- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06040437
Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens. (Be-Prox)
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.
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ingrid Kvestad, dr
- Phone Number: +4799400431
- Email: inkv@norceresearch.no
Study Contact Backup
- Name: Merete Aasheim, Dr.
- Phone Number: +47 99 26 46 30
- Email: merete.aasheim@uit.no
Study Locations
-
-
-
Bergen, Norway, 5008
- Recruiting
- NORCE Norwegian Research Center
-
Contact:
- Ingrid Kvestad, dr
- Phone Number: +4799400431
- Email: inkv@norceresearch.no
-
Narvik, Norway
- Recruiting
- Narvik municipality
-
Contact:
- Gro Hoseth, MA
- Email: gro.hoseth@narvik.kommune.no
-
Os, Norway
- Recruiting
- Bjørnafjorden municipality
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Contact:
- Irene K Foer, MA
- Email: irfo@bjornafjorden.kommune.no
-
Contact:
- Lena E Sløgedal, MA
- Email: lenslo@bjornafjorden.kommune.no
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Tromsø, Norway
- Recruiting
- University of Tromsø
-
Contact:
- Merete Aasheim, Dr
- Email: merete.aasheim@uit.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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:
- children born 2021-2023
- children with no parental consent to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Standard care
|
|
Experimental: Be-Prox intervention
Training in the 6 Be-Prox module
|
Be-Prox is an intervention developed to prevent, uncover and handle negative behavior in kindergartens.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of children exposing other children to negative behavior
Time Frame: Pre- to post-intervention, 9 months
|
Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score where "exposing others" is defined as exposing others to one of the negative acts "more than once a week".
|
Pre- to post-intervention, 9 months
|
Change in number of children exposed by other children to negative behavior
Time Frame: Pre- to post-intervention, 9 months
|
Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score "being exposed" is defined as being exposing by others to one of the negative acts "more than once a week".
|
Pre- to post-intervention, 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of children exposing other children to negative behavior 1 and 2 years after the intervention
Time Frame: 1 and 2 year post intervention
|
Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score where "exposing others" is defined as exposing others to one of the negative acts "more than once a week".
|
1 and 2 year post intervention
|
Change in number of children exposed by other children to negative behavior 1 and 2 years after the intervention
Time Frame: 1 and 2 year post intervention
|
Using a scale on physical, verbal, relational and object-related negative acts, For the primary outcome, the scales will be used as a sum-score "being exposed" is defined as being exposing by others to one of the negative acts "more than once a week".
|
1 and 2 year post intervention
|
Change in child prosocial bystander behavior
Time Frame: Pre- to post-intervention, 9 months and 1 and 2 years post intervention
|
12 item questionnaire, Alsaker 2004
|
Pre- to post-intervention, 9 months and 1 and 2 years post intervention
|
Change in Authoritative climate
Time Frame: Pre- to post-intervention, 12 months and then 1 and 2 years following
|
10 item scale, adjusted from Ertesvåg, 2011
|
Pre- to post-intervention, 12 months and then 1 and 2 years following
|
Change in personnel self-efficacy beliefs
Time Frame: Pre- to post-intervention, 12 months and then 1 and 2 years following
|
5 item scale, adjusted from Fischer, 2019
|
Pre- to post-intervention, 12 months and then 1 and 2 years following
|
Change in personnel understanding of bullying among children in kindergartens
Time Frame: Pre- to post-intervention, 12 months and then 1 and 2 years following
|
8 items questionnaire
|
Pre- to post-intervention, 12 months and then 1 and 2 years following
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ingrid Kvestad, Dr, NORCE Norwegian Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 105246
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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