Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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.
Secondary ID [1] 293446 0
Nil Known
Universal Trial Number (UTN)
U1111-1205-7841
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicide 305650 0
self-harm 305651 0
Condition category
Condition code
Mental Health 304870 304870 0 0
Suicide
Public Health 304871 304871 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299704 0
Prevention
Intervention code [2] 299705 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 304186 0
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).
Timepoint [1] 304186 0
24 months post commencement of Aftercare intervention.
Primary outcome [2] 305285 0
All-cause mortality as assessed by data linkage to medical records.
Timepoint [2] 305285 0
24 months post commencement of Aftercare intervention.
Secondary outcome [1] 343052 0
Total psychological pain score, as measured by the Psych-ache Scale.
Timepoint [1] 343052 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [2] 344717 0
Total hopelessness score, as measured by the Beck Hopelessness Scale.
Timepoint [2] 344717 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [3] 344718 0
Total self-esteem score, as measured by the The Rosenberg Self-Esteem Scale.
Timepoint [3] 344718 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [4] 344719 0
Total depression score, as measured by the Depression sub-scale of the Depression, Anxiety and Stress Scales.
Timepoint [4] 344719 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [5] 344720 0
Total anxiety score, as measured by the Anxiety sub-scale of the Depression, Anxiety and Stress Scales.
Timepoint [5] 344720 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [6] 344721 0
Total stress score, as measured by the Stress sub-scale of the Depression, Anxiety and Stress Scales.
Timepoint [6] 344721 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [7] 344722 0
Total suicide capacity score, as measured by the Suicide Capacity Scale.
Timepoint [7] 344722 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [8] 344723 0
Total thwarted belongingness score, as measured by the Thwarted Belongingness sub-scale of the Interpersonal Needs Questionnaire.
Timepoint [8] 344723 0
Baseline and 4 weeks after intervention commencement.
Secondary outcome [9] 344724 0
Total perceived burdensomeness score, as measured by the Perceived Burdensomeness sub-scale of the Interpersonal Needs Questionnaire.
Timepoint [9] 344724 0
Baseline and 4 weeks after intervention commencement.

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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Admission to hospital as an inpatient.
The person is currently actively case managed by the mental health services.
Non-English speaking.

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
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/11/2017
Date of last participant enrolment
Anticipated
10/11/2019
Actual
Date of last data collection
Anticipated
10/12/2019
Actual
Sample size
Target
204
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 19329 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 298073 0
University
Name [1] 298073 0
University of Wollongong
Country [1] 298073 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue
Wollongong 2522
NSW
Country
Australia
Secondary sponsor category [1] 297820 0
None
Name [1] 297820 0
Address [1] 297820 0
Country [1] 297820 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299094 0
UOW & ISLHD Health and Medical Research Human Research Ethics Committee
Ethics committee address [1] 299094 0
Ethics committee country [1] 299094 0
Australia
Date submitted for ethics approval [1] 299094 0
01/09/2017
Approval date [1] 299094 0
08/11/2017
Ethics approval number [1] 299094 0
217/426

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

Contacts
Principal investigator
Name 79266 0
Dr Vida Bliokas
Address 79266 0
School of Psychology
University of Wollongong
Northfields Avenue
NSW 2522
Country 79266 0
Australia
Phone 79266 0
+61 2 42214789
Fax 79266 0
Email 79266 0
[email protected]
Contact person for public queries
Name 79267 0
Vida Bliokas
Address 79267 0
School of Psychology
University of Wollongong
Northfields Avenue
NSW 2522
Country 79267 0
Australia
Phone 79267 0
+61 2 42214789
Fax 79267 0
Email 79267 0
[email protected]
Contact person for scientific queries
Name 79268 0
Vida Bliokas
Address 79268 0
School of Psychology
University of Wollongong
Northfields Avenue
NSW 2522
Country 79268 0
Australia
Phone 79268 0
+61 2 42214789
Fax 79268 0
Email 79268 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.