- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02898324
KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component (KiVa-Chile)
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KiVa program full
The schools allocated in this arm will receive the Chilean adaptation of KiVa program with all its universal and indicated actions.
|
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.
|
Experimental: KiVa program w/o the digital component
The schools allocated in this arm will receive the Chilean adaptation of KiVa program without the digital component (online game)
|
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.
|
No Intervention: Control group
The schools allocated in this arm will not receive the KiVa program.
If successful, these schools will receive the program the following academic year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported victimisation
Time Frame: 12 months followup
|
Victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
|
12 months followup
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported bullying
Time Frame: 12 months followup
|
Bullying actions will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
|
12 months followup
|
Peer-reported victimisation
Time Frame: 12 months followup
|
Peer-reported victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
|
12 months followup
|
Peer-reported bullying
Time Frame: 12 months followup
|
Peer-reported bullying will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
|
12 months followup
|
Self-reported psychological difficulties
Time Frame: 12 months followup
|
The psychological difficulties will be assessed using the total subscale of difficulties of the Adolescent version of The Strengths and Difficulties Questionnaire (SDQ).
|
12 months followup
|
Self-reported psychological strengths
Time Frame: 12 months followup
|
The psychological strengths will be assessed using the total subscale of strengths (prosocial skills) of the Adolescent version of The Strengths and Difficulties Questionnaire (SDQ).
|
12 months followup
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jorge Gaete, MD, MSc, PhD, Universidad de Los Andes
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKA-EDU/15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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