Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000853549
Ethics application status
Approved
Date submitted
17/06/2015
Date registered
17/08/2015
Date last updated
17/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an online Psycho-Education and Cognitive-Behavioural Intervention Program for young people decrease the likelihood and impact of cyber bullying?
Scientific title
Can an online Psycho-Education and Cognitive-Behavioural Intervention Program for young people decrease the likelihood and impact of cyber bullying?
Secondary ID [1] 286715 0
NIL
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cyber Bullying 295074 0
Condition category
Condition code
Mental Health 295327 295327 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Every session has the same structure (starting with a quiz, facts and new content, exercises to practice and ending with a self-compassion exercise) the 9 topics of the online sessions are: Cyber Bullying
Feelings
Staying Calm
Being Confident
Problem Solving
Being Assertive
Worrying
Keeping Calm
Self-Esteem


2. We do not need an activity log as the programme itself monitors adherence. any activities will be automatic emailed to the USYD email account.

3.We will meet with the teacher for a 1 hours training session with a clinical psychologist (myself).

The online program includes psycho-education about cyber bullying and cognitive-behavioural strategies aimed at reducing the likelihood that a young person will experience cyber bullying or reducing the impact of any bullying experienced. The online intervention includes 9 online sessions (each between 15 to 20 minutes every 2 or 3 days) over 4-5 weeks.

The first session will be led by a teacher in the class room, either using the students' personal laptops or in a computer laboratory. Session 2 to 9 will be conducted under supervision by the teacher. Teachers will be trained and made familiar with each session before completed by the children, and will be prepared for potential questions or problems.
Intervention code [1] 291870 0
Behaviour
Comparator / control treatment
3 weeks wait list control
Control group
Active

Outcomes
Primary outcome [1] 295070 0
Self-reported victimisation (PECK; Personal Experiences Checklist and the OBQ; Olweus Bully/Victim Questionnaire)
Timepoint [1] 295070 0
pre-intervention after randomisation (before session 1); post-intervention after last online session (session 9)
Secondary outcome [1] 314704 0
Emotional and behavioural symptoms (SDQ; Strengths and Difficulties Questionnaire)
Timepoint [1] 314704 0
pre-intervention after randomisation (before session 1); post-intervention (after last session, session 9)
Secondary outcome [2] 315385 0
Process outcomes will be collected as part of the online intervention: online quiz about content after each session; cyber bullying actions
Timepoint [2] 315385 0
Outcome assessed through out intervention trial: after sessions 1, 2, 3, 4, 5, 6, 7, 8, 9
Secondary outcome [3] 315524 0
self-reported self-compassion (SCS-SF; Self Compassion Scale – Short Form),
Timepoint [3] 315524 0
Outcome assessed through out intervention trial: after sessions 1, 2, 3, 4, 5, 6, 7, 8, 9
Secondary outcome [4] 315525 0
qualitative feedback given about intervention program online after each sessions online and within the post questionnaires. the Questions have been designed specifically for this study.
Timepoint [4] 315525 0
Outcome assessed through out intervention trial: online after sessions 1, 2, 3, 4, 5, 6, 7, 8, 9 and within the post questionnaires. Post questionnaires are filled in after completing session nine.

Eligibility
Key inclusion criteria
Being a student at one of the recruited schools.
Minimum age
12 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
not english speaking children (but we expect all kids in school to speak english)

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)
All students in grades 7 to 9 in each participating school will be invited to participate in the trial. Students must provide written consent and parents will have the option to opt their child out of the research.

The randomisation will be carried out at a school level, not an individual student level (cluster randomisation). Once i determine whether a school is eligible, a second person (Caroline Hunt) will conduct the allocation (concealed).

The concealed randomisation will be carried out at a school level, not an individual student level (cluster randomisation). Once the Lead Investigator (Karoline Prinz) determines whether a school is eligible, she will make contact with a second person at a central administration site (Caroline Hunt) who will conduct the allocation, using a spreadsheet which hides the random number sequence until required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will be used to create a sequence t determine whether a school is in the treatment or waitlist condition. After each school is recruited the school will be entered into a spread sheet where it will be determined if the school is in the control group. One of the investigators other than the lead investigator will organise the random allocation to conditions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A two-group mixed model ANOVA will be used to assess for differential change over time between the two conditions for the key primary and secondary outcomes.

A sample size of approximately 60 students within each group will be sufficient to detect a medium effect size differences between interventions (standardised mean difference of 0.50; power .80; alpha .05). In terms of the effect of cluster randomisation, we believe that a child’s grade will provide the most appropriate level of clustering for the analysis and the intracluster correlation will need to be large to significantly reduce power in this case (Kerry et al., 1998). Reliable estimates of the intra-class correlation are required to ensure robust sample size calculations and we will not have these until our data are analysed; however our previous school analyses have shown similar clustering effects to be small and non-significant (e.g. Berry & Hunt, 2009; Rose, Hawes & Hunt, 2014).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2015
Actual
Date of last participant enrolment
Anticipated
21/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291492 0
University
Name [1] 291492 0
The University of Sydney
Country [1] 291492 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Caroline Hunt
Address
School of Psychology
The University of Sydney
Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 290172 0
Individual
Name [1] 290172 0
Karoline Prinz
Address [1] 290172 0
School of Psychology
The University of Sydney
NSW 2006
Country [1] 290172 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293035 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 293035 0
Ethics committee country [1] 293035 0
Australia
Date submitted for ethics approval [1] 293035 0
15/04/2015
Approval date [1] 293035 0
05/06/2015
Ethics approval number [1] 293035 0
Project No: 2015/306

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

Contacts
Principal investigator
Name 57290 0
Ms Karoline Prinz
Address 57290 0
School of Psychology
The University of Sydney
NSW 2006
Country 57290 0
Australia
Phone 57290 0
+61 431067510
Fax 57290 0
Email 57290 0
[email protected]
Contact person for public queries
Name 57291 0
Karoline Prinz
Address 57291 0
School of Psychology
The University of Sydney
NSW 2006
Country 57291 0
Australia
Phone 57291 0
+61 431067510
Fax 57291 0
Email 57291 0
[email protected]
Contact person for scientific queries
Name 57292 0
Caroline Hunt
Address 57292 0
School of Psychology
The University of Sydney
NSW 2006
Country 57292 0
Australia
Phone 57292 0
+61 411170173
Fax 57292 0
Email 57292 0
[email protected]

No information has been provided regarding IPD availability


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.