Condition category
Mental and Behavioural Disorders
Date applied
14/05/2020
Date assigned
20/05/2020
Last edited
20/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Approximately 10-15% of children and adolescents have experienced bullying victimization in their lifetime. Exposure to bullying is associated with an increased risk of mental and physical health problems. Children with disabilities are at greater risk of suffering from bullying and mental disorders. Making anti-bullying interventions web-enabled may increase their applicability to different settings and incur significantly lower costs than traditional interventions.

This project aims to evaluate the efficacy of a specific, web-enabled, school-based bullying prevention intervention in reducing bullying behavior as well as to analyze the effects of such intervention on psychological measures and quality of life in children and adolescents.

Who can participate?
Students attending publicly funded primary and secondary schools in the region of Madrid.

What does the study involve?
Twenty public schools enrolling children with special educational needs in regular classrooms are randomly allocated to one of two groups. Ten schools will receive a web-enabled, school-based preventive intervention targeting bullying behavior and promoting respect to diversity for 12 weeks. This intervention consists of an online training programme for teachers and parents, an educational programme for pupils, and a targeted intervention for victims and bullies. Materials and sessions have been adapted for children with special educational needs.

The other ten schools will not receive any specific intervention besides anti-bullying policies already available in the region of Madrid.

Before the study begins pupils will be invite to complete a web-enabled assessment about bullying behavior that they have experienced or witnessed, their mental health and wellbeing, and quality of life. This assessment will be repeated after the intervention and then again after 1 year.

What are the possible benefits and risks of participating?
It is expected that the schools and participants may benefit from identifying bullying situations through the online platform in both treatment arms and from the intervention in the intervention arm. The participants may also contribute to improving knowledge of school bullying and development of anti-bullying preventive strategies. This is a minimal risk research study testing a preventive educational programme. There are no expected risks directly derived from the intervention. Adverse events are not assessed at the individual level. If there are negative outcomes at the school level, researchers may decide to terminate the trial.

Where is the study run from?
The study is coordinated by
1. The Department of Research and Psychology in Education, Universidad Complutense (Spain)
2. The Department of Child and Adolescent Psychiatry, Hospital General Universitario Gregorio Marañón (Spain)
The trial will be conducted at publicly funded schools in the Madrid region.

When is the study starting and how long is it expected to run for?
From January 2017 to June 2020

Who is funding the study?
1. Instituto de Salud Carlos III, Spanish Ministry of Science, and Innovation (Spain)
2. The European Regional Development Fund, "A way of making Europe" (EU)

Who is the main contact?
Dr. Celso Arango López
carango@hggm.es

Trial website

Contact information

Type

Public

Primary contact

Prof Celso Arango

ORCID ID

http://orcid.org/0000-0003-3382-4754

Contact details

Institute of Psychiatry and Mental Health
Hospital General Universitario Gregorio Marañón
School of Medicine
Universidad Complutense
(Instituto de Investigación Sanitaria Gregorio Marañón) IiSGM
Center for Biomedical Research in Mental Health Network (CIBERSAM)
Madrid
28009
Spain
+34 914265006
carango@hggm.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Efficacy of a school-based preventative intervention on bullying prevalence and mental health in children and adolescents: a cluster-randomized trial

Acronym

LINKlusive

Study hypothesis

A web-enabled, school-based preventive intervention targeting bullying and promoting respect for diversity will be associated with a reduction in bullying prevalence, improved mental health and quality of life in children and adolescents receiving the intervention relative to the control group.

Ethics approval

Approved 21/01/2019, The Deontology Commission at the School of Psychology of Universidad Complutense (Campus de Somosaguas, 28223, Pozuelo de Alarcón, Madrid, Spain; lelopezb@psi.ucm.es; +34 91 394 3095), ref: 2018/19-005

Study design

Controlled, parallel, school-based cluster-randomized 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

Bullying, bullying victimization, mental health

Intervention

Twenty public schools are randomised 1:1 to either a preventive intervention or the control condition.

The intervention group receives a school-based web-enabled bullying prevention programme (LINKlusive) over approximately 12 weeks. The intervention consists of three main components: i) an online training programme for teachers and parents, ii) a web-guided educational programme for students, focusing on promoting respect for diversity, empathy, and social skill development, and iii) a web-guided, teacher-delivered, targeted intervention programme for those involved in bullying situations based on peer-support strategies.

The control group receives usual practice (including anti-bullying strategies already in place in publicly funded schools in the Madrid region) for the same period.

Participants are assessed at baseline, after the intervention (12 weeks), and one year after the intervention.

