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Trial registered on ANZCTR


Registration number
ACTRN12617000457347
Ethics application status
Approved
Date submitted
26/10/2016
Date registered
28/03/2017
Date last updated
28/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
LifeSpan: A whole-population stepped-wedge cluster-randomized trial of a multilevel systems approach to reduce suicide attempts and deaths in four NSW regions.
Scientific title
LifeSpan: A stepped-wedge cluster-randomized trial of a multi-level systems approach to suicide prevention, including means restrictions, community based campaigns and enhanced identification and treatment of suicidal individuals to reduce suicide attempts and deaths in individuals of all ages in four sites in New South Wales.
Secondary ID [1] 290342 0
None
Universal Trial Number (UTN)
U1111-1190-0793
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide 300614 0
Intentional self-harm 300615 0
indigenous mental health 300616 0
youth mental health 300617 0
men's mental health 300618 0
women's mental health 300619 0
Condition category
Condition code
Mental Health 300464 300464 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
LifeSpan is a large-scale, community-wide trial for suicide prevention that will be implemented in four sites within New South Wales. LifeSpan will involve implementing nine strategies ranging from universal interventions to indicated interventions. The interventions will be implemented in each of the four trial sites for a period of two years, with evaluation occurring at 12-months and 24-months after baseline. Each site has a minimum population of 140,000 and its own local implementation team so that interventions, whilst maintaining core features for effectiveness, may be implemented differently to suit the local environment. The four sites are supported by a central implementation team and a research team based at the Black Dog Institute.

The universal strategies include:
1. Means restriction: A suicide audit will be conducted, which will include the analysis of coronial and police data to assess trends, access to means and other contextual factors contributing to suicides and suicide attempts, at each of the four sites. The suicide audit will inform recommendations for tailored means restrictions strategies to reduce further suicide attempts and deaths in each of the four sites. The suicide audit will be supplemented by a focus group with professionals (e.g. hospital emergency department staff, community mental health staff) who have local knowledge of any suicide clusters in their community and what measures have been taken to deal with the risk. The site lead agencies and suicide prevention collaboratives will be provided with a guide to evidence-based strategies to reduce access to or lethality of means. The Black Dog Institute and the sites will work collaboratively to develop means restrictions strategies, based on the evidence-based guide. Strategies will also be guided by the dominant means identified, local needs, and local stakeholders relevant to facilitating specific means restriction. All means restriction actions will be documented for trial evaluation purposes.

2. School programs: Year nine high school students in all public, independent, and Catholic high schools within the four sites will be offered an evidence-based, universal school program designed to reduce stigma, increase help seeking behaviours and resilience, and reduce suicidal ideation and behaviours. YAM will be delivered over the two-year duration of the LifeSpan trial, meaning two consecutive cohorts of year 9 students will receive the YAM program.

The intervention being used is Youth Aware Mental Health (YAM), which is a school-based suicide prevention program delivered by trained facilitators from outside of the school. YAM was developed by researchers and clinicians from the Karolinska Institute in Sweden and Cornell University in the US. Its primary aim is to raise awareness about suicide risk and the factors that may protect against suicidality. YAM will be delivered as per the SEYLE study protocol: Master trainers will travel from US and Europe to conduct a 4.5 day course to certify YAM instructors. YAM instructors will identify helpers and conduct half- day helper training. The helper can either be another accredited instructor, relevant youth worker or person with lived experience. YAM consists of five sessions delivered over a three-week period. These sessions include a mix of direct instruction, reading material, visual information and interactive workshops where young people are encouraged to role play skills within a supervised environment. The program is delivered by the accredited YAM instructors with the aid of one helper to class groups of up to approximately 30 students.
The five sessions cover the following six central themes: what is mental health?; self-help advice; stress and crisis; depression and suicidal thoughts; helping a friend in need; and who can I ask for advice?

3. Community campaigns: Centrally developed resources and materials, created with the assistance of a media and advertising agency and containing key consistent messages, will be disseminated within each of the four sites. Locally delivered communications campaigns will be disseminated to the general public to reduce stigma, and to increase identification and referral of individuals with suicidal ideation or self-harming behaviours. In addition, sites will be provided with a budget and support to engage with existing suicide prevention campaign providers, such as beyondblue and R U OK, to deliver their campaigns within their region. Number of type of activities will be recorded for evaluation purposes.

4. Media guidelines: Journalists, media representatives and local health services will receive group-based face-to-face media training, delivered by MindFrame Australia, aimed at reducing dangerous reporting of suicide, and increasing responsible coverage of mental health and suicide. Local media organisations will be targeted to ensure sufficient training in, and compliance with, these guidelines, including: report suicide deaths in a sensitive and non-sensationalist manner; avoid giving suicide deaths undue prominence (e.g. front page of newspaper, or lead items in radio bulletins); prevent ‘copycat’ incidents, avoid providing specific details about the suicide, such as method or location; take the opportunity to educate the public and challenge myths about suicide; provide help and support resources to vulnerable viewers, such as listing crisis and helpline numbers; consider the needs of at-risk individuals in the aftermath of a suicide (e.g. taking care when interviewing the bereaved); provide opportunities for debriefing of those exposed to suicide stories, such as journalists themselves. The target audience is local media representatives, suicide prevention multiagency group members, organisational leaders and local leaders who might be asked to comment on suicide by media and who are involved in community support after suicide. A 2-day, face-to-face group program will be delivered early in year 1 of implementation at each site, with a half day refresher program delivered in year 2.

The individual-based strategies are:
5. Gatekeepers (e.g. sports coaches, pharmacists, welfare workers) will receive training to identify and refer individuals with suicidal ideation or self-harming behaviour. Training will be provided to gatekeepers in each of the four sites in both face-to-face and online format. Gatekeeper training teaches lay and professional gatekeepers to recognise and respond positively to someone exhibiting suicide warning signs and behaviours, including providing appropriate referral information. The program includes orientation to suicide prevention and the role of gatekeepers, a review of the common myths about suicide, review and recognition of suicide warning signs, instruction on how to set up an intervention and how to ask the suicide question, how to persuade a suicidal person to accept help, how to refer a suicidal person to local/national resources, and how to improve self-efficacy and enhance hope by offering a personal belief in a positive outcome. One hundred gatekeepers will be trained per region.

6. Frontline staff training: First responders (police, paramedics, and emergency department staff) will receive face to face and online training to support individuals with suicidal ideation or self-harming behaviours. Training will be provided to first responders in each of the four sites. Where training already exists, such as the NSW Police Mental Health IT program, support will be offered to ensure the program is meeting local needs. Other frontline staff, such as emergency department staff, will be offered tailored training which includes gatekeeper skills but also addresses their particular needs. The local implementation teams have identified key decision makers within each sector to work with them in implementing training. The total number of staff trained will vary by sector and site.

7. Psychosocial treatments: A guide to evidence-based psychological and pharmacological treatments for the care of individuals with suicidal ideation and/or behaviours will be provided to privately and publicly employed psychologists, psychiatrists, and other mental health professionals at each site. The Advanced Suicide Prevention Training program, designed and facilitated by the Black Dog Institute, will be provided for these professionals, to inform appropriate assessment of suicidal ideation and/or behaviours. This 6 hour face-to-face group program trains participants to undertake a suicide risk assessment effectively; develop a collaborative safety plan; implement a team approach to treatment planning; provide effective management following a suicide attempt; and respond to the needs of people bereaved by suicide. This training will be supplemented by information on local referral pathways, delivered by a local subject matter expert and program champion. We aim to train 200 mental health professionals at each of the four sites.

8. GP capacity building and support: General practitioners will receive training and practice support to identify and refer individuals with suicidal ideation or self-harming behaviours. The Advanced Suicide Prevention Training program, designed and facilitated by the Black Dog Institute, will be provided to general practitioners. This 6 hour face-to-face group-based program trains participants to undertake a suicide risk assessment effectively; develop a collaborative safety plan; implement a team approach to treatment planning; provide effective management following a suicide attempt; and respond to the needs of people bereaved by suicide.

Practice support is in the form of an electronically delivered stepped care program. General practices will be provided with training by the Black Dog Institute developers of the program (StepCare). Participating ractices will be provided with tablets to be placed in the waiting room. Practice staff will invite patients over the age of 18 years to complete a 2-minute screener in the waiting room on a mobile tablet. The patient is provided with information about StepCare and is asked to provide consent prior to progressing. If consent is provided, the patient will be asked to complete demographic information and questionnaires assessing anxiety, depression, alcohol use, suicidal ideation and risk. The patient will receive minimal immediate feedback and will be encouraged to discuss the results with their GP in detail. The GP will also be provided with more detailed immediate feedback, verbal scripts and recommendations for the patient within the practice management software. The recommended treatment steps up for more severe symptoms. The program automatically populates a Medicare Mental Health Treatment Plan if required. Patients who report symptoms are asked to complete screening every two weeks for 12 weeks, and these results are transmitted back to their GP so that the treatment plan can be modified if necessary. Training for the general practice staff in StepCare will come from a trainer located within the Primary Health Network, who will have received ‘train-the-trainer’ from the Black Dog Institute StepCare coordinator. We aim to train and/or provide StepCare access to 50-60 general practitioners per site.

9. Aftercare and crisis care following a suicide attempt: The reform of care in the emergency department and aftercare will be ongoing through the two-year implementation phase of the project. Guidelines will be developed regarding most appropriate aftercare and crisis care. These guidelines will be implemented in collaboration with hospitals, community mental health centres, and others involved in aftercare in each of the four sites. The guidelines will include recommendations for completing a psychosocial assessment for all patients who present at hospital following a suicide attempt (not just those considered high-risk), explicit communication to the patient about the role of the psychosocial assessment, and an emphasis on the relational aspects of the assessment. With the patient’s consent, families and carers will be included in the aftercare process. Each site has or will commission an aftercare support service which is based on the Outreach, Problem Solving, Adherence, and Continuity (OPAC) model, which includes assertive outreach, solution focused counselling, support to adhere to treatment, and where possible, continuity of contact with the same staff member.
Intervention code [1] 296154 0
Prevention
Intervention code [2] 296155 0
Behaviour
Comparator / control treatment
As the study is utilising a stepped-wedge design, each site has a baseline period which acts as its own control.
Control group
Active

Outcomes
Primary outcome [1] 299902 0
Number of suicides and suicide attempts (composite variable) over time by region, measured by official statistics from multiple sources, including the National Coronial Information System (NCIS), and the New South Wales Admitted Patient Dataset (admissions for deliberate self-harm) for call outs to deliberate self harm episodes or suicide attempts, and the New South Wales Computerised Operational Policing System (COPS) data for call outs to suicide or suicide attempts. At a minimum, these datasets will be acquired back to January 2013, thus providing enough data points to form a baseline prior to the intervention.
Timepoint [1] 299902 0
Data will be acquired at baseline and, at a minimum, up to 24 months post-baseline.
Secondary outcome [1] 333149 0
Changes in community level suicide stigma (Stigma of Suicide Scale), measured via community-wide online survey.
Timepoint [1] 333149 0
Measurement will occur at baseline and at 24 months post-baseline.
Secondary outcome [2] 333150 0
Changes in community level suicide literacy (Literacy of Suicide Scale) measured via community-wide online survey.
Timepoint [2] 333150 0
Measurement will occur at baseline and at 24 months post-baseline.
Secondary outcome [3] 333151 0
Changes in community level help-seeking behaviours (Actual Help-Seeking Questionnaire) measured via community-wide online survey.
Timepoint [3] 333151 0
Measurement will occur at baseline and at 24 months post-baseline.
Secondary outcome [4] 333152 0
Changes in community level suicidality (Suicidal Ideation Assessment Scale) measured via community-wide online survey.
Timepoint [4] 333152 0
Measurement will occur at baseline and at 24 months post-baseline.
Secondary outcome [5] 333153 0
Changes in community level depression (PHQ-9) measured via community-wide online survey.
Timepoint [5] 333153 0
Measurement will occur at baseline and at 24 months post-baseline.
Secondary outcome [6] 333154 0
Changes in number of repeat episodes of hospital-treated deliberate self-harm, measured using linked, routinely collected data (the New South Wales Admitted Patient Dataset, admissions for deliberate self-harm).
Timepoint [6] 333154 0
Data will be acquired over the two-year duration of the intervention.
Secondary outcome [7] 333155 0
Changes in risk of repeat deliberate self-harm or suicide attempt following hospital treated deliberate self-harm, measured using NSW Health hospital admissions data and self-report.

