Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001206718
Ethics application status
Approved
Date submitted
18/08/2022
Date registered
8/09/2022
Date last updated
11/08/2023
Date data sharing statement initially provided
8/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
teenAID: An Uncontrolled Trial of teen Mental Health First Aid 7-9 Edition 3 for students in Year 8
Scientific title
teenAID: Uncontrolled trial of Year 8 secondary school student training in teen Mental Health First Aid 7-9 Edition 3 to gather initial evidence of efficacy.
Secondary ID [1] 307758 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
A Randomised Controlled Trial (RCT) of the tMHFA 7-9 Ed 3 course and Red Cross Physical First Aid is planned (ACTRN12621001589875). However, the impact of COVID-19 and a suspension to research in some States has prevented this. The current record will undertake a Uncontrolled Trial of the teen mental health first aid program prior to a Randomised Controlled Trial (RCT) of the tMHFA 7-9 Ed 3 course and Red Cross Physical First Aid (ACTRN12621001589875) being undertaken.

Health condition
Health condition(s) or problem(s) studied:
Adolescent Mental Health 327330 0
Youth Suicide Prevention 327331 0
Condition category
Condition code
Mental Health 324460 324460 0 0
Suicide
Mental Health 324461 324461 0 0
Depression
Mental Health 324462 324462 0 0
Anxiety
Public Health 324463 324463 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional
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, over a 2-3 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] 324223 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332267 0
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 16 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 (8 items, e.g. “Ask Lucy if she is thinking about suicide”) or distractor items that are contrary to the plan (8 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] 332267 0
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 - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [1] 412763 0
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] 412763 0
The Secondary outcome [1] will be measured at three time points: baseline - a week before training begins, post- training - a week after training, and follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [2] 412764 0
Help provided to peers will be assessed by asking the adolescents at baseline, over the previous 6 weeks, 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 4 month follow-up) 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, 16 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] 412764 0
The Secondary outcome [2} will be measured at baseline - a week before training begins and follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [3] 412765 0
The social distance scale for mental health problem will be assessed using items from the personal sigma 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] 412765 0
The Secondary outcome [3] will be measured at baseline - a week before training begins, post- training - a week after training, (primary timepoint ) and follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [4] 412766 0
The weak-not-sick scale for social phobia, will be assessed using items from the personal sigma 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] 412766 0
The Secondary outcome [4] will be measured at baseline - a week before training begins, post- training - a week after training, (primary timepoint ) and follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [5] 412768 0
The dangerous-unpredictable scale for depression will be assessed using items from the personal sigma 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] 412768 0
The Secondary outcome [5] will be measured at baseline - a week before training begins, post- training - a week after training and follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [6] 412771 0
Psychological distress in students and safety of the course will be measured using the K6 questionnaire, which has been extensively validated against diagnostic measures and using item response theory.
Timepoint [6] 412771 0
The Secondary outcome [6] will be measured at baseline - a week before training begins, post- training - a week after training, (primary timepoint ) and follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [7] 412772 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/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 [7] 412772 0
The Secondary outcome [7] will be measured at baseline - a week before training begins, post- training - a week after training, (primary timepoint ) and follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [8] 412774 0
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 you 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 [8] 412774 0
The Secondary outcome [8] will be measured at baseline - a week before training begins, post- training - a week after training, (primary timepoint ) and follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [9] 412775 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 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 [9] 412775 0
The Secondary outcome [9] will be measured at baseline - a week before training begins, post- training - a week after training and follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [10] 412776 0
Satisfaction and acceptability of 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, how useful it is now and likely to be in the future and how much the different program teaching materials were liked.
An open ended item will allow students to comment further on their satisfaction of the course "Is there anything else you would like to say about the program - strengths, weaknesses, or how we might make it better?" .
Timepoint [10] 412776 0
The Secondary outcome {10} will be measured at post training only (a week after training).
Secondary outcome [11] 412777 0
Use and acceptability 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 [11] 412777 0
The Secondary outcome [11] will be measured at follow-up - 4 months after training.
The 6 week follow-up survey has been replaced with a four month follow-up.
Secondary outcome [12] 412778 0
Student distress and safety of the course will be measured by asking participants the following survey items.

Did any of the information provided in the program make you feel distressed (e.g. sad, stressed, overwhelmed, nervous or depressed)?
Responses - No, Not sure or Yes

Please describe what information in particular made you feel distressed? Open answer response

How long did the distressed feeling last for?
Responses - A few moments, a few hours, a few days, a week or more

If you felt distressed, would you say that it was still worthwhile attending the “teen Mental Health First Aid” program?
Responses 5 Point Likert - Yes Probably to Definitely not
Timepoint [12] 412778 0
The Secondary outcome [12] will be measured at post- training - a week after training.
Secondary outcome [13] 412779 0
Student support requests and course safety will be measured by asking participants the following survey items.
Do you want someone to contact you to talk about how you are feeling, or about the “teen Mental Health First Aid” program?
Responses - Yes/No

Who would you like to contact you?
Responses - I do not want to be contacted, My regular homeroom teacher, School counsellor/welfare coordinator, teenAID research staff member.
Timepoint [13] 412779 0
The Secondary outcome [13] will be measured at baseline - a week before training begins, post- training - a week after training and follow-up - 4 months after training.

The 6 week follow-up survey has been replaced with a four month follow-up.

Eligibility
Key inclusion criteria
Schools to be included in the trial must be secondary schools located in Victoria 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 with year 8 cohorts of less than 80 students to ensure likely level of active parental consent and maintenance of participation at 6 month follow-up.
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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. To evaluate the effects of the tMHFA , changes in key outcomes over time (pre, post and follow-up) and across clusters 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 course 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".
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
Recruiting
Date of first participant enrolment
Anticipated
12/09/2022
Actual
17/10/2022
Date of last participant enrolment
Anticipated
16/11/2023
Actual
Date of last data collection
Anticipated
16/11/2023
Actual
Sample size
Target
450
Accrual to date
423
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312023 0
Government body
Name [1] 312023 0
National Health and Medical Research Council
Country [1] 312023 0
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] 313524 0
Charities/Societies/Foundations
Name [1] 313524 0
Mental Health First Aid Australia
Address [1] 313524 0
Level 18, 150 Lonsdale Street
Melbourne VIC 3000
AUSTRALIA
Country [1] 313524 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311443 0
'University of Melbourne Science, Technology, Engineering, Mathematics and Medicine (STEMM 1)-Greater Than Low Risk (GTLR) committee'
Ethics committee address [1] 311443 0
Human Research Ethics
STEMM 1 Ethics Committee
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] 311443 0
Australia
Date submitted for ethics approval [1] 311443 0
25/07/2022
Approval date [1] 311443 0
29/08/2022
Ethics approval number [1] 311443 0
2023-24644-38206-4

Summary
Brief summary
A significant curriculum redevelopment of the teen Mental Health First Aid for Year 7-9 secondary students (tMHFA 7-9) Edition 2 course has occurred with input from multiple curriculum specialists. The course has been piloted with a class of Year 8 students and responses received to the course from students, MHFA Instructors and supervising teachers used to make further minor revisions.
This Uncontrolled Trial will allow for sufficient data to be sure the tMHFA 7-9 Edition 3 program is effective, safe and acceptable to schools, students and instructors prior to it being launched by Mental Health First Aid Australia and subsequently evaluated in a planned Randomised Controlled Trial (ACTRN12621001589875).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121110 0
Dr Laura Hart
Address 121110 0
Level 4, 207 Bouverie Street, Carlton
The University of Melbourne, Victoria 3010 Australia
Country 121110 0
Australia
Phone 121110 0
+61 421 548 505
Fax 121110 0
Email 121110 0
lhart@unimelb.edu.au
Contact person for public queries
Name 121111 0
Dr Laura Hart
Address 121111 0
Level 4, 207 Bouverie Street, Carlton
The University of Melbourne, Victoria 3010 Australia
Country 121111 0
Australia
Phone 121111 0
+61 421 548 505
Fax 121111 0
Email 121111 0
lhart@unimelb.edu.au
Contact person for scientific queries
Name 121112 0
Dr Laura Hart
Address 121112 0
Level 4, 207 Bouverie Street, Carlton
The University of Melbourne, Victoria 3010 Australia
Country 121112 0
Australia
Phone 121112 0
+61 421 548 505
Fax 121112 0
Email 121112 0
lhart@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Melbourne University Ethics committee will not grant access to the data for individuals other than those named on the research Ethics Application.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16893Study protocol    On request via email to the lead researcher lhart@... [More Details]
16894Informed consent form    On request via email to the lead researcher lhart@... [More Details]
16895Ethical approval    On request via email to the lead researcher lhart@... [More Details]



Results publications and other study-related documents

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