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Trial registered on ANZCTR

Registration number

ACTRN12621000325808

Ethics application status

Approved

Date submitted

15/02/2021

Date registered

23/03/2021

Date last updated

7/02/2022

Date data sharing statement initially provided

23/03/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluation of a school-based mental health literacy program for youth aged 12 to 16 years

Scientific title

Evaluation of the Youth Education and Support (YES) program for young people (12-16 years) in a school setting: Outcomes of mental health literacy and action

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Mental health

Condition category

Condition code

Public Health

Health promotion/education

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Youth Education and Support (YES) is a mental health literacy program developed by Professor Joanne Riebschleger over a span of 12 years based on relevant literature, recommendations from mental health professionals and the perspectives of young people. The program has been adapted to suit an Australian context based on feedback from health care professionals, youth, researchers and educators.

The group intervention includes 10 weekly sessions of 50 minutes duration each. It is designed to be delivered within a school setting by trained facilitators with expertise of working with young people. This trial will evaluate the program's effectiveness in Australian school settings for youth aged 12 to 16 years old.

The Australian adapted YES program includes activities and discussions related to specific mental health and wellbeing topics for each session. The topics are as follows:
- Understanding mental illness, including risks/causes and specific mental health disorders
- The effects of mental illness on families
- The recovery process from mental illness
- Stress management and coping strategies
- Promoting emotionally healthy behaviours
- Responding to stigma and stereotypes (related to mental illness)
- How to seek help for mental health difficulties and what the process of therapy can look like

The intervention will be delivered by provisional psychologists completing the Masters of Psychology program at Monash University. The facilitators will receive training from the researchers prior to the program consisting of an approximately 4 hour workshop. Three facilitators will deliver the program to groups, in which two will deliver the program and the other will observe and complete a fidelity measure each session.

Outcomes of the program will be measured using standardised scales, such as Youth Mental Health Literacy (YMHL) scale, the 14 item Resilience Scale, the Actual Help Seeking Questionnaire (AHSQ) and the General Help Seeking Questionnaire (GHSQ) before, immediately after, 3 months after and 1 year after the program. As well as qualitative, open-ended feedback forms for participants to complete after each session.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Comparator / control treatment

Participants recruited through schools will be allocated to the intervention (YES Program). Randomisation will not be possible due to availability of schools to take part and time frame of program delivery.
Participants for the control group will be recruited through advertisements and snowballing. Participants in the control group will not receive the intervention.

Participants will also be recruited through social media advertisements for the non-waitlist control group. This group will not receive the YES program.

Control group

Active

Outcomes

Primary outcome [1]

Primary outcome: Mental Health Literacy
Mental health literacy will be measured using the Youth Mental Health Literacy (YMHL) scale. This scale is in the process of validation for youth 10-18 years old and is based on a comprehensive review with expert contribution. The scale consists of 44 items and takes approximately 20 minutes to complete. Subscales include knowledge of mental illness conditions, recovery behaviours/strategies, stigma, help seeking and responding to mental health difficulties among family and friends.

Timepoint [1]

Intervention group: At the beginning of the program (approximately 1 week before program - baseline data). At end of program (end of 10th session - primary endpoint). 3 months post-program (short term follow up). 1 year post-program (long term follow up).

Control group: Completed twice with a 10 week interval between timepoints.

Primary outcome [2]

Primary outcome: Help seeking - split into help seeking intention and actual help seeking
Help seeking intentions will be measured using the General Help Seeking Questionnaire (GHSQ). This scale was developed in Australia and measures help-seeking intentions. The scale asks the participant to rate how likely they are to seek help from various sources if they were experiencing a personal-emotional problem or experiencing suicidal thoughts. The participant rates the likelihood on a 7-point Likert scale (Extremely Unlikely - Extremely Likely).
Actual help seeking will be measured using the Actual Help Seeking Questionnaire (AHSQ). This scale asks participants to state who they have gone to for help in the past 2 weeks and what type of problem they sought help for.

Timepoint [2]

Primary outcome [3]

Primary outcome: Resilience
Resilience will be measured using the 14 item Resilience Scale (RS-14). This scale has been validated within an adolescent sample and has a Flesch-Kincaid Grade score of 4.9. Items are measured along a 7-point Likert scale with statements rated from Strongly Disagree to Strongly Agree (e.g., “I can usually find something to laugh about.”). Lower scores indicate lower levels of resilience.

Timepoint [3]

Secondary outcome [1]

Evaluation of the session: Participants will be invited to provide feedback at the end of each session. The evaluation instrument includes 5 open-ended questions relating to what the participant gained or did not gain from the session, what they learnt, and suggestions for conversation topics for future sessions.

Timepoint [1]

At end of each session of program

Secondary outcome [2]

Fidelity Observer Instrument: The Fidelity Instrument was designed and created to be used with the YES program. It consists of ratings of facilitator fidelity and general observations of youth participants to be completed by the observer during the sessions.

Timepoint [2]

At end of each session of program

Secondary outcome [3]

End of program evaluation: This instrument allows participants to give feedback on the overall YES program. It consists of 10 items aiming to examine the participant's experience of the program, with open-ended questions and 2 rating items. It also asks whether participants would tell/recommend others for the program and how beneficial aspects of the program were (e.g. coping skills).

Timepoint [3]

10th/final session of the program

Secondary outcome [4]

Facilitator feedback: This instrument allows facilitators to give feedback on their experience during the YES program. The questionnaire takes approximately 15-30 minutes to complete and consists a 5-point Likert rating scale for statements (e.g. “I felt supported throughout my
involvement in the YES program”) and open-ended questions (e.g. “What was challenging
during your involvement in the YES program?”).

Timepoint [4]

After end of the program

Eligibility

Key inclusion criteria

Young person attending school
Fluent in English

Minimum age

12 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Young person not attending school
Adults
Non-English speaking

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

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

No sequence generation as randomisation will not occur.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Participants will be split into (a) intervention group who receive the YES program, or (b) control group who are not offered the YES program.

Intervention group timepoints for data collection:
Timepoint 1 (approx 1 week before program): YMHL scale, GHSQ, AHSQ, RS-14
Timepoint 2 (final session/week of program): YMHL scale, GHSQ, AHSQ, RS-14
Timepoint 3 (3 months after final session, only intervention group): YMHL scale, GHSQ, AHSQ, RS-14
Timepoint 4 (1 year after final session, only intervention group): YMHL scale, GHSQ, AHSQ, RS-14

Control group timepoints for data collection:
Timepoint A: YMHL scale, GHSQ, AHSQ, RS-14
Timepoint B (approximately 10 weeks after timepoint A): YMHL scale, GHSQ, AHSQ, RS-14

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Variables to be measured will be mental health literacy calculated from the YMHL, help seeking behaviour calculated from the GHSQ and AHSQ, and resilience from the RS-14.

An a priori power analysis using G*Power was conducted to determine the number of participants required to detect a post-intervention effect size of 0.20 on the primary outcomes with a power of .80, alpha set to .05, and correlation of .50 between pre- and post-intervention scores. To allow for possible clustering effects (participants within the same schools being more alike), we calculated a design effect assuming an intraclass correlation coefficient of .02 and an average school size of 45 (average group size of 15 participants). The estimated sample size is 263. To account for an attrition rate of 20%, we set the target sample size to 329. Approximately five to seven schools will be recruited to obtain this sample size.

Analyses will be conducted using repeated measures Analysis of Covariance for differences between timepoints for the intervention whilst controlled for school as a covariate. Analysis of differences between control and intervention groups will be conducted using a Welch's Analysis of Variance (ANOVA). Analysis of differences within the intervention group for COPMI and children without a parent with a mental illness will be conducted using a Welch's ANOVA.

