Condition category
Mental and Behavioural Disorders
Date applied
19/02/2013
Date assigned
05/04/2013
Last edited
05/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The term ‘social and emotional wellbeing’ is used to describe having the resilience and self-awareness needed to manage your own feelings, have empathy and build good relationships with others, and feel confident, positive and able to cope with challenges in life.
We have developed a programme (SEED – Social and Emotional Education and Development) designed to promote social and emotional wellbeing in primary school children and in order to determine how well this will work we are conducting a study in Scottish primary schools to assess it.

Who can participate?
The study will involve 36 primary schools across 3 local authorities.

What does the study involve?
Half of these schools will be randomly selected to take part in the SEED programme and half will not. We will compare these two groups over the course of 5 years to determine if the SEED programme has any impact on the social and emotional wellbeing of children. We will look specifically at two groups of children (those in P1 at the start of the study and those in P5) and using questionnaires completed by parents, teachers and pupils themselves we will look at differences in responses to questions over time and between schools receiving the SEED programme and those that are not.
Pupils and parents of pupils in the schools receiving the SEED programme are unlikely to notice any change to the curriculum itself.
The process of the SEED programme involves giving feedback to the school about any issues or specific needs of the school that are highlighted in the completed questionnaires and supporting them in developing plans to address these needs. At the end of the study, schools who did not receive the SEED programme initially will be given delayed feedback of their completed questionnaires and support in developing plans to address their school’s needs.

What are the possible benefits and risks of participating?
All schools taking part in the study (not just those receiving the SEED programme) will be given £1000 to thank them for their time. All schools will be given feedback (half immediately and half after the end of the study) from their questionnaires and will be given support to be able to use this to put in place plans to address any issues or needs that are highlighted. If the study shows that the SEED programme is of benefit to pupils then the approach may be used across Scotland, and elsewhere, to improve social and emotional wellbeing of young people. It is hoped that improving social and emotional wellbeing of young people will have further reaching implications for society as a whole in the future.
In terms of participating in the research associated with the trial there is very little risk to the participants as it simply involves completing repeat questionnaires in their classroom settings by trained and disclosed researchers. The questions being asked are well established and not known to lead to problems for participants. Pupil focus group discussions and parent meetings on the topic of emotional wellbeing may touch on areas of a sensitive nature which could result in unintended negative consequences for participating children and parents. The child survey will include information about where children can go for support including the contact details of ChildLine and the lead researcher, and prior to visiting schools we will identify a contact within each school who may be approached by pupils who, prompted by the study, require further support. The researchers will also remain alert to any discomfort, taking appropriate steps to change the direction of discussion and avoid concentration on individuals’ personal experiences. Thus, participating in the research may lead to pupils receiving support when they may otherwise not have been identified as having such need. Furthermore, all schools will receive aggregated feedback and this is intended to help focus their actions in a way that responds to their pupils’ needs, for the control schools this feedback is simply delayed.

Where is the study run from?
The study is being carried out by a team of experienced researchers based at the Medical Research Council’s Social and Public Health Sciences Unit, Glasgow and in conjunction with researchers at the Universities of Aberdeen, Brisbane, Edinburgh Napier, Glasgow, St Andrews and Stirling.

When is the study starting and how long is it expected to run for?
Study is due to run from November 2012 for 5 years.

Who is funding the study?
National Institute for Health Research (NIHR)

Who is the main contact?
For further information about the study please contact Dr Marion Henderson, Sarah Tweedie or Susie Smillie on seed@sphsu.mrc.ac.uk

Trial website

http://www.sphsu.mrc.ac.uk/research-programmes/sh/shvg/seedtr.html

Contact information

Type

Scientific

Primary contact

Dr Marion Henderson

ORCID ID

Contact details

MRC Social and Public Health Sciences Unit
4 Lilybank Gardens
Glasgow
G12 8RZ
United Kingdom
+44 (0)141 357 7526
m.henderson@sphsu.mrc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10/3006/13 - Funded by UK's National Institute for Health Research Public Health Research

Study information

Scientific title

Social and Emotional Education and Development (SEED): a stratified, cluster randomised trial of a multi-component primary school intervention that follows the pupils’ transition into secondary school

Acronym

SEED

Study hypothesis

We propose that the SEED programme will be effective in improving the social and emotional wellbeing of young people because it will enable schools to focus their social and emotional curricular materials and whole school practices according to their pupils needs. In addition, the teacher training will support a positive classroom and school level ethos. There will be the opportunity for schools to engage the pupils’ parents, which would further support a consistent approach between home and school.

