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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06040437
Other study ID # 105246
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 7, 2023
Est. completion date September 15, 2024

Study information

Verified date September 2023
Source NORCE Norwegian Research Centre AS
Contact Ingrid Kvestad, Dr
Phone +4799400431
Email inkv@norceresearch.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date September 15, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Norway NORCE Norwegian Research Center Bergen
Norway Narvik municipality Narvik
Norway Bjørnafjorden municipality Os
Norway University of Tromsø Tromsø

Sponsors (4)

Lead Sponsor Collaborator
NORCE Norwegian Research Centre AS Bjørnafjorden municipality, Narvik municipality, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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". Pre- to post-intervention, 9 months
Primary 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". Pre- to post-intervention, 9 months
Secondary 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". 1 and 2 year post intervention
Secondary 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". 1 and 2 year post intervention
Secondary Change in child prosocial bystander behavior 12 item questionnaire, Alsaker 2004 Pre- to post-intervention, 9 months and 1 and 2 years post intervention
Secondary Change in Authoritative climate 10 item scale, adjusted from Ertesvåg, 2011 Pre- to post-intervention, 12 months and then 1 and 2 years following
Secondary Change in personnel self-efficacy beliefs 5 item scale, adjusted from Fischer, 2019 Pre- to post-intervention, 12 months and then 1 and 2 years following
Secondary Change in personnel understanding of bullying among children in kindergartens 8 items questionnaire Pre- to post-intervention, 12 months and then 1 and 2 years following
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