Clinical trial NCT02898324: KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component
Official title: KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bullying
Keywords: Bullying
KiVa program
Primary school students
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
Collaborators: name: University of Turku
name: Pontificia Universidad Catolica de Chile
name: London School of Hygiene and Tropical Medicine
First posted: 2016-09-13
Enrollment: 4485
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria for schools:

* 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.

Primary outcomes:
measure: Self-reported victimisation
timeFrame: 12 months followup
Secondary outcomes:
measure: Self-reported bullying
timeFrame: 12 months followup
measure: Peer-reported victimisation
timeFrame: 12 months followup
measure: Peer-reported bullying
timeFrame: 12 months followup
measure: Self-reported psychological difficulties
timeFrame: 12 months followup
measure: Self-reported psychological strengths
timeFrame: 12 months followup
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Los Andes
name: Jorge Gaete, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.