- 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
Status
Conditions
Intervention / Treatment
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 Locations
-
-
-
Bergen, Norway, 5008
- NORCE Norwegian Research Center
-
Narvik, Norway
- Narvik municipality
-
Os, Norway
- Bjørnafjorden municipality
-
Tromsø, Norway
- University of Tromsø
-
-
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 |
|---|---|---|
|
Total number of negative acts children have been exposed to by peers the last months post intervention.
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
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.
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in number of children being exposed to negative acts overall "2-3 times a months" or more post intervention
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
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.
|
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.
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
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.
|
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
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
12 item questionnaire, Alsaker 2004
|
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
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
|
10 item scale, adjusted from Ertesvåg, 2011
|
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
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
5 item scale, adjusted from Fischer, 2019
|
Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
|
Change in personnel understanding of bullying among children in kindergartens
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
8 items questionnaire
|
Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
|
Specific negative acts the child has been exposed to the last month
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
Using the set of questions on specific negative acts; physical, verbal, relational and object-related
|
Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
|
Specific negative acts the child has exposed peers to the last month
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
Using the set of questions on specific negative acts; physical, verbal, relational and object-related
|
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 been exposed to by peers the last
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
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
Time Frame: Scorers are asked to use "the last 4 weeks" as the time frame for their registration of the negative acts
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ingrid Kvestad, Dr, NORCE Norwegian Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
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.
Clinical Trials on Bullying of Child
-
Babes-Bolyai UniversityNot yet recruitingBullying of Child | Bullying Victimisation | Bullying BehaviorRomania
-
Babes-Bolyai UniversityNot yet recruitingBullying | Bullying of Child | Bullying VictimisationRomania
-
The University of Hong KongThe Hong Kong Jockey Club Charities TrustRecruiting
-
Auburn UniversityCompletedBullying of ChildUnited States
-
Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Boise...CompletedBullying | Bullying of ChildUnited States
-
University of PittsburghEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedBullying of ChildUnited States
-
Narcis Cardoner, MD, PhDRecercaixa; Fundació Eurecat; Escola Parc del Guinardó; Fundació FC BarcelonaCompleted
-
KronikguneNorwegian University of Science and Technology; University of Aarhus; University... and other collaboratorsUnknownDepressive Symptoms | Anxiety Symptoms | Violence in Adolescence | Mental Disorder in Adolescence | Cyberbullying | Bullying of Child | School Absenteeism | Behavioral Problem of ChildIceland, Denmark, Italy, Poland, Spain
-
University Hospital, GrenobleUniversity Grenoble Alps; Université Lumière Lyon 2; Maison des Sciences de l... and other collaboratorsActive, not recruitingMental Health | Social Behavior | Child Behavior Disorders | Bullying of Child | Prevention and Control | Interpersonal Relations | School Health ServicesFrance
-
Cairo UniversityNot yet recruitingBruxism | Bullying | Bullying of Child | Nail Biting
Clinical Trials on Be-Prox
-
University of California, Los AngelesUniversity of ExeterNot yet recruitingDepression | Anxiety | Anxiety Depression | Rumination - Thoughts | WorryUnited States
-
Baskent UniversityHacettepe UniversityCompletedExercise Training | Physiotherapy | Energy Metabolism | AmputeesTurkey
-
Ankara Yildirim Beyazıt UniversityAnkara Training and Research HospitalRecruiting
-
KeifeRx, LLCWorldwide Clinical Trials; Life Molecular Imaging GmbH; Sun Pharmaceuticals Industries...Not yet recruiting
-
Montefiore Medical CenterConsano Clinical Research, LLC; Everytown for Gun SafetyCompleted
-
University of CoimbraFundação para a Ciência e a TecnologiaRecruitingPostpartum DepressionPortugal
-
National Taiwan University HospitalCompletedStroke RehabilitationTaiwan
-
University Hospital, LimogesCompleted
-
Inonu UniversityNot yet recruitingStroke | Quality of Life | Neglect, Hemispatial | Upper Extremity Function | Motor ımargery | Daily Life Activity
-
University of PennsylvaniaEnrolling by invitationImplementation ScienceUnited States