Clinical trial NCT06578260: Support Groups - a Model for Social Inclusion and Reduction of Bullying in School
Official title: Support Groups - a Model for Social Inclusion and Reduction of Bullying in School
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bullying
Keywords: Supportgroups
schoolchildren
solution-focused-approach
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 1586
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Controlled trial (CRCT)
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Primary Schools with less than 200 students

Primary outcomes:
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.
timeFrame: Baseline, Week 6, Week 18 and Week 32
measure: 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.
timeFrame: Baseline, Week 6, Week 18 and Week 32
measure: 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.
timeFrame: Baseline, Week 6, Week 18 and Week 32
measure: 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.
timeFrame: Baseline, Week 17, Week 30 and Week 56
measure: 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.
timeFrame: Baseline, Week 17, Week 30 and Week 56
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OsloMet
Study officials:
affiliation: OsloMet
name: Lisbeth Valla, Phd
role: PRINCIPAL_INVESTIGATOR
References: