NCT06578260

Brief Summary

Study Title: Support Groups - a model for social inclusion and reduction of bullying in school Study Design: Cluster Randomized Controlled trial (CRCT) Objective: To investigate the effectiveness of a support group intervention using a solution-focused approach among school children in 5th-7th grade in southeastern Norway Intervention: Peer support groups with a solution-focused approach Study Population: School Children

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,586

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress40%
Nov 2024Aug 2028

First Submitted

Initial submission to the registry

August 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Expected
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

August 16, 2024

Last Update Submit

August 27, 2024

Conditions

Keywords

Supportgroupsschoolchildrensolution-focused-approach

Outcome Measures

Primary Outcomes (5)

  • Bullying- change from baseline in bullying using the Olweus questionnaire at end of intervention, 3 months and 6 months after end of intervention on individual level at intervention schools.

    The Olweus questionnaire is a validated self-reported questionnaire that may be answered from ; Not at all (no bullying), one or seldom, 2-3 times in the months or about one times a week or more (worst possible bullying score) (Olweus, 2013).

    Baseline, Week 6, Week 18 and Week 32

  • Mental health- change from baseline in mental health using the Strength and Difficulties Questionnaires (SDQ), at end of intervention, 3 months and 6 months after end of intervention on individual level at intervention schools.

    The Strength and Difficulties Questionnaires (SDQ) is a validated self-reported questionnaire which consists of 25-items (Goodman, 1999). The questionnaires measure emotional problems, conduct problems, hyperactivity, peer problems, pro-social behavior and impact score. The questionnaires may be answered form "not true" (lowest possible score) to "certainly true" (highest possible score). A high total difficulties score indicates that the individual is experiencing a high level of difficulties, while a low score indicates a low level of difficulties.

    Baseline, Week 6, Week 18 and Week 32

  • Self-efficacy-change from baseline in self-efficacy using the General self-efficacy scale, at end of intervention, 3 months and 6 months after end of intervention on individual level at intervention schools.

    The General self-efficacy scale is a self-administered form with five response categories from "Completely agrees to "not agrees". The scale measures the belief in self-efficacy. Highest scores indicate best self-efficacy (Bandura, 1997).

    Baseline, Week 6, Week 18 and Week 32

  • Quality of life-change from baseline in quality of life using the Kidscreen -10, 4 months after baseline, end of intervention and 6 months after end of intervention in both intervention and control schools in 5th to 7th grade on class level.

    The KIDSCREEN-10 index is the shortest version of the KIDSCREEN questionnaires and measures general health-related quality of life (Detmar, Bruil, Ravens-Sieberer, Gosch \& Bisegger, 2006). Possible scores range from "not at all" or "never" (lowest possible score) to "a high degree" or "always" (highest possible score).

    Baseline, Week 17, Week 30 and Week 56

  • Class environment- change from baseline using the Norwegian student survey (Elevundersøkelsen), 4 months, end of intervention and 6 months after end of intervention in both intervention and control schools in 5th to 7th grade on class level.

    To measure class environment all children in 5th to 7th grade will complete the Norwegian student survey (Elevundersøkelsen, UDIR 2023). The survey which asking among other things about bullying and inclusion in the school environment and peer relationship.

    Baseline, Week 17, Week 30 and Week 56

Study Arms (2)

The effect and outcomes in the intervention schools

EXPERIMENTAL

The intervention schools will use the Support Group intervention regarding bullying and exclusion.

Behavioral: Peer support groups with a solution-focused approach

The outcomes in the control schools

NO INTERVENTION

The control schools will implement the same measures as they normally do regarding bullying and exclusion.

Interventions

To investigate the effectiveness of a support group intervention using a solution-focused approach among school children in 5th-7th grade in southeastern Norway

The effect and outcomes in the intervention schools

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Primary Schools with more than 200 students
  • Public Health Nurse employed in a 50% position or more

You may not qualify if:

  • Primary Schools with less than 200 students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OsloMet

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Bullying

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Study Officials

  • Lisbeth Valla, Phd

    OsloMet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisbeth Valla, Phd

CONTACT

Therese Haugerud Bjerketveit, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster Randomized Controlled trial (CRCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Lisbeth Valla

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 29, 2024

Study Start

November 1, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

August 1, 2028

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations