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Trial registered on ANZCTR


Registration number
ACTRN12619001486112
Ethics application status
Approved
Date submitted
4/10/2019
Date registered
29/10/2019
Date last updated
21/01/2020
Date data sharing statement initially provided
29/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
LifeSpan Trial of Youth Aware of Mental Health (YAM) Program in ACT Schools.
Scientific title
LifeSpan Trial of Youth Aware of Mental Health (YAM) Program: A Waitlist Controlled Evaluation of Suicide Prevention Among Young People in ACT Secondary Schools.
Secondary ID [1] 299476 0
none
Universal Trial Number (UTN)
U1111-1241-5212
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicidal ideation 314699 0
self-harm 314701 0
Condition category
Condition code
Mental Health 313048 313048 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: The Youth Aware of Mental Health (YAM) program is a universal, evidence-based program that encourages young people between the ages of 14 to 16 to learn about and discuss everyday mental health. It is a place for young people to express their feelings and talk about mental health freely. In five 1-hour classroom sessions over three weeks, 20-30 students participate in discussions and role-plays guided by two trained adults in the school setting.

YAM was created by a group of interdisciplinary researchers from NASP/Karolinska Institutet and Columbia University. All materials involved in program delivery and training of Instructors and Helpers are copyrighted (2014 Youth Aware of Mental Health. All Rights Reserved - info@y-a-m.org).

In the first session, the Instructors introduce mental health using the YAM pedagogical materials that include slides, posters, and a booklet for each student to keep. The four sessions that follow differ depending on the group of youth present as the topics to be role-played and discussed are proposed by them. The topics range from relationships with peers and adults, difficulties in and around school, to feeling sad or facing a stressful situation.
YAM program delivery materials comprise a booklet, posters, and slide-set that includes information about the following six topics that also serve as a basis for the discussions and role-plays in YAM: (1) What is mental health, (2) Self-help advice, (3) Stress and crisis, (4) Depression and suicidal thoughts, (5) Helping a friend in need, and (6) Getting advice: who to contact.

The YAM Instructor Course teaches prospective Instructors about YAM’s theoretical framework, scientific research, program implementation and how best to engage with youth in YAM through workshops, discussions, lectures, role-play and simulations. There is a manual provided to Instructors during the course. Over four and a half days of training by certified trainers, they learn how to foster reciprocal and impartial relationships with youth as well as how to effectively implement all aspects of the program. YAM Instructors can be anyone who has previous experience working with youth, such as psychologists, psychiatrists, social workers, youth counsellors, social assistants, school guidance counsellors, teachers, school nurses, youth advocates, or support group workers. YAM Instructors should have no pre-existing relationship with the youth participating and cannot work in the school in which YAM is being implemented.

Instructors are assisted by trained Helpers who provide support to the Instructor and students in the group. Helpers undergo a half day of training by YAM Instructors. There is a brief training guide to assist Helper training. The Helper can either be another accredited Instructor, relevant youth worker or person with lived experience.

YAM Instructors and Helpers, who are involved in delivering the program, are expected to complete an online survey immediately after the last session of YAM within the school, as a standard requirement of program delivery. The survey measures the degree to which YAM has been delivered across schools as intended by assessing various aspects of fidelity, including YAM instructor adherence to program delivery, student exposure to the program (ie attendance records), materials prescribed, and quality (rated by instructor and helper) of program delivery.


Trial design: YAM will be evaluated in the ACT using a waitlist-controlled design. All Education Directorate (government) mainstream high schools and all Independent and Catholic schools will be invited to trial YAM through an expression of interest process.

The active intervention phase will take place over a 9-month period, beginning Term 2, 2020 and finishing at the end of Term 4, 2020. Data collected will be in the form of a self-report student survey. Measurement of primary and secondary outcomes will be taken at three time-points: pre-intervention (baseline), post-intervention, and at 3-month follow-up. Parent/guardian consent will be sought for students to participate in the data collection.
Intervention code [1] 315731 0
Prevention
Intervention code [2] 315732 0
Behaviour
Comparator / control treatment
YAM will be evaluated in the ACT using a waitlist-controlled design with two arms (cluster A and cluster B schools). Consenting schools will be allocated to the intervention or waitlist control arm via cluster (school) based on feasible delivery of the program to schools throughout the year.

