Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000557831
Ethics application status
Approved
Date submitted
14/05/2012
Date registered
25/05/2012
Date last updated
25/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of the effectiveness of Biteback - A comprehensive youth online positive psychology intervention.
Scientific title
Is a comprehensive youth online positive psychology intervention ('Biteback') more effective at increasing wellbeing than usage of neutral websites in youth aged 12-18 years?
Secondary ID [1] 280476 0
nil
Universal Trial Number (UTN)
U1111-1130-7059
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental wellbeing 286454 0
Condition category
Condition code
Mental Health 286712 286712 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 286743 286743 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two different samples - a community and a schools sample. In the community sample, participants are instructed to use the site www.biteback.org.au for 1 hour per week for a period of 6 weeks. The website is built around 9 domains: gratitude, social relationships, flow, mindfulness, kindness, character strengths, hope, optimism, and healthy lifestyles. Website includes interviews, videos, interactive activities, meditation tracks, and information. In the community sample, participants are given the choice of two neutral websites, 'ABC3' and 'The Fix'. Reminders to use the website are sent weekly. In the schools sample, participating classes of students are given individual workbooks which students work through during their class time. The workbooks contain reflective questions, instructions, and links to follow which guide them through the Biteback website. In the schools sample, the control group are given workbooks that contains reflective questions, instructions, and links to a variety of neutral websites, ABC, AYCC, NRDC, WWF, Wikipedia, IMDB, and world youth news. Students will use the program for a total of 6 hours over a period of approximately 6 weeks.
Intervention code [1] 284839 0
Lifestyle
Intervention code [2] 284840 0
Prevention
Intervention code [3] 284841 0
Behaviour
Comparator / control treatment
For the control intervention in the community sample, participants can chose between the 'ABC3' website and 'The Fix' website. They are instructed to use one of the websites for 1 hour per week for 6 weeks. Weekly reminders to continue using the control website are received by participants. In the schools sample, participants are given a workbook that is similar to the workbook for Biteback - it contains reflective questions, instructions, and links to follow for a variety of neutral websites - ABC, AYCC, NRDC, WWF, Wikipedia, IMDB, and world youth news. They use the workbook for the same amount of time as the group using the Biteback workbook - equivalent to 6 hours over approximately 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 287105 0
Flourishing will be measured with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMBS)
Timepoint [1] 287105 0
Community sample: pre- and post-intervention (at 6 weeks), and at 3 month follow up.
Schools sample: pre- and post-intervention (at 6 weeks).
Primary outcome [2] 287106 0
Cognitive and emotional wellbeing as measured by the Student Life Satisfaction Scale (SLSS) and the Scale of Positive and Negative Experience (SPANE)
Timepoint [2] 287106 0
Community sample: pre- and post-intervention (at 6 weeks), and at 3 month follow up.
Schools sample: pre- and post-intervention (at 6 weeks).
Secondary outcome [1] 297387 0
Psychopathology as measured by the Depression, Anxiety, and Stress Scale - 21 item version (DASS-21).
Timepoint [1] 297387 0
Community sample: pre- and post-intervention, and at 3 month follow up.
Schools sample: pre- and post-intervention.
Secondary outcome [2] 297388 0
Wellbeing indicators including quality of social relationships, as measured by a social relations questionnaire; optimism, as measured by the modified Life Orientation Test - Revised (LOT-R); self-efficacy, as measured by the modified General Self-Efficacy Scale (GSE); and self-esteem, as measured by the modified Rosenberg's Self-Esteem scale.
Timepoint [2] 297388 0
Community sample: pre- and post-intervention, and at 3 month follow up.
Schools sample: pre- and post-intervention.

Eligibility
Key inclusion criteria
Aged 12 to 18 years and living in Australia.
Minimum age
12 Years
Maximum age
18 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Community study: potential participants are recruited through advertisements, flyers, and websites. The study is described as being an investigation into websites' effects on the way young people view the world. Expressions of interest are made by completing an online battery of questionnaires. Once parental permission is obtained for those under 16 years of age, a battery of baseline questionnaires are sent. Upon completion of baseline questionnaires, participants are allocated to either a control or an experimental condition. Participants are then emailed the relevant website to use. Randomisation is performed by a researcher who is independent of the study.
Schools study: a decision to enrol classes (usually the entire year) is made by the principles of the schools. Parental permission is obtained for students under 16 years of age. Randomisation is conducted by entire classrooms (each comprising up to 33 students). Classrooms are randomised by school blocks to ensure even numbers of control and experimental groups. If there are uneven numbers, the experimental group is given an additional class. Randomisation is performed by a researcher who is independent of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Community: Block randomisation by groups of 10 participants
Schools: Block randomisation of classes by schools
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
620
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285233 0
Government body
Name [1] 285233 0
Federal Department of Health and Ageing (DoHA)
Country [1] 285233 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Black Dog Institute
Address
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 284100 0
None
Name [1] 284100 0
Address [1] 284100 0
Country [1] 284100 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287245 0
University of New South Wales Medical and Community Human Research Ethics Advisory Panel
Ethics committee address [1] 287245 0
The University of New South Wales, SYDNEY, NSW 2052
Ethics committee country [1] 287245 0
Australia
Date submitted for ethics approval [1] 287245 0
Approval date [1] 287245 0
04/10/2011
Ethics approval number [1] 287245 0
2011-7-35

Summary
Brief summary
This study is a pilot study as part of the development of Bite Back, an online positive psychology intervention for young people. The Study seeks to understand the effectiveness and useability of Bite Back in a group of young people aged 12 to 18 years from both a community sample and a high school sample. In the community sample, participants are encouraged to use the program at their leisure, while in the schools sample, the website is used in a structured format with the aid of a workbook. Participants are randomly allocated to either the experimental condition (Bite Back) or the control condition (neutral websites). It is hypothesised that the experimental conditions will demonstrate increased wellbeing at the end of the trial period in comparison to the control condition.
Trial website
www.biteback.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34167 0
Address 34167 0
Country 34167 0
Phone 34167 0
Fax 34167 0
Email 34167 0
Contact person for public queries
Name 17414 0
Vijaya Manicavasagar
Address 17414 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 17414 0
Australia
Phone 17414 0
+ 61 2 93824320
Fax 17414 0
Email 17414 0
[email protected]
Contact person for scientific queries
Name 8342 0
Vijaya Manicavasagar
Address 8342 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 8342 0
Australia
Phone 8342 0
+ 61 2 93824320
Fax 8342 0
Email 8342 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.