Timepoint [7] 333155 0
Measurement will occur at baseline and at 24 months post-baseline.
Secondary outcome [8] 333156 0
Changes in patient satisfaction with health services following a suicide attempt, measured by Your Experience of Services Survey and in-depth interviews.
Timepoint [8] 333156 0
Measurement will occur at baseline, 6, 12, 18, and 24 months post-baseline.
Secondary outcome [9] 333157 0
Changes in carer satisfaction with health services following suicide attempt by a person under their care, measured by Your Experience of Services Survey modified for carers and in-depth interviews.
Timepoint [9] 333157 0
Measurement will occur at baseline, 12, and 24 months post-baseline.
Secondary outcome [10] 333158 0
Changes in health service provider response to suicide attempts, measured by in-depth interviews.
Timepoint [10] 333158 0
Measurement will occur at baseline, 12, and 24 months post-baseline.
Secondary outcome [11] 333159 0
Changes in access to evidence-based psychological treatment for depression and suicidality, using data from the Medicare Benefits Scheme, ATAPS data, and PENCAT data (composite measure).
Timepoint [11] 333159 0
Data will be acquired, comparing outcomes, from 24months prior to the intervention, through to 24months post-baseline.
Secondary outcome [12] 333160 0
Changes in general practitioner screening for depression anxiety, and suicidality, measured by PENCAT data.
Timepoint [12] 333160 0
Data will be acquired over the two-year duration of the intervention.
Secondary outcome [13] 333161 0
Changes in general practitioner referral for depression, anxiety, and suicidality, measured by data from the Medicare Benefits Scheme, and PENCAT data.
Timepoint [13] 333161 0
Data will be acquired over the two-year duration of the intervention.
Secondary outcome [14] 333162 0
Changes in general practitioner prescribing practices for depression, anxiety, and suicidality, measured by data from the Pharmaceutical Benefits Scheme, and PENCAT data.
Timepoint [14] 333162 0
Data will be acquired over the two-year duration of the intervention.
Secondary outcome [15] 333163 0
Changes in frontline staff identification of suicide risk, measured by self-report data using a risk identification scale.
Timepoint [15] 333163 0
Measurement will occur at pre- and post-training, and 12months after the training.
Secondary outcome [16] 333164 0
Changes in frontline staff responses to suicide risk, measured by self-report data from a referral behaviour scale.
Timepoint [16] 333164 0
Measurement will occur at pre- and post-training, and 12months after the training.
Secondary outcome [17] 333165 0
Changes in frontline staff suicide stigma, measured by self-report data from the Stigma of Suicide Scale (SOSS).
Timepoint [17] 333165 0
Measurement will occur at pre- and post-training, and 12months after the training.
Secondary outcome [18] 333166 0
Changes in frontline staff suicide literacy, measured by self-report data from the Literacy of Suicide Scale (LOSS).
Timepoint [18] 333166 0
Measurement will occur at pre- and post-training, and 12months after the training.
Secondary outcome [19] 333167 0
Changes in community gatekeeper identification of suicide risk, measured by self-report data from a measure of risk identification.
Timepoint [19] 333167 0
Measurement will occur at pre- and post-training, and 12months after the training.
Secondary outcome [20] 333168 0
Changes in community gatekeeper responses to suicide risk, measured by self-report data from a measure of referral behaviours.
Timepoint [20] 333168 0
Measurement will occur at pre- and post-training, and 12months after the training.
Secondary outcome [21] 333169 0
Changes in community gatekeeper suicide literacy, measured by self-report data from the Literacy of Suicide Scale (LOSS).
Timepoint [21] 333169 0
Measurement will occur at pre- and post-training, and 12months after the training.
Secondary outcome [22] 333170 0
Changes in community gatekeeper suicide stigma, measured by self-report data from the Stigma of Suicide Scales (SOSS).
Timepoint [22] 333170 0
Measurement will occur at pre- and post-training, and 12months after the training.
Secondary outcome [23] 333171 0
Changes in high-school students’ suicide behaviour and suicidal ideation, by self-report data from the Suicidal Ideation Assessment Scale (SIDAS).

