Condition category
Mental and Behavioural Disorders
Date applied
23/12/2019
Date assigned
11/02/2020
Last edited
12/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Bullying in childhood is one of the most tractable public mental health problems facing young people. Population studies suggest that 25-40% of mental health problems including depression, anxiety and self-harm in young adults may be attributable to childhood bullying. Young people who are bullied are more than 2.5 times more likely to use mental health services in childhood and adolescence, and almost 1.5 times more likely to experience poor mental health up to age 50. Bullying may also lead to school refusal and absenteeism which can have serious impacts on educational attainment and employment prospects. Bullying perpetration also has negative impacts and is linked to later antisocial and violent behaviour and illegal drug use. Therefore, there is an urgent need to identify and scale-up effective interventions to address bullying in schools, particularly in the early school years.

KiVa is an antibullying programme that was developed by researchers in Finland. It was shown to significantly reduce several types of bullying and victimization, and anxiety and depression in primary school pupils and is now delivered in over 90% of Finnish public schools. Two pilot trials in Wales have shown promising results and demonstrated school, teacher and pupil acceptability. We now need to investigate whether KiVa can be rolled-out on a larger scale in the UK and if the programme is effective in more socioeconomically disadvantaged schools and with socially disadvantaged children.

This study aims to determine whether KiVa is a more effective and cost-effective way of reducing bullying in pupils in years 3-6 in UK primary schools than usual practice.

Who can participate?
Schools that:
1. Are primary schools only (up to Year 6)
2. Are state funded
3. Have at least two Key Stage 2 classes
4. Are within one of the four recruitment areas (North Wales, Birmingham, Devonshire and Oxfordshire)
5. Deliver education through English or Welsh language
6. Have leadership that can support the programme over one school year
7. Have not used the KiVa programme before
8. Do not already use a recognised anti-bullying programme that extends beyond standard approaches 9. Do not cater solely for pupils with special educational needs (i.e. Special schools)

What does the study involve?
Half of participating schools will be randomly selected to deliver the KiVa antibullying programme over one school year (September 2020 to July 2021). Two staff from KiVa schools will attend two-day KiVa training and will then train other school staff in the delivery of. The KiVa programme involves three main components: 1. Core curriculum delivered through 45-minute fortnightly class lessons taught by teachers, 2. Scripted forms and processes for dealing with confirmed incidents of bullying and 3. Whole school components including assemblies and posters. Some schools will be visited by a researcher who will check to see how KiVa is going.

Half of participating schools will be randomly selected to continue to implement their usual antibullying practices over the school year.

All pupils and teachers will complete questionnaires before and after the trial. Some pupils, parents and teachers will also be invited to participate in focus groups and questionnaires towards the end of the trial.

What are the possible benefits and risks of participating?
As reimbursement for time and effort, schools who complete the trial and provide all trial data are eligible to receive a maximum of £308. Schools will receive a report showing their pre- and post-trial results. Participation in the trial may be used as evidence in Ofsted/Esytn inspections. Participation in the trial will also help us to figure out how to address school bullying - a national priority.

Most of the costs associated with delivering the KiVa programme are covered by funding arranged by the researchers. However, teacher supply cover two-day KiVa training will need to be paid by the school. There is a chance that some pupils may become distressed when completing questionnaires. The researcher will reassure them that they can stop at any time without needing to provide a reason. The pupils’ teacher will be present to comfort any child who is distressed.

Where is the study run from?
Participating schools will be recruited from North Wales, Birmingham, Devonshire and Oxfordshire (UK). The KiVa programme will be delivered in schools by school staff.

When is the study starting and how long is it expected to run for?
July 2019 to March 2022

Who is funding the study?
The study is funded by the National Institute for Health Research (UK)

Who is the main contact?
Mackenzie Fong, fongm@cardiff.ac.uk

Trial website

https://standtogethertrial.weebly.com/

Contact information

Type

Public

Primary contact

Dr Mackenzie Fong

ORCID ID

https://orcid.org/0000-0001-7237-9038

Contact details

Centre for Trials Research
4th Floor
Neuadd Meirionnydd
Heath Park Campus
Cardiff University
Cardiff
CF14 4YS
United Kingdom
+44 (0)29 20687602
fongm@cardiff.ac.uk

Type

Scientific

Additional contact

Prof Judy Hutchings

ORCID ID

Contact details

Centre of Evidence Based Early Intervention (CEBEI)
School of Psychology
Ground Floor
Nantlle Building
Normal Site
Bangor University
Gwynedd
LL57 2PZ
United Kingdom
+44 (0) 1248 383758
j.hutchings@bangor.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PHR 17/92/11

Study information

Scientific title

A multi-centre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of KiVa to reduce bullying in primary schools

Acronym

Study hypothesis

After one school year of implementation of the programme, KiVa will produce a 4% absolute reduction, or 22% relative reduction, in the proportion of pupil self-reported bullying victimization from baseline among pupils aged 7-11 years in UK primary schools than usual practice at 12 Month follow-up.

Ethics approval

Approved 20/11/2019, Bangor University school of Psychology (Brigantia Building, Bangor Univeristy, Bangor, Gwynedd, LL57 2AS; +44 124 838 2262; psychology.admin@bangor.ac.uk), ref: 2019-16592

Study design

Multi-centre Cluster Randomised-Controlled Trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

https://standtogethertrial.weebly.com/information-sheets.html

Condition

Bullying (Mental Health)

Intervention

KiVa (meaning ‘nice’ in Finnish and, ‘Ki’ and ‘Va’ beginning the Finnish words for ‘against bullying’) is an antibullying programme developed in Finland where it is has now been scaled up extensively.

