an intervention to three year 7 classes and three year 8 classes

What does this study involve?
This study involves pupils being allocated to one of three interventions (Mindfulness, Relaxation and Strategies for Safety and Wellbeing) or continuing with usual provision.

1. Mindfulness: This intervention is based on delivering mindfulness-based skills with a particular emphasis on activities which focus on the mind, the body and the world. It will be delivered by trained schools professionals with daily exercises lasting approximately ten minutes from January – April 2019
2. Relaxation: This intervention is based on delivering relaxation-based skills, with a particular focus on deep breathing and progressive muscle relaxation techniques. It will be delivered by trained school professionals with daily exercises lasting approximately ten minutes from January – April 2019.
3. Strategies for Safety and Wellbeing: The focus of this programme is on mental health awareness within the context of developing safety behaviours, and identifying and accessing appropriate support networks. It consists of eight consecutive weekly lessons around 45 minutes, which are delivered by a trained school professional.
4. Usual Provision (Control): Schools will continue with usual practice without partaking in one of the above interventions.

What are the benefits or risks of participating?
This will help the government and researchers understand what interventions may help improve mental health and wellbeing in schools. Pupils may experience a decrease in mental health difficulties or increase in wellbeing, however this is not guaranteed. Young people may become aware of their own mental health and wellbeing which could cause discomfort of distress.

What research institutions are involved in the project?
This study is being run by the Evidence Based Practice Unit, University of Manchester, the University of Dundee, and London School of Economics.

When is the study starting?
Preparation for the trial, including some initial piloting, began in September 2017. The estimated completion date by which findings will be collated and disseminated is June 2021.

Who is funding this study?
This study is being funded by the Department for Education.

Who are the main contacts:
Dr Jessica Deighton: Jessica.deighton@annafreud.org
Dr Daniel Hayes: Daniel.hayes@annafreud.org

Trial website

https://www.annafreud.org/what-we-do/schools-in-mind/our-work-with-schools/education-for-wellbeing-programme/inspire/

Contact information

Type

Scientific

Primary contact

Dr Jessica Deighton

ORCID ID

Contact details

Evidence Based Practice Unit
University College London and Anna Freud National Centre for Children and Families
London
N1 9JH
United Kingdom

Type

Public

Additional contact

Dr Daniel Hayes

ORCID ID

Contact details

Evidence Based Practice Unit
University College London and Anna Freud National Centre for Children and Families
London
N1 9JH
United Kingdom
02074432220
daniel.hayes@annafreud.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EOR/SBU/2017/015

Study information

Scientific title

INterventions in Schools for PromotIng Mental Wellbeing: Research in Education (INSPIRE)

Acronym

INSPIRE

Study hypothesis

1. Young people receiving Mindfulness will report more favourable change in emotional difficulties at six and twelve months follow up relative to baseline than those who receive the usual school curriculum
2. Young people receiving Relaxation will report more favourable change in emotional difficulties at six and twelve months follow up relative to baseline than those who receive the usual school curriculum
3. Young people receiving Strategies for Safety and Wellbeing will report more favourable change in help seeking at six and twelve months follow up relative to baseline than those who receive the usual school curriculum

Ethics approval

Approval committee: University College London ethics committee, approval reference number: 6735/009, approval date: 20/02/18

Study design

Interventional, multicentre, cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request the participant information sheet

Condition

Mental health and wellbeing

Intervention

1. Mindfulness-based skills, emphasising the mind, the body and the world, delivered by trained schools professionals through ten minute daily exercises from January – April 2019
2. Relaxation-based skills, emphasising deep breathing and progressive muscle relaxation techniques, delivered by trained school professionals through ten minute daily exercises from January – April 2019.
3. A mental health awareness programme, emphasising developing safety behaviours and identifying and accessing appropriate support networks, delivered by a trained school professional over eight consecutive, 45 minute weekly lessons.
4. Usual Provision (Control): Schools continue with usual practice without partaking in one of the above interventions.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Mindfulness and Relaxation Interventions:
1. Emotional difficulties will be measured using the online Short Mood and Feelings questionnaire (Angold, 1995) at baseline, 6 months and 12 months post intervention

Strategies for Safety and Wellbeing intervention:
1. Intended help seeking will be collected online and measured at baseline, 6 months, and 12 months post intervention. General Help-Seeking Questionnaire (Wilson et al., 2011)

Secondary outcome measures

Secondary measures will be measured at baseline, 6 months and 12 months post intervention

Mindfulness and Relaxation intervention:
1. Positive wellbeing will be measured using the Huebner Life Satisfaction Scale (LSS) (Huebner, 1991)
2. Behavioural problems will be measured using the Me & My Feelings questionnaire (Deighton et al., 2013)
3. Support from school staff will be measured using the Student Resilience Survey (SRS) (Sun & Stewart, 2007) - School Connection subscale
4. Quality of life will be measured using the Child Health Utility 9D quality of life measure
5. The support and services received by participants will be measured using the short client service receipt of intervention (adapted for young people)

Strategies for Safety and Wellbeing intervention:
1. Positive wellbeing will be measured using the Huebner Life Satisfaction Scale (LSS) (Huebner, 1991)
2. Emotional difficulties will be measured using the Short Mood and Feelings questionnaire (SMFQ) (Angold, 1995)
3. Behavioural problems will be measured using the Me & My Feelings questionnaire (Deighton et al., 2013)
4. Support from school staff will be measured using the Student Resilience Survey (SRS) (Sun & Stewart, 2007) - School Connection subscale
5. Mental health first aid Mental Health First Aid Intentions and Behaviours questionnaire (Hart et al., 2016)
6. Quality of life will be measured using the Child Health Utility 9D quality of life measure
7. The support and services received by participants will be measured using the short client service receipt of intervention (adapted for young people)
8. Stigma-related mental health knowledge of secondary school-age participants will be measured using the Mental Health Knowledge Schedule (MAKS) (Evans-Lacko et al., 2010)
9. Reported and intended behavioural discrimination of secondary school-age participants will be measured using the Reported and Intended Behaviour Scale (RIBS) (Evans-Lacko et al., 2011)
10. Attitudes towards mental health Attitudes Toward Mental Illness Questionnaire (Milin, et al., 2016)

Across all interventions:
1). Mental health literacy of teachers Mental Health Literacy and Capacity Survey for Educators questionnaire (Fortier et al, 2017), Teacher mental health literacy questionnaire (Jorm, 1997; Kutcher, 2015)

Overall trial start date

01/11/2017

Overall trial end date

31/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Primary schools
1. Willing to deliver an intervention to one or two year four classes, and one or two year five classes

Secondary schools:
1. Willing to deliver an intervention to three year seven classes and three year eight classes

All schools
1. Willing to be allocated to Mindfulness, Relaxation, Strategies for Safety and Wellbeing or continue with usual provision.
2. Willing to allocate ten minutes per day for young people to practice mindfullness and relaxation skills for the spring term
3. Willing to allocate eight one hours lessons to deliver the Strategies for Safety and Wellbeing programme over the spring term.
4. Within the area of either London, Birmingham and the Midlands, Bristol, Bath and Somerset, Durham and the North East orManchester
5. Able to send teachers of delivery groups to training after October half term 2018/2019
6. Sign a MOU, data sharing agreement and provide pupil lists to the research team

Pupils
1. Be in year groups 4, 5, 7 or 8
2. Parental consent and young person assent provided

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

17,600 participants over 224 schools (160 primary and 64 secondary)

Participant exclusion criteria

Schools:
1. Pupil referral units (PRU)

Recruitment start date

01/03/2018

Recruitment end date

14/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Evidence Based Practice Unit (EBPU). University College London and Anna Freud National Centre for Children and Families.
4-8 Rodney Street
London
N1 9JH
United Kingdom

Trial participating centre

Manchester Institute for Education
Ellen Wilkinson Building, Oxford Road, M13 9PL
Manchester
M13 9PL
United Kingdom

Trial participating centre

London School of Economics
Houghton St
London
WC2A 2AE
United Kingdom

Trial participating centre

University of Dundee
Nethergate
Dundee
DD1 4HN
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Office of the Vice-Provost (Research)
University College London
2 Taviton St
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

https://ethics.grad.ucl.ac.uk/index.php

Funders

Funder type

Not defined

Funder name

Department for Education

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in peer-reviewed journal.
Report to the Department for Education

IPD sharing statement: we will provide an anonymised dataset with some variables removed if they would cause an individual to be identifiable (such as a looked after child with special educational needs). This will be undertaken with advice from the Department for Education.

Intention to publish date

31/07/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes