COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Public Health 237385 237385 0 0
Public Health 237386 237386 0 0
Health promotion/education

Study type
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
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

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)

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
Both males and females
Can healthy volunteers participate?
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
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.
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237169 0
Name [1] 237169 0
Australian National University
Address [1] 237169 0
Centre for Mental Health Research
College of Medicine, Biology and Environment
Eggleston Road
Acton ACT 0200
Country [1] 237169 0
Primary sponsor type
Australian National University
School of Psychology
Building 39
Australian National University
Acton ACT 0200
Secondary sponsor category [1] 4658 0
Name [1] 4658 0
Kerry Howard
Address [1] 4658 0
PO Box 4003
Country [1] 4658 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 239261 0
Approval date [1] 239261 0
Ethics approval number [1] 239261 0

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
Trial related presentations / publications
Public notes

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
Country 13006 0
Phone 13006 0
+61 2 6287 1019
Fax 13006 0
Email 13006 0
Contact person for scientific queries
Name 3934 0
Professor Kathy Griffiths
Address 3934 0
Centre for Mental Health Research
Australian National University
Eggleston Road
Country 3934 0
Phone 3934 0
+61 2 6125 9723
Fax 3934 0
Email 3934 0

No information has been provided regarding IPD availability
Summary results
No Results