Randomisation of schools will occur after all schools within area and strata have been recruited and they will be informed of their allocation after baseline data have been collected. All schools will be assigned a site ID number, after which an independent CTR statistician, will randomly allocate recruited schools to Intervention or Control using computer generated random number block allocations. The independent CTU statistician will allocate KiVa or Usual practice to ID numbers and inform the designated intervention delivery team member in each area.

In intervention schools KiVa will be delivered to KS2 pupils in intervention schools over one academic year. The core KiVa curriculum involves the delivery of class lessons (fortnightly or monthly depending on the school’s timetable) delivered by class teachers who have received KiVa training from the school KiVa coordinator. Lessons cover definition of bullying, understanding and reflecting on emotions, group interactions processes, the mechanisms and consequences of bullying, group pressure, they also describe how bullying is affected by bystander behaviours and how to reduce different types of bullying, including cyberbullying, and support fellow pupils. KiVa lessons map onto over 50% of Welsh Personal Social Education (PSE) and English Personal Social Health Education (PSHE) curriculum. Confirmed incidents of bullying are addressed by the school’s KiVa team using the KiVa scripted strategies and forms. KiVa is also implemented and visible schoolwide through whole school assemblies, KiVa vests worn by staff at break times to identify them as part of the school’s KiVa team, and KiVa posters to increase the presence of the programme at the school.

In control schools the staff will continue to implement their usual antibullying practices for the duration of the trial (the 2020/2021 academic year). Control schools will not deliver the KiVa programme during this time.

All schools will provide Month-12 follow-up data in May-June 2021.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Pupil-level self-reported rate of bullying victimisation assessed using the Olweus Bully/Victim Questionnaire (OBVQ) at baseline and 12 months.

Secondary outcome measures

1. The proportion of pupil self-reported bullying perpetration assessed using the OBVQ at baseline and 12 months
2. Cost effectiveness ratio. Cost per incidence of bullying avoided using KiVa compared to Usual Practice (UP) will involve fully costing the implementation of the KiVa programme and assessing pupil-level self-reported bullying incidence using the OBVQ at baseline and 12 months. Wider cost consequence analysis will involve fully costing the implementation of the KiVa programme and assessing child reported quality of life using the Child Health Utility 9D (CHU-9D) at baseline and 12 months, and frequency of child and/or parental contacts with the school and/or other services regarding bullying using the bespoke Client Receipt Service Inventory (CRSI) completed by parents at 12 months.
3. Teacher-reported pupil behavioural, hyperactive/inattentive, emotional, and peer problems and pro-social strengths will be assessed using the Teacher Strengths and Difficulties Questionnaire (TSDQ) at baseline and 12 months
4. Teacher self-efficacy in dealing with bullying incidents will be assessed using a modified version of the Challenging Behaviour Self-Efficacy Scale (CBSES) at baseline and 12 months
5. Teacher mental wellbeing will be assessed using the Warwick Edinburgh Mental Wellbeing Scale (WEMWS) at baseline and 12 months
6. Teacher burnout will be assessed using the Maslach Burnout Inventory - Educator Scale (MBI-ES) at baseline and 12 months
7. Subjective pupil wellbeing at school will be assessed using the How I Feel About My School (HIFAMS) questionnaire at baseline and 12 months
8. Pupil empathy will be assessed using the Empathy Toward Victim Scale at baseline and 12 months
9. Pupil self-efficacy in defending bullying will be assessed by averaging scores from three items of the Participant Role Questionnaire (PRQ) related to self-efficacy in defending bullying to give a single measure at baseline and 12 months

Overall trial start date

01/07/2019

Overall trial end date

31/07/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Key Stage 2 (KS2) pupils (aged 7-11 years)

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

12828 pupils

Participant exclusion criteria

1. Mixed primary and secondary schools
2. Schools that deliver education through a language other than English or Welsh
3. Already implement a recognised anti-bullying programme that is considered to extend beyond a standard approach
4. Any school that has already implemented KiVa
5. Schools that cater solely for pupils with special educational needs (i.e., Special schools)
6. Schools without leadership that can guarantee project participation for the year of data collection/implementation

Recruitment start date

01/12/2019

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bangor University
Bangor Gwynedd
Bangor
LL57 2DG
United Kingdom

Sponsor information

Organisation

Bangor University

Sponsor details

Bangor University
Bangor
Gwynedd
Bangor
LL57 2DG
United Kingdom
+ 44 (0) 1248 38 2211/8453
psychology@bangor.ac.uk

Sponsor type

University/education

Website

http://www.bangor.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Publication of:
1. Trial protocol
2. Baseline characteristics paper
3. Main results paper
4. Rates of bullying moderation paper
5. Association with educational attainment and school absenteeism paper

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/08/2020: The recruitment end date was changed from 30/05/2021 to 31/12/2020. 10/06/2020: The following changes were made to the trial record: 1. Due to current public health guidance, recruitment for this study has been paused. 2. The recruitment end date was changed from 31/05/2020 to 30/05/2021. 3. The overall trial end date was changed from 31/03/2022 to 31/07/2022. 4. The intention to publish date was changed from 31/03/2022 to 31/03/2023. 19/02/2020: The recruitment end date has been changed from 01/02/2020 to 31/05/2020. 02/01/2020: Trial’s existence confirmed by the Secretary of State for Health and Social Care.