Cluster A schools:
Students in Cluster A schools will complete a baseline survey before participating in the YAM program and immediate post survey after program completion, all occurring in Term 2, 2020. They will then complete a 3-month post survey in Term 3, 2020.

Cluster B schools:
Surveys will be administered at the same time for students in Cluster B schools, but instead of receiving the YAM program in Term 2, 2020, they will have classes as usual. These students will receive YAM in Term 4, 2020.

If there are schools receiving the YAM program in Term 3, 2020 we aim to invite them to participate in the study as additional data would be valuable. These schools would administer surveys at pre- and post-YAM only, within Term 3.
Control group
Active

Outcomes
Primary outcome [1] 321596 0
Change in suicidal ideation severity across time compared to the waitlist control. Suicidal ideation will be measured with the Suicidal Ideation Attributes Scale (SIDAS).
Timepoint [1] 321596 0
Baseline to immediately post-intervention and 3-month follow-up.
Secondary outcome [1] 375515 0
Change in self-harm, measured using four items (yes/no) that assess the history of suicide attempt and when the attempt occurred (during the past month, during the past year, or earlier), the presence of self-injury, whether the intention of the self-injury was to die. These items have been drawn from the evaluation of the Sources of Strength program.
Timepoint [1] 375515 0
Baseline to immediate post-intervention and 3-month follow up.
Secondary outcome [2] 375516 0
Change in help-seeking intentions for suicide, measured by the General Help-Seeking Questionnaire (GHQ adapted).
Timepoint [2] 375516 0
Baseline to immediate post-intervention and 3-month follow up.
Secondary outcome [3] 375517 0
Change in help-seeking behaviours for suicide, measured by the Actual Help-Seeking Questionnaire (AHQ adapted).
Timepoint [3] 375517 0
Baseline to immediate post-intervention and 3-month follow up.
Secondary outcome [4] 375518 0
Change in depression, measured with the Patient Health Questionnaire Depression Scale – adolescent version (PHQ-A) .
Timepoint [4] 375518 0
Baseline to immediate post-intervention and 3-month follow up.
Secondary outcome [5] 375519 0
Change in suicide literacy, measured by the Literacy of Suicide Scale (LOSS short-form).
Timepoint [5] 375519 0
Baseline to immediate post-intervention and 3-month follow up.
Secondary outcome [6] 375521 0
Change in loneliness, measured by the UCLA 3 Item Loneliness Scale.
Timepoint [6] 375521 0
Baseline to immediate post-intervention and 3-month follow up.
Secondary outcome [7] 375522 0
Change in confidence supporting peers (adapted items taken from the evaluation of the Silence is Deadly intervention).
Timepoint [7] 375522 0
Baseline to immediate post-intervention and 3-month follow up.
Secondary outcome [8] 375523 0
Change in mental well-being, measured by the Short Warwick-Edinburgh Mental Well-being Scale (WEMWBS short-form).
Timepoint [8] 375523 0
Baseline to immediate post-intervention and 3-month follow up.
Secondary outcome [9] 376301 0
Attitudes to seeking help from personnel at school, measured by two, four-item measures, including the help-seeking from adults in general and adults at school. Both scales were derived from the US Sources of Strength trial.
Timepoint [9] 376301 0
Baseline to immediate post-intervention and 3-month follow-up.

Eligibility
Key inclusion criteria
Year 9 students, aged between 14-16 years who are enrolled to participate in the YAM program at their school. The YAM program will be offered to all government and non-government mainstream secondary schools.
Minimum age
14 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
YAM is a universal intervention, designed for delivery in mainstream schools. Special needs or justice schools will not be suitable. In addition, any school that has experienced a recent adverse event (e.g., suicide or death) will not be eligible to receive the program for a minimum of 6-months.

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)
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
Other
Other design features
While arms (school clusters) are not technically randomised, decisions to allocate schools to either cluster A or B will be concealed from researchers. The Education Directorate (off-site organisation) will allocate cluster schools based on program delivery schedule, which is based on practical delivery logistics (e.g., number of program instructors per classroom per school, staggered over the course of 2020).
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Linear mixed models will be used to test the effect of the intervention on continuous, scaled outcome measures between groups and are able to include participants with missing data without using biased techniques. These models will include fixed effects for intervention status (baseline/unexposed vs post intervention and follow-up occasions) and random effects for cluster (school) and for participants within schools. Binary and count outcomes will be evaluated using generalized extensions of the mixed models used for scaled variables. Analysis of program fidelity data will involve univariate analysis of quantitative data. Specifically, regression analysis will be used to assess whether pre to post change in program outcomes is moderated by fidelity to the program.

We estimate that 15 government schools and 18 Independent/Catholic schools will be eligible to participate. The specific numbers of schools, staff and students per site is as follows:
1. Government schools: 15 eligible schools and 2378 Year 9 students.
2. Non-government schools: 18 eligible schools and 2494 Year 9 students.

Given that school participation rates are estimated to range between 50-65% (19x0.5=7.5), and the proportion of students from participating schools returning consent forms will be approximately 20% (1189/0.2=238), an initial sample size for the Cluster A & B schools is set at a conservative 119 students per Cluster. Conservatively assuming an intraclass correlation of 0.05 between schools leads to a design effect of 1.65, making our effective sample size 195. Such a sample size will provide at least 90% power to detect moderate differences (Cohen’s d=0.4) between Cluster A and Cluster B schools in the outcome variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 303977 0
Government body
Name [1] 303977 0
ACT Health
Address [1] 303977 0
4 Bowes St, Phillip ACT 2606
Country [1] 303977 0
Australia
Primary sponsor type
University
Name
Black Dog Institute, University of New South Wales
Address
Hospital Rd, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 304149 0
University
Name [1] 304149 0
The Australian National University
Address [1] 304149 0
Canberra ACT 0200
Country [1] 304149 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304476 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 304476 0
UNSW, Kensington, Sydney NSW 2052
Ethics committee country [1] 304476 0
Australia
Date submitted for ethics approval [1] 304476 0
28/10/2019
Approval date [1] 304476 0
13/12/2019
Ethics approval number [1] 304476 0
HC190908

Summary
Brief summary
The overall goal of this project is to investigate the effectiveness of a universal, mental health and suicide prevention program – Youth Aware of Mental Health (YAM) – for reducing suicidal ideation and increasing help-seeking. The study will test the effectiveness of the YAM intervention for decreasing suicidal ideation from baseline to post-intervention and at 3-month follow-up compared to a waitlist control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97082 0
Dr Michelle Tye
Address 97082 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 97082 0
Australia
Phone 97082 0
+61293824387
Fax 97082 0
Email 97082 0
m.torok@unsw.edu.au
Contact person for public queries
Name 97083 0
Dr Lauren McGillivray
Address 97083 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 97083 0
Australia
Phone 97083 0
+61293824387
Fax 97083 0
Email 97083 0
l.mcgillivray@unsw.edu.au
Contact person for scientific queries
Name 97084 0
Dr Lauren McGillivray
Address 97084 0
Black Dog Institute, Hospital Rd, Randwick NSW 2031
Country 97084 0
Australia
Phone 97084 0
+61293824387
Fax 97084 0
Email 97084 0
l.mcgillivray@unsw.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
Sensitive data (suicidal ideation and behaviours) of minors (<18 years old)
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 5216 0
Informed consent form
Citation [1] 5216 0
Link [1] 5216 0
Email [1] 5216 0
Other [1] 5216 0
Type [2] 5217 0
Study protocol
Citation [2] 5217 0
Link [2] 5217 0
Email [2] 5217 0
Other [2] 5217 0
Summary results
No Results