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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] 303363 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 320628 0
Condition category
Condition code
Public Health 318482 318482 0 0
Health promotion/education
Mental Health 318483 318483 0 0
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] 319673 0
Prevention
Intervention code [2] 320001 0
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] 326441 0
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] 326441 0
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] 326559 0
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] 326559 0
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 [3] 326848 0
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] 326848 0
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.
Secondary outcome [1] 391498 0
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] 391498 0
At end of each session of program
Secondary outcome [2] 391499 0
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] 391499 0
At end of each session of program
Secondary outcome [3] 391849 0
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] 391849 0
10th/final session of the program
Secondary outcome [4] 392881 0
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] 392881 0
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
75
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307778 0
University
Name [1] 307778 0
Monash University
Country [1] 307778 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton, VIC, 3800
Country
Australia
Secondary sponsor category [1] 308482 0
None
Name [1] 308482 0
Address [1] 308482 0
Country [1] 308482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307797 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 307797 0
Ethics committee country [1] 307797 0
Australia
Date submitted for ethics approval [1] 307797 0
15/03/2021
Approval date [1] 307797 0
12/04/2021
Ethics approval number [1] 307797 0
27733
Ethics committee name [2] 308100 0
Melbourne Archdiocese Catholic Schools: Analysis, Policy and Research Unit
Ethics committee address [2] 308100 0
Ethics committee country [2] 308100 0
Australia
Date submitted for ethics approval [2] 308100 0
09/03/2021
Approval date [2] 308100 0
22/04/2021
Ethics approval number [2] 308100 0
1072
Ethics committee name [3] 308145 0
Department of Education and Training
Ethics committee address [3] 308145 0
Ethics committee country [3] 308145 0
Australia
Date submitted for ethics approval [3] 308145 0
24/02/2021
Approval date [3] 308145 0
19/04/2021
Ethics approval number [3] 308145 0
2021_004369

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

Contacts
Principal investigator
Name 108530 0
Dr Christine Grové
Address 108530 0
Faculty of Education, Monash University, Building 92, 19 Ancora Imparo Way, Clayton, VIC, 3800, Australia
Country 108530 0
Australia
Phone 108530 0
+61 3 9905 0803
Fax 108530 0
Email 108530 0
[email protected]
Contact person for public queries
Name 108531 0
Christine Grové
Address 108531 0
Faculty of Education, Monash University, Building 92, 19 Ancora Imparo Way, Clayton, VIC, 3800, Australia
Country 108531 0
Australia
Phone 108531 0
+61 3 9905 0803
Fax 108531 0
Email 108531 0
[email protected]
Contact person for scientific queries
Name 108532 0
Christine Grové
Address 108532 0
Faculty of Education, Monash University, Building 92, 19 Ancora Imparo Way, Clayton, VIC, 3800, Australia
Country 108532 0
Australia
Phone 108532 0
+61 3 9905 0803
Fax 108532 0
Email 108532 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?
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.TypeCitationLinkEmailOther DetailsAttachment
10639Study protocolMarinucci, 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   
10640Informed consent form    Once ethical approval has been received informed c... [More Details] 381368-(Uploaded-18-08-2021-16-44-48)-Study-related document.pdf
10642Ethical approval    Once ethical approval has been received it will be... [More Details] 381368-(Uploaded-18-08-2021-16-43-01)-Study-related document.pdf
14967Informed consent form    381368-(Uploaded-18-08-2021-16-45-18)-Study-related document.pdf



Results publications and other study-related documents

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