ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001589875

Ethics application status

Approved

Date submitted

3/08/2021

Date registered

19/11/2021

Date last updated

23/06/2024

Date data sharing statement initially provided

19/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

teenAID - Evaluating first aid training for students in Year 8

Scientific title

Cluster Randomised Controlled trial of secondary school student training in teen Mental Health First Aid 7-9 Edition 3 versus Red Cross Physical First Aid on ability to assist peers with a mental health problem, physical illness, injury or emergency.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Adolescent Mental Health

Youth Suicide Prevention

Adolescent Physical illness and injury

Condition category

Condition code

Mental Health

Suicide

Mental Health

Depression

Mental Health

Anxiety

Respiratory

Asthma

Emergency medicine

Resuscitation

Injuries and Accidents

Fractures

Inflammatory and Immune System

Allergies

Injuries and Accidents

Poisoning

Injuries and Accidents

Burns

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

teen Mental Health First Aid
The teen Mental Health First Aid (tMHFA) 7-9 Edition 3 is a redesigned course of MHFA Australia for students in Years 7-9 that has been developed with input from multiple curriculum specialists and student focus groups. tMHFA builds on the familiar first aid model and teaches students an easy to use and remember 5-step action plan for helping a friend with a mental health problem.
The tMHFA program is designed to develop students’ knowledge and skills in:
- recognising warning signs that a friend is developing a mental health problem;
- understanding how to talk to a friend 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; and
- how to respond in a crisis situation.

tMHFA has been designed by experts in MHFA training and youth mental health. tMHFA contains a multimedia presentation, videos, a workbook and learning activities. The program is presented by Accredited MHFA Instructors who have specialist knowledge in youth mental health and experience working within schools.
tMHFA involves delivery of 4 x 50-minute sessions. For this trial, tMHFA will be delivered to Year 8 students in regular school classes, in groups of 20-30 students, once a week, over a four week period.
Class attendance will be taken by supervising teachers and provided to researchers according to Unique student ID to maintain anonymity.

Intervention code [1]

Behaviour

Comparator / control treatment

Red Cross Let’s Talk First Aid
The Red Cross Let’s Talk First Aid program is a non-accredited course, presented over 4 x 50-minute sessions, designed to equip adolescents
with the skills to provide basic physical first aid to their peers. The program is designed to develop students’ knowledge and skills in:
- Chain of Survival
- DRSABC - action plan
- Recovery Position
- CPR and defibrillation
- Basic first aid for common injuries and emergencies such as sprains, strains, fractures, dislocations, concussions, asthma, anaphylaxis etc.

The program is presented by an experienced first aid instructor from Australian Red Cross. Teaching sessions involve a multimedia presentation and practical demonstrations of techniques such as the recovery position and CPR.

For this trial, Let's Talk First Aid will be delivered to Year 8 students in regular school class time, in groups of 20-30 students, once a week, over a four week period.

Class attendance will be taken by supervising teachers and provided to researchers according to Unique student ID to maintain anonymity.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome of interest will be the quality of mental health first aid intentions. These will be measured using responses to a video vignette depicting a young person with mental health problems. 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 video. 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 Lucy if she 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 Lucy’s head”). Response items are scored as a criterion referenced
test against the action plan.

Timepoint [1]

The Primary outcome will be measured at three time points: baseline - a week before training begins, post-training - a week after training, (primary timepoint ) and follow-up - 12 months after training.

Secondary outcome [1]

Confidence in supporting a peer will be assessed by asking: “If you had contact with someone who had a problem like Lucy’s, how confident would you feel in helping them?” (rated on a 5-point Likert scale).

Timepoint [1]

The Secondary outcome {1} will be measured at baseline (a week before training begins), post-training (a week after training) and follow-up (12 months after training).

Secondary outcome [2]

Help provided to peers will be assessed by asking the adolescents at baseline and 12 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) 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, 11 actions will be listed for endorsement including recommended actions e.g. "Suggested they tell an adult (other than a health professional) about their problems" (e.g. a parent or teacher) and non-recommended actions e.g. "Avoided talking about suicide, because it might have put the idea in their head." As well as "I didn't do anything" , "I don't know" and open text response for "something else". The quality of help provided to the peer will be scored using the teen MHFA action plan as the standard.

Timepoint [2]

The Secondary outcome {2} will be measured at baseline (a week before training begins) and follow-up (12 months after training).

Secondary outcome [3]

The social distance scale for mental health problem 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 Lucy on the weekend?”. The 5-point Likert scale options range from: yes definitely to definitely not.

Timepoint [3]

The Secondary outcome {3} will be measured at baseline (a week before training begins), post training (a week after training) and follow-up (12 months after training).

Secondary outcome [4]

The weak-not-sick scale for social phobia, will be assessed using items from the personal stigma questionnaire (validated using exploratory structural equation modelling). e.g. Please indicate how strongly you personally agree or disagree with the statement "A problem like Lucy's is a sign of personal weakness" responses (rated on a 5-point Likert scale). The 5-point Likert scale options range from: yes definitely to definitely not.

Timepoint [4]

The Secondary outcome {4} will be measured at three time points: baseline (a week before training begins), post-training (a week after training) and follow-up (12 months after training).

Secondary outcome [5]

The dangerous-unpredictable scale for depression will be assessed using items from the personal stigma 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 Lucy's are dangerous" (responses rated on a 5 point Likert scale).

Timepoint [5]

The Secondary outcome {5} will be measured at baseline (a week before training begins), post-training (a week after training) and follow-up (12 months after training).

Secondary outcome [6]

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 [6]

The Secondary outcome {6} will be measured at baseline (a week before training begins), post-training (a week after training) and follow-up (12 months after training).

Secondary outcome [7]

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 illness, injury or emergency? 8 items relating to first aid situations on a five point Likert scale from Not at all confident to Extremely confident.

Timepoint [7]

The Secondary outcome {7} will be measured at baseline (a week before training begins), post-training (a week after training) and follow-up (12 months after training).

Secondary outcome [8]

The Secondary outcome of interest will be the quality of physical first aid intentions. These will be measured using responses to a vignette depicting a young person called Alex with symptoms of asthma. 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 16 possible actions towards Alex. The possible actions are to engage in different first aid actions. Response options are based on messages that are either consistent with the Red Cross Physical First Aid recommendations (8 items, e.g. “Locate and assist with Alex’s inhaler.”) or distractor items that are contrary to the plan (8 items, e.g. “Avoid using Alex’s inhaler in case he doesn’t need it and it makes him worse.”). Response items are scored as a criterion referenced test against the recommended actions.

Timepoint [8]

The Secondary outcome {8} will be measured at three time points: baseline (a week before training begins), post-training (a week after training) and follow-up (12 months after training).

Secondary outcome [9]

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/depends for Lucy's problem from a list of Counsellor, General Practitioner or family doctor, psychologist, close friend, family member, parent, teacher, school welfare coordinator/school counsellor and religious leader.

Timepoint [9]

The Secondary outcome {9} will be measured at three time points: baseline (a week before training begins), post-training (a week after training) and follow-up (12 months after training).

Secondary outcome [10]

Recognition of a mental health problem will be assessed by a single item in response to a video vignette depicting a young person with symptoms or mental health problem "What if anything do your think is wrong with Lucy?" Student responses will be facilitated with options presented to endorse mental health illnesses (e.g. she has depression) or stigmatising responses (e.g. she is being over dramatic).

Timepoint [10]

The Secondary outcome {10} will be measured at three time points: baseline (a week before training begins), post-training (a week after training) and follow-up (12 months after training).

Secondary outcome [11]

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 Lucy, 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 [11]

The Secondary outcome {11} will be measured at three time points: baseline (a week before training begins), post-training (a week after training) and follow-up (12 months after training).

Secondary outcome [12]

Satisfaction with the tMHFA program will be assessed by asking participants to rate on a 5-point Likert scale how new the information was, how easy to understand, how well presented, and how much the different program teaching materials were liked.

Timepoint [12]

The Secondary outcome {12} will be measured at post training only (a week after training).

Secondary outcome [13]

Satisfaction with the LTFA program will be assessed by asking participants to rate on a 5-point Likert scale how new the information was, how easy to understand, how well presented, and how much the different program teaching materials were liked.

Timepoint [13]

The Secondary outcome {13} will be measured at post training only (a week after training).

Secondary outcome [14]

A further measure of satisfaction with the tMHFA program will be assessed by asking participants to rate on a 5-point Likert scale how useful the program was and how useful it is likely to be in the future. Participants will also be asked an open-ended question of the program, asking if there is anything else they would like to say "strengths, weaknesses, or how we might make it better?"

Timepoint [14]

Secondary item [14] will be measured at post training (a week after the training) and at 12 month follow-up.

Secondary outcome [15]

A further measure of satisfaction with the LTFA program will be assessed by asking participants to rate on a 5-point Likert scale how useful the program was and how useful it is likely to be in the future. Participants will also be asked an open-ended question of the program, asking if there is anything else they would like to say "strengths, weaknesses, or how we might make it better?"

Timepoint [15]

Secondary item [15] will be measured at post training (a week after the training) and at 12 month follow-up.

Secondary outcome [16]

Use of the tMHFA training manual by students after the program will be assessed by asking participants the following survey items.
How much of the manual did you read after completing the tMHFA program? - None of it - Part of it - Most of it - All of it
If you have you read the manual after the training, and how easy it was to understand? (5 point Likert scale Very easy to Very difficult),
Do you think you will use the manual in the future, - Yes - No - Not sure - I have already used it since the training finished.
What have you done with it? - Kept it - Lent it to someone - Given it away -Thrown it away - Lost it - Don't know
Did you show your manual to anyone in your family? - Yes - No - Not sure/Can't remember
Did you speak about the tMHFA program to anyone in your family? - No - Yes - Please tell us briefly what you spoke about __________________

Timepoint [16]

The Secondary outcome {16} will be measured at 12 month follow-up training only.

Secondary outcome [17]

Use of the LTFA training manual by students after the program will be assessed by asking participants the following survey items.
How much of the manual did you read after completing the LTFA program? - None of it - Part of it - Most of it - All of it
If you have you read the manual after the training, and how easy it was to understand? (5 point Likert scale Very easy to Very difficult),
Do you think you will use the manual in the future, - Yes - No - Not sure - I have already used it since the training finished.
What have you done with it? - Kept it - Lent it to someone - Given it away -Thrown it away - Lost it - Don't know
Did you show your manual to anyone in your family? - Yes - No - Not sure/Can't remember
Did you speak about the LTFA program to anyone in your family? - No - Yes - Please tell us briefly what you spoke about __________________

Timepoint [17]

The Secondary outcome {17} will be measured at 12 month follow-up training only.

Secondary outcome [18]

In the online questionnaire, participants will be asked about situations in the previous 12 months where the participant encountered someone who has required first aid because of a physical emergency illness or injury, whether they offered any help and what they did to help, and (at 12 months) whether the information in the PFA course influenced what they did. To facilitate responses, common first-aid situations and helpful and unhelpful actions will be provided for participants to endorse.

Timepoint [18]

The Secondary outcome {18} will be measured at baseline (a week before training begins), and follow-up (12 months after training).

Eligibility

Key inclusion criteria

Schools to be included in the trial must be public high schools located in greater Perth Western Australia and have at least 10% of staff with Youth Mental Health First Aid accreditation. Schools must not have received any mental health first aid training for students in their current Year 8 cohort. All Year 8 students from host schools will be eligible to participate.

Minimum age

12 Years

Maximum age

15 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Schools that do not have least 10% of staff with Youth Mental Health First Aid accreditation.
Schools with year 8 cohorts of less than 160 students to ensure maintenance of participation at 12 month follow-up. Schools with an ICSEA of more or less than 1 standard deviation than the mean (of the list of those eligible) to try to limit variability between randomised pairs.

tMHFA is not designed as a suicide postvention program. If a recent suicide has occurred in a school, the appropriateness of running the tMHFA program will be assessed before formally recruiting the school.

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)

The design of the study is a cluster randomised controlled trial, using schools as the cluster. All schools will receive either teen Mental Health First Aid or physical first aid.
Neither research staff determining eligibility nor host schools will be aware of their allocation at enrolment into the study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Once consent forms signed by school principals are received from two schools they will be numbered according to order of enrolment (1-2, 3-4, 5-6, 7-8). Once school order has been established, a random sequence of numbers between 1 and 2 is generated, where 1 = treatment group (tMHFA) and 2 = control group (LTFA). Computer-generated random numbers (obtained at http://www.random.org/sequences) will be used by the trial statistician, who will be blind to the identity of the school to randomly allocate schools to receive either tMHFA or LTFA training. Lead staff at the schools will be advised of randomisation to tMHFA or LTFA training at least 8 weeks prior to their first training session, to allow time for planning and scheduling of training sessions.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Neither the schools nor the instructors will be blinded to allocation as they will be aware which training they are receiving or delivering. However, researchers handling the final dataset and coding participant responses will be blinded to group and time variables.
Students in Year 8 at paired schools will receive either the intervention tMHFA or the control training PFA in parallel.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Exploratory power analysis was completed to determine the feasibility of a Parallel Cluster Randomised Controlled Trial with 8 schools to detect effects of the training. If we anticipate cohorts of approximately 180 Year 8 students at each of the 8 host schools, approximately 1440 students in total will be available to complete the training. In the 2017 uncontrolled trial of tMHFA 7-9 the ICC for quality of intended support (primary outcome) was 0.009 and the median across measures was 0.013. Assuming a small ICC of 0.01 and a correlation of 0.7 across time for participant outcomes, a sample of 128 students at each school will give 90% power to detect a small effect size of d=0.2 between training types. This takes into account number of students with parent consent, lower attendance than reported enrolment and attrition across post training to 12-month follow-up

Data analysis for this study will include descriptive statistics, such as means and percentages, to examine the main socio-demographic characteristics of the students. To evaluate the effects of the tMHFA and PFA training, changes in key outcomes over time (pre, post and follow-up) will be examined using logistic and linear regression mixed-models for binary and continuous outcomes. Results will be reported as odds ratios or unstandardized regression coefficients, with 95% confidence intervals. The strength of these maximum likelihood-based models is that they can account for the clustered data (i.e. the correlation of individual responses over time and the correlation of individual responses within schools). Open-ended questions, related primarily to participants’ thoughts on the strengths and weaknesses of the training, will be subjected to a content analysis, where common opinions are extracted to provide an overall impression of participants’ views of the tMHFA and PFA courses and their participation in the research project.

We have published data for the Primary outcome Quality of mental health first aid intentions reporting omega =0.84 for the helpful subscale and omega =0.76 for unhelpful subscale" to the 'Statistical methods/analysis' field in step 6.
We have published data for Secondary outcome [1] Confidence in supporting a peer that confidence predicts quality of subsequent helping actions 6 months later. In the control group of a previous randomised controlled trial evaluation of tMHFA 10–12, the test–retest reliability for this measure was r = 0.48 after 4 weeks. https://doi.org/10.1177/0004867417753552
In the previous Uncontrolled trial of tMHFA 7-9 Secondary outcome [2] Help provided to peers Omega total at pre-test was 0.68 (interval) and 0.82 (ordinal). https://doi.org/10.1186/s13033-019-0325-4
In the previous Uncontrolled trial of tMHFA 7-9 Secondary outcome [3] The social distance scale for mental health problem Omega total at pre-test was 0.68 (interval) and 0.82 (ordinal) for weak-not-sick. https://doi.org/10.1186/s13033-019-0325-4
In the previous Uncontrolled trial of tMHFA 7-9 Secondary outcome [4] The weak-not-sick scale for social phobia Omega total at pre-test was 0.68 (interval) and 0.74 (ordinal). https://doi.org/10.1186/s13033-019-0325-4
In the previous Uncontrolled trial of tMHFA 7-9 Secondary outcome [5] The dangerous-unpredictable scale Omega total at pre-test 0.60 was (interval) and 0.67 (ordinal) for dangerous-unpredictable, https://doi.org/10.1186/s13033-019-0325-4

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

2/09/2024

Actual

Date of last participant enrolment

Anticipated

29/04/2025

Actual

Date of last data collection

Anticipated

29/04/2026

Actual

Sample size

Target

1024

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

16 Marcus Clarke St
Canberra, ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

The University of Melbourne
Grattan St Parkville,
Victoria, 3010, Australia

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Mental Health First Aid Australia

Address [1]

Level 6, 369 Royal Parade
Parkville VIC 3052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Ethics Committee (Health Sciences HESC)

Ethics committee address [1]

Human Research Ethics
Office for Research Ethics and Integrity
Level 1, 780 Elizabeth Street (near cnr Grattan Street), (University Building No. 220) Melbourne VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/07/2021

Approval date [1]

16/09/2021

Ethics approval number [1]

2021-20905-21670-3

Summary

Brief summary

The teen Mental Health First Aid program for students in Year 7-9 (tMHFA7-9) teaches students aged 12-15 years how to:
- recognise warning signs that a friend is developing a mental health problem
- understand how to talk to a friend 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

The course was previously evaluated in an uncontrolled trial with year 8 students. As a result of the research findings a revised edition of the tMHFA 7-9 was developed in 2020 and is being piloted with year 8 students in two Western Australian secondary schools in 2021. The aim of this project is to provide evidence on the effectiveness of the tMHFA 7-9 Edition 3 course in a parallel randomised controlled trial with year 8 students, using the Red Cross "Let's Talk First Aid" course for Year 8 (LTFA) as the comparator.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Laura Hart

Address

Level 4, 207 Bouverie Street, Carlton

The University of Melbourne, Victoria 3010 Australia

Country

Australia

Phone

+61 421 548 505

Fax

[email protected]

Contact person for public queries

Name

Dr Laura Hart

Address

Level 4, 207 Bouverie Street, Carlton

The University of Melbourne, Victoria 3010 Australia

Country

Australia

Phone

+61 421 548 505

Fax

[email protected]

Contact person for scientific queries

Name

Dr Laura Hart

Address

Level 4, 207 Bouverie Street, Carlton

The University of Melbourne, Victoria 3010 Australia

Country

Australia

Phone

+61 421 548 505

Fax

[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, available 15 years after completion of research activity.

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 researcher [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Other Details
12622	Study protocol	On request via email to the lead researcher lhart@... [More Details]
12623	Informed consent form	On request via email to the lead researcher lhart@... [More Details]
12624	Ethical approval	On request via email to the lead researcher lhart@... [More Details]

Results publications and other study-related documents

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Trial Review

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