Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000048482
Ethics application status
Approved
Date submitted
21/09/2015
Date registered
19/01/2016
Date last updated
10/12/2023
Date data sharing statement initially provided
10/12/2023
Date results provided
10/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Sources of Strength Australia Project: a trial investigating the effect of the Sources of Strength program on help-seeking for suicidality in adolescents.
Scientific title
The Sources of Strength Australia Project: a randomised controlled trial investigating the effect of the Sources of Strength program on help-seeking for suicidality in adolescents
Secondary ID [1] 287442 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Help-seeking
Suicidality
 296154 0
Condition category
Condition code
Mental Health 296439 296439 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The universal Sources of Strength peer leadership program (https://sourcesofstrength.org/) takes a social connectedness approach to improving help-seeking for suicide and general psychological distress. The program will be run in ACT and NSW high schools.

The Sources of Strength program will consist of four phases in the first year of implementation. The first phase will be school and community preparation and will involve a 1-hour presentation to all school staff, and the nomination and training (4-6 hours) of 2-3 staff members per school to act as adult advisors. The initial one-hour recruitment presentation will be delivered by webinar by the United States Sources of Strength Team (Scott LoMurray), facilitated by the research teams at the Australian National University and the Black Dog Institute. The webinar will be presented to the staff members that are nominated to attend from each school. Following school consent to participate in the trial, a one-hour presentation will be delivered to school staff by the trial managers located at the Australian National University and Black Dog Institute. The role of adult advisors will be to support and guide the peer leaders to conduct safe suicide prevention messaging. The adult advisor training will be carried out during one 4-6 hour session. This will be led by the research teams at the Australian National University and the Black Dog Institute. The training is based on a training manual that has been developed by the US Sources of Strength Team. The mode of administration of the training sessions will be group sessions with a researcher. The first phase, school preparation and training of adult advisors, will take place over several months in early 2016.

The second phase of the program will be the nomination and training of peer leaders. Schools will be invited to nominate 2-10% (max 50 students) of their students as peer leaders, selecting key opinion leaders in diverse groups. The peer leaders will be nominated by school staff (e.g., executive staff, year co-ordinators, classroom teachers), as identified ‘peer leaders’ of the student body. The focus of peer leader training (4 hours) will be on interactive learning about the 8 protective sources of strength, skills for increasing these resources for themselves and others in times of need, and engaging trusted adults to help distressed and suicidal peers. The term ‘strength’ in this program primarily refers to resilience and coping strategies that may be drawn upon during difficult periods of life. The training and program will focus on positivity, influence and leadership, rather than purely on suicide prevention. The peer-leader training will be conducted by nominated adult advisors and the research teams at the Australian National University and the Black Dog Institute. It will be group information sessions, focusing on teaching skills about asking for help and coping strategies, which they can then pass on to their peer groups. The mode of peer leader training will be one single 4 hour group session. The second phase, nomination and training of peer leaders, is hoped to be completed over two months in early 2016. If enough schools are not recruited into the trial at this time, the training will take place again over two months in the second half of 2016.

The third phase of the intervention will be whole-school messaging, which will entail activities to increase connectedness and will be undertaken over a 3-month period. In the first year, the messaging will involve (i) engaging trusted adults by contacting them and acknowledging them as such, (ii) encouraging friends to identify their trusted adults and sharing these on a wall of trust, (iii) undertaking pre-rehearsed classroom presentations to spread the sources of strength message by modelling how they have overcome adversity using positive coping and how they would engage a trusted adult for support for a suicidal friend, and (iv) wider school "Hope, Help, and Strength" messaging using posters, public service announcements, videos and messages posted on social media sites (creating their own materials or using those available on the Sources of Strength Facebook page) to further disseminate the messages of the Sources of Strength program. Messaging will be empowering and strength-based, avoiding trauma, shock or negative messaging, which could instill hopelessness. Peer leaders will meet fortnightly with the adult advisors to plan and approve messaging activities. The third phase, whole-school messaging, will take place over 3 months in each high school allocated to the intervention condition.

