Condition category
Mental and Behavioural Disorders
Date applied
17/09/2019
Date assigned
03/10/2019
Last edited
27/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Most mental health difficulties manifest in early life. One in five children worldwide experience mental health problems with 50% of mental health problems evident by the age of 14. Mental health services in the UK are currently over-stretched, individuals are having long waiting times, and certain regions lack specialist services. Specialist Child and Adolescent Mental Health Services (CAMHS) in Wales are under more pressure than ever before, as over the past four years these services have observed a 100% increase in demand. Early detection of a mental health disorder, coupled with early intervention, has led to better health outcomes and more positive attitudes to mental illness and the need for help-seeking behaviours.
Mental health literacy originates from the domain of health literacy which aims to improve patient knowledge on physical health and treatments in order to promote and improve physical health. Just like health literacy, mental health literacy is defined as the knowledge and beliefs about mental disorders which aid their detection, recognition, management, or prevention. This definition of mental health literacy incorporates current theories such as stigma theory, which postulates that a lack of knowledge about mental health is a driver of prejudice (negative attitudes) which, in turn, influences behaviour (discrimination). As a result, it is crucial to improve the knowledge of children and adolescents about mental health as currently research in the UK has addressed significant low levels of mental health literacy in secondary schools. Improvements in mental health literacy have led to increased resilience and control over the young person’s own mental health and increased self-helping efficacy.
Action for Children (AfC) has received funds from the Welsh Government to deliver an evidence-based mental health literacy programme (The Guide Cymru) to school children in Year 9 throughout Wales. The Guide Cymru is an evidence-based intervention and resource aimed at improving knowledge and attitudes towards mental health in adolescent populations. All secondary schools across Wales are invited to take part in this intervention. This study will evaluate the effectiveness of the intervention across a whole population. The researchers think that children who receive the Guide Cymru will show: (1) greater knowledge of mental health, (2) less stigma towards those with mental illness, (3) a greater intention to seek help if they experience or develop a mental health problem, (4) better mental health-related behaviours, and (5) better current mental health.

Who can participate?
All state secondary schools in Wales are invited to take part in the intervention. Three designated members of staff per school will receive the Guide Cymru teacher-training and these teachers will then deliver the Guide curriculum to all Year 9 pupils.

What does the study involve?
All state secondary schools will be invited to take part. Once schools agree to participate in the intervention, all schools will be randomly allocated into either the immediate training (active group) on the Guide Cymru or delayed training (control group) who will receive the Guide Cymru about 12 weeks later. The evaluation will consist of three sessions where measures of mental health literacy are taken from both the Year 9 pupils and the teachers who have been trained in the Go-To intervention and who are delivering the Guide Cymru within their respective schools. For the Active group, the measures will be taken one week before teachers receive the Go-To teacher-training, one week following the delivery of the Guide Cymru to Year 9 pupils (the teachers have 10 weeks in which to deliver the Guide Cymru to the pupils), and a follow-up evaluation 12 weeks later to assess for sustainability of any changes in mental health knowledge and reduced stigma. For the control group, measures will be taken at exactly the same times and in the same manner as for the active group (and this will equate to about 12 weeks before the control group teachers receive the Go-To teacher-training, one week before the training, and one week after the delivery of the Guide Cymru to Year 9 pupils).

What are the possible benefits and risks of participating?
In taking part in this intervention, the researchers think that children who receive the Guide Cymru will show: (1) greater knowledge of mental health issues, (2) less stigma towards those with mental illness, (3) a greater intention to seek help if they experience or develop a mental health problem in the future, (4) better mental health-related behaviours, and (5) better current mental health. The researchers do not foresee any risks involved in participating.

Where is the study run from?
Swansea University (UK)

When is the study starting and how long is it expected to run for?
September 2019 to July 2021

Who is funding the study?
The Welsh Government is funding Action for Children for service delivery of the Go-To Training to teachers in all state secondary schools in Wales. A Knowledge Economy Skills Scholarship grant (KESS) is funding a PhD studentship, which will focus on the evaluation of the Guide Cymru via a Randomised Control Trial (RCT).

Who is the main contact?
Prof. Nicola Gray
Nicola.s.gray@swansea.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Prof Nicola Gray

ORCID ID

Contact details

Swansea University
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 602006
Nicola.S.Gray@swansea.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

The Guide Cymru: a randomised control trial

Acronym

GUIDE Cymru

Study hypothesis

Children who receive the Guide will show:
1. Greater knowledge of mental health issues
2. Less stigma towards those with mental illness
3. A greater intention to seek help if they have a mental health problem
4. Better mental health-related behaviours
5. Better current mental health

Ethics approval

Approved 28/10/2018, Department of Psychology Ethics Committee, Swansea University (Vivian Tower, Swansea, SA2 8PP, UK; Email: G.Jiga@swansea.ac.uk), ref: 2018-0272-259

Study design

Cluster randomised control 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 a participant information sheet

Condition

Mental health and well-being

Intervention

All state schools in Wales will be sent a letter to their Headteacher offering free training for up to 3 teachers on the mental health literacy intervention: The Guide Cymru. This is an evidence-based intervention and resource that can be used as part of the PSHE (Personal, Social and Health Education) or as part of the Health and Well-being area of Learning and Experience, within each school (Milin et al. 2016). The Guide Cymru involves mental health literacy training for teachers and six curriculum-based modules for pupils. Schools that sign-up for the intervention will be chosen in clusters of approximately 20 schools and, of these, 10 schools will be randomised into the intervention or into delayed training (a wait-list control), who will receive The Guide Cymru approximately 12 weeks later. Clusters will be dependent on geographical location.

