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KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component (KiVa-Chile)

Primary Purpose

Bullying

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
KiVa program
Sponsored by
Universidad de los Andes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bullying focused on measuring Bullying, KiVa program, Primary school students

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    KiVa program full

    KiVa program w/o the digital component

    Control group

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Self-reported bullying
    Bullying actions will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
    Peer-reported victimisation
    Peer-reported victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
    Peer-reported bullying
    Peer-reported bullying will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
    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).
    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).

    Full Information

    First Posted
    September 8, 2016
    Last Updated
    January 17, 2020
    Sponsor
    Universidad de los Andes, Chile
    Collaborators
    University of Turku, Pontificia Universidad Catolica de Chile, London School of Hygiene and Tropical Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02898324
    Brief Title
    KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component
    Acronym
    KiVa-Chile
    Official Title
    KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    April 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de los Andes, Chile
    Collaborators
    University of Turku, Pontificia Universidad Catolica de Chile, London School of Hygiene and Tropical Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bullying
    Keywords
    Bullying, KiVa program, Primary school students

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4485 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    KiVa program full
    Arm Type
    Experimental
    Arm Description
    The schools allocated in this arm will receive the Chilean adaptation of KiVa program with all its universal and indicated actions.
    Arm Title
    KiVa program w/o the digital component
    Arm Type
    Experimental
    Arm Description
    The schools allocated in this arm will receive the Chilean adaptation of KiVa program without the digital component (online game)
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    The schools allocated in this arm will not receive the KiVa program. If successful, these schools will receive the program the following academic year.
    Intervention Type
    Other
    Intervention Name(s)
    KiVa program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Self-reported victimisation
    Description
    Victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
    Time Frame
    12 months followup
    Secondary Outcome Measure Information:
    Title
    Self-reported bullying
    Description
    Bullying actions will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
    Time Frame
    12 months followup
    Title
    Peer-reported victimisation
    Description
    Peer-reported victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
    Time Frame
    12 months followup
    Title
    Peer-reported bullying
    Description
    Peer-reported bullying will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
    Time Frame
    12 months followup
    Title
    Self-reported psychological difficulties
    Description
    The psychological difficulties will be assessed using the total subscale of difficulties of the Adolescent version of The Strengths and Difficulties Questionnaire (SDQ).
    Time Frame
    12 months followup
    Title
    Self-reported psychological strengths
    Description
    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).
    Time Frame
    12 months followup

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jorge Gaete, MD, MSc, PhD
    Organizational Affiliation
    Universidad de Los Andes
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35739339
    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.
    Results Reference
    derived
    PubMed Identifier
    33912096
    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.
    Results Reference
    derived
    PubMed Identifier
    28219403
    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.
    Results Reference
    derived

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    KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component

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