Bullying of ChildBe-ProxNCT06040437
Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens.
A study testing Be-Prox in people with Bullying of Child, run by NORCE Norwegian Research Centre AS at 4 sites in Norway.
Trial summary
With an overall aim to ensure a safe and sound kindergarten environment for all Norwegian children in accordance with the Kindergarten Act §§41-43, the objectives of the current project are: To evaluate the effectiveness of Be-Prox Norway to prevent and handle negative behavior and bullying among peers in Norwegian… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Bullying of Child
- What is being tested?
- Be-Prox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 4 sitesNorway
- Study dates
- 7 Aug 2023to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children born 2018-2020 in kindergartens enrolled to the Be-Prox project and with parental consent to participate.
- Personnel i Norwegian kindergartens enrolled in the Be-Prox project and who consent to participate.
- Parents of children in kindergartens enrolled to the Be-prox project
Who cannot join
- children born 2021-2023
- children with no parental consent to participate
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
NORCE Norwegian Research Center
Bergen, 5008
Narvik municipality
Narvik
Bjørnafjorden municipality
Os i Østerdalen
University of Tromsø
Tromsø
About this study
With an overall aim to ensure a safe and sound kindergarten environment for all Norwegian children in accordance with the Kindergarten Act §§41-43, the objectives of the current project are:
To evaluate the effectiveness of Be-Prox Norway to prevent and handle negative behavior and bullying among peers in Norwegian kindergartens.
To examine implementation factors that promote and inhibit the effectiveness of Be-Prox Norway in Norwegian kindergartens.
To describe the cost-effectiveness of the Be-Prox Norway intervention in Norwegian kindergartens.
To generate knowledge on how the Be-Prox Norway intervention can be aligned and implemented in Norwegian kindergartens.
Read the detailed description
January 1st, 2021, new additions to the Kindergarten Act came into force in Norway introducing the right for all children to a safe and sound kindergarten environment. According to this act, Norwegian kindergartens shall systematically work to preventing bullying and social exclusion, including adopting a zero-tolerance for violations such as exclusion, bullying, violence, discrimination, and harassment. While relatively little is known about bullying at this age, a growing body of research suggests that bullying occurs also between kindergarten peers and that experiencing bullying at early age is associated with negative consequences.
Currently there are few evidence-based interventions directly targeting bullying among kindergarten peers. Be-Prox, developed for Swiss kindergartens to prevent, uncover and handle negative behavior and bullying in kindergartens have been translated and adjusted to a Norwegian context in a previous pilot study.
The current project is a close collaboration between two Norwegian municipalities, regional centres for child and youth mental health and welfare, and research and educational institutions.
The project aims to evaluate the effectiveness of the Be-Prox Norway in a cluster randomized controlled trial, including process and implementation evaluation and cost-effectiveness analyses. Hence the project complies with the current call through introducing research on tools, systems and models that promote evidence-based practices in Norwegian kindergartens in general, and to prevent negative acts and bullying between kindergarten peers in particular.
If proven effective, Be-Prox Norway can be offered to kindergartens nationwide as evidence-based practice to prevent, uncover and handle negative behavior and bullying among Norwegian kindergarten peers.
- Conditions
- Bullying of Child
- Being tested
- Be-Prox
- Keywords
- Early Childhood and Educational Care, Norway, Bullying intervention, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be-ProxBehavioural
Be-Prox is an intervention developed to prevent, uncover and handle negative behavior in kindergartens.
| Study group | Role | What they receive |
|---|---|---|
| Be-Prox intervention | Experimental | Training in the 6 Be-Prox module Receives: Behavioral: Be-Prox |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of negative acts children have been exposed to by peers the last months post intervention.
Using a set of questions on physical, verbal, relational and object-related negative acts, primary outcome will be the total number of negative acts the child has been exposed to overall. The range for the specific negative acts is 0-5, the range for negative acts overall is 0-20.
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Total number of negative acts children have exposed peers to the last month post intervention.
Using a set of questions on physical, verbal, relational and object-related negative acts, primary outcome will be the total number of negative acts the child has exposed peers to overall. The range for the specific negative acts is 0-5, the range for negative acts overall is 0-20.
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Secondary outcomes (10)
Change in number of children being exposed to negative acts overall "2-3 times a months" or more post intervention
Using a set of questions on physical, verbal, relational and object-related negative acts, the secondary outcome will be a binary outcome on 0) not been exposed to negative acts 2-3 months or more and 1) being exposed to negative acts 2-3 times a month or more.
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Change in number of children exposing other children to negative acts overall "2-3 times a month" or more.
Using a set of questions on physical, verbal, relational and object-related negative acts, the secondary outcome will be a binary outcome on 0) not been exposed to negative acts 2-3 months or more and 1) being exposed to negative acts 2-3 times a month or more.
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Child prosocial bystander behavior post intervention
12 item questionnaire, Alsaker 2004
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Change in Authoritative climate, post intervention
10 item scale, adjusted from Ertesvåg, 2011
Measured: The last month post Scorers are asked to use "the 4 weeks" as the time frame for their registration of the negative acts, 1 and 2 years after post intervention
Change in personnel self-efficacy beliefs, post intervention
5 item scale, adjusted from Fischer, 2019
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Change in personnel understanding of bullying among children in kindergartens
8 items questionnaire
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Specific negative acts the child has been exposed to the last month
Using the set of questions on specific negative acts; physical, verbal, relational and object-related
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Specific negative acts the child has exposed peers to the last month
Using the set of questions on specific negative acts; physical, verbal, relational and object-related
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Total number of negative acts children have been exposed to by peers the last
Using a set of questions on physical, verbal, relational and object-related negative acts, primary outcome will be the total number of negative acts the child has been exposed to overall. The range for the specific negative acts is 0-5, the range for negative acts overall is 0-20.
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Total number of negative acts children have exposed peers to the last month post
Using a set of questions on physical, verbal, relational and object-related negative acts, primary outcome will be the total number of negative acts the child has exposed peers to overall. The range for the specific negative acts is 0-5, the range for negative acts overall is 0-20.
Measured: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start7 Aug 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bullying of ChildStudies 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
- Model description
- Cluster-randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, Bjørnafjorden municipality, Narvik municipality
- Responsible party
- Sponsor
- Investigators
- Ingrid Kvestad, Dr, Principal investigator, NORCE Norwegian Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040437
- Sponsor's protocol ID
- 105246
- Acronym
- Be-Prox
- Status last verified
- Dec 2024
- First submitted
- 2 Sep 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jonsson J, Mabille G, Kvestad I, Martinussen M, Kyrrestad H, Aasheim M. Employees' Readiness for an Evidence-Based Bullying Prevention Intervention in Early Childhood Education and Care Centers. J Prev (2022). 2026 Oct 22. doi: 10.1007/s10935-026-00955-1. Online ahead of print.
PubMed 42911501Kvestad I, Adolfsen F, Angeles RC, Brandseth OL, Breivik K, Evertsen JG, Foer IK, Haaland M, Homola BM, Hoseth GE, Jonsson J, Kjerstad E, Kyrrestad H, Martinussen M, Moberg A, Moberg K, Skogstrand A, Solberg LR, Aasheim M. Effectiveness of a Bullying Intervention (Be-Prox) in Norwegian Early Childhood and Education Care Centers: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 24;13:e60626. doi: 10.2196/60626.
PubMed 39447170
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens.
- ClinicalTrials.gov ID
- NCT06040437
- Acronym / sponsor ID
- Be-Prox / 105246
- Conditions
- Bullying of Child
- Keywords
- Early Childhood and Educational Care, Norway, Bullying intervention, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- University of Tromso, Bjørnafjorden municipality, Narvik municipality
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 Sep 2023 (actual)
- 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.
With an overall aim to ensure a safe and sound kindergarten environment for all Norwegian children in accordance with the Kindergarten Act §§41-43, the objectives of the current project are:
To evaluate the effectiveness of Be-Prox Norway to prevent and handle negative behavior and bullying among peers in Norwegian kindergartens.
To examine implementation factors that promote and inhibit the effectiveness of Be-Prox Norway in Norwegian kindergartens.
To describe the cost-effectiveness of the Be-Prox Norway intervention in Norwegian kindergartens.
To generate knowledge on how the Be-Prox Norway intervention can be aligned and implemented in Norwegian kindergartens.
Detailed description
January 1st, 2021, new additions to the Kindergarten Act came into force in Norway introducing the right for all children to a safe and sound kindergarten environment. According to this act, Norwegian kindergartens shall systematically work to preventing bullying and social exclusion, including adopting a zero-tolerance for violations such as exclusion, bullying, violence, discrimination, and harassment. While relatively little is known about bullying at this age, a growing body of research suggests that bullying occurs also between kindergarten peers and that experiencing bullying at early age is associated with negative consequences.
Currently there are few evidence-based interventions directly targeting bullying among kindergarten peers. Be-Prox, developed for Swiss kindergartens to prevent, uncover and handle negative behavior and bullying in kindergartens have been translated and adjusted to a Norwegian context in a previous pilot study.
The current project is a close collaboration between two Norwegian municipalities, regional centres for child and youth mental health and welfare, and research and educational institutions.
The project aims to evaluate the effectiveness of the Be-Prox Norway in a cluster randomized controlled trial, including process and implementation evaluation and cost-effectiveness analyses. Hence the project complies with the current call through introducing research on tools, systems and models that promote evidence-based practices in Norwegian kindergartens in general, and to prevent negative acts and bullying between kindergarten peers in particular.
If proven effective, Be-Prox Norway can be offered to kindergartens nationwide as evidence-based practice to prevent, uncover and handle negative behavior and bullying among Norwegian kindergarten peers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Be-Prox intervention | Experimental | Behavioral: Be-ProxTraining in the 6 Be-Prox module |
| Control | No intervention | –Standard care |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children born 2018-2020 in kindergartens enrolled to the Be-Prox project and with parental consent to participate.
- Personnel i Norwegian kindergartens enrolled in the Be-Prox project and who consent to participate.
- Parents of children in kindergartens enrolled to the Be-prox project
Key exclusion criteria (2 listed)
- children born 2021-2023
- children with no parental consent to participate
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 |
|---|---|---|
| Be-ProxBe-Prox is an intervention developed to prevent, uncover and handle negative behavior in kindergartens. | Behavioural | Be-Prox intervention |
Primary outcome
Total number of negative acts children have been exposed to by peers the last months post intervention.
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Using a set of questions on physical, verbal, relational and object-related negative acts, primary outcome will be the total number of negative acts the child has been exposed to overall. The range for the specific negative acts is 0-5, the range for negative acts overall is 0-20.
Total number of negative acts children have exposed peers to the last month post intervention.
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Using a set of questions on physical, verbal, relational and object-related negative acts, primary outcome will be the total number of negative acts the child has exposed peers to overall. The range for the specific negative acts is 0-5, the range for negative acts overall is 0-20.
10 secondary outcomes
Change in number of children being exposed to negative acts overall "2-3 times a months" or more post intervention
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Change in number of children exposing other children to negative acts overall "2-3 times a month" or more.
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Child prosocial bystander behavior post intervention
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Change in Authoritative climate, post intervention
Time frame: The last month post Scorers are asked to use "the 4 weeks" as the time frame for their registration of the negative acts, 1 and 2 years after post intervention
Change in personnel self-efficacy beliefs, post intervention
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Change in personnel understanding of bullying among children in kindergartens
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Specific negative acts the child has been exposed to the last month
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Specific negative acts the child has exposed peers to the last month
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Total number of negative acts children have been exposed to by peers the last
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Total number of negative acts children have exposed peers to the last month post
Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 42911501Jonsson J, Mabille G, Kvestad I, Martinussen M, Kyrrestad H, Aasheim M. Employees' Readiness for an Evidence-Based Bullying Prevention Intervention in Early Childhood Education and Care Centers. J Prev (2022). 2026 Oct 22. doi: 10.1007/s10935-026-00955-1. Online ahead of print.
- Derived from this study: PubMed 39447170Kvestad I, Adolfsen F, Angeles RC, Brandseth OL, Breivik K, Evertsen JG, Foer IK, Haaland M, Homola BM, Hoseth GE, Jonsson J, Kjerstad E, Kyrrestad H, Martinussen M, Moberg A, Moberg K, Skogstrand A, Solberg LR, Aasheim M. Effectiveness of a Bullying Intervention (Be-Prox) in Norwegian Early Childhood and Education Care Centers: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 24;13:e60626. doi: 10.2196/60626.
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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.
Ingrid Kvestad, Dr principal investigator
NORCE Norwegian Research Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Be-Prox in people with Bullying of Child, run by NORCE Norwegian Research Centre AS at 4 sites in Norway.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Total number of negative acts children have been exposed to by peers the last months post intervention. (time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts). The study lists 2 primary outcomes in all. 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 NCT06040437, which also lists 2 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 9 Dec 2024.