The fourth phase will be an honouring celebration to recognise the peer leaders for their roles and accomplishments. Peer leaders will provide brief suicide prevention training to parents by sharing what they have learnt. This final phase, of recognising the peer leaders for their roles and accomplishments, and peer leaders providing brief suicide prevention training to parents by sharing what they have learnt, will take place over one session per school at the conclusion of the intervention period.

In the second year (2017), the program will be continued with the addition of new adult advisors and peer leaders, and a repeat of the whole-school messaging. The reach and sophistication of messaging is expected to increase in the second year, as peer leaders become more comfortable and confident in their role.

The questionnaires that will be delivered at post-intervention will include questions relating to adherence to the intervention for students in the intervention schools, and some questions specific to peer leaders regarding their involvement in the program. Teachers in intervention schools will also be delivered a brief questionnaire regarding the level of intervention exposure and reach that they have witnessed, to monitor school’s adherence to the intervention program. Additionally, researchers will attend sporadic peer-leader meetings at schools, to monitor the conduct of the intervention.
Intervention code [1] 292814 0
Prevention
Comparator / control treatment
Wait list: The wait-list control condition will continue usual school activities during the intervention phase of the trial and will receive the program after the follow-up periods.
Control group
Active

Outcomes
Primary outcome [1] 296062 0
Help-seeking.

The adapted version of the General Help-Seeking Questionnaire (GHSQ; Wilson et al, 2005) is the primary outcome measure in the current study and assesses intentions to seek help for personal or emotional problems from 11 different formal and informal sources (e.g., friend, parent, psychologist, teacher). Respondents indicate how likely they are to seek help from each of the sources on a scale ranging from 1 (extremely unlikely) to 7 (extremely likely).

Timepoint [1] 296062 0
Post-intervention questionnaires containing the primary outcome variable will be administered at the conclusion of the 3-month intervention period (at program completion).
Secondary outcome [1] 317405 0
Suicidality.

Suicidality will be measured by a number of questionnaires.

The Youth Risk Behaviour Survey (cdc.gov) investigates suicidal ideation, plans and attempts over 4 questions (Yes/No). Suicidal ideation will be further investigated using the Suicidal Ideation Attributes Scale (SIDAS; Van Spijker et al, 2014), which contains 5 questions rated on 10-point scales assessing various levels of severity of suicidal ideation.
Timepoint [1] 317405 0
Post-intervention questionnaires containing secondary outcome variables will be administered at the conclusion of the 3-month intervention period (at program completion).

Eligibility
Key inclusion criteria
Students in Years 7 - 11
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There will be no exclusion criteria applied as this is a universal intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
High school students in Years 7-11 of participating high schools will be invited to participate in the universal prevention trial. Participating year levels will be determined by individual schools.

Cluster randomisation (by individual school) will be employed for administrative convenience, and to avoid control condition contamination. Randomisation will be carried out by an off-site researcher not involved in the day-to-day conduct of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Due to the number of schools, a minimisation approach will be used to ensure balance across conditions on the basis of school type (public/Catholic/independent), number of students and gender balance. This approach allocates schools to conditions on the basis of selecting the condition that results in the least imbalance, while incorporating a random process to ensure that allocation cannot be predicted in advance.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses of continuous measures will be undertaken on an intent-to-treat basis, including all participants randomised regardless of treatment actually received or withdrawal from the study. Mixed-model repeated measures (MMRM) analyses will be used because of the ability of this approach to include participants with missing data without using biased techniques, such as last observation carried forward. In addition, by incorporating appropriate random effects for schools, this approach can accommodate and assess the strength and significance of clustering effects. The primary hypothesis will be evaluated by a contrast evaluating change from baseline to the intervention endpoint in the Sources of Strength arm compared to that in the control condition. For suicide attempts and other dichotomous outcomes, a comparable binary mixed modelling approach will be used. Differences in relative risk for suicide attempt at follow-up will be calculated and its significance assessed. The role of suicidal ideation, depressive symptoms and exposure to school-based messaging as mediators of intervention outcome will be explored using interaction terms in mixed effects models, and using latent class analyses. Models of suicide risk will be developed using regression analyses and structural equation models, testing the Interpersonal Theory of Suicidal Behavior framework and examining the role of additional psychosocial and demographic risk factors. Social network factors will be assessed in a subset of 2 schools (1 control, 1 intervention), evaluating up to 7 connections per student at pre- and post-intervention, to estimate a range of network indices of density, reciprocity, clustering and individual centrality. Change in social network characteristics as a function of intervention condition will be tested. During the messaging phase, engagement with social media messages posted by peer leaders at the intervention schools will be analysed by categorising posts and assessing the types of messaging that best engage students by measuring reach through likes, shares and comments. This sub-study measures ‘digital footprint’ behaviour, and thus complements self-report measures of connectivity.

