Condition category
Mental and Behavioural Disorders
Date applied
30/08/2018
Date assigned
05/09/2018
Last edited
06/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study 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. Recent programmes aimed at either improving mental health literacy, or raising awareness of and promotion of mental health, have been trialled abroad, but their effects are currently unknown in the UK population. 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 two programmes, YAM and the Guide, on mental health and wellbeing outcomes in schools.

Who can participate?
Secondary schools in one of five hubs: 1) London, 2) Manchester, 3) Durham and the North East, 4) Bath, Bristol and Somerset, 5) Birmingham and the Midlands. Schools will need to deliver interventions to at least 60 year nine students across three delivery groups.

What does this study involve?
This study involves pupils being randomly allocated to one of two interventions (YAM or the Guide) or continuing with usual provision. Youth Aware of Mental Health (YAM) is a universal, evidence-based and culturally sensitive intervention programme aimed at young people aged 14-17 with a focus on increasing awareness about mental health. Through group-based interactive lectures, dialogue and role-play, YAM seeks to enhance young people’s knowledge on mental health issues such as depression, suicidal thoughts, and stress, while providing them with important skills on how to seek help and advice, and help others. YAM consists of five sessions and it is designed to be implemented in the classroom by YAM instructors who have been trained in its application. The Mental Health and High School Curriculum Guide (The Guide) aims at enhancing the mental health literacy of students. Through classroom-ready lesson plans and activities, within a supportive, familiar environment, The Guide enhances pupils' knowledge on mental health and illness. It also helps them understand how to optimize and maintain good mental health, combat stigma, and enhances help-seeking efficacy in order to help themselves and/or others. The Guide is delivered during school hours by teachers who have been trained in its application (1-day training). It consists of six modules that are taught as in consecutive weeks and are each designed to fit into around 60 minutes of classroom time. The usual provision schools continue with their usual practice without being allocated to one of the two interventions mentioned above.

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

Where is the study run from?
This study is being run by the Evidence Based Practice Unit, University of Manchester, the University of Dundee, and London School of Economics (UK)

When is the study starting and how long is it expected to run for?
September 2017 to July 2021

Who is funding the study?
Department for Education (UK)

Who is the main contact?
1. Dr Jessica Deighton
2. 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/aware/

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
+44 (0)2074432220
daniel.hayes@annafreud.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EOR/SBU/2017/015

Study information

Scientific title

Approaches for Wellbeing and Mental Health literAcy: Research in Education (AWARE)

Acronym

AWARE

Study hypothesis

Aims:
1. To examine whether YAM is more effective than the usual school-based provision in reducing emotional difficulties in young people
2. To examine whether The Guide is more effective than the usual school-based provision in increasing help seeking of young people around mental health

Hypothesis:
H1: Young people receiving YAM will report a greater reduction in emotional difficulties from baseline to 6 and 12 months follow up than those who receive the usual school curriculum
H2: Young people receiving The Guide will report a greater increase in help seeking from baseline to 6 and 12 months follow up relative to those who receive the usual school curriculum

Ethics approval

University College London ethics committee, 20/02/2018, ref: 6735/009

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

This study involves pupils being allocated to one of two interventions (YAM or the Guide) or continuing with usual provision. The method of randomisation is minimisation.

1. Youth Aware of Mental Health (YAM): a universal, evidence-based and culturally sensitive intervention programme aimed at young people aged 14-17 with a focus on increasing awareness about mental health. Through group-based interactive lectures, dialogue and role-play, YAM seeks to enhance young people’s knowledge on mental health issues such as depression, suicidal thoughts, and stress, while providing them with important skills on how to seek help and advice, and help others. YAM consists of five sessions and it is designed to be implemented in the classroom by YAM instructors who have been trained in its application.

2. The Mental Health and High School Curriculum Guide (The Guide), aims at enhancing the mental health literacy of students. Through classroom-ready lesson plans and activities, within a supportive, familiar environment, The Guide enhances pupils' knowledge on mental health and illness. It also helps them to understand how to optimize and maintain good mental health, combat stigma, and enhance help-seeking efficacy in order to help themselves and/or others. The Guide is delivered during school hours by teachers who have been trained in its application (1-day training). It consists of six modules that are taught as a block and are designed to each fit into 60 minutes of classroom time

3. Usual Provision (Control)
Schools will continue with usual practice without partaking in one of the above interventions.

Interventions will be for 5 weeks (YAM) and 6 weeks (the Guide). Follow up will happen approximately 6 and 12 months after interventions start.

The statistician undertaking analysis will be blind to the study conditions.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

For YAM: Emotional difficulties on the Short Mood and Feelings questionnaire (SMFQ) (Angold, 1995) collected online and measured at baseline, 6 months and 12 months post intervention

For The Guide: Help seeking (Wilson et al., 2011) collected online and measured at baseline, 6 months, and 12 months post intervention

Secondary outcome measures

All measures will be collected online and measured at baseline, 6 months and 12 months post intervention:

Pupils:
1. Positive wellbeing (Hueber, 1991)
2. Behavioural problems (Deighton, 2013)
3. Support from School Staff (Sun and Stewart, 2007)
4. Attitudes Toward Mental Illness Questionnaire (Milin et al. 2016)
5. Pediatric Quality of Life (Stevens, 2009)
6. Service Use (Client Service Receipt Inventory)
7. Knowledge based stigma (Evans-Lacko et al., 2011)
8. Sigma related behaviour (Evans-Lacko et al., 2011)
9. Mental health first aid (Hart et al, 2015)
10. The Guide questions*
11. Emotional difficulties* : Short Mood and Feelings questionnaire (SMFQ)) (Angold, 1995)
12. Intended help seeking^ : General Help-Seeking Questionnaire (Wilson et al., 2011)

Teachers:
1. Mental health literacy (Fortier et al., 2017)
2. Mental health literacy (Jorm 1997)
3. Mental health literacy (Kutcher et al., 2015)
4. The Guide questions*

*For the Guide only
^ For YAM only

Overall trial start date

01/09/2017

Overall trial end date

31/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Schools:
1. Be willing to deliver/have an intervention delivered to around 60 year 9 pupils in three delivery classes
2. Are able to allocate one hour per week to deliver in the intervention for six weeks in the spring term of 2018 or 2019
3. Fall under one of the five hubs: 1) London, 2) Birmingham and the Midlands, 3) Bristol, Bath and Somerset, 4) Durham and the North East, 5) Manchester
4. For The Guide only, be able to send teachers of delivery groups to training after October half term 2018/2019
5. Sign a Memorandum of Understanding, data sharing agreement and provide pupil lists to the research team

Pupils:
1. Be in Year 9
2. Parental consent and young person assent

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

8,640 participants over 144 secondary schools

Participant exclusion criteria

Schools:
1. Not able to deliver/have an intervention delivered to around 60 year 9 pupils in three delivery classes
2. Unable to allocate one hour per week to deliver in the intervention for six weeks in the spring term of 2018 or 2019
3. Fall outside one of the five hubs: 1) London, 2) Birmingham and the Midlands, 3) Bristol, Bath and Somerset, 4) Durham and the North East, 5) Manchester
4. For the Guide only, unable to send teachers of delivery groups to training after October half term 2018/2019
5. Unable to sign a MOU, data sharing agreement or provide pupil lists to the research team
6. Be a primary school or alternative provision (e.g. pupil referral unit)

Pupils:
1. Not in Year 9
2. Parental consent and young person assent not provided

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
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

Government

Funder name

Department for Education

Alternative name(s)

DfE

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

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

IPD sharing statement
The trialists 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

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes