Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000338167
Ethics application status
Approved
Date submitted
22/02/2019
Date registered
5/03/2019
Date last updated
23/12/2021
Date data sharing statement initially provided
5/03/2019
Date results information initially provided
18/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
LifeSpan Trial of Youth Aware of Mental Health (YAM) Program in NSW Schools.
Scientific title
LifeSpan Trial of Youth Aware of Mental Health (YAM) Program to Evaluate Suicide Prevention Among Young People in NSW Secondary Schools.
Secondary ID [1] 297426 0
none
Universal Trial Number (UTN)
U1111-1228-6869
Trial acronym
Linked study record
LifeSpan Trial registration number: ACTRN12617000457347. YAM is a sub-study of this larger LifeSpan Trial.

Health condition
Health condition(s) or problem(s) studied:
suicidal behaviour 311600 0
suicidal ideation 311601 0
Condition category
Condition code
Mental Health 310229 310229 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313692 0
Prevention
Intervention code [2] 313693 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319165 0
Suicidal ideation severity, measured using Paykel's Suicidal Feelings in the General Population Scale.
Timepoint [1] 319165 0
Baseline, 3months post-intervention (primary timepoint), and 6 and 12 months post-intervention.
Secondary outcome [1] 367161 0
Frequency of new incidents of reported suicide attempt, measured using three questions developed in the US Sources of Strength trial (Wyman et al., 2010).
Timepoint [1] 367161 0
Baseline, 3months post-intervention, and 6 and 12-months post-intervention.
Secondary outcome [2] 367163 0
Changes in help-seeking intentions, measured using the General Help-Seeking Questionnaire.
Timepoint [2] 367163 0
Baseline, 3months post-intervention, and 6 and 12-months post-intervention.
Secondary outcome [3] 367164 0
Changes in help-seeking behaviours, measured using the Actual Help-Seeking Questionnaire.
Timepoint [3] 367164 0
Baseline, 3months post-intervention, and 6 and 12-months post-intervention.
Secondary outcome [4] 367620 0
Changes in suicide literacy, measured using Literacy of Suicide Scale (short form).
Timepoint [4] 367620 0
Baseline, 3months post-intervention, and 6 and 12-months post-intervention.
Secondary outcome [5] 367771 0
Changes in suicide stigma, measured using Stigma of Suicide Scale (short form)
Timepoint [5] 367771 0
Baseline, 3months post-intervention (primary timepoint), and 6 and 12 months post-intervention.
Secondary outcome [6] 367772 0
Changes in severity of depressive symptoms, measured using the Patient Health Questionnaire Depression Scale (PHQ-8).
Timepoint [6] 367772 0
Baseline, 3months post-intervention (primary timepoint), and 6 and 12 months post-intervention.

Eligibility
Key inclusion criteria
All year 9 students (between the ages of 14-16 years) in mainstream public, independent, and catholic schools across the 4 NSW LifeSpan trial sites will be eligible to participate in the study. These students will need to be participating in the YAM program that will be offered through their school.
Minimum age
14 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools will not be delivering the program nor invited to the study if their students have significant learning or behavioural difficulties, or are in juvenile justice settings.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The Stata steppedwedge program (Hemming & Girling, 2014) was used to estimate power and sample size requirements. Shackleton, Hale, Bonell, and Viner (2016) report observed intra-class correlation (ICC) values of measures of psychosocial health in adolescents between 0.01 and .07 in a range of European studies. Values at the lower end of this range have been observed in Australian studies (e.g., see Calear, Christensen, Mackinnon, Griffiths, & O'Kearney, 2009). Conservatively assuming the upper range of ICC (.07) within an incomplete stepped wedge design having only four occasions of measurement per school (pre- and post-intervention, and 6- and 12-month follow-up), 20 schools recruiting 50 students each will allow the detection of an effect of the intervention common to all occasions of measurement of 0.24 standard deviations. The design will maintain 80% power to detect an effect of 0.30 standard deviations with an average cluster size of 20 students, thus allowing for the possibility of recruitment targets not being met within some schools. Therefore, five schools per trial site (20 in total) will be recruited, with schools requiring a minimum of 50 students in Year 9. This equates to a minimum sample size of 1,000.

