Trial Review

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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.


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.
Secondary ID [1] 282776 0
Nil known
Universal Trial Number (UTN)
U1111-1145-2464
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression literacy
 289530 0
Help seeking 289531 0
Stigma 289532 0
Psychological distress 289533 0
Resilience 289534 0
Suicidal ideation 289535 0
Condition category
Condition code
Mental Health 289857 289857 0 0
Depression

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287447 0
Prevention
Intervention code [2] 287600 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 289919 0
Depression literacy as assessed using a specifically developed
questionnaire designed to assess students’ knowledge and understanding of the information covered by the HeadStrong program.
Timepoint [1] 289919 0
Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
Secondary outcome [1] 303569 0
Help seeking as measured by the Inventory of Attituted Toward Seeking Mental Health Services (IASMHS)
Timepoint [1] 303569 0
Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
Secondary outcome [2] 303570 0
Depression stigma as measured by the Depression Stigma Scale (DSS)
Timepoint [2] 303570 0
Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
Secondary outcome [3] 303571 0
Psychological distress as measured by the Depression and Anxiety Stress Scale (DASS-21)
Timepoint [3] 303571 0
Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
Secondary outcome [4] 303572 0
Suicidal ideation as measured by 5 items from the Mood and Feelings Questionnaire (MFQ)
Timepoint [4] 303572 0
Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
Secondary outcome [5] 303573 0
Resilience as measured by Resilience Scale (RS)
Timepoint [5] 303573 0
Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
Secondary outcome [6] 303574 0
School bullying will be assessed using a specifically developed
questionnaire.
Timepoint [6] 303574 0
Baseline(beginning of Term 1), post-test (end of Term 1), follow up (end of Term 3).
Secondary outcome [7] 303857 0
Risk of substance abuse using the Substance Use Risk Profile Scale (SURPS)
Timepoint [7] 303857 0
Post-test (end of Term 1), follow up (end of Term 3).

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.
Minimum age
13 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None identified.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2013
Actual
4/02/2013
Date of last participant enrolment
Anticipated
Actual
16/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287545 0
Charities/Societies/Foundations
Name [1] 287545 0
Black Dog Institute
Country [1] 287545 0
Australia
Funding source category [2] 287663 0
Commercial sector/Industry
Name [2] 287663 0
NIB Health Fund
Country [2] 287663 0
Australia
Primary sponsor type
Individual
Name
Professor Helen Christensen
Address
Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 286298 0
None
Name [1] 286298 0
Address [1] 286298 0
Country [1] 286298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289626 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 289626 0
Grants Management Office
Level 3, Rupert Myers Building South Wing
UNSW Kensington Campus NSW 2052
Ethics committee country [1] 289626 0
Australia
Date submitted for ethics approval [1] 289626 0
Approval date [1] 289626 0
04/12/2012
Ethics approval number [1] 289626 0

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.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 41190 0
Prof Helen Christensen
Address 41190 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick NSW 2031
Country 41190 0
Australia
Phone 41190 0
+61 2 9382 3717
Fax 41190 0
Email 41190 0
h.christensen@blackdog.org.au
Contact person for public queries
Name 41191 0
Ms Hannah Buckley
Address 41191 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick NSW 2031
Country 41191 0
Australia
Phone 41191 0
+61 2 9382 4530
Fax 41191 0
Email 41191 0
h.buckley@blackdog.org.au
Contact person for scientific queries
Name 41192 0
Prof Helen Christensen
Address 41192 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick NSW 2031
Country 41192 0
Australia
Phone 41192 0
+61 2 9382 3717
Fax 41192 0
Email 41192 0
h.christensen@blackdog.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.