Ethics approval

The University of Glasgow's Medicine Veterinary and Life Sciences (MVLS) College Ethics Committee approved the SEED Trial project on 27th November 2012, ref: 2012087

Study design

Stratified cluster randomised trial. In addition, we will conduct a process and health economics evaluation.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

SEED Trial
MRC SPHSU
4 Lilybank Gardens
Glasgow
G12 8RZ
Scotland
UK
Phone: +44 141 357 7526
SEED@sphsu.mrc.ac.uk

Condition

Social and emotional wellbeing

Intervention

Experimental Intervention
The core of our intervention is to provide an evidence-based process by which schools can meet their obligations under the Curriculum for Excellence to develop pupils’ social and emotional wellbeing. Curriculum for Excellence is the Scottish Government’s framework guidance for education which aims to achieve a transformation in education in Scotland by providing a more coherent, more flexible and enriched curriculum from 3 to 18 years.

We are proposing a multi-level intervention with the primary outcome of improved students’ wellbeing, as assessed by the Strengths and Difficulties Questionnaire (SDQ). The intervention involves a student needs assessment using the SDQ and a school needs assessment exercise on school practice (completed by teachers). Guided by an educational psychologist and the needs assessments, schools will choose from a menu of actions (or develop bespoke actions) to address these needs at each of the following levels:
1. Whole school actions to promote and support students’ social and emotional development. For example if the SDQ shows that pupils have high levels of conduct problems, then school staff may implement restorative (justice) practices or solution oriented approaches, which aim to change school culture and more targeted approaches to address more serious negative behaviour.
2. Teacher/classroom actions that promote social and emotional development and engagement with learning. For example if the SDQ shows that pupils have high levels of hyperactivity/inattention, then teachers may implement clear and consistent classroom rules and expectations, create shorter work periods, create more opportunities for individual instruction, adjust the curriculum to maintain pupils’ interest, use interactive learning and positive reinforcement.
3. Social and Emotional Learning (SEL) curriculum for students – identifying the components that they need to work on. For example if SDQ detects high levels of emotional symptoms, then teachers may implement Creating Confident Kids. These actions will be incorporated into the school’s annual Improvement Plans which are required by the Scottish Government to be developed by all schools during June.

Comparator intervention
The comparison schools will adhere to the normal Scottish curriculum, which is the recently launched Curriculum for Excellence

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Social and emotional wellbeing at baseline and at follow-up will be measured using the widely used, validated, reliable and sensitive to change Strengths and Difficulties Questionnaire (SDQ).
2. Primary outcome measure for pupils is the Total Difficulties Score of the Strengths and Difficulties Questionnaire (SDQ).
3. The older cohort pupils will self-complete SDQ as part of a broader self-complete questionnaire at baseline (P5) and again at follow up in P7 and in secondary school years 1 and 2. Since the SDQ has not previously been validated for use with this age group (8/9 years) teachers of the older cohort will also complete SDQ for them at baseline (P5), as will parents/carers of these pupils as part of a broader questionnaire. Parents/carers of these pupils will complete the SDQ again as part of a broader questionnaire at one subsequent follow up when pupils are in P7.
4. The younger cohort pupils will have SDQ completed for them by their teachers at baseline (P1) and at the three subsequent follow ups in P3, P4 and P5. In addition they will self-complete the SDQ at final follow up in P5, and their parents/carers will be asked to complete SDQ about their child as part of a broader questionnaire at baseline (P1), and at one subsequent follow up when pupils are in P5.

Secondary outcome measures

We will evaluate the five SDQ subscales (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behaviour); primary pupils’ self respect; ability to manage their feelings and behaviour; resilience; respect and empathy for others; relationships with others, attitudes to school, academic performance and school attendance.

For the older cohort we will assess intervention impact on health-related behaviours (e.g. smoking, drinking and fighting) at S2. In addition, we will explore changes in staff and parents’ knowledge, attitudes and behaviour relating to children’s social and emotional wellbeing, the intervention, their own mental health and wellbeing and to nurturing confident children. There will be a cost utility evaluation which will be based on a Quality-Adjusted Life Year suited to young children.

Overall trial start date

01/11/2012

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Schools:
Mainstream, state-run, Primary schools within Falkirk, South Lanarkshire and Dundee District Councils

Individual participants:
1. Pupil within P1 (aged 4/5) or P5 (aged 8/9) class (in academic year 2012/13) within selected schools
2. Parents of the study pupils
3. Staff member (including support staff) of selected schools

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

36 Primary schools 200 Primary School staff 1368 P1 pupils (average 38 per year across 36 schools) 1368 P5 pupils (average 38 per year across 36 schools). Parents of study pupils.

Participant exclusion criteria

Participants who are unable to comprehend spoken English

Recruitment start date

01/11/2012

Recruitment end date

30/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Social and Public Health Sciences Unit
Glasgow
G12 8RZ
United Kingdom

Sponsor information

Organisation

Medical Research Council Social and Public Health Sciences Unit (UK)

Sponsor details

c/o Prof Dame Sally Macintyre
4 Lilybank Gardens
Glasgow
G12 8RZ
United Kingdom
+44 (0)141 357 3949
s.macintyre@sphsu.mrc.ac.uk

Sponsor type

Research council

Website

http://www.sphsu.mrc.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Public Health Research (NIHR PHR) programme ref:10/3006/13

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes