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Trial registered on ANZCTR
Registration number
ACTRN12618001701213
Ethics application status
Approved
Date submitted
12/02/2018
Date registered
16/10/2018
Date last updated
16/10/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of a community-based assertive follow-up suicide prevention program for people who have attempted suicide or are at high risk of suicide
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Scientific title
A non-randomised controlled trial of a community-based aftercare suicide prevention program for people who have attempted suicide or are at high risk of suicide targeting repeat presentations to emergency departments.
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Secondary ID [1]
293446
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Nil Known
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Universal Trial Number (UTN)
U1111-1205-7841
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
suicide
305650
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self-harm
305651
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Condition category
Condition code
Mental Health
304870
304870
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0
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Suicide
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Public Health
304871
304871
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The primary aim of the research is to determine the effectiveness of a community-based assertive follow-up (aftercare) program in reducing repeat suicide attempts for people who have presented to a hospital emergency department following a non-fatal suicide attempt or with high risk of suicide. The assertive follow-up intervention will be delivered by mental health clinicians and peer workers, using both face-to-face interventions and phone follow-up sessions, for a duration of four weeks (with an option of extension to 12 weeks). Each participant will attend a 1-hour community-based outpatient appointment for an initial session with a mental health clinician. They will then receive follow-up phone calls, initially three times each week then tapering to weekly, from a peer worker (approx. 30 minutes duration), followed by a follow-up face-to-face appointment with the mental health clinician after four weeks.
The intervention is based on the GROW coaching model and will utilise the Suicide Status Form-4 (SSF-4) from the Collaborative Assessment and Management of Suicide (CAMS) model (Jobes, 2016; Jobes, Jacoby, Cimbolic, & Hustead, 1997). The SSF-4 is a multicomponent assessment, monitoring and treatment planning tool (Jobes 2016, p. 13). Participants will be asked to outline the key issues that are contributing to their suicide risk, and in collaboration with a clinician, will produce a set of goals and objectives for addressing these issues in a set timeframe, and follow a stabilisation plan. Participants will re-rate their suicide risk factors and evaluate their goals and stabilisation plan at each contact with a clinician or peer worker. Quantitative and qualitative measures of progress toward goals, stabilisation plan and suicide risk will be monitored using the SSF-4 at each contact, measuring psychological pain, agitation, stress, hopelessness, self-hate and overall risk. Records will be kept of adherence to the stabilisation plan, attendance at meetings and participation in phone calls.
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Intervention code [1]
299704
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Prevention
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Intervention code [2]
299705
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Treatment: Other
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Comparator / control treatment
Data on re-presentation rates (for suicide attempt or serious risk of suicide) to an emergency department and all-cause mortality will be collected from the three participating emergency departments for 24 months. The control group will be people who met criteria for the intervention but did not participate in the Aftercare intervention, and who therefore received treatment as usual (TAU). Treatment as usual following discharge from an emergency department varies for individuals. It may consist of; a follow-up visit to a general medical practitioner; continuing to attend services already established, such as from a health professional; or a referral from the emergency department to other services as appropriate, such as housing support.
Primary analyses will compare the intervention group with the TAU control group.
A further analysis (population based) will assess trends in overall number of presentations to the emergency departments in the region (for suicide attempt or serious risk of suicide) for the two years prior to the implementation of the aftercare intervention in the region, and the two years following implementation.
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Control group
Active
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Outcomes
Primary outcome [1]
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Total number of repeat presentations to a hospital emergency department following a suicide attempt or high risk of suicide over 24 months. This measure will be attained by a data linkage between the intervention service and the health service. Data on number of emergency department suicide-related re-presentations for participants of the Aftercare service will be compared to data on suicide-related re-presentations for non-participants (TAU control group).
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Assessment method [1]
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Timepoint [1]
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24 months post commencement of Aftercare intervention.
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Primary outcome [2]
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All-cause mortality as assessed by data linkage to medical records.
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Assessment method [2]
305285
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Timepoint [2]
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24 months post commencement of Aftercare intervention.
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Secondary outcome [1]
343052
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Total psychological pain score, as measured by the Psych-ache Scale.
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Assessment method [1]
343052
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Timepoint [1]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [2]
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Total hopelessness score, as measured by the Beck Hopelessness Scale.
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Assessment method [2]
344717
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Timepoint [2]
344717
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [3]
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Total self-esteem score, as measured by the The Rosenberg Self-Esteem Scale.
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Assessment method [3]
344718
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Timepoint [3]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [4]
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Total depression score, as measured by the Depression sub-scale of the Depression, Anxiety and Stress Scales.
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Assessment method [4]
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Timepoint [4]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [5]
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Total anxiety score, as measured by the Anxiety sub-scale of the Depression, Anxiety and Stress Scales.
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Assessment method [5]
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Timepoint [5]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [6]
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Total stress score, as measured by the Stress sub-scale of the Depression, Anxiety and Stress Scales.
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Assessment method [6]
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Timepoint [6]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [7]
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Total suicide capacity score, as measured by the Suicide Capacity Scale.
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Assessment method [7]
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Timepoint [7]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [8]
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Total thwarted belongingness score, as measured by the Thwarted Belongingness sub-scale of the Interpersonal Needs Questionnaire.
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Assessment method [8]
344723
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Timepoint [8]
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Baseline and 4 weeks after intervention commencement.
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Secondary outcome [9]
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Total perceived burdensomeness score, as measured by the Perceived Burdensomeness sub-scale of the Interpersonal Needs Questionnaire.
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Assessment method [9]
344724
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Timepoint [9]
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Baseline and 4 weeks after intervention commencement.
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Eligibility
Key inclusion criteria
People aged over 16 years old who have presented to a hospital emergency department following suicide attempt or with high risk of suicide.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Admission to hospital as an inpatient.
The person is currently actively case managed by the mental health services.
Non-English speaking.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Primary analyses will compare the intervention group with the control group (treatment as usual). A further analysis (population-based) will assess trends in overall number of presentations to the emergency departments in the region (for suicide attempt or serious risk of suicide) for the two years prior to the implementation of the aftercare intervention in the region, and the two years following implementation.
Secondary analyses will assess changes in suicide risk factors (psych ache, hopelessness, depression etc.) as a result of the intervention in participants of the aftercare intervention. Within-subject change will be assessed by comparing pre-intervention and post-intervention measures.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The primary analyses will be conducted according to the intention-to-treat approach. The number of people who present to an emergency department with a repeat suicide-related event and number of deaths by any cause will be compared between the two non-randomised groups (intervention vs TAU control group) using a log-rank test. Based on Hvid et al.'s (2011) report that an intervention group had approximately half the rate of deaths by suicide than a TAU group at 12 months (.087 vs .219) and using G*Power, the total number of participants required at a level .05 for power of 80% is estimated as 204.
A negative binomial regression model will be applied to the data to estimate the effect of the intervention on re-presentation rates, accounting for varying lengths of follow-up period and adjusting for service and person-level characteristics (e.g. facility, age, sex, indigenous status) and censoring.
Secondary outcome measures, investigating the impact of the service on suicide risk factors for those who participated in the Aftercare intervention, will be evaluated by comparing pre- and post-intervention outcomes of participants of the intervention using paid t-test, or a Wilcoxon signed-ranks test (if the sample size is insufficient or non-normally distributed), with adjustment for multiple comparisons (Bonferroni correction).
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
10/11/2017
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Date of last participant enrolment
Anticipated
10/11/2019
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Actual
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Date of last data collection
Anticipated
10/12/2019
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Actual
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Sample size
Target
204
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Accrual to date
40
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
19329
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2500 - Wollongong
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Funding & Sponsors
Funding source category [1]
298073
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University
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Name [1]
298073
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University of Wollongong
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Address [1]
298073
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Northfields Avenue
Wollongong 2522
NSW
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Country [1]
298073
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Australia
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Primary sponsor type
University
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Name
University of Wollongong
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Address
Northfields Avenue
Wollongong 2522
NSW
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Country
Australia
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Secondary sponsor category [1]
297820
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None
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Name [1]
297820
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Address [1]
297820
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Country [1]
297820
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299094
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UOW & ISLHD Health and Medical Research Human Research Ethics Committee
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Ethics committee address [1]
299094
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University of Wollongong
Northfields Avenue
NSW 2522
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Ethics committee country [1]
299094
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Australia
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Date submitted for ethics approval [1]
299094
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01/09/2017
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Approval date [1]
299094
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08/11/2017
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Ethics approval number [1]
299094
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217/426
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Summary
Brief summary
The study aims to evaluate the efficacy of a community-based assertive aftercare follow-up suicide prevention program in reducing repeat suicide attempts for people who have presented to the participating emergency departments following a suicide attempt or with high risk of suicide. A secondary aim of the study is to measure changes in known suicide risk factors (e.g. depressed mood, psychache) for people who participated in the intervention.
The assertive follow-up intervention will be delivered by mental health clinicians and peer workers, using both face-to-face interventions and phone follow-up sessions, for a duration of four weeks (with an option of extension to 12 weeks). The intervention is based on the GROW coaching model and will utilise the Suicide Status Form-4 (SSF-4) from the Collaborative Assessment and Management of Suicide (CAMS) model (Jobes, 2016; Jobes, Jacoby, Cimbolic, & Hustead, 1997). Participants will be asked to outline the key issues that are contributing to their suicide risk, and in collaboration with a clinician, will produce a set of goals and objectives for addressing these issues in a set timeframe, and follow a stabilisation plan. Participants will re-rate their suicide risk factors and evaluate their goals and stabilisation plan at each contact with a clinician or peer worker. Quantitative and qualitative measures of progress toward goals, stabilisation plan and suicide risk will be monitored using the SSF-4 at each contact, measuring psychological pain, agitation, stress, hopelessness, self-hate and overall risk.
It is hypothesised that;
1. Compared to health consumers who receive treatment as usual (TAU) following their episode of care in an emergency department as a result of a suicide attempt or high risk of suicide, participants of the Aftercare intervention will be significant less likely to re-present to an emergency department for suicide attempt or high risk of suicide.
2. Compared to health consumers who receive TAU following their episode of care in an emergency department for suicide attempt or high risk of suicide, participants of the Aftercare intervention will experience a significant reduction in the number repeat suicide attempts (as measured by re-presentations to an emergency department for a suicide attempt or being deemed to be at high risk of suicide).
3. Compared to health consumers who receive treatment as usual (TAU) following their episode of care in an emergency department as a result of a suicide attempt or high risk of suicide, participants of the Aftercare intervention will be significant less likely to die by any cause in 24 months.
4. Participants of the Aftercare intervention will show significant reductions in suicide risk factors following the intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Vida Bliokas
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Address
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School of Psychology
University of Wollongong
Northfields Avenue
NSW 2522
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Country
79266
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Australia
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Phone
79266
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+61 2 42214789
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Fax
79266
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Email
79266
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[email protected]
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Contact person for public queries
Name
79267
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Dr Vida Bliokas
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Address
79267
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School of Psychology
University of Wollongong
Northfields Avenue
NSW 2522
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Country
79267
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Australia
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Phone
79267
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+61 2 42214789
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Fax
79267
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Email
79267
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[email protected]
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Contact person for scientific queries
Name
79268
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Dr Vida Bliokas
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Address
79268
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School of Psychology
University of Wollongong
Northfields Avenue
NSW 2522
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Country
79268
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Australia
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Phone
79268
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+61 2 42214789
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Fax
79268
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Email
79268
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23581
Study protocol
https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-7751-8
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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