BullyingKiVa-ChileNCT02898324
KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component
A study testing KiVa program in people with Bullying, run by Universidad de los Andes, Chile.
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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Bullying
- What is being tested?
- KiVa program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,485 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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.
Read more
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.
- Conditions
- Bullying
- Being tested
- KiVa program
- Keywords
- Bullying, KiVa program, Primary school students
- Medical subject headings
- Bullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported victimisation
Victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
Measured: 12 months followup
Secondary outcomes (5)
Self-reported bullying
Bullying actions will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
Measured: 12 months followup
Peer-reported victimisation
Peer-reported victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
Measured: 12 months followup
Peer-reported bullying
Peer-reported bullying will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
Measured: 12 months followup
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).
Measured: 12 months followup
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).
Measured: 12 months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BullyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, Pontificia Universidad Catolica de Chile, London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Jorge Gaete, Universidad de los Andes, Chile
- Investigators
- Jorge Gaete, MD, MSc, PhD, Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898324
- Sponsor's protocol ID
- AKA-EDU/15
- Acronym
- KiVa-Chile
- Status last verified
- Jan 2020
- First submitted
- 8 Sep 2016
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35739339Gaete 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.
PubMed 33912096Gaete 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.
PubMed 28219403
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component
- ClinicalTrials.gov ID
- NCT02898324
- Acronym / sponsor ID
- KiVa-Chile / AKA-EDU/15
- Conditions
- Bullying
- Keywords
- Bullying, KiVa program, Primary school students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,485 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- University of Turku, Pontificia Universidad Catolica de Chile, London School of Hygiene and Tropical Medicine
- Study start
- May 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KiVa program full | Experimental | Other: KiVa programThe schools allocated in this arm will receive the Chilean adaptation of KiVa program with all its universal and indicated actions. |
| KiVa program w/o the digital component | Experimental | Other: KiVa programThe schools allocated in this arm will receive the Chilean adaptation of KiVa program without the digital component (online game) |
| 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. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KiVa programKiVa 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. | Other | KiVa program full, KiVa program w/o the digital component |
Primary outcome
Self-reported victimisation
Time frame: 12 months followup
Victimisation will be assessed using the corresponding item from the revised Olweus Bully/Victim Questionnaire (OBVQ)
5 secondary outcomes
Self-reported bullying
Time frame: 12 months followup
Peer-reported victimisation
Time frame: 12 months followup
Peer-reported bullying
Time frame: 12 months followup
Self-reported psychological difficulties
Time frame: 12 months followup
Self-reported psychological strengths
Time frame: 12 months followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Derived from this study: PubMed 35739339Valenzuela 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.
- Derived from this study: PubMed 33912096Gaete 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.
- Derived from this study: PubMed 28219403Gaete 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Gaete, MD, MSc, PhD principal investigator
Universidad de los Andes, Chile
Questions about this trial
What is this clinical trial studying?
A study testing KiVa program in people with Bullying, run by Universidad de los Andes, Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported victimisation (time frame: 12 months followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02898324, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.