Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001145796
Ethics application status
Approved
Date submitted
13/09/2013
Date registered
15/10/2013
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Date results provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing peer victimisation in Australian schools through targeted and universal approaches
Scientific title
Comparing Friendly Schools Plus and Cool Kids (bullying) for the reduction of peer victimisation among school children aged 8-11.
Secondary ID [1] 283215 0
Nil known
Universal Trial Number (UTN)
U1111-1148-0068
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peer victimisation 290078 0
Bullying 290079 0
Child anxiety 290080 0
Condition category
Condition code
Public Health 290460 290460 0 0
Health promotion/education
Public Health 290540 290540 0 0
Other public health
Mental Health 290541 290541 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Friendly-Schools Plus teaching and learning resources use a strengths-based approach to focus on positive health rather than emphasising risk factors. The Year 4 and 5 teaching and learning resources are designed to address three key aspects of students’ school experiences shown to be related to improved social and emotional development: promoting positive peer relationships, promoting positive teacher-child relationships, and explicit teaching related to emotions, social knowledge and social skills. The resources aim to develop students’ social and emotional competencies to enable them to recognise and control their emotions; build positive relationships; show consideration for others; make thoughtful and sensible choices; and cope successfully with difficult situations.
The Friendly-Schools Plus program is supported by 1 session of 6-hour training for school personnel and additional session of 6-hour training for classroom teachers. Training of school personnel includes: understanding social & emotional learning; evidence-based policies; building leadership; seven steps for whole school improvement. Additional training for classroom teachers includes: evidence for class teaching; bullying prevention strategies; utilising teacher support resources. The program comprises a whole-school manual, 8-10 hours of classroom teaching and learning materials, delivered one hour per week, as well as online capacity assessment and planning tools (a one-off screening tool to help schools determine current strengths and future improvements for positive student outcomes). The overall program is delivered over two school terms.

The targeted intervention will be a modification of the well-established Cool Kids program. To reduce risk of stigmatisation, the program will be conducted by parents outside school so that only the school counsellor and the investigators will be aware of which children are in the targeted program. The self-help program involves 10 modules covering psychoeducation, cognitive restructuring for child and parents, graduated in vivo exposure, child management and interaction skills for parents, and general social and relationship management skills for children. Detailed information materials and extensive practice exercises are delivered over the internet, where parents receive the majority of the information, but specific components are directed also to the children. Parents and children are encouraged to complete modules weekly (ie 10 weeks) but as a self-help program, they can work at their own pace. The program will be supported by school counsellors who attend a one-day training workshop conducted by the researchers. Each parent will have 4 scheduled meetings with their school counsellor at key points in the program to discuss goals and problem-solve difficulties. Parents will also be encouraged to contact the school counsellor for additional advice as needed. The overall program is designed to be delivered over 1 school term.

Schools will be randomly allocated to one of four conditions: 1) Both Cool Kids and Friendly Schools; 2) Friendly Schools alone; 3) Cool Kids alone; 4) School procedures as usual (no intervention). The no intervention schools will receive Friendly Schools Plus at the end of the trial (24 months).
Questionnaire items to schools, counsellors, and parents, will assess use and implementation of both programs.
Intervention code [1] 287941 0
Behaviour
Intervention code [2] 287942 0
Prevention
Comparator / control treatment
Treatment as usual. Comparison schools will receive no specific intervention and hence will continue to implement their usual, current anti-bullying policies and procedures.
Control group
Active

Outcomes
Primary outcome [1] 290486 0
Reductions on Peer Experiences Checklist (PECK) scores
Timepoint [1] 290486 0
0-month (2 months before program implementation), 6-month, 12-month, 24-month
Primary outcome [2] 290487 0
Reductions on Revised Olweus Bully-Victim Questionnaire
Timepoint [2] 290487 0
0-month (2 months before program implementation), 6-month, 12-month, 24-month
Primary outcome [3] 290488 0
Reductions on Participant Role Questionnaire (PRQ)
Timepoint [3] 290488 0
0-month (2 months before program implementation), 6-month, 12-month, 24-month
Secondary outcome [1] 304607 0
Reductions on Spence Childrens Anxiety Scale (parent and child versions)
Timepoint [1] 304607 0
0-month (2 months before program implementation), 6-month, 12-month, 24-month
Secondary outcome [2] 304608 0
Reductions on the Short Moods and Feelings Questionnaire (SMFQ)
Timepoint [2] 304608 0
0-month (2 months before program implementation), 6-month, 12-month, 24-month
Secondary outcome [3] 304609 0
Improvements in quality of life assessed by Child Health Utility Index 9D (CHU9D)
Timepoint [3] 304609 0
0-month (2 months before program implementation), 6-month, 12-month, 24-month

Eligibility
Key inclusion criteria
Schools expressing interest in participation from private, religious, and public systems.

