Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000449235
Ethics application status
Approved
Date submitted
20/01/2009
Date registered
12/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving the Quality of Advice on Suicide Prevention Websites Using Feedback to Website Administrators: A Randomized Controlled Trial
Scientific title
Evaluation of suicide prevention websites to assess if feedback on the quality of suicide prevention content will lead to an improvement in the quality of website content.
Secondary ID [1] 262961 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
quality of content on suicide prevention websites 4207 0
Condition category
Condition code
Mental Health 4418 4418 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Suicide prevention websites will be scored for quality of information about how to help someone who is suicidal, using a 26-item checklist titled Suicidal Thoughts and Behaviours: First Aid Guidelines (Kelly, Jorm, Kitchener & Langlands, 2008). These guidelines were developed using the Delphi methodology whereby a consensus was reached by a panel of experts, to produce guidelines to encourage a suicidal individual to seek professional help or decide against suicide. Website administrators will be emailed a letter giving detailed scoring of their website (on a scale from 0 - 26) and the 26-item checklist, which they can use to improve the content of their own website. An article about how the Guidelines were produced and an Information Sheet about the website evaluation research project will also be included. Scoring will take place at baseline date (pre-test) and 6 months after baseline date (post-test).
Intervention code [1] 3920 0
Prevention
Comparator / control treatment
The control condition will be no feedback to website administrators (i.e. no treatment given).
Control group
Active

Outcomes
Primary outcome [1] 5302 0
the content of suicide website quality measured against a 26-item checklist based on document: Suicidal thoughts and behaviours: first aid guidlines (Kelly et al., 2008). Each item in the checklist will be scored 'yes' or 'no' depending on whether or not a particular action is recommended on the website.
Timepoint [1] 5302 0
at pre-test scoring in months 1-2 of the study and post-test scoring in months 6-7.
Secondary outcome [1] 8922 0
assess whether an improvement in suicide website quality has been made, using a 26-item checklist based on document: Suicidal thoughts and behaviours: first aid guidlines.
Timepoint [1] 8922 0
at post-test scoring in months 6-7 of the research project

Eligibility
Key inclusion criteria
Websites will comprise teh top 52 English-language websites from a Google Australia search with the terms "help suicide" on 6 Nov 2008. Websites which were sponsored by organizations and listed a Website Administrator, were included. Website content and date was captured using Teleport Pro.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
websites which were sponsored by individuals (such as personal blogs) were excluded. Websites which did not provide contact details of a Website Administrator (or equivalent) were also excluded.

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)
Websites will be selected and scored for quality by two researchers, who will provide the Principal Investigator with website IDs numbered from 1 to 52 and their quality scores (the Principal Investigator will be responsible for sending out the feedback letters containing the quality scores and guidelines for improvement). A list of ID numbers from 1 - 52 will be given to a third researcher who is offsite, to determine the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
One of the two researchers who scored the websites for quality will provide a list of website IDs numbered from 1 to 52, to a third researcher who is off-site and not involved in the scoring. A restricted randomization will be conducted using a Sequence Generator from the Random.org website, to randomly order the IDs. The first 26 IDs will be in the feedback group and the second 26 in the control group. This will ensure that the two groups have the same sample size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Data will be analysed using a 2X2 analysis of variance, where the factors are group (feedback or control) and time (pre or post). No missing data are expected. However, if a website were to cease to exist, an intention to treat approach would be used, using data imputation for the missing score.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1394 0
3000
Recruitment postcode(s) [2] 1395 0
2000
Recruitment postcode(s) [3] 1396 0
4000
Recruitment postcode(s) [4] 1397 0
5000
Recruitment outside Australia
Country [1] 1529 0
Canada
State/province [1] 1529 0
Ottawa
Country [2] 1530 0
United States of America
State/province [2] 1530 0
Washington DC
Country [3] 1531 0
United States of America
State/province [3] 1531 0
Ohio
Country [4] 1532 0
Canada
State/province [4] 1532 0
Saskatchewan
Country [5] 1533 0
United States of America
State/province [5] 1533 0
California
Country [6] 1534 0
United States of America
State/province [6] 1534 0
Alaska
Country [7] 1535 0
United States of America
State/province [7] 1535 0
South Dakota
Country [8] 1536 0
United States of America
State/province [8] 1536 0
Florida
Country [9] 1537 0
United Kingdom
State/province [9] 1537 0
Lancashire

Funding & Sponsors
Funding source category [1] 4397 0
University
Name [1] 4397 0
The University of Melbourne
Country [1] 4397 0
Australia
Primary sponsor type
Individual
Name
Anthony Jorm
Address
Orygen Youth Health Research Centre
35 Poplar Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 3956 0
Individual
Name [1] 3956 0
Julie-Anne Fischer
Address [1] 3956 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville VIC 3052
Country [1] 3956 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6446 0
Psychiatry Human Ethics Advisory Group
Ethics committee address [1] 6446 0
The University of Melbourne
Main Block Level 1 North
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3052
Ethics committee country [1] 6446 0
Australia
Date submitted for ethics approval [1] 6446 0
Approval date [1] 6446 0
01/12/2008
Ethics approval number [1] 6446 0
0830655

Summary
Brief summary
Orygen Youth Health Research Centre aims to evaluate the quality of advice on the web about how to help someone who is suicidal. It also aims to assess whether there is an improvement in the quality of suicide prevention advice, after website administrators are given feedback on the quality of their website and guidelines on how to help someone who is suicidal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35095 0
Address 35095 0
Country 35095 0
Phone 35095 0
Fax 35095 0
Email 35095 0
Contact person for public queries
Name 12442 0
Julis-Anne Fischer
Address 12442 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville VIC 3052
Country 12442 0
Australia
Phone 12442 0
+ 61 3 9342 3767
Fax 12442 0
+ 61 3 9342 3745
Email 12442 0
[email protected]
Contact person for scientific queries
Name 3370 0
Professor Anthony Jorm
Address 3370 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville VIC 3052
Country 3370 0
Australia
Phone 3370 0
+ 61 3 9342 3747
Fax 3370 0
+ 61 3 9342 3745
Email 3370 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.