Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000633381
Ethics application status
Approved
Date submitted
31/03/2017
Date registered
2/05/2017
Date last updated
18/02/2022
Date data sharing statement initially provided
15/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
teenAid: A Cluster Randomised Controlled Trial to evaluate first aid training for adolescents
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] 291613 0
Nil known
Universal Trial Number (UTN)
Trial acronym
teenAID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent Mental Health 302664 0
Youth Suicide Prevention 302665 0
Condition category
Condition code
Mental Health 302179 302179 0 0
Suicide
Mental Health 302180 302180 0 0
Depression
Mental Health 302181 302181 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
teen Mental Health First Aid (teen MHFA) is a 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 75 minute sessions of a teen MHFA training course for adolescents. These 3 sessions are spread over a minimum of 2 and maximum of 4 weeks (usually 1 session p/week for 3 weeks) depending on each school's timetabling requirements. Sessions are administered by an experienced teen MHFA instructor, with a regular classroom staff also present to class groups of between 15-30 students.

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 an optional course administered by the same experienced instructor, and can be given via either: 2 days of 7 hours of training, or 4x 4-hour sessions of an evening (allows time for extra breaks), depending on what suits each school community. While attendance is optional a register of attendance will be taken by the instructor for the purposes of sending a certificate of completion to those completing the course.
In the following year, a new cohort of Year 10 students will receive the cross-over (opposite) intervention, while the original cohort complete the (second follow-up of three with post completed and 18 month to come) 12 month follow-up measures after the first intervention.
Intervention code [1] 297631 0
Prevention
Intervention code [2] 297632 0
Behaviour
Comparator / control treatment
The active control will be a 3x 75 minute 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 75 minute sessions. The 3 sessions are spread over a minimum of 2 and maximum of 4 weeks (usually 1 session p/week for 3 weeks) depending on each school's timetabling requirements. Sessions will be administered by an experienced Red Cross first aid instructor, in class groups of 15-30 students.
Control group
Active

Outcomes
Primary outcome [1] 301602 0
The primary outcome of interest will be the quality of mental health first aid intentions. These will be measured using responses to vignettes describing a young person with depression and suicidal thoughts and one with social anxiety disorder. Participants will be asked to rate on a 5-point Likert scale (from ‘Never do this’ to ‘Definitely do this’) how likely they are to do each of 12 possible actions 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.
Timepoint [1] 301602 0
The Primary outcome will be measured at four time points: baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [1] 333274 0
Confidence in supporting a peer will be assessed by asking: “If you had contact with someone who had a problem like Jeannie’s/John’s, how confident would you feel in helping them?” (rated on a 5-point scale). We have unpublished data that confidence predicts quality of subsequent helping actions 6 months later. Test-retest is 0.67.
Timepoint [1] 333274 0
The Secondary outcome {1} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [2] 333490 0
Help provided to peers will be assessed by asking the adolescents at baseline, 12 months and 18 months whether, over the previous 12 months, they had come across someone with a mental health problem, what the nature of the problem was, whether they tried to help the person, what they did to help, and (at 12 months and 18 months) whether the information in the teen MHFA course influenced what they did. These questions are adapted from an evaluation of public use of MHFA guidelines. To facilitate responses, options will be given in drop-down menus. The quality of help provided to the peer will be scored using the teen MHFA action plan as the standard. Cronbach’s alpha is 0.77.
In order to get more detailed qualitative data on stories of providing mental health first aid to an adolescent with a mental health problem, participants who report giving help will be asked permission to be phoned and given an interview. The questions asked and the method of analysis will be based on previous work collecting and analysing stories of mental health first aid experiences. Data will be analysed using thematic analysis. NVivo will be used to code the text of the interviews. Sampling will be continued until saturation is reached with new themes. It is estimated that around a third of participants will be eligible for an interview over the following 18 months.
Timepoint [2] 333490 0
The Secondary outcome {2} will be measured at baseline (before training begins) and follow-up (12 and 18 months after training).
Secondary outcome [3] 333491 0
Help received from peers will be assessed by asking participants whether in the previous 12 months, they have started to experience a mental health problem or a mental health crisis (definitions of ‘mental health problem’ and ‘mental health crisis’ are provided). Participants who say “Yes”, will then be asked whether anyone has tried to support or assist them with this mental health problem or crisis, what the person did to help and whether the participant received any treatment or advice from a professional for this problem or crisis. To facilitate responses, options will be given in drop-down menus. The quality of help received from peers will be scored using the teen MHFA action plan as the standard. Cronbach’s alpha, based on 60 students from the pilot who had mental health problems at baseline, is 0.56. Participants with mental health problems will also be asked whether they consent to a telephone interview, which will be used to gather qualitative data on stories of receiving mental health first aid. The qualitative analysis will use the methods described for help provided to peers.
Timepoint [3] 333491 0
The Secondary outcome {3} will be measured at baseline (before training begins) and follow-up (12 and 18 months after training)
Secondary outcome [4] 333492 0
The social distance scale for depression will be assessed using items from the personal stigma questionnaire and social distance questionnaire (validated using exploratory structural equation modelling). e.g. “Would you be happy to go out with John on the weekend?”. The response options are: yes definitely, yes probably, probably not or definitely not. Test-retest for the social distance scale ranges from 0.68 to 0.79.
Timepoint [4] 333492 0
The Secondary outcome {4} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [5] 333493 0
The weak-not-sick scale for depression will be assessed using items from the personal stigma questionnaire and social distance questionnaire (validated using exploratory structural equation modelling). e.g. Please indicate how strongly you personally agree or disagree with the statement "A problem like John's is a sign of personal weakness" responses (rated on a 5-point scale). Test-retest for the weak-not-sick scale ranges from 0.68 to 0.79.
Timepoint [5] 333493 0
The Secondary outcome {5} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [6] 333494 0
The dangerous-unpredictable scale for depression will be assessed using items from personal stigma questionnaire and social distance questionnaire (validated using exploratory structural equation modelling). e.g. Please indicate how strongly you personally agree or disagree with the statement "People with a problem like John's are dangerous" (responses rated on a 5-point scale).Test-retest for the dangerous-unpredictable scale ranges from 0.68 to 0.79
Timepoint [6] 333494 0
The Secondary outcome {6} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [7] 333495 0
The social distance scale for social phobia will be assessed will be assessed using items from personal stigma questionnaire and social distance questionnaire (validated using exploratory structural equation modelling). e.g. “Would you be happy to go out with Jeannie on the weekend?”. The response options are: yes definitely, yes probably, probably not or definitely not. Test-retest for the social distance scale ranges from 0.68 to 0.79.
Timepoint [7] 333495 0
The Secondary outcome {7} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [8] 333496 0
The weak-not-sick scale for social phobia, will be assessed using items from personal stigma questionnaire and social distance questionnaire (validated using exploratory structural equation modelling). e.g. Please indicate how strongly you personally agree or disagree with the statement "A problem like Jeannie's is a sign of personal weakness" responses (rated on a 5-point scale). Test-retest for weak-not-sick scale scale ranges from 0.68 to 0.79.
Timepoint [8] 333496 0
The Secondary outcome {8} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [9] 333497 0
The dangerous-unpredictable scale for social phobia, will be assessed using items from personal stigma questionnaire and social distance questionnaire (validated using exploratory structural equation modelling). e.g. Please indicate how strongly you personally agree or disagree with the statement "People with a problem like Jeannie's are dangerous" (responses rated on a 5-point scale). Test-retest for the dangerous-unpredictable scale ranges from 0.68 to 0.79
Timepoint [9] 333497 0
The Secondary outcome {9} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [10] 333674 0
Psychological distress in students will be measured using the K6 questionnaire, which has been extensively validated against diagnostic measures and using item response theory.
Timepoint [10] 333674 0
The Secondary outcome {10} will be measured at baseline (before training begins) and follow-up (12 and 18 months after training).
Secondary outcome [11] 333675 0
Physical first aid actions will be asked about to assess the impact of the control condition and to make the evaluation questionnaire appropriate for both interventions. Participants will be asked about situations in the previous 12 months where the participant came across someone who has required first aid because of a physical emergency or injury, whether they offered any help and what they did.To facilitate responses, options will be given in drop-down menus.
Timepoint [11] 333675 0
The Secondary outcome {11} will be measured at baseline (before training begins) and follow-up (12 and 18 months after training).
Secondary outcome [12] 333676 0
Physical first aid actions will be asked about to assess the impact of the control condition and to make the evaluation questionnaire appropriate for both interventions. Participants will be asked about situations in the previous 12 months and if they were a recipient of any physical first aid and what was done to help them. To facilitate responses, options will be given in drop-down menus.
Timepoint [12] 333676 0
The Secondary outcome {12} will be measured at baseline (before training begins) and follow-up (12 and 18 months after training).
Secondary outcome [13] 333677 0
Satisfaction with the teenMHFA program will be assessed by asking participants to rate on a Likert scale how new the information was, how easy to understand, how well presented, how enjoyable, and how much the different program teaching materials were liked. Participants will also be asked open-ended questions asking about strengths and weaknesses of the program.
Timepoint [13] 333677 0
The Secondary outcome {13} Administered at post training only.
Secondary outcome [14] 333678 0
Satisfaction with the Red Cross Physical First Aid program will be assessed by asking participants to rate on Likert scales how new the information was, how easy to understand, how well presented, how enjoyable, and how much the different program teaching materials were liked. Participants will also be asked open-ended questions asking about strengths and weaknesses of the program.
Timepoint [14] 333678 0
The Secondary outcome {14} Administered at post training only.
Secondary outcome [15] 333679 0
Adverse events will be assessed by asking students about any distress they have experienced as a result of the teenMHFA course, completing the questionnaires or any first aid they provided or received. In our previous piloting work we experienced no adverse events. CID Sawyer is a child and adolescent psychiatrist and is available for liaising with school staff to ensure student safety if an adverse event arises.
Timepoint [15] 333679 0
The Secondary outcome {15} will be assessed at post-test, 12- and 18-month follow-up.
Secondary outcome [16] 333680 0
Adverse events will be assessed by asking students about any distress they have experienced as a result of the Red Cross Physical First Aid course, completing the questionnaires or any first aid they provided or received. In our previous piloting work we experienced no adverse events. CID Sawyer is a child and adolescent psychiatrist and is available for liaising with school staff to ensure student safety if an adverse event arises.
Timepoint [16] 333680 0
The Secondary outcome {16} will be assessed at post-test, 12- and 18-month follow-up.
Secondary outcome [17] 333803 0
A single item for personal stigma of depression "If I had a problem like John/Jeanie's I would not tell anyone" (validated using exploratory structural equation modelling) will be assessed. Test-retest for the "would not tell anyone" ranges from 0.68 to 0.79
Timepoint [17] 333803 0
The Secondary outcome {17} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [18] 333805 0
A single item for personal stigma of social phobia "If I had a problem like John/Jeanie's I would not tell anyone" (validated using exploratory structural equation modelling) will be assessed. Test-retest for the "would not tell anyone" ranges from 0.68 to 0.79
Timepoint [18] 333805 0
The Secondary outcome {18} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training)..
Secondary outcome [19] 333806 0
Recognition of depression, suicidal thoughts and social anxiety disorder will be assessed by a single item in response to vignettes describing a young person with depression and suicidal thoughts and one with social anxiety disorder "What if anything do your think is wrong with John/Jeannie?"
Timepoint [19] 333806 0
The Secondary outcome {19} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training)..
Secondary outcome [20] 333807 0
To obtain a measure of students likelihood to seek the help of an adult for a friend, students will be asked which people they consider helpful, harmful or neither for John/Jeanie's problem from a list of Counsellor, General Practitioner or family doctor, psychologist, close friend, family member, parent, teacher, school welfare coordinator/school counsellor, minister or priest and which of these people would they consider most helpful.
Timepoint [20] 333807 0
The Secondary outcome {20} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [21] 333808 0
To assess student's likelihood of seeking help for themselves they will be asked to select one or a number of options to "If I had a problem like John/Jeanie, I would....

Options include "try to deal with it on my own", "talk to a friend about it", "talk to a health professional about it (counsellor, GP or psychologist)", "talk to an adult (other than a health professional) about it (e.g. a parent or teacher "improve my diet", "try to get more sleep", "spend more time with my friends", "try to do more exercise", "look for information about my problem on the internet", "do nothing" and Other (please specify)
Timepoint [21] 333808 0
The Secondary outcome {21} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [22] 337091 0
Students will be asked an open ended question to identify the mental health problem experienced by a friend. “What was the mental health problem or crisis?”
Timepoint [22] 337091 0
The Secondary outcome {22} will be measured at baseline (before training begins) and follow-up (12 and 18 months after training).
Secondary outcome [23] 337092 0
Students will be asked an open ended question to identify the physical injury/emergency experienced by a friend. “What was the emergency or injury that required first aid?”
Timepoint [23] 337092 0
This question was added to the protocol after baseline measures were conducted with only one cohort. For the remaining 19 cohorts it will be instigated prior to their enrollment. The Secondary outcome {23} will be measured at baseline (before training begins) and follow-up (12 and 18 months after training).
Secondary outcome [24] 337093 0
Student confidence in assisting a peer in a physical first aid situation. Students will answer "How confident are you about using first aid when a friend around your age has the following accident, illness or emergency?" 8 items relating to first aid situations on a 5 point scale - Not at all confident to Extremely confident
Timepoint [24] 337093 0
The Secondary outcome {24} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).
Secondary outcome [25] 337094 0
Student self efficacy in assisting a peer in a physical first aid situation. Students will answer "I intend to use first aid when a friend around my age has the following accident, illness or emergency." 8 items relating to first aid situations on a 5 point scale - Strongly disagree to Strongly agree
Timepoint [25] 337094 0
The Secondary outcome {25} will be measured at baseline (before training begins), post-training (immediately after training) and follow-up (12 and 18 months after training).

Eligibility
Key inclusion criteria
Schools to be included in the trial must be public high schools located in greater Melbourne or regional Victoria. Schools must not have received any mental health first aid training for students in their current Year 9 and 10 cohorts. All Year 10 students from host schools will be eligible to participate. We estimate conservatively that there will be 100 Year 10 students per school.
Minimum age
15 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
teen MHFA is not designed as a suicide postvention program. If a recent suicide has occurred 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), across subsequent cohorts of Year 10 students. See below for information about the order of training. In the first year of training, four 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 six 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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 10 schools will consist of five matched pairs. Pairs will be matched according to Regional or Metropolitan location, Index of Community Socio-Educational Advantage (ICSEA), Year 10 cohort size, and proportion of EAL (English as an Additional Language) students. The first school of the pair to enrol will be assigned '1', the second '2'. Following pairing of schools, randomization will be carried out using a random sequence generator (random.org) by an independent statistician, who will be blind to the identity of the schools. Whichever number (1 or 2) appears first, will determine the school to receive teen MHFA first. In the subsequent year, the schools will crossover and receive the alternate condition. 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
Parallel
Other design features
Students in Year 10 at matched paired schools will receive either the intervention or the control training in parallel. In the following year there will be crossover at the cluster (school) level, as the new wave of Year 10 students at each school receive the alternative intervention.
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 100 Year 10 students per school and that 80% the parents will give consent for their child to participate using the passive consent approach. With 10 schools participating over 2 years, this gives 20 Year 10 clusters and 1600 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), including the pilot uncontrolled data (ICC=0.006) we have used a small ICC for the school Year 10 clusters in these power and sample size calculations. According to Optimal Design software (Version 3.01), for linear change trajectories with 80 students per Year 10 cluster (10 intervention and 10 control clusters), 1 pre and 3 post-training measurements and assuming an ICC=0.006 for school Year 10 clusters, the study will the study will have a 0.80 power to detect a relatively small effect size (delta=0.24) at an alpha level of .05. In our pilot data, effect sizes were small to medium.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2017
Actual
15/05/2017
Date of last participant enrolment
Anticipated
31/07/2019
Actual
18/10/2019
Date of last data collection
Anticipated
31/12/2021
Actual
5/12/2021
Sample size
Target
3000
Accrual to date
Final
3759
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296055 0
Government body
Name [1] 296055 0
National Health and Medical Research Council
Country [1] 296055 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne
Melbourne Victoria 3010
Country
Australia
Secondary sponsor category [1] 294946 0
Charities/Societies/Foundations
Name [1] 294946 0
Mental Health First Aid Australia
Address [1] 294946 0
Level 6, 369 Royal Parade
Parkville VIC 3052
Country [1] 294946 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297312 0
University of Melbourne Human Ethics Advisory Group (HEAG)
Ethics committee address [1] 297312 0
Ethics committee country [1] 297312 0
Australia
Date submitted for ethics approval [1] 297312 0
30/01/2017
Approval date [1] 297312 0
08/02/2017
Ethics approval number [1] 297312 0
1341238.4
Ethics committee name [2] 297314 0
University of Melbourne Human Ethics Sub-Committee (Health Sciences HESC)
Ethics committee address [2] 297314 0
Ethics committee country [2] 297314 0
Australia
Date submitted for ethics approval [2] 297314 0
30/01/2017
Approval date [2] 297314 0
08/02/2017
Ethics approval number [2] 297314 0
1341238.4

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

Contacts
Principal investigator
Name 73674 0
Dr Laura Hart
Address 73674 0
University of Melbourne, 207 Bouverie St, Carlton VIC 3010
Country 73674 0
Australia
Phone 73674 0
+61 3 8344 0612
Fax 73674 0
Email 73674 0
[email protected]
Contact person for public queries
Name 73675 0
Karen Gregg
Address 73675 0
University of Melbourne, 207 Bouverie St, Carlton VIC 3010
Country 73675 0
Australia
Phone 73675 0
+61 3 9035 6515
Fax 73675 0
Email 73675 0
[email protected]
Contact person for scientific queries
Name 73676 0
Laura Hart
Address 73676 0
University of Melbourne, 207 Bouverie St, Carlton VIC 3010
Country 73676 0
Australia
Phone 73676 0
+61 3 8344 0612
Fax 73676 0
Email 73676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
survey responses
When will data be available (start and end dates)?
After analysis, and publication of findings by the research team.
Data collection is ongoing until June 2021.
Expected start date of IPD availability June 2022.
Expected end date of IPD availability at the discretion of lead researcher.
Available to whom?
On application by fellow researchers.
Available for what types of analyses?
Statistical qualitative and quantitative.
How or where can data be obtained?
On request via email to the lead researchers [email protected] or [email protected]


What supporting documents are/will be available?




Results publications and other study-related documents

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