Analysis will follow the framework the analysis of stepped wedge trials proposed by Hussey and Hughes (2007) and, where feasible and appropriate, incorporate more recently extensions proposed by Hemming, Taljaard, and Forbes (2017). Linear mixed models will be used to test the effect of the intervention on continuous, scaled outcome measures. These models will include fixed effects for intervention status (baseline/unexposed vs post intervention and follow-up occasions) and for the time at each assessment was undertaken. The latter effect will account for any overall change or ‘drift’ in outcomes over the course of the stepped introduction of the intervention. Models will include 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.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
17/05/2018
Date of last participant enrolment
Anticipated
20/12/2019
Actual
7/08/2019
Date of last data collection
Anticipated
18/12/2020
Actual
19/08/2020
Sample size
Target
1000
Accrual to date
Final
556
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301997 0
Charities/Societies/Foundations
Name [1] 301997 0
Paul Ramsay Foundation
Country [1] 301997 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Black Dog Institute
Address
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 301777 0
University
Name [1] 301777 0
University of New South Wales
Address [1] 301777 0
22-32 King St, Randwick NSW 2031
Country [1] 301777 0
Australia
Other collaborator category [1] 280560 0
University
Name [1] 280560 0
The Australian National University
Address [1] 280560 0
Canberra ACT 0200
Country [1] 280560 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302672 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 302672 0
22-32 King St, Randwick NSW 2031
Ethics committee country [1] 302672 0
Australia
Date submitted for ethics approval [1] 302672 0
18/10/2017
Approval date [1] 302672 0
23/10/2017
Ethics approval number [1] 302672 0
HC17710
Ethics committee name [2] 302716 0
State Education Research Applications Process committee
Ethics committee address [2] 302716 0
NSW Department of Education, Locked Bag 53, Darlinghurst NSW 1300
Ethics committee country [2] 302716 0
Australia
Date submitted for ethics approval [2] 302716 0
07/08/2017
Approval date [2] 302716 0
23/10/2017
Ethics approval number [2] 302716 0
2017199

Summary
Brief summary
This study aims to investigate the effectiveness of a universal, mental health promotion and suicide prevention program – Youth Aware of Mental Health (YAM) – for reducing suicidal ideation and attempts, and increasing help-seeking in young people. The primary hypothesis is that after completing the YAM program, P1) students will report decreased severity of suicidal ideation.. Secondary hypotheses are, after completing the YAM program, students will self-report S1) no new incidents of suicide attempt, S2) increased help-seeking intentions and behaviours for suicide, and an associated increase in suicide literacy, and S3) decreased depressive symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91014 0
Dr Fiona Shand
Address 91014 0
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 91014 0
Australia
Phone 91014 0
+61 02 9382 4530
Fax 91014 0
Email 91014 0
fionas@unsw.edu.au
Contact person for public queries
Name 91015 0
Dr Lauren McGillivray
Address 91015 0
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 91015 0
Australia
Phone 91015 0
+61 02 9382 4387
Fax 91015 0
Email 91015 0
l.mcgillivray@blackdog.org.au
Contact person for scientific queries
Name 91016 0
Dr Lauren McGillivray
Address 91016 0
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 91016 0
Australia
Phone 91016 0
+61 02 9382 4387
Fax 91016 0
Email 91016 0
l.mcgillivray@blackdog.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants are minors, aged 14-16 years old, and a higher degree of protection of their information is required.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Youth Aware of Mental Health program in Australian Secondary Schools: 3- and 6-month outcomes.2021https://dx.doi.org/10.1186/s13033-021-00503-w
N.B. These documents automatically identified may not have been verified by the study sponsor.