Multi-stage cluster sampling is done among publicly funded schools in Madrid. In a first stage, all schools fulfilling inclusion criteria are selected. In a second stage, these centres are randomised 1:1 to the intervention and control groups. Ten schools (5 primary schools and 5 secondary schools) are offered participation in each cluster, with a list of back-up schools in case of refusal to participate.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Peer-reported bullying victimization measured using student-provided peer nominations and ratings of their social preferences collected through a web-based platform (www.sociescuela.es) to develop social maps at baseline, 12 weeks, and one year after the intervention ends. Sociescuela is a web-based bullying assessment instrument and is composed of three subscales: i) a victimisation subscale, ii) an acceptance subscale, and iii) a subscale of perceived attributes, which helps identify different victim profiles (e.g. active vs. passive).

Secondary outcome measures

1. Self-reported bullying and victimization measured using a self-report questionnaire collected through a web-based platform (www.sociescuela.es) at baseline, 12 weeks, and one year after the intervention ends. This specifically designed questionnaire, assesses different bullying behaviours and their intensity and frequency, and is based on customary bullying definitions and previous questionnaires used in other bullying prevention programmes such as KiVA.
2. Psychological measures of general psychopathology, psychotic-like experiences, depressive symptoms, and self-esteem are measured using questionnaires collected through a web-based platform (www.sociescuela.es) at baseline, 12 weeks, and one year after the intervention ends. General psychopathology is assessed using the self-report Spanish version of the Strengths and Difficulties Questionnaire (SDQ). Internalising and externalising psychopathology are measured with the internalising and externalising subscales of the SDQ. Positive psychotic-like experiences are assessed with the Spanish version of the Community Assessment of Psychic Experiences (CAPE-P15). Depressive symptoms are assessed using nine selected items on the Major Depression Disorder subscale of the Revised Child Anxiety and Depression Scale. Self-esteem is assessed with an adapted version of the Rosenberg self-esteem scale.
3. Quality of life measured using the Spanish version of the KIDscreen-10 via a web-based platform (www.sociescuela.es) at baseline, 12 weeks, and one year after the intervention ends

Overall trial start date

01/01/2017

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primary and secondary publicly funded schools in the Madrid region where
1.1. Headteacher consent is provided
1.2. Pupils with special educational needs are enrolled in regular classrooms and/or specialized educational services for children with neurodevelopmental disorders are provided
2. Pupils enrolled in participating schools
2.1. Parental consent is given for participation
2.2. Aged 8 to 16 years (primary school grades 3 to 6 and secondary school grades 1 to 4)
3. Teachers at participating schools primary schools, teaching primary school grades 3 to 6 or secondary school grades 1 to 4 who agree to participate in the study

Participant type

All

Age group

Child

Gender

Both

Target number of participants

20 schools (10 intervention, 10 control)

Participant exclusion criteria

Private or concerted schools will not be included

Recruitment start date

01/11/2018

Recruitment end date

31/01/2019

Locations

Countries of recruitment

Spain

Trial participating centre

Universidad Complutense de Madrid
Department of Research and Psychology in Education School of Psychology Universidad Complutense de Madrid Campus de Somosaguas Ctra. de Húmera Pozuelo de Alarcón
Madrid
28223
Spain

Sponsor information

Organisation

Celso Arango

Sponsor details

Institute of Psychiatry and Mental Health
Hospital General Universitario Gregorio Marañón
School of Medicine
Universidad Complutense
(Instituto de Investigación Sanitaria Gregorio Marañón) IiSGM
Center for Biomedical Research in Mental Health Network (CIBERSAM)
Madrid
28009
Spain
+34 914265006
carango@hggm.es

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

Ministerio de Ciencia e Innovación, Instituto de Salud Carlos III

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Regional Development Fund

Alternative name(s)

Den Europæiske Fond for Regionaludvikling, Fondo Europeo de Desarrollo Regional, Fondul European de Dezvoltare Regională, Európai Regionális Fejlesztési Alap, Europos Regionines Pletros Fondas, Europejski Fundusz Rozwoju Regionalnego, Eiropas Regionālās Attīstības Fonda, Europski Fond za Regionalni Razvoj, Fonds Européen de Développement Régional, Fundo Europeu de Desenvolvimento Regional, Fondo Europeo di Sviluppo Regionale, Európsky Fond Regionálneho Rozvoja, Europees Fonds voor Regionale Ontwikkeling, Euroopa Regionaalarengu Fond, Europäische Fonds für regionale Entwicklung 3, FEDER, ERDF, EFRE

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Results and Publications

Publication and dissemination plan

Planned publication in high-impact peer-reviewed journal

IPD sharing statement:
The datasets generated during the current study will be available upon request from the principal investigator after de-identification. Individual de-identified data will be available for researchers who provide a methodologically sound research proposal, to conduct the analyses required to achieve the aims included in the approved proposal. These proposals should fulfill all the applicable ethical and legal requirements. To gain access, data requestors will need to sign a data access agreement. Proposals should be directed to carango@hggm.es. This data will become will available immediately after the main paper has been published, with no end date.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/05/2020: Trial’s existence confirmed by The Deontology Commission at the School of Psychology of Universidad Complutense.