Timepoint [23] 333171 0
Measurement will occur at pre- and post-program, and 12months after the program.
Secondary outcome [24] 333172 0
Changes in high-school students’ attitudes to and actual help seeking, by self-report data from the General Help-Seeking Questionnaire and Actual Help-Seeking Questionnaire.
Timepoint [24] 333172 0
Measurement will occur at pre- and post-program, and 12months after the program.
Secondary outcome [25] 333173 0
Changes in high-school students’ risk behaviour by self-report data from the Youth Risky Behaviour Survey.

Timepoint [25] 333173 0
Measurement will occur at pre- and post-program, and 12months after the program.
Secondary outcome [26] 333174 0
Changes in high-school students’ suicide stigma by self-report data from the Stigma of Suicide Scale (SOSS).
Timepoint [26] 333174 0
Measurement will occur at pre- and post-program, and 12months after the program.
Secondary outcome [27] 333175 0
Changes in high-school students’ suicide literacy by self-report data from the Literacy of Suicide Scale (LOSS).
Timepoint [27] 333175 0
Measurement will occur at pre- and post-program, and 12months after the program.
Secondary outcome [28] 333176 0
Change in stigmatising or harmful reporting of suicide by local media, measured by media monitoring.

Timepoint [28] 333176 0
Measurement will occur over the two-year duration of the intervention.
Secondary outcome [29] 333177 0
Changes in suicide reporting which encourages help-seeking or covers stories of recovery by local media, measured by media monitoring.

Timepoint [29] 333177 0
Measurement will occur over the two-year duration of the intervention.
Secondary outcome [30] 333188 0
To evaluate the cost effectiveness of LifeSpan on reducing suicide mortality and suicide attempt rates compared to current practice. This will include calculating differences in the number of suicides and suicide attempts for the intervention and control groups, and comparing these to differences in resource use costs associated with program delivery and management, primary and clinical mental health services, non-clinical mental health support services, and indirect costs such productivity and informal care. Data on benefits and costs will be collected from hospital and government administrative datasets, and purpose built surveys administered to patients and their immediate family. Results will be presented through Incremental Cost Effectiveness Ratios (ICERs) as the cost per suicide avoided, cost per suicide attempt avoided, and cost per life-year gained. Benefits and costs will be categorised into government, non-government and patient for presentation purposes.
Timepoint [30] 333188 0
Outcomes will be measured over the two-year duration of the intervention.
Secondary outcome [31] 333189 0
Changes in access to suicide means, measured via a suicide audit (using NCIS data, COPS data) and geospatial analysis of clusters.
Timepoint [31] 333189 0
Data will be acquired over the two-year duration of the intervention.