A thematic analysis using Braun & Clark's method will be conducted for the qualitative data from the open-ended responses in the evaluations of each session and the entire program. This method will also be conducted for the facilitator feedback qualitative data.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

5/04/2021

Actual

18/06/2021

Date of last participant enrolment

Anticipated

24/05/2022

Actual

Date of last data collection

Anticipated

28/04/2023

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Faculty of Education, Monash University
19 Ancora Imparo Way, Clayton, VIC 3800 Australia

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Rd, Clayton, VIC, 3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University, Clayton, Victoria, 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/03/2021

Approval date [1]

12/04/2021

Ethics approval number [1]

27733

Ethics committee name [2]

Melbourne Archdiocese Catholic Schools: Analysis, Policy and Research Unit

Ethics committee address [2]

228 Victoria Parade, East Melbourne, Victoria, 3002

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

09/03/2021

Approval date [2]

22/04/2021

Ethics approval number [2]

1072

Ethics committee name [3]

Department of Education and Training

Ethics committee address [3]

33 St Andrews Place, East Melbourne, Victoria, 3002

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

24/02/2021

Approval date [3]

19/04/2021

Ethics approval number [3]

2021_004369

Summary

Brief summary

Increasing young people's mental health literacy and action could reduce the alarming rise in mental health challenges predicted due to COVID-19, by improving youths: understanding of mental health and stigma, help-seeking and giving, and also coping.

The current study aims to evaluate a school-based mental health literacy and action program, called Youth Education and Support (YES) Program, with 12 to 16 years within an Australian context.

Trial website

Trial related presentations / publications

Public notes

There is an incline in mental health concerns during the COVID-19 pandemic, particularly among young people, and these difficulties are likely to continue into 2021. In Australia, a Headspace report found approximately one in three young people experienced high levels of psychological distress during the peak of the COVID-19 pandemic in 2020. There is a need for more support and preventative approaches for youth, especially during these uncertain times.

Presentations/publications related to the study:
- Conference Presentation - So What Are You Working On? at Stanford University, May 2020
- "The need for mental health education in Australian schools" - Monash Lens, February 2021 (https://lens.monash.edu/@education/2021/02/09/1382779/the-need-for-mental-health-education-in-australian-schools)
-"A Scoping Review Analysis of Mental Health Literacy Programs and Best Practice Guidelines" - Currently under review

Contacts

Principal investigator

Name

Dr Christine Grové

Address

Faculty of Education, Monash University, Building 92, 19 Ancora Imparo Way, Clayton, VIC, 3800, Australia

Country

Australia

Phone

+61 3 9905 0803

Fax

[email protected]

Contact person for public queries

Name

Dr Christine Grové

Address

Faculty of Education, Monash University, Building 92, 19 Ancora Imparo Way, Clayton, VIC, 3800, Australia

Country

Australia

Phone

+61 3 9905 0803

Fax

[email protected]

Contact person for scientific queries

Name

Dr Christine Grové

Address

Faculty of Education, Monash University, Building 92, 19 Ancora Imparo Way, Clayton, VIC, 3800, Australia

Country

Australia

Phone

+61 3 9905 0803

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?

After de-identification, individual participant data underlying published results only

When will data be available (start and end dates)?

Immediately following publication for a maximum of 5 years

Available to whom?

Any reasonable requests directed to Dr Christine Grové

Available for what types of analyses?

Any purpose

How or where can data be obtained?

Access subject to approvals by Principal Investigator ([email protected])

What supporting documents are/will be available?

Doc. No.	Type	Citation	Other Details	Attachment
10639	Study protocol	Marinucci, A., Grové, C., Allen, K.-A., & Riebschleger, J. (2021). Evaluation of a youth mental health literacy and action program: Protocol for a cluster controlled trial. Mental Health & Prevention, 24, 200216. https://doi.org/10.1016/j.mhp.2021.200216
10640	Informed consent form		Once ethical approval has been received informed c... [More Details]	381368-(Uploaded-18-08-2021-16-44-48)-Study-related document.pdf
10642	Ethical approval		Once ethical approval has been received it will be... [More Details]	381368-(Uploaded-18-08-2021-16-43-01)-Study-related document.pdf
14967	Informed consent form			381368-(Uploaded-18-08-2021-16-45-18)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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Documents added automatically