Support Groups - a Model for Social Inclusion and Reduction of Bullying in School

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

Study Overview

• Status: Recruiting
• Conditions: Bullying
• Intervention / Treatment: Behavioral: Peer support groups with a solution-focused approach

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 Type: Interventional
• Enrollment (Estimated): 1586
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisbeth Valla, Phd; Phone Number: 004796236870; Email: lisval@oslomet.no
• Study Contact Backup: Name: Therese Haugerud Bjerketveit, Master; Phone Number: 004797647479; Email: thhau5268@oslomet.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • OsloMet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The effect and outcomes in the intervention schools; The intervention schools will use the Support Group intervention regarding bullying and exclusion.	Behavioral: Peer support groups with a solution-focused approach; To investigate the effectiveness of a support group intervention using a solution-focused approach among school children in 5th-7th grade in southeastern Norway
No Intervention: The outcomes in the control schools; The control schools will implement the same measures as they normally do regarding bullying and exclusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Investigators: Principal Investigator: Lisbeth Valla, Phd, OsloMet

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: schoolchildren; Supportgroups; solution-focused-approach
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression; Bullying
• Other Study ID Numbers: 717417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No