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Trial registered on ANZCTR
Registration number
ACTRN12613000823774
Ethics application status
Approved
Date submitted
22/07/2013
Date registered
25/07/2013
Date last updated
14/04/2015
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of a year 9 and 10 high school program, Headstrong, on adolescent depression and mental health literacy.
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Scientific title
A randomised controlled trial to investigate the effects that a high school mental health literacy program, HeadStrong, has on students knowledge, attitudes, intentions, and symptoms, with regard to mental health, well being, and help-seeking.
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Secondary ID [1]
282776
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Nil known
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Universal Trial Number (UTN)
U1111-1145-2464
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression literacy
289530
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Help seeking
289531
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Stigma
289532
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Psychological distress
289533
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Resilience
289534
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Suicidal ideation
289535
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Condition category
Condition code
Mental Health
289857
289857
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The HeadStrong program comprises of a booklet, a slideshow and various appendices freely downloadable from the HeadStrong website. The program consists of 5 modules designed to teach students about the nature of depression and bipolar disorder, and how to (a) recognise the symptoms of these illnesses, (b) help friends and relatives who exhibit symptoms, (c) help themselves if they should experience symptoms, (d) increase their levels of resilience, (e) raise community awareness about mood disorders, and (f) break down stigma surrounding mood disorders.
The program will be delivered in class alongside classroom activities over a period of 5-8 weeks within Term 1 (approximately 10 hours in total). Note that there is no online component to the delivery of the program, the materials are simply available freely and downloadable online.
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Intervention code [1]
287447
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Prevention
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Intervention code [2]
287600
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Behaviour
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Comparator / control treatment
The control schools will deliver classes as normal but will be welcome to deliver the HeadStrong program once follow up measures for intervention schools have been collected.
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Control group
Active
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Outcomes
Primary outcome [1]
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Depression literacy as assessed using a specifically developed
questionnaire designed to assess students’ knowledge and understanding of the information covered by the HeadStrong program.
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Assessment method [1]
289919
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Timepoint [1]
289919
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Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
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Secondary outcome [1]
303569
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Help seeking as measured by the Inventory of Attituted Toward Seeking Mental Health Services (IASMHS)
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Assessment method [1]
303569
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Timepoint [1]
303569
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Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
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Secondary outcome [2]
303570
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Depression stigma as measured by the Depression Stigma Scale (DSS)
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Assessment method [2]
303570
0
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Timepoint [2]
303570
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Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
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Secondary outcome [3]
303571
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Psychological distress as measured by the Depression and Anxiety Stress Scale (DASS-21)
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Assessment method [3]
303571
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Timepoint [3]
303571
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Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
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Secondary outcome [4]
303572
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Suicidal ideation as measured by 5 items from the Mood and Feelings Questionnaire (MFQ)
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Assessment method [4]
303572
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Timepoint [4]
303572
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Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
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Secondary outcome [5]
303573
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Resilience as measured by Resilience Scale (RS)
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Assessment method [5]
303573
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Timepoint [5]
303573
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Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
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Secondary outcome [6]
303574
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School bullying will be assessed using a specifically developed
questionnaire.
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Assessment method [6]
303574
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Timepoint [6]
303574
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Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
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Secondary outcome [7]
303857
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Risk of substance abuse using the Substance Use Risk Profile Scale (SURPS)
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Assessment method [7]
303857
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Timepoint [7]
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Post-test (end of Term 1), follow up (end of Term 3).
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Eligibility
Key inclusion criteria
Students in years 9 and 10 who are attending the schools receiving the intervention programs. Students and their parents must have consented to participate in the program.
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Minimum age
13
Years
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None identified.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
4/02/2013
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Actual
4/02/2013
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Date of last participant enrolment
Anticipated
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Actual
16/12/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
287545
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Charities/Societies/Foundations
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Name [1]
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Black Dog Institute
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Address [1]
287545
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Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
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Country [1]
287545
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Australia
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Funding source category [2]
287663
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Commercial sector/Industry
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Name [2]
287663
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NIB Health Fund
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Address [2]
287663
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Locked Bag 2010
Newcastle NSW 2300
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Country [2]
287663
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Australia
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Primary sponsor type
Individual
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Name
Professor Helen Christensen
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Address
Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
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Country
Australia
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Secondary sponsor category [1]
286298
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None
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Name [1]
286298
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Address [1]
286298
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Country [1]
286298
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289626
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University of New South Wales Human Research Ethics Committee
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Ethics committee address [1]
289626
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Grants Management Office
Level 3, Rupert Myers Building South Wing
UNSW Kensington Campus NSW 2052
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Ethics committee country [1]
289626
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Australia
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Date submitted for ethics approval [1]
289626
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Approval date [1]
289626
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04/12/2012
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Ethics approval number [1]
289626
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Summary
Brief summary
The HeadStrong program is a mood disorders prevention program delivered to Years 9 and 10 secondary school students in NSW. The program is delivered by teachers within Personal Development, Health, and Physical Education (PDHPE) classes. Schools will be randomly allocated to the intervention or control condition with measures being administered at baseline, immediately post program completion and 6 months follow up. The goal is to determine whether the HeadStrong program causes lasting improvements in students’ knowledge, attitudes, intentions, and symptoms, with regard to mental health, well being, and help-seeking.
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Trial website
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Trial related presentations / publications
N/A
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Public notes
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Contacts
Principal investigator
Name
41190
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Prof Helen Christensen
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Address
41190
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Black Dog Institute
University of New South Wales
Hospital Road
Randwick NSW 2031
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Country
41190
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Australia
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Phone
41190
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+61 2 9382 3717
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Fax
41190
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Email
41190
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[email protected]
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Contact person for public queries
Name
41191
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Ms Hannah Buckley
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Address
41191
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Black Dog Institute
University of New South Wales
Hospital Road
Randwick NSW 2031
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Country
41191
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Australia
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Phone
41191
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+61 2 9382 4530
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Fax
41191
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Email
41191
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[email protected]
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Contact person for scientific queries
Name
41192
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Prof Helen Christensen
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Address
41192
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Black Dog Institute
University of New South Wales
Hospital Road
Randwick NSW 2031
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Country
41192
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Australia
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Phone
41192
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+61 2 9382 3717
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Fax
41192
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Email
41192
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[email protected]
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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.
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