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Trial registered on ANZCTR


Registration number
ACTRN12614000061639
Ethics application status
Approved
Date submitted
22/11/2013
Date registered
20/01/2014
Date last updated
13/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
teen Mental Health First Aid: A Cluster Randomised Controlled Trial
Scientific title
Cluster randomised controlled trial of secondary school student training in teen Mental Health First Aid versus physical first aid on ability to assist peers with a mental health problem.
Secondary ID [1] 283609 0
Nil
Universal Trial Number (UTN)
U1111-1150-4287
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent Mental Health 290532 0
Youth Suicide prevention 290533 0
Condition category
Condition code
Mental Health 290931 290931 0 0
Suicide
Mental Health 290932 290932 0 0
Depression
Mental Health 290933 290933 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
teen Mental Health First Aid (teen MHFA) is a new training course for adolescents in the upper High School years. The key messages of the program were developed using the expert consensus of youth mental health consumer advocates and MHFA instructors who work with youth. The program focuses on developing knowledge and skills in:
- recognising warning signs that a peer is developing a mental health problem
- understanding how to talk to a peer about mental health and seeking help
- when and how to tell a responsible adult
- where to find appropriate and helpful resources about mental illness and professional help
- how to respond in a crisis situation, including where a peer is suicidal or self-harming.

The teen MHFA Program consists of 3x 1 hour sessions of a teen MHFA training course for adolescents. These 3 sessions are spread over a maximum of 3 weeks (1 session p/week) depending on each school's timetabling requirements. Sessions are administered by an experienced Youth Mental Health instructor, with a student welfare staff member also present, to class groups of between 20-25.

Also included in the teen MHFA program is the offer of the 14-hour Youth MHFA course for teachers and parents of adolescents who attend the teen MHFA course. This is administered by the same experienced Youth Mental Health instructor, and can be given in either: 2 days with 7 hours of training, or 3-4 shorter sessions of an evening, depending on what suits each school community.

In the following year, a new cohort of Year 10 students will receive the cross-over (opposite) intervention, while the original cohort complete 12 month follow-up measures after the first intervention.
Intervention code [1] 288302 0
Prevention
Intervention code [2] 288333 0
Early detection / Screening
Comparator / control treatment
The active control will be a 3-hour abbreviated Physical First Aid course. This will cover: what is first aid, chain of survival, DRSABCD, recovery position, CPR, defibrillation, and basic first aid for common sports injuries: sprains, strains, wound care esp. abrasions and nose bleeds, fractures and dislocations, concussion, and asthma.

The physical first aid course will also be administered in 3x 1hr sessions, over a period of around 5-8 schools days (depending on school timetabling). Sessions will be administered by an experienced Red Cross first aid instructor, in class groups of 20-25 students.
Control group
Active

Outcomes
Primary outcome [1] 290915 0
First Aid intentions will be measured using forced choice responses to a vignette describing a young person with depression and suicidal thoughts. Participants will be asked to asked to select which of 12 possible actions they would take towards the person in the vignette. The possible actions are to engage in different first aid actions. Response options are based on messages that are either consistent with the teen MHFA Action Plan (6 items, e.g. “Ask John if he is thinking about suicide”) or distractor items that are contrary to the plan (6 items, e.g. “Avoid talking about suicide, because it might put the idea in John’s head”). Response items are scored as a criterion- referenced test against the action plan. Participants will be able to respond 'other (please specify)'.
Timepoint [1] 290915 0
The outcome will be measured at three time points: baseline (before training begins), post-training (immediately after training) and follow-up (12 months after training).
Secondary outcome [1] 305591 0
First aid actions provided to a peer. This will be assessed using the first aid experiences questionnaire developed by Kitchener & Jorm for evaluations of Mental Health First Aid Training. It includes questions such "Have you come across someone you thought might have a mental health problem or has experienced a mental health crisis?" (Jorm, Kitchener, & Mugford, 2005).
Timepoint [1] 305591 0
At baseline (before training begins) and follow-up (12 months after training).
Secondary outcome [2] 306196 0
Confidence in supporting a peer. This will be assessed using a 5-point Likert-type scale where 1 = Not at all confident and 5 = Extremely confident.
Timepoint [2] 306196 0
The outcome will be measured at three time points: baseline (before training begins), post-training (immediately after training) and follow-up (12 months after training).

Eligibility
Key inclusion criteria
Schools to be included in the trial must be high schools located in the greater Melbourne region. Year 10 students from these schools will be involved in the research. We estimate conservatively that there will be 100 Year 10 students per school.
Minimum age
15 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
teen Mental Health First Aid is not designed as a suicide postvention program. If a recent suicide has occured in a school, the appropriateness of running the teen MHFA program will be assessed before formally recruiting the school.

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)
The design of the study is a cluster randomised controlled trial, using schools as the cluster. All schools will receive both teen Mental Health First Aid (the intervention) and physical first aid (the control), as the study employs a crossover design. See below for information about the order of training. In the first year of training, two schools will be randomly assigned to either the intervention or control using an online random sequence generator. In the following year, these schools will cross-over to receive the alternate intervention. The same procedure will be used for the remaining two schools in Year 2. Neither the schools nor the instructors will be blinded to allocation as they will be aware which training they are receiving and in what order. However, researchers handling the final dataset and coding participant responses will be blinded to group and time variables.

Allocation is not concealed because the person who determines the random allocation is also likely to know whether or not the school (cluster) is eligible to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The four schools will be randomised by using an online random number sequence generator.
Schools will be assigned a number (from 1-4) based on the order in which the enrol in the study. A random sequence of 1-4 will be generated, which will determine the order in which the schools are provided the intervention. Schools will receive both courses over two years; randomisation will determine the order in which schools receive the intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data analysis for this study will include descriptive statistics, such as means and percentages, to examine the main socio-demographic characteristics of the students.

The hypotheses will be analyzed using mixed models for continuous and binary outcome variables, with group-by-measurement-occasion interactions. This method of analysis is well suited to the data that will be collected for this study as it takes into account its hierarchical structure, i.e. the correlation of measurement occasions within students. While we expect the school year cohort cluster level to have little substantial impact on the results, adjustment for the correlation of student responses within school year cohort clusters will be made in the analyses of
the study. Another advantage of these maximum likelihood-based methods is that they are able to
produce unbiased estimates when a proportion of the participants withdraw before the completion of the study, based on the reasonable assumption that these data are missing at random.

Possible effects of the order of school intervention and control conditions on the outcomes of interest will also be examined – i.e., whether school year cohorts that received the intervention first differed in their responses to those that received it after the control condition.

We estimate conservatively that there will be 200 Year 10 students per school and that half the parents will give consent for their child to participate. With 4 schools participating over 2 years, this gives 8 clusters and 400 adolescents. Given the matching of schools and counter-balancing of school conditions in the study design, and our previous research (Jorm, Kitchener, Sawyer, Scales, Cvetkovski, 2010) which showed a very small school cluster influence on the intra-class correlation for students (ICC=0.003), we have ignored the school cluster level in these power calculations. According to Stata 12 software, with 400 students (200 per intervention and control), and assuming a 0.70 correlation between pre-post measurements, the study will have a 0.80 power to detect small (d=0.17) group-by-measurement occasion differences in the outcomes of interest at an alpha level of 0.05. Even with a further loss of up to 20% of students due to attrition (320, 160 per intervention and control), the study will still have a 0.80 power to detect a small effect size (d=0.19) at an alpha level of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2014
Actual
2/06/2014
Date of last participant enrolment
Anticipated
Actual
10/08/2016
Date of last data collection
Anticipated
23/08/2017
Actual
17/08/2017
Sample size
Target
400
Accrual to date
Final
1938
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288292 0
Charities/Societies/Foundations
Name [1] 288292 0
Australian Rotary Health
Country [1] 288292 0
Australia
Funding source category [2] 297151 0
Government body
Name [2] 297151 0
National Health and Medical Research Council
Country [2] 297151 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne
Victoria 3010
Country
Australia
Secondary sponsor category [1] 287013 0
Charities/Societies/Foundations
Name [1] 287013 0
Mental Health First Aid Australia
Address [1] 287013 0
Level 6, 369 Royal Parade
Parkville VIC 3052
Country [1] 287013 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290187 0
University of Melbourne Human Ethics Advisory Group (HEAG)
Ethics committee address [1] 290187 0
Ethics committee country [1] 290187 0
Australia
Date submitted for ethics approval [1] 290187 0
05/12/2013
Approval date [1] 290187 0
11/02/2014
Ethics approval number [1] 290187 0
Ethics committee name [2] 290189 0
University of Melbourne Human Ethics Sub-Committee (Health Sciences HESC)
Ethics committee address [2] 290189 0
Ethics committee country [2] 290189 0
Australia
Date submitted for ethics approval [2] 290189 0
03/02/2014
Approval date [2] 290189 0
18/03/2014
Ethics approval number [2] 290189 0
Ethics committee name [3] 292676 0
Department of Education and Early Childhood Development
Ethics committee address [3] 292676 0
Ethics committee country [3] 292676 0
Australia
Date submitted for ethics approval [3] 292676 0
18/04/2014
Approval date [3] 292676 0
15/04/2014
Ethics approval number [3] 292676 0

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

Contacts
Principal investigator
Name 44394 0
Dr Laura Hart
Address 44394 0
University of Melbourne,
207 Bouverie St, Carlton VIC 3010
Country 44394 0
Australia
Phone 44394 0
+61 3 9035 6771
Fax 44394 0
Email 44394 0
lhart@unimelb.edu.au
Contact person for public queries
Name 44395 0
Alyssia Rossetto
Address 44395 0
University of Melbourne,
207 Bouverie St, Carlton VIC 3010
Country 44395 0
Australia
Phone 44395 0
+61 3 9035 6029
Fax 44395 0
Email 44395 0
alyssia.rossetto@unimelb.edu.au
Contact person for scientific queries
Name 44396 0
Laura Hart
Address 44396 0
University of Melbourne,
207 Bouverie St, Carlton VIC 3010
Country 44396 0
Australia
Phone 44396 0
+61 3 9035 6771
Fax 44396 0
Email 44396 0
lhart@unimelb.edu.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
SourceTitleYear of PublicationDOI
Embaseteen Mental Health First Aid as a school-based intervention for improving peer support of adolescents at risk of suicide: Outcomes from a cluster randomised crossover trial.2020https://dx.doi.org/10.1177/0004867419885450
N.B. These documents automatically identified may not have been verified by the study sponsor.