Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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
Query!
Scientific title
Online Health Psycho-Education and Cognitive-Behavioural Intervention Program (step-up) for Young People to Combat Cyberbullying
Query!
Secondary ID [1]
290674
0
NIL
Query!
Universal Trial Number (UTN)
NIL
Query!
Trial acronym
NIL
Query!
Linked study record
NIL
Query!
Health condition
Health condition(s) or problem(s) studied:
Cyber Bullying
301206
0
Query!
Condition category
Condition code
Mental Health
300968
300968
0
0
Query!
Anxiety
Query!
Intervention/exposure
Study type
Interventional
Query!
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).
Query!
Intervention code [1]
296562
0
Behaviour
Query!
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.
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
300396
0
Self-reported victimisation (PECK; Personal Experiences Checklist and the OBQ; Olweus Bully/Victim Questionnaire)
Query!
Assessment method [1]
300396
0
Query!
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.
Query!
Secondary outcome [1]
329879
0
Emotional and behavioural symptoms (SDQ; Strengths and Difficulties Questionnaire)
Query!
Assessment method [1]
329879
0
Query!
Timepoint [1]
329879
0
Pre-intervention (before session 1), post-intervention (after session 7), 1-month follow-up (1-month after session 7).
Query!
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.
Query!
Assessment method [2]
329880
0
Query!
Timepoint [2]
329880
0
Outcome assessed at the end of each session completed: 1, 2, 3, 4, 5, 6, 7, 8 & 9
Query!
Secondary outcome [3]
329881
0
self-reported self-compassion (SCS-SF; Self Compassion Scale – Short Form),
Query!
Assessment method [3]
329881
0
Query!
Timepoint [3]
329881
0
Outcome assessed through out intervention trial: after sessions 1, 2, 3, 4, 5, 6, 7, 8, 9
Query!
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.
Query!
Assessment method [4]
329882
0
Query!
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).
Query!
Eligibility
Key inclusion criteria
Aged 16 to 19 years
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
19
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
NIL
Query!
Study design
Purpose of the study
Educational / counselling / training
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
nil
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
NIL
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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)
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
16/12/2016
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
15/12/2017
Query!
Actual
Query!
Date of last data collection
Anticipated
31/01/2018
Query!
Actual
Query!
Sample size
Target
60
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Recruitment outside Australia
Country [1]
8439
0
New Zealand
Query!
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.
Query!
Country [2]
8440
0
United States of America
Query!
State/province [2]
8440
0
As all components of the study can be completed online, the study is not restricted to a specific site.
Query!
Country [3]
8443
0
Canada
Query!
State/province [3]
8443
0
As all components of the study can be completed online, the study is not restricted to a specific site.
Query!
Country [4]
8444
0
United Kingdom
Query!
State/province [4]
8444
0
As all components of the study can be completed online, the study is not restricted to a specific site.
Query!
Funding & Sponsors
Funding source category [1]
295105
0
University
Query!
Name [1]
295105
0
The University of Sydney
Query!
Address [1]
295105
0
School of Psychology
The University of Sydney
Prof Caroline Hunt
Camperdown, NSW, 2006
Query!
Country [1]
295105
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Prof Caroline Hunt
Query!
Address
School of Psychology
The University of Sydney
Prof Caroline Hunt
Camperdown, NSW, 2006
Query!
Country
Australia
Query!
Secondary sponsor category [1]
293924
0
Individual
Query!
Name [1]
293924
0
Karoline Prinz
Query!
Address [1]
293924
0
School of Psychology
The University of Sydney
Prof Caroline Hunt
Camperdown, NSW, 2006
Query!
Country [1]
293924
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
296459
0
The University of Sydney Human Research Ethics Committee
Query!
Ethics committee address [1]
296459
0
The University of Sydney
NSW 2006
Query!
Ethics committee country [1]
296459
0
Australia
Query!
Date submitted for ethics approval [1]
296459
0
16/08/2016
Query!
Approval date [1]
296459
0
16/11/2016
Query!
Ethics approval number [1]
296459
0
2016/738
Query!
Summary
Brief summary
The aim of the trial is to establish if the use of an online psycho-education and cognitive-behavioural intervention will decrease the likelihood that a young person will experience being cyber bullied, and also reduce the impact of any bullying experienced. The program is designed to decrease vulnerability to bullying by building coping responses over time. We hypothesise that young people who complete the on-line intervention will experience decreased bullying (particularly cyber bullying), increased self-compassion, and decreased emotional and behavioural symptoms from pre-test to post-test, and these changes will either be maintained or improved over the 1-month follow-up..
Query!
Trial website
www.step-up.co
Query!
Trial related presentations / publications
NIL
Query!
Public notes
NIL
Query!
Contacts
Principal investigator
Name
70922
0
Ms Karoline Prinz
Query!
Address
70922
0
School of Psychology
The University of Sydney
c/o Prof Caroline Hunt
NSW 2006
Query!
Country
70922
0
Australia
Query!
Phone
70922
0
+61 411170173
Query!
Fax
70922
0
Query!
Email
70922
0
[email protected]
Query!
Contact person for public queries
Name
70923
0
Ms Karoline Prinz
Query!
Address
70923
0
School of Psychology
The University of Sydney
c/o Prof Caroline Hunt
NSW 2006
Query!
Country
70923
0
Australia
Query!
Phone
70923
0
+61 431067510
Query!
Fax
70923
0
Query!
Email
70923
0
[email protected]
Query!
Contact person for scientific queries
Name
70924
0
Prof Carline Hunt
Query!
Address
70924
0
School of Psychology
The University of Sydney
NSW 2006
Query!
Country
70924
0
Australia
Query!
Phone
70924
0
+61 411170173
Query!
Fax
70924
0
Query!
Email
70924
0
[email protected]
Query!
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.
Download to PDF