NCT06040437

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Aug 2023Jul 2026

Study Start

First participant enrolled

August 7, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

September 2, 2023

Last Update Submit

December 5, 2024

Conditions

Keywords

Early Childhood and Educational CareNorwayBullying interventionRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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.

    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

    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

    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

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

  • +5 more secondary outcomes

Study Arms (2)

Be-Prox intervention

EXPERIMENTAL

Training in the 6 Be-Prox module

Behavioral: Be-Prox

Control

NO INTERVENTION

Standard care

Interventions

Be-ProxBEHAVIORAL

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

Be-Prox intervention

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

NORCE Norwegian Research Center

Bergen, 5008, Norway

Location

Narvik municipality

Narvik, Norway

Location

Bjørnafjorden municipality

Os i Østerdalen, Norway

Location

University of Tromsø

Tromsø, Norway

Location

Related Publications (1)

  • 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.

Study Officials

  • Ingrid Kvestad, Dr

    NORCE Norwegian Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster-randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 15, 2023

Study Start

August 7, 2023

Primary Completion

July 1, 2024

Study Completion (Estimated)

July 1, 2026

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations