Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000274572
Ethics application status
Approved
Date submitted
27/06/2006
Date registered
3/07/2006
Date last updated
29/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Postcard Study
Scientific title
Suicide prevention amongst help-seeking adolescents: a postcard intervention study designed to reduce suicide risk among young people at risk of suicide who have been referred to a public mental health service.
Secondary ID [1] 262949 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide risk 1249 0
Condition category
Condition code
Mental Health 1335 1335 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized controlled trial. The intervention is receipt of a postcard enquiring about well-being, reminding about individual sources of help in times of crisis and containing a simple health promotion message. The postcard is received once a month for 12 months. The treatment group will receive the monthly postcard plus any treatment required.
Intervention code [1] 1170 0
Prevention
Comparator / control treatment
The comparison group will also receive treatment as required but no postcard.
Control group
Active

Outcomes
Primary outcome [1] 1821 0
Reduced risk of suicide as measured by reduced rates of suicidal behaviour and reduced rates of suicidal ideation.
Timepoint [1] 1821 0
Measured at baseline, 12 months (ie the end of the intervention) and 18 months.
Secondary outcome [1] 3188 0
Improved self-esteem; improved help-seeking; improved sense of perceived social support; reduced rates of hopelessness and reduced symptoms of depression.
Timepoint [1] 3188 0
These will be measured at baseline, 12 months (ie the end of the intervention) and 18 months.

Eligibility
Key inclusion criteria
1. Young people referred to ORYGEN Youth Health with a non-psychotic diosorder (Both males and females will be included in the study). 2. A recent or lifetime history of suicide risk as indicated by suicidal ideation or behaviour (including suicide attempts). 3. Resident in the Northwestern metropolitan region of Melbourne.
Minimum age
15 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known organic cause for presentation2. Intellectual disability3. Inability to speak English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be done by the statistician using a computer program. The trial researchers will not be involved in this.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation using computer generated random numbers will be used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
295
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1460 0
Charities/Societies/Foundations
Name [1] 1460 0
Australian Rotary Health Research Fund
Country [1] 1460 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Rotary Health Research Fund
Address
PO Box 3455
Parramatta, NSW 2124
Australia
Country
Australia
Secondary sponsor category [1] 1289 0
None
Name [1] 1289 0
N/A
Address [1] 1289 0
Country [1] 1289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2840 0
Mental Health Research Ethics Committee; Royal Melbourne Hospital
Ethics committee address [1] 2840 0
Ethics committee country [1] 2840 0
Date submitted for ethics approval [1] 2840 0
Approval date [1] 2840 0
05/04/2006
Ethics approval number [1] 2840 0
MHREC 2006.001

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

Contacts
Principal investigator
Name 35710 0
Address 35710 0
Country 35710 0
Phone 35710 0
Fax 35710 0
Email 35710 0
Contact person for public queries
Name 10359 0
Jo Robinson
Address 10359 0
ORYGEN Research Centre
35 Poplar Road
Parkville
VIC
3052
Country 10359 0
Australia
Phone 10359 0
03 9342 2866
Fax 10359 0
Email 10359 0
jo.robinson@mh.org.au
Contact person for scientific queries
Name 1287 0
Jo Robinson
Address 1287 0
ORYGEN Research Centre
35 Poplar Road
Parkville
Vic
3052
Country 1287 0
Australia
Phone 1287 0
03 9342 2866
Fax 1287 0
Email 1287 0
jo.robinson@mh.org.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.