Plain English Summary

Background and study aims?
A recent review commissioned by the Government (Fair Society Healthy Lives, 2010) recommended that every child should be given the best start in life and that more money should be spent on programmes that promote the development and well being of all children. In particular, schools should be helped in trying to improve children’s social and emotional development, physical and mental health and well-being. Previous research has shown that well designed programmes that are delivered in the school setting can have a positive and lasting impact on these outcomes in children.
Roots of Empathy (ROE) is one such programme. This study aims to find out whether ROE improves children's helping behaviour (prosocial behaviour) and decreases their aggressive behaviour. The study will try to find out whether the programme increases children's understanding of infant crying; their ability to recognise emotions; their empathy; and their ability to control their own emotions. The study will look at whether there are also improvements in children's school performance and their general quality of life as well as whether the programme is good value for money (cost effective).

Who can participate?
70 primary schools from across Northern Ireland have agreed to take part in the evaluation. In participating schools, all children in Year 5 (aged 8-9 years), and their parents, will be invited to take part . Participants will have to give their informed consent.

What does the study involve?
Half of the 70 schools will deliver the ROE programme to their Year 5 pupils between October 2011 and June 2012 (the intervention group) and the other half will not deliver the ROE programme between October 2011 and June 2012 (the control group).
Children in Year 5 in the control group will continue with usual classroom activities and practice. All schools in Northern Ireland, as part of the statutory requirements of the Revised Curriculum, deliver Personal Development and Mutual Understanding (PDMU) which follows an issues-based approach and aims to explore pupils’ and society’s attitudes and beliefs. This evaluation will therefore look at the effect of ROE above and beyond any effects of the PDMU part of the curriculum, which is also focused on the social and emotional development of the child.
Children in Year 5 in the intervention group will receive the ROE programme, which is a 27 lessons programme that runs for one school year and is based around a monthly classroom visit by a parent and their baby. The class 'adopts' the parent and baby at the start of the school year and during these monthly visits children learn about the baby’s growth and development through interacting with the baby and watching the baby and parent together.
Each month a trained ROE instructor, who is not the class teacher, visits the classroom three times for:
• a pre-family visit;
• the visit of the parent and baby; and
• a post-family visit.
Each lesson allows children to talk and learn about the different aspects of empathy, such as: being able to name and describe different emotions; being able to take the view of another person; and being sensitive to other people's emotions.
Participating children will complete carefully chosen measures of social, emotional and behavioural development before the programme starts in October 2011 and again at the end of the programme in May 2012. Teacher and parent ratings of children’s behaviour will also be collected. We will collect the same information from children, parents and teachers every June for another three years until children are aged 12. This will allow us to see if the programme has any lasting effects.

What are the potential benefits and risks of participating?
There are no anticipated risks associated with taking part. Participants in the control group are not at any educational disadvantage as the study will be an add-on to the existing Personal Development and Mutual Understanding (PDMU) curriculum that all children in Northern Ireland receive. Expected benefits of taking part are anticipated improvements in social and emotional well being.

Where is the study run from?
The study will take place in 70 schools across Northern Ireland and will be coordinated by the lead partners in the research team who are based in Queen’s University Belfast.

When is the study starting and how long is it expected to run for?
The study started in October 2011 and will be finished in December 2015.

Who is funding the study?
The National Institute for Health Research NIHR.
The Health and Social Care Trusts and Public Health Agency in Northern Ireland are meeting the costs of delivering the ROE programme in schools.

Who is the main contact?
Dr Sarah Miller
s.j.miller@qub.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Connolly

ORCID ID

Contact details

School of Education
Queen's University Belfast
Belfast
BT7 1NN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A cluster randomised controlled trial evaluation and cost-effectiveness analysis of the Roots of Empathy (ROE) schools-based programme for improving social and emotional wellbeing outcomes among 8-9 year olds in Northern Ireland

Acronym

ROE

Study hypothesis

1. What is the impact of the programme at post-test and at one, two and three years following the end of the programme on a number of specific social and emotional wellbeing outcomes for participating children?
2. Is the programme having a differential impact on children depending on:
2.1. Their gender?
2.2. The number of siblings they have?
2.3. Their socio-economic status and/or the socio-economic profile of the school?
3. Does the impact of the programme vary significantly with any variations in implementation fidelity found?
4. What is the cost effectiveness of the programme in reducing cases of aggressive behaviour and increasing prosocial behaviour among school-aged children?