Eligibility
Key inclusion criteria
All residents in each of the four trial sites will be eligible for inclusion in the study, given the universal nature of some of the strategies.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil.

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)
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
The trial is utilising a stepped-wedge design in which the time at which the intervention was scheduled for introduction at each of the four trial sites was selected randomly without replacement from a pool of four possible start dates. This established cascading start dates for the sites. Pre-intervention (baseline) measures of each outcome measure (primary and secondary) will be taken prior to implementation of the intervention. Where possible, institutionally-supplied outcome measures will be collected at each site over the entire span of the trial.
Phase
Type of endpoint(s)
Statistical methods / analysis

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)
NSW

Funding & Sponsors
Funding source category [1] 294738 0
Charities/Societies/Foundations
Name [1] 294738 0
Paul Ramsay Foundation
Address [1] 294738 0
Level 9, 154 Pacific Highway
St Leonards NSW 2065
Country [1] 294738 0
Australia
Primary sponsor type
University
Name
Black Dog Institute/UNSW
Address
Hospital Road
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 293586 0
None
Name [1] 293586 0
n/a
Address [1] 293586 0
n/a
Country [1] 293586 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296155 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 296155 0
Research Ethics and Governance Office
Hunter New England Human Research Ethics Committee
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 296155 0
Australia
Date submitted for ethics approval [1] 296155 0
21/09/2016
Approval date [1] 296155 0
12/10/2016
Ethics approval number [1] 296155 0
HREC/16/HNE/399

Summary
Brief summary
Background: Lifespan is the systems approach to suicide prevention developed by Black Dog Institute (BDI) and the NHMRC Centre for Research Excellence in Suicide Prevention. BDI is undertaking an evaluation of the LifeSpan approach in four sites across NSW, funded by the Paul Ramsay Foundation and with the support of the NSW Government and the NSW Mental Health Commission. LifeSpan includes nine evidence-based interventions implemented simultaneously within a localised region. Recognising that multiple strategies implemented at the same time are likely to generate bigger effects than just the sum of its parts (i.e., due to synergistic effects), LifeSpan offers a data driven, evidence-based approach, setting it apart from current practise and raising the bar in suicide prevention. Based on the most up-to-date evidence available and drawing from positive results of similar suicide prevention programs overseas, this integrated systems approach is expected to prevent 20% of suicide deaths, and 30% of suicide attempts.
Design: LifeSpan involves a stepped-wedge, randomised design whereby the intervention will be sequentially rolled-out in each of the four sites at three month intervals. This design will avoid the effect of the intervention being confounded with any underlying temporal trend. Once rolled-out, the intervention will be active in each site for two years.
Methods: LifeSpan will involve implementing nine intervention strategies. The individual-based strategies include: aftercare and crisis care, psychosocial and pharmacotherapy treatments, GP capacity building and support, frontline staff training, and gatekeeper training. The universal strategies include: school programs, community campaigns, media guidelines and means restriction. Furthermore, the project will include a community, professionals, and key stakeholder self-report measures. The project will incorporate and be measured against an Implementation Science framework, to ensure maximum engagement and fidelity to the model.
Trial website
http://www.lifespan.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69714 0
Prof Helen Christensen
Address 69714 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 69714 0
Australia
Phone 69714 0
+61 2 9382 9288
Fax 69714 0
Email 69714 0
h.christensen@blackdog.org.au
Contact person for public queries
Name 69715 0
Ms Rachel Green
Address 69715 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 69715 0
Australia
Phone 69715 0
+61 2 9382 9295
Fax 69715 0
Email 69715 0
rachel.green@blackdog.org.au
Contact person for scientific queries
Name 69716 0
Dr Fiona Shand
Address 69716 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 69716 0
Australia
Phone 69716 0
+61 2 9382 9291
Fax 69716 0
Email 69716 0
fionas@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results