Two levels of analysis - Universal and targeted.
Universal - all children in grades 4 & 5, who provide consent.
Targeted - children in grades 4 & 5 with consent who score greater than 1 standard deviation above the norm on child anxiety (SCAS) and
report victimisation "every few weeks or more often" on the BVQ.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parent refusal for child to participate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation is at a school level and will be done by online random number generator. Eligibility of schools for the study will be determined before randomisation. Therefore, allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group-based (schools) simple randomisation using a randomisation table created by computer software including stratification of schools according to school size and socioeconomic level
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Analyses will be conducted at both a universal (whole of school) level and a targeted subsample level.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Approximately 6,000 students from grades 4 and 5 (ages 9-11 years) will be invited to participate in this project. This is based on an assumption that average enrolments in grades 4 and 5 are 80 students. Assuming a 85% participation rate, this will provide a total sample of approximately 5,100 students, with 1,457 students in each of the three treatment conditions and 729 students in the comparison group. It is estimated that 12% of the total sample (i.e., 612 children) will be identified in the targeted subsample.

The most conservative analyses will compare the three active treatment conditions. For the universal population, with a sample size of around 5000 (based on intent-to-treat), power will be sufficient to detect small effect size differences between interventions (standardised mean difference of 0.15; power .80; alpha .05). For the targeted population, a sample size of around 600 students will be sufficient to detect small to medium effect size differences between interventions (standardised mean difference of 0.3; power .80; alpha .05).

On the primary outcomes, self-nominated and peer nominated proportions of students identified as victims will be compared between conditions using log-linear analyses. Odds ratios will be determined to compare with international literature. The proportion of identified bullies can also be compared to see whether the programs have an impact on actual bullying behaviour. Continuous scores on the Personal Experiences Checklist (PECK; Hunt et al., 2012) will be analysed using random effects regression which allows for the test and control of school and class cluster effects. Analyses will be based on intent-to-treat to provide the most salient information for policy relevance. Missing data will be estimated using multiple imputation. Analyses will be conducted on both the overall sample (entire grade population) as well as on the subsample who were victimised at baseline. Similar analyses will be conducted on the additional outcomes. Post-hoc analyses will examine the influence of a variety of moderators on outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2014
Actual
2/06/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
19/12/2014
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
5100
Accrual to date
Final
8453
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 287960 0
Government body
Name [1] 287960 0
National Health & Medical Research Council
Country [1] 287960 0
Australia
Funding source category [2] 287961 0
Government body
Name [2] 287961 0
Department of Education Employment and Workplace Relations (DEEWR),
Country [2] 287961 0
Australia
Funding source category [3] 287962 0
University
Name [3] 287962 0
Macquarie University
Country [3] 287962 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road,
North Ryde. NSW. 2109
Country
Australia
Secondary sponsor category [1] 286681 0
None
Name [1] 286681 0
Address [1] 286681 0
Country [1] 286681 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289886 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 289886 0
Ethics committee country [1] 289886 0
Australia
Date submitted for ethics approval [1] 289886 0
11/09/2013
Approval date [1] 289886 0
25/11/2013
Ethics approval number [1] 289886 0
5201300641

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42950 0
Prof Ronald Rapee
Address 42950 0
Centre for Emotional Health
Macquarie University
Sydney. NSW. 2109.
Country 42950 0
Australia
Phone 42950 0
61 2 98508032
Fax 42950 0
61 2 98508062
Email 42950 0
[email protected]
Contact person for public queries
Name 42951 0
Ronald Rapee
Address 42951 0
Centre for Emotional Health
Macquarie University
Sydney. NSW. 2109.
Country 42951 0
Australia
Phone 42951 0
+61 2 98508032
Fax 42951 0
61 2 98508062
Email 42951 0
[email protected]
Contact person for scientific queries
Name 42952 0
Ronald Rapee
Address 42952 0
Centre for Emotional Health
Macquarie University
Sydney. NSW. 2109.
Country 42952 0
Australia
Phone 42952 0
+61 2 98508032
Fax 42952 0
61 2 98508062
Email 42952 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included in ethics.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.