ClinicalTrials.gg
Active, not recruitingNCT06040437Be-ProxUpdated Dec 9, 2024

Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens.

An interventional study of Be-Prox in Bullying of Child, sponsored by NORCE Norwegian Research Centre AS. Active, not recruiting at 4 sites in Norway. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by NORCE Norwegian Research Centre AS · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
2,500
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bullying of Child

Keywords

  • Early Childhood and Educational Care
  • Norway
  • Bullying intervention
  • Randomized controlled trial
03

In context

Lead sponsor

NORCE Norwegian Research Centre AS is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • children born 2021-2023
  • children with no parental consent to participate
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,500 participants (estimated)

Study arms

  • Experimental
    Be-Prox intervention

    Training in the 6 Be-Prox module

    Behavioral: Be-Prox

  • No intervention
    Control

    Standard care

Interventions

  • BehavioralBe-Prox

    Be-Prox is an intervention developed to prevent, uncover and handle negative behavior in kindergartens.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

  2. 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.

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

Secondary outcomes

  1. 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.

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

  2. 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.

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

  3. Child prosocial bystander behavior post intervention

    12 item questionnaire, Alsaker 2004

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

  4. Change in Authoritative climate, post intervention

    10 item scale, adjusted from Ertesvåg, 2011

    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

  5. Change in personnel self-efficacy beliefs, post intervention

    5 item scale, adjusted from Fischer, 2019

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

  6. Change in personnel understanding of bullying among children in kindergartens

    8 items questionnaire

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

  7. 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

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

  8. 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

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

  9. 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.

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

  10. 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.

    Time frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts

07

Study locations

4 sites
  • NORCE Norwegian Research Center
    Bergen, 5008, Norway
  • Narvik municipality
    Narvik, Norway
  • Bjørnafjorden municipality
    Os i Østerdalen, Norway
  • University of Tromsø
    Tromsø, Norway
08

References and documents

Publications

  • Kvestad 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 documents

  • Statistical analysis plan · Aug 15, 2024

Documents are hosted by the registry — open the source record to download them.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2023 to primary completion in Jul 2024, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2023
First posted
Sep 15, 2023
StartActual
Aug 7, 2023
Primary completionActual
Jul 1, 2024
CompletionEst.
Jul 1, 2026
Last update
Dec 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06040437
Lead sponsor
NORCE Norwegian Research Centre AS
Collaborators
University of Tromso, Bjørnafjorden municipality, Narvik municipality
Responsible party
Sponsor
First posted
Sep 15, 2023
Start date
Aug 7, 2023
Primary completion
Jul 1, 2024
Completion
Jul 1, 2026 (estimated)
Last update
Dec 9, 2024

Study contacts

Ingrid Kvestad, Dr
principal investigator · NORCE Norwegian Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion