NCT02898324

Brief Summary

Bullying is a major problem worldwide and, with no exception, in Chile. Bullying is defined as a systematic aggressive behavior against a victim who cannot defend himself or herself. Victims suffer many consequences such as social isolation, psychological maladjustment, and self-injury behavior. Additionally, bullies have a higher risk for conduct problems and substance use disorders. These problems appear to last in time, affecting mental health even years later since the experience of bullying. There are few studies in Chile aiming to determine the prevalence of bullying. In one of such studies, 47% of the students reported having been bullied during the last month before the application of the questionnaire. Even though there are many initiatives and guidelines in Chile supported by the government to help schools in order to deal with bullying, there is no any cluster randomized controlled trial (RCT) aiming to assess the effectiveness of an anti-bullying program. KiVa anti-bullying prevention program contains universal and indicated actions. Main universal actions for 5 to 6 graders consist of 10 two-hours lessons given during a year and an online game, which have the aim to raise awareness of the role of the group in bullying, increase empathy and promote strategies to support victims. Indicated actions consist of a set of discussion groups with the victims and with the bullies with proper follow-up. The aims of this study are: 1) To develop a culturally appropriate version of the Kiva material, and 2) to test its effectiveness of KiVa program with and without the online game, to reduce bullying behavior among low-income primary schools in Santiago using a cluster RCT design with three arms: i) KiVa full program group, ii) KiVa without online game program group, and iii) Control group.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,485

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

September 8, 2016

Last Update Submit

January 17, 2020

Conditions

Bullying

Keywords

BullyingKiVa programPrimary school students

Outcome Measures

Primary Outcomes (1)

  • Self-reported victimisation

    Victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)

    12 months followup

Secondary Outcomes (5)

  • Self-reported bullying

    12 months followup

  • Peer-reported victimisation

    12 months followup

  • Peer-reported bullying

    12 months followup

  • Self-reported psychological difficulties

    12 months followup

  • Self-reported psychological strengths

    12 months followup

Study Arms (3)

KiVa program full

EXPERIMENTAL

The schools allocated in this arm will receive the Chilean adaptation of KiVa program with all its universal and indicated actions.

Other: KiVa program

KiVa program w/o the digital component

EXPERIMENTAL

The schools allocated in this arm will receive the Chilean adaptation of KiVa program without the digital component (online game)

Other: KiVa program

Control group

NO INTERVENTION

The schools allocated in this arm will not receive the KiVa program. If successful, these schools will receive the program the following academic year.

Interventions

KiVa programOTHER

KiVa program is an anti-bullying intervention developed in University of Turku, Finland. It is based on the participant role model, where bullying is seen as a group process focused on the bystanders' reactions to the bullying. This program includes universal and indicated actions. Universal actions include ten students lessons given by teachers where pupils learn the role of bystanders in the bullying process, how to increase empathy towards the victim, and safe strategies to supports victims. Indicated actions are delivered by a school team of three staff members, who handle acute cases of bullying.

KiVa program fullKiVa program w/o the digital component

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Primary education
  • Co-educational
  • High vulnerability (measured by the Chilean index IVESINAE \>75%)
  • Location: Santiago, Chile.
  • Exact two classes per level (5th Grade and 6th Grade), during the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Valenzuela D, Turunen T, Gana S, Rojas-Barahona CA, Araya R, Salmivalli C, Gaete J. Effectiveness of the KiVa Antibullying Program with and without the Online Game in Chile: a Three-Arm Cluster Randomized Controlled Trial. Prev Sci. 2022 Nov;23(8):1470-1482. doi: 10.1007/s11121-022-01379-z. Epub 2022 Jun 24.

    PMID: 35739339DERIVED

  • Gaete J, Valenzuela D, Godoy MI, Rojas-Barahona CA, Salmivalli C, Araya R. Validation of the Revised Olweus Bully/Victim Questionnaire (OBVQ-R) Among Adolescents in Chile. Front Psychol. 2021 Apr 12;12:578661. doi: 10.3389/fpsyg.2021.578661. eCollection 2021.

    PMID: 33912096DERIVED

  • Gaete J, Valenzuela D, Rojas-Barahona C, Valenzuela E, Araya R, Salmivalli C. The KiVa antibullying program in primary schools in Chile, with and without the digital game component: study protocol for a randomized controlled trial. Trials. 2017 Feb 20;18(1):75. doi: 10.1186/s13063-017-1810-1.

    PMID: 28219403DERIVED

MeSH Terms

Conditions

Bullying

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Study Officials

  • Jorge Gaete, MD, MSc, PhD

    Universidad de Los Andes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

April 30, 2019

Last Updated

January 21, 2020

Record last verified: 2020-01