Ethics approval

School of Education Research Ethics Committee, Queen’s University Belfast, 2 September 2011

Study design

Cluster randomised controlled trial and cost effectiveness analysis

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

Condition

Social and emotional well being

Intervention

Roots of Empathy (ROE) is a 27 lesson programme that runs over a school year and is based around a monthly classroom visit by an infant and parent, typically recruited from the local community, whom the class 'adopts' at the start of the school year. During these monthly visits children learn about the baby’s growth and development via interactions and observations with the baby. Each month a trained ROE instructor, who is not the class teacher, visits the classroom three times for:
1. A pre-family visit
2. The visit of the parent and infant
3. Post-family visit

Instructors undergo a total of four days intensive training that is delivered directly by a specialist ROE trainer from Canada. The specialist trainer also provides on-going mentoring support via regular telephone calls to all instructors. In addition, on-going support is also available to each instructor through each Health and Social Care Trust’s lead ROE coordinator. Each ROE lesson provides opportunities to discuss and learn about the different dimensions of empathy, namely:
1. Emotion identification and explanation
2. Perspective-taking
3. Emotional sensitivity
The parent-infant visit serves as a springboard for discussions about understanding feelings, infant development and effective parenting practices. ROE seeks to develop children’s social and emotional understanding, promote prosocial behaviours and decrease aggressive behaviours, and increase children’s knowledge about infant development and effective parenting practices.

The control group will not receive the ROE programme between October 2011 and June 2012. Instead they will continue with usual classroom activities and practice. In this regard, all schools in Northern Ireland, as part of the statutory requirements of the Revised Curriculum, deliver Personal Development and Mutual Understanding (PDMU). The developers of the curriculum, CCEA (Council for the Curriculum, Examinations and Assessment), describe PDMU as: "Encouraging each child to become personally, emotionally, socially and physically effective to lead healthy, safe and fulfilled lives and to become confident, independent and responsible citizens, making informed and responsible choices and decisions throughout their lives". PDMU is delivered using active and participatory learning methods, follows an issues-based approach and aims to explore pupils’ and society’s attitudes and beliefs.This evaluation will therefore examine the effect of Roots of Empathy above and beyond any effects of the PDMU part of the curriculum, which is also focused on the social and emotional development of the child.

Control schools will be offered the ROE programme the following year for their 8-9 year olds. The control schools will, however, be required not to deliver the programme to children participating in the trial, who move into Years 6 and 7, to avoid their exposure to the intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Increases in prosocial behaviour and decreases in aggressive behaviour measured using the Strengths and Difficulties Questionnaire (SDQ). There are three versions of the SDQ: parent, teacher and child and all three versions will be used to triangulate the data
2. The teacher and parent versions will be administered to teachers and parents at every data collection sweep
3. The child version is only suitable for administration with children aged 11 and above and so this version will be used in the final two data sweeps (June 2014 and June 2015).
4. Additional measures:
4.1. Child Behaviour Scale
4.2. Olweus bully/victim questionnaire
4.3. Class detention rates

Secondary outcome measures

1. Increase in understanding of infant crying - Infant Facial Expression of Emotions Scale
2. Increase in ability to recognise emotions - Emotional Recognition Questionnaire
3. Increase in empathy - Interpersonal Reactivity Index
4. Increase in ability to regulate emotions - Child Anger Management Scale
5. Increased quality of life - CHU 9D
6. Increased educational attainment - InCAS standardised maths and English scores that all schools in Northern Ireland now collect

Overall trial start date

01/09/2011

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. All primary schools located in the four participating Health and Social Care Trust areas (Belfast, South Eastern, Southern and Western)
2. All children who are entering Year 5 (aged 8-9) at baseline in the participating schools

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1,260

Participant exclusion criteria

1. Special Schools
2. Schools with Year 5 (aged 8-9) classes that have less that 10 children
3. Schools already implementing the ROE programme

Recruitment start date

01/09/2011

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Education
Belfast
BT7 1NN
United Kingdom

Sponsor information

Organisation

Queen's University Belfast (UK)

Sponsor details

University Road
Belfast
BT7 1NN
United Kingdom

Sponsor type

University/education

Website

http://www.qub.ac.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) - Public Health Research Programme (UK) ref: 10/3006

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

Editorial Notes