Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000497202
Ethics application status
Approved
Date submitted
17/06/2009
Date registered
22/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Help-seeking for Depression by Young People - considering the impact of Stigma
Scientific title
A randomised control trial for the effectiveness of a mental health literacy intervention promoting a biological model of depression to facilitate a reduction in stigma and increase help-seeking intention in young people
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effectiveness of a mental health literacy intervention promoting a biological model of depression to facilitate a reduction in stigma and increase help-seeking intention in young people 237050 0
Condition category
Condition code
Mental Health 237370 237370 0 0
Depression
Public Health 237385 237385 0 0
Epidemiology
Public Health 237386 237386 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It will comprise a randomised control trial (RCT) where students are randomly assigned to one of three educational paradigms: a biological attribution condition, a psychosocial attribution condition or a control condition involving the provision of general information about depression. The intervention will be delivered online.

The Biological Condition

Content for this experimental intervention will include a vignette outlining information about the biological basis for depression. The general message will be that 'Depression is an illness like any other illness' and that the onset of depression is due to a chemical imbalance in the brain.

The Psychosocial Condition

Content for this experimental intervention will include a vignette outlining information about the psychosocial basis for depression. The general message will be that depression results from the stress in our social environment and our reactions to it.

The survey and intervention will be completed online in one lesson of the normal class schedule (approximately 50 minutes), in a one-off educational intervention.
Intervention code [1] 236772 0
Behaviour
Comparator / control treatment
This intervention will comprise a vignette and standard general information around depression which focuses on the symptoms experienced by a person with depression (eg. trouble sleeping, low mood, irritability, feeling lethargic) without providing a causal explanation.
Control group
Active

Outcomes
Primary outcome [1] 238174 0
Reduction in anticipated self-stigma for depression
Timepoint [1] 238174 0
Immediately post-intervention using Barney's (2007) Self-Stigma for Depression Scale (SSDS)
Secondary outcome [1] 242467 0
Increased general help-seeking intention by young people for depression
Timepoint [1] 242467 0
Immediately post-intervention using Rickwood's General Help-Seeking Questionnaire (GHSQ)

Eligibility
Key inclusion criteria
This will be a universal intervention (ie, participants selected regardless of mental health status) involving all Year 11 and 12 students in each college.
Minimum age
16 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
15 years or under.

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)
We anticipate that all Year 11 and 12 students in the consenting colleges will be invited to participate. We propose operating on the basis of passive consent for participation from the parents/guardians of students and informed consent (via online acceptance) from each student who participates.

The participants will be young mature minors aged 16 to 18 years. As college students they are likely to have achieved a sufficient maturity and competence to enable them to understand fully what is proposed (NS4.2a: Consent by children under the age of majority but with sufficient competence to decide).

We anticipate that the young person's consent is implied by clicking on the “I agree” button at the bottom of the online Information and Consent page and by completing the questionnaire and intervention. .

Parental consent is normally required where an anonymous questionnaire is to be administered to children in schools. However, the experience of other researchers in schools is that there are major barriers to receiving back such permission forms in the school context as they become lost in bags or otherwise mislaid or overlooked. Given the age and educational level of the students, potential benefits of the study and the low level of risk (particularly as the survey is anonymous and no data can be linked to individual students) and the provision of opt-out options for parents, we ask that the committee approve the proposed implied consent from parents and active consent from young people.

Conditions are randomly allocated to students via a sealed white envelope, inside which is a piece of paper with a 'password' code that is required to be entered into the online environment. Each group has a unique colour code allocated to that condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to one of three intervention conditions. The randomisation will occur via sealed intervention envelopes, prepared by a statistician who will prepare the intervention envelopes using a computer based random number generator, independently of the primary investigator prior to the intervention taking place.

Envelopes are then handed out in order to the school students as they sit at the computers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This intervention will be delivered in a single lesson over approximately 50 minutes. Each participant will complete an online survey with data collected on a server hosted behind a firewall by the Centre for Mental Health Research. The first screen will ask for the participants consent and when consent is provided then each participant will independently work through the online questionnaire. Participants will be randomly allocated into a group via the manual process outlined earlier. Data extraction will be automated and no identifying information will be collected from participants or attached to data.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237169 0
University
Name [1] 237169 0
Australian National University
Country [1] 237169 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
School of Psychology
Building 39
Australian National University
Acton ACT 0200
Country
Australia
Secondary sponsor category [1] 4658 0
Individual
Name [1] 4658 0
Kerry Howard
Address [1] 4658 0
PO Box 4003
WESTON CREEK ACT 2611
Country [1] 4658 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239261 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 239261 0
Research Office
Chancelry Building 10B LG
East Road
Australian National University
Acton ACT 0200
Ethics committee country [1] 239261 0
Australia
Date submitted for ethics approval [1] 239261 0
11/05/2009
Approval date [1] 239261 0
03/06/2009
Ethics approval number [1] 239261 0
2009/208

Summary
Brief summary
Based on biological attribution theory it is hypothesised that the biological explanation for depression will lead to a greater decrease in young peoples’ anticipated self-stigma associated with depression than the other two conditions. It is further hypothesised that any decrease in self-stigma will lead to increased help-seeking intention (from a mental health professional) by these young people if they were to experience depression in the future.
Trial website
https://mentalhealth.anu.edu.au/survey
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29759 0
Address 29759 0
Country 29759 0
Phone 29759 0
Fax 29759 0
Email 29759 0
Contact person for public queries
Name 13006 0
Kerry Howard
Address 13006 0
PO Box 4003
WESTON CREEK ACT 2611
Country 13006 0
Australia
Phone 13006 0
+61 2 6287 1019
Fax 13006 0
Email 13006 0
[email protected]
Contact person for scientific queries
Name 3934 0
Professor Kathy Griffiths
Address 3934 0
Centre for Mental Health Research
Australian National University
Eggleston Road
ACTON ACT 2601
Country 3934 0
Australia
Phone 3934 0
+61 2 6125 9723
Fax 3934 0
Email 3934 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
SourceTitleYear of PublicationDOI
EmbaseCan a brief biologically-based psychoeducational intervention reduce stigma and increase help-seeking intentions for depression in young people? A randomised controlled trial.2018https://dx.doi.org/10.2989/17280583.2018.1467323
N.B. These documents automatically identified may not have been verified by the study sponsor.