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

Primary Purpose

Bullying of Child

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Be-Prox
Sponsored by
NORCE Norwegian Research Centre AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bullying of Child focused on measuring Early Childhood and Educational Care, Norway, Bullying intervention, Randomized controlled trial

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NORCE Norwegian Research CenterRecruiting
  • Narvik municipalityRecruiting
  • Bjørnafjorden municipalityRecruiting
  • University of TromsøRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Be-Prox intervention

Control

Arm Description

Training in the 6 Be-Prox module

Standard care

Outcomes

Primary Outcome Measures

Change in number of children exposing other children to negative behavior
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".
Change in number of children exposed by other children to negative behavior
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".

Secondary Outcome Measures

Change in number of children exposing other children to negative behavior 1 and 2 years after the 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".
Change in number of children exposed by other children to negative behavior 1 and 2 years after the 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".
Change in child prosocial bystander behavior
12 item questionnaire, Alsaker 2004
Change in Authoritative climate
10 item scale, adjusted from Ertesvåg, 2011
Change in personnel self-efficacy beliefs
5 item scale, adjusted from Fischer, 2019
Change in personnel understanding of bullying among children in kindergartens
8 items questionnaire

Full Information

First Posted
September 2, 2023
Last Updated
September 13, 2023
Sponsor
NORCE Norwegian Research Centre AS
Collaborators
University of Tromso, Bjørnafjorden municipality, Narvik municipality
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1. Study Identification

Unique Protocol Identification Number
NCT06040437
Brief Title
Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens.
Acronym
Be-Prox
Official Title
Be-Prox. An Effectiveness Study of Bullying Intervention in Norwegian Kindergartens.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
Collaborators
University of Tromso, Bjørnafjorden municipality, Narvik municipality

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullying of Child
Keywords
Early Childhood and Educational Care, Norway, Bullying intervention, Randomized controlled trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster-randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Be-Prox intervention
Arm Type
Experimental
Arm Description
Training in the 6 Be-Prox module
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Be-Prox
Intervention Description
Be-Prox is an intervention developed to prevent, uncover and handle negative behavior in kindergartens.
Primary Outcome Measure Information:
Title
Change in number of children exposing other children to negative behavior
Description
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".
Time Frame
Pre- to post-intervention, 9 months
Title
Change in number of children exposed by other children to negative behavior
Description
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".
Time Frame
Pre- to post-intervention, 9 months
Secondary Outcome Measure Information:
Title
Change in number of children exposing other children to negative behavior 1 and 2 years after the intervention
Description
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".
Time Frame
1 and 2 year post intervention
Title
Change in number of children exposed by other children to negative behavior 1 and 2 years after the intervention
Description
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".
Time Frame
1 and 2 year post intervention
Title
Change in child prosocial bystander behavior
Description
12 item questionnaire, Alsaker 2004
Time Frame
Pre- to post-intervention, 9 months and 1 and 2 years post intervention
Title
Change in Authoritative climate
Description
10 item scale, adjusted from Ertesvåg, 2011
Time Frame
Pre- to post-intervention, 12 months and then 1 and 2 years following
Title
Change in personnel self-efficacy beliefs
Description
5 item scale, adjusted from Fischer, 2019
Time Frame
Pre- to post-intervention, 12 months and then 1 and 2 years following
Title
Change in personnel understanding of bullying among children in kindergartens
Description
8 items questionnaire
Time Frame
Pre- to post-intervention, 12 months and then 1 and 2 years following

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Kvestad, Dr
Phone
+4799400431
Email
inkv@norceresearch.no
First Name & Middle Initial & Last Name or Official Title & Degree
Merete Aasheim, Dr.
Phone
+47 99 26 46 30
Email
merete.aasheim@uit.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid Kvestad, Dr
Organizational Affiliation
NORCE Norwegian Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NORCE Norwegian Research Center
City
Bergen
ZIP/Postal Code
5008
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Kvestad, dr
Phone
+4799400431
Email
inkv@norceresearch.no
Facility Name
Narvik municipality
City
Narvik
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gro Hoseth, MA
Email
gro.hoseth@narvik.kommune.no
Facility Name
Bjørnafjorden municipality
City
Os
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene K Foer, MA
Email
irfo@bjornafjorden.kommune.no
First Name & Middle Initial & Last Name & Degree
Lena E Sløgedal, MA
Email
lenslo@bjornafjorden.kommune.no
Facility Name
University of Tromsø
City
Tromsø
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merete Aasheim, Dr
Email
merete.aasheim@uit.no

12. IPD Sharing Statement

Learn more about this trial

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

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