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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02898324
Other study ID # AKA-EDU/15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date April 30, 2019

Study information

Verified date January 2020
Source Universidad de los Andes, Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 4485
Est. completion date April 30, 2019
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
KiVa program
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.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Universidad de los Andes, Chile London School of Hygiene and Tropical Medicine, Pontificia Universidad Catolica de Chile, University of Turku

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported victimisation Victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ) 12 months followup
Secondary Self-reported bullying Bullying actions will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ) 12 months followup
Secondary Peer-reported victimisation Peer-reported victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ) 12 months followup
Secondary Peer-reported bullying Peer-reported bullying will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ) 12 months followup
Secondary Self-reported psychological difficulties 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
Secondary Self-reported psychological strengths 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
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