Calculation of required sample size was based on detecting a post-intervention effect size of 0.33. This is a small effect but reflects the universal nature of this intervention and is based on effect sizes obtained in the US evaluation of the program (Wyman et al, 2010). Power was set at 0.8, a = .05 (two-tailed) and correlation of .5 assumed between baseline and endpoint scores. To allow for possible clustering effects (participants from the same school having characteristics and outcomes more alike than between schools) a design effect was calculated assuming an intraclass correlation (ICC) of 0.04 and an average school size of 300 students. The estimate of the ICC was derived from previous Australian school-based studies that have found non-significant intraclass correlations (ICC = .02) and from the US trial ICC = .04 (12, 26). Accommodating a 20% attrition rate, we set the target sample size at 4,800, or 2,400 students across 8 schools per condition.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2016
Actual
18/05/2016
Date of last participant enrolment
Anticipated
2/03/2018
Actual
30/08/2017
Date of last data collection
Anticipated
20/11/2018
Actual
14/03/2019
Sample size
Target
4800
Accrual to date
Final
1781
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 292016 0
Government body
Name [1] 292016 0
National Health and Medical Research Council
Country [1] 292016 0
Australia
Primary sponsor type
University
Name
The National Institute for Mental Health Research, The Australian National University
Address
Building 63
Eggleston Road
Acton ACT 2601
Country
Australia
Secondary sponsor category [1] 290686 0
University
Name [1] 290686 0
The University of New South Wales
Address [1] 290686 0
The Black Dog Institute
The University of New South Wales
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country [1] 290686 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293504 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 293504 0
Ethics committee country [1] 293504 0
Australia
Date submitted for ethics approval [1] 293504 0
Approval date [1] 293504 0
08/05/2015
Ethics approval number [1] 293504 0
2015/199

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

Contacts
Principal investigator
Name 60190 0
Dr Alison Calear
Address 60190 0
Building 63
Eggleston Road
Acton ACT 2601
Country 60190 0
Australia
Phone 60190 0
+61 2 6125 8406
Fax 60190 0
Email 60190 0
[email protected]
Contact person for public queries
Name 60191 0
Sonia McCallum
Address 60191 0
Building 63
Eggleston Road
Acton ACT 2601
Country 60191 0
Australia
Phone 60191 0
+61 2 6125 8412
Fax 60191 0
Email 60191 0
[email protected]
Contact person for scientific queries
Name 60192 0
Alison Calear
Address 60192 0
Building 63
Eggleston Road
Acton ACT 2601
Country 60192 0
Australia
Phone 60192 0
+61 2 6125 8406
Fax 60192 0
Email 60192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No current plans to share IPD


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21162Study protocolCalear, A.L., Brewer, J.L., Batterham, P.J. et al. The Sources of Strength Australia Project: study protocol for a cluster randomised controlled trial. Trials 17, 349 (2016). https://doi.org/10.1186/s13063-016-1475-1  



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseApplication of the inter-personal psychological theory of suicide in a non-clinical community-based adolescent population.2021https://dx.doi.org/10.1016/j.jad.2021.07.011
EmbaseThe Sources of Strength Australia project: A cluster randomised controlled trial of a peer-connectedness school-based program to promote help-seeking in adolescents.2022https://dx.doi.org/10.1016/j.jad.2021.12.043
EmbaseSpecific anxiety and depression symptoms are risk factors for the onset of suicidal ideation and suicide attempts in youth.2023https://dx.doi.org/10.1016/j.jad.2023.02.024
N.B. These documents automatically identified may not have been verified by the study sponsor.