Teachers are invited to a two-day training on the Guide Cymru known as the Go-To training, following which schools will have 8-10 weeks to then deliver the Guide curriculum to Year 9 pupils.

The evaluation will consist of three sessions where measures of mental health literacy are taken from both the Year 9 pupils and the teachers involved in delivering The Guide Cymru. Measures will be taken before the teachers receive their training, following delivery of The Guide to pupils, and a 12-week follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Knowledge and Attitudes to Mental Health (KAMH, Snowden, Simkiss and Gray, unpublished). The KAMH measure is a questionnaire designed for children aged 11-16 years. The KAMH instrument consists of 7 domains: (1) Mental health knowledge, (2) Mental health stigma, (3) Help-seeking behaviour, (4) Good mental health behaviour, (5) Social desirability, (6) Self-stigma and (7) Avoidant coping. Participants respond to statements on a five-point Likert scale (Strongly agree, agree, don’t know, disagree, strongly disagree) with higher numbers indicating higher knowledge, lack of stigma, social desirability, help-seeking behaviour, good mental health behaviour, a lack of self-stigma and a lack of avoidant coping. The KAMH will be completed by both Year 9 pupils and teachers involved in delivering The Guide Cymru 1 week prior to teachers receiving the training, following delivery of The Guide Cymru to pupils and at a 12-week follow-up.

Secondary outcome measures

1. PedsQL: (Varni et al. 1998) The Pediatric Quality of life inventory (PedsQL) 4.0 Generic Core Scales is a health-related quality of life measure that has demonstrated good reliability and construct validity in various populations (Desai et al. 2014). The PedsQL 4.0 Generic Core Scales instrument consists of the following 4 domains: (1) Physical Functioning, (2) Emotional Functioning, (3) Social Functioning, and (4) School Functioning. It includes a format for typically developing children aged 5 to 18 years old. Participants rate each description regarding their heath over the past month. The PedsQL will be completed by both Year 9 pupils and teachers involved in delivering The Guide Cymru 1 week prior to teachers receiving the training, following delivery of The Guide Cymru to pupils and at a 12-week follow-up.
2. Strengths and Difficulties Questionnaire: (Goodman, 2001). The Strengths and Difficulties Questionnaire (SDQ) is a one-page questionnaire for assessing the psychological adjustment of children and youths. The SDQ asks the person to rate 25 attributes, both positive and negative, using a 3-point Likert scale to indicate how far each attribute applies to the individual. The 25 items are divided between five scales of five items each, generating scores for emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behaviour. Emotional, conduct, hyperactivity- inattention and peer problems are summed to generate a total difficulties score, while the prosocial behaviour scale generates a strengths score. Participants rate each question on the basis of how they have been over the past six months. The SDQ will be completed by both Year 9 pupils and teachers involved in delivering The Guide Cymru 1 week prior to teachers receiving the training, following delivery of The Guide Cymru to pupils and at a 12-week follow-up.

Overall trial start date

05/09/2019

Overall trial end date

01/10/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Child aged 13-14, in Year 9 of secondary school, attending a state school in Wales
2. Three designated teachers for each secondary school participating in the trial, who will attend the Go-To training and then deliver the Guide curriculum modules to Year 9 pupils attending their school

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

The researchers will approach all state secondary schools in Wales, representing approximately 30,000 students. This consists of 205 schools with approximately 150 students per school. They hope for a take-up rate of approximately two thirds resulting in inclusion of approximately 150 schools.

Participant exclusion criteria

Schools:
1. Not to be able to deliver the Guide Cymru intervention following the Go-To Training
2. Not be able to send three designated teachers to the Go-To Training
3. Schools outside of Wales
4. Be a primary school, a special school (for young people with Learning Disability or Behavioural difficulties), or an independent sector school

Pupils:
1. Not in Year 9

Teachers:
1. A teacher not attending the Go-To training
2. A teacher unable to deliver the Guide-curriculum to Year 9 pupils (due to work-load, ill-health, etc)

Recruitment start date

01/10/2018

Recruitment end date

01/10/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Swansea University
Swansea University
Swansea
SA2 8PP
United Kingdom

Sponsor information

Organisation

Swansea University

Sponsor details

Swansea University
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 513100
researchintegrity@swansea.ac.uk

Sponsor type

University/education

Website

https://www.swansea.ac.uk/

Funders

Funder type

Government

Funder name

Knowledge, Economy Skills Scholarship and Welsh Government

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. A protocol will become available at a later date.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a publically available repository such as Mendeley. The data shared will be an anonymised SPSS database that contains the item by item scores from the questionnaires as well as the scale scores and demographic information. The data will be published at the time of submission of the paper describing the results of the RCT and will remain indefinitely. Access will be open to anyone via the usual access to Mendeley.

Intention to publish date

01/10/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/09/2019: Trial's existence confirmed by ethics committee.