Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001332617
Ethics application status
Approved
Date submitted
15/03/2023
Date registered
19/12/2023
Date last updated
19/12/2023
Date data sharing statement initially provided
19/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an aftercare service reduce suicide risk in young people? An evaluation of the O-HOPE service.
Scientific title
Can an aftercare service reduce suicide risk in young people? An evaluation of the O-HOPE service.
Secondary ID [1] 308410 0
none
Universal Trial Number (UTN)
Trial acronym
O-HOPE evaluation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicide prevention 328213 0
Condition category
Condition code
Mental Health 325263 325263 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Orygen Hospital Outreach Post-suicidal Engagement (O-HOPE) aftercare provide intensive, person-centred multidisciplinary support, which is tailored to the unique needs and circumstances of the individual.
The treatment will be administered by a multi-disciplinary team of health professionals and peer support workers,
Eligible young people are contacted within 24 hours of hospital discharge, and provided with weekly face-to-face 1-h sessions for up to three months.
Holistic support across psychological, family, psychosocial including peer support, physical domains is offered based on each young person’s unique stressors and needs.
Psychological treatment modules will include, but not be limited, the following: suicide safety planning, behavioural activation, emotional regulation, brief (CBT) interventions targeting substance use, depression etc.
Psychosocial