BullyingNCT06578260
Support Groups - a Model for Social Inclusion and Reduction of Bullying in School
A study testing Peer support groups with a solution-focused approach in people with Bullying, run by Oslo Metropolitan University at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Bullying
- What is being tested?
- Peer support groups with a solution-focused approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,188 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2024to 21 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary Schools with more than 200 students
- Public Health Nurse employed in a 50% position or more
Who cannot join
- Primary Schools with less than 200 students
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
The primary objective of this study is to investigate the effectiveness of a support group intervention using a solution-focused approach in reducing bullying, enhancing mental health, improving quality of life, and increasing general self-efficacy among school children in 5th-7th grade. Investigators hypothesize that the awareness of bullying created by the intervention, and the empowerment of children as contributors to the solution, will generate positive ripple effects benefiting all children in the intervention schools. Furthermore, investigators hypothesize that children with a peer support group will exhibit lower levels of bullying, improved mental health, better quality of life, and increased general self-efficacy after the intervention compared to their baseline levels. Investigators expect these effects to persist even after 3 and 6 months. Aligned with the cluster RCT, the investigators will undertake a parallel process evaluation to assess the extent of the intervention coverage, whether the intervention was implemented according to the protocol, and identify factors that hinder or aid the implementation of a support group intervention. For the process evaluation, investigators will use the framework presented by the Medical Research Council guidelines focusing on the implementation (what is implemented and how), the mechanisms of impact (how the delivered intervention produces change), and the context (how the context affects implementation and outcomes).
- Conditions
- Bullying
- Being tested
- Peer support groups with a solution-focused approach
- Keywords
- Supportgroups, schoolchildren, solution-focused-approach
- Medical subject headings
- Bullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support groups with a solution-focused approachBehavioural
To investigate the effectiveness of a support group intervention using a solution-focused approach among school children in 5th-7th grade in southeastern Norway
| Study group | Role | What they receive |
|---|---|---|
| The effect and outcomes in the intervention schools | Experimental | The intervention schools will use the Support Group intervention regarding bullying and exclusion. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline, Week 17, Week 30 and Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Nov 2024
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BullyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Controlled trial (CRCT)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisbeth Valla, Phd, Principal investigator, OsloMet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578260
- Sponsor's protocol ID
- 717417
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Groups - a Model for Social Inclusion and Reduction of Bullying in School
- ClinicalTrials.gov ID
- NCT06578260
- Acronym / sponsor ID
- 717417
- Conditions
- Bullying
- Keywords
- Supportgroups, schoolchildren, solution-focused-approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,188 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The primary objective of this study is to investigate the effectiveness of a support group intervention using a solution-focused approach in reducing bullying, enhancing mental health, improving quality of life, and increasing general self-efficacy among school children in 5th-7th grade. Investigators hypothesize that the awareness of bullying created by the intervention, and the empowerment of children as contributors to the solution, will generate positive ripple effects benefiting all children in the intervention schools. Furthermore, investigators hypothesize that children with a peer support group will exhibit lower levels of bullying, improved mental health, better quality of life, and increased general self-efficacy after the intervention compared to their baseline levels. Investigators expect these effects to persist even after 3 and 6 months. Aligned with the cluster RCT, the investigators will undertake a parallel process evaluation to assess the extent of the intervention coverage, whether the intervention was implemented according to the protocol, and identify factors that hinder or aid the implementation of a support group intervention. For the process evaluation, investigators will use the framework presented by the Medical Research Council guidelines focusing on the implementation (what is implemented and how), the mechanisms of impact (how the delivered intervention produces change), and the context (how the context affects implementation and outcomes).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster Randomized Controlled trial (CRCT)
| Arm | Type | Receives |
|---|---|---|
| The effect and outcomes in the intervention schools | Experimental | Behavioral: Peer support groups with a solution-focused approachThe intervention schools will use the Support Group intervention regarding bullying and exclusion. |
| The outcomes in the control schools | No intervention | –The control schools will implement the same measures as they normally do regarding bullying and exclusion. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Primary Schools with more than 200 students
- Public Health Nurse employed in a 50% position or more
Key exclusion criteria (1 listed)
- Primary Schools with less than 200 students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer support groups with a solution-focused approachTo investigate the effectiveness of a support group intervention using a solution-focused approach among school children in 5th-7th grade in southeastern Norway | Behavioural | The effect and outcomes in the intervention schools |
Primary outcome
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.
Time frame: Baseline, Week 6, Week 18 and Week 32
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).
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.
Time frame: Baseline, Week 6, Week 18 and Week 32
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.
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.
Time frame: Baseline, Week 6, Week 18 and Week 32
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).
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.
Time frame: Baseline, Week 17, Week 30 and Week 56
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).
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.
Time frame: Baseline, Week 17, Week 30 and Week 56
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisbeth Valla, Phd principal investigator
OsloMet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support groups with a solution-focused approach in people with Bullying, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline, Week 6, Week 18 and Week 32). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.