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Trial registered on ANZCTR


Registration number
ACTRN12616001711404
Ethics application status
Approved
Date submitted
2/12/2016
Date registered
14/12/2016
Date last updated
14/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Online Health Psycho-Education and Cognitive-Behavioural Intervention Program (step-up) for Young People to Combat Cyberbullying
Scientific title
Online Health Psycho-Education and Cognitive-Behavioural Intervention Program (step-up) for Young People to Combat Cyberbullying
Secondary ID [1] 290674 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record
NIL

Health condition
Health condition(s) or problem(s) studied:
Cyber Bullying 301206 0
Condition category
Condition code
Mental Health 300968 300968 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 Facts
- Understanding Feelings
- Staying Calm/Thinking Calmly
- Being Confident in our Interactions with Others
- Worry/Overcoming fear by facing fear
- More ways to stay calm
- Self-esteem
- Problem Solving
- Communicating Assertively

We do not need an activity log as the program itself monitors adherence. Any activities will be automatically emailed to the University of Sydney email account.

Participants (aged 16-19 years) will be recruited directly to the program through advertisement and on-line media, including Facebook. 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 7 core online sessions (each between 10 to 15 minutes ); two - three new session will be opened up to participants every week, and participants will be able to complete the sessions at their own convenience. When assessments have been completed, 2 additional booster sessions will be opened up for participants to complete.

Study is an open trial with pre post and follow-up assessments. The content of the sessions has been restructured into core information (7 sessions) and 2 booster sessions.

As 2 to 3 sessions will be completed each week. the 7 core sessions will be completed within 3 to 4 weeks (around 1 month).
Intervention code [1] 296562 0
Behaviour
Comparator / control treatment
Open trial with 3 - 4 weeks follow up.

It was thought more feasible to run an open trial, at least to gain some preliminary evidence of the impact of the program.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300396 0
Self-reported victimisation (PECK; Personal Experiences Checklist and the OBQ; Olweus Bully/Victim Questionnaire)
Timepoint [1] 300396 0
Pre-intervention (before session 1), post-intervention (after session 7), 1-month follow-up (1 month after session 7). Two booster sessions (8 and 9) will be released after participants complete a 1-month follow-up.
Secondary outcome [1] 329879 0
Emotional and behavioural symptoms (SDQ; Strengths and Difficulties Questionnaire)
Timepoint [1] 329879 0
Pre-intervention (before session 1), post-intervention (after session 7), 1-month follow-up (1-month after session 7).
Secondary outcome [2] 329880 0
These outcome questions listed below are a composite secondary outcome and will answer the question around usability of the program. Questions are specially designed for the online program. All questions are answered online.

Questions include:
- the automatic online log of the completion of sessions (and their components) and time taken to complete them;
- the number of correct answers to the quiz at the start of each session, which will test retention of knowledge from the previous session; and
- a feedback questionnaire completed at the end of 7 sessions asking participants to provide feedback on the acceptability and usefulness of the program.
Timepoint [2] 329880 0
Outcome assessed at the end of each session completed: 1, 2, 3, 4, 5, 6, 7, 8 & 9
Secondary outcome [3] 329881 0
self-reported self-compassion (SCS-SF; Self Compassion Scale – Short Form),
Timepoint [3] 329881 0
Outcome assessed through out intervention trial: after sessions 1, 2, 3, 4, 5, 6, 7, 8, 9
Secondary outcome [4] 329882 0
Qualitative feedback about the program assesses the programs acceptability to participants, as well as the components they found to be more or less useful. The questions have been designed specifically for this study.
Timepoint [4] 329882 0
Qualitative feedback about the program is collected after each session (1-9) and also within the follow-up questionnaire battery (4 weeks after the 7 core session were completed).

Eligibility
Key inclusion criteria
Aged 16 to 19 years
Minimum age
16 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
NIL

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NIL
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The aim is to get N=60. As we have an open trial a small number will be enough to show any change. The number is still big enough to be able to compair variables like: gender, culture, age groups, ... Outcome assessed: pre, post and follow up questionnaire

Using SPSS we will have a look at different changes like:
- Self-reported victimisation (PECK; Personal Experiences Checklist and the OBQ; Olweus Bully/Victim Questionnaire)
- Emotional and behavioural symptoms (SDQ; Strengths and Difficulties Questionnaire)
- Process outcomes will be collected as part of the online intervention: online quiz about content after each session; cyber bullying actions
- self-reported self-compassion (SCS-SF; Self Compassion Scale – Short Form)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/12/2016
Actual
Date of last participant enrolment
Anticipated
15/12/2017
Actual
Date of last data collection
Anticipated
31/01/2018
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8439 0
New Zealand
State/province [1] 8439 0
ALL - As all components of the study can be completed online, the study is not restricted to a specific site.
Country [2] 8440 0
United States of America
State/province [2] 8440 0
As all components of the study can be completed online, the study is not restricted to a specific site.
Country [3] 8443 0
Canada
State/province [3] 8443 0
As all components of the study can be completed online, the study is not restricted to a specific site.
Country [4] 8444 0
United Kingdom
State/province [4] 8444 0
As all components of the study can be completed online, the study is not restricted to a specific site.

Funding & Sponsors
Funding source category [1] 295105 0
University
Name [1] 295105 0
The University of Sydney
Country [1] 295105 0
Australia
Primary sponsor type
Individual
Name
Prof Caroline Hunt
Address
School of Psychology
The University of Sydney
Prof Caroline Hunt
Camperdown, NSW, 2006
Country
Australia
Secondary sponsor category [1] 293924 0
Individual
Name [1] 293924 0
Karoline Prinz
Address [1] 293924 0
School of Psychology
The University of Sydney
Prof Caroline Hunt
Camperdown, NSW, 2006
Country [1] 293924 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296459 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 296459 0
Ethics committee country [1] 296459 0
Australia
Date submitted for ethics approval [1] 296459 0
16/08/2016
Approval date [1] 296459 0
16/11/2016
Ethics approval number [1] 296459 0
2016/738

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

Contacts
Principal investigator
Name 70922 0
Ms Karoline Prinz
Address 70922 0
School of Psychology
The University of Sydney
c/o Prof Caroline Hunt
NSW 2006
Country 70922 0
Australia
Phone 70922 0
+61 411170173
Fax 70922 0
Email 70922 0
kprinz@uni.sydney.edu.au
Contact person for public queries
Name 70923 0
Karoline Prinz
Address 70923 0
School of Psychology
The University of Sydney
c/o Prof Caroline Hunt
NSW 2006
Country 70923 0
Australia
Phone 70923 0
+61 431067510
Fax 70923 0
Email 70923 0
kprinz@uni.sydney.edu.au
Contact person for scientific queries
Name 70924 0
Carline Hunt
Address 70924 0
School of Psychology
The University of Sydney
NSW 2006
Country 70924 0
Australia
Phone 70924 0
+61 411170173
Fax 70924 0
Email 70924 0
caroline.hunt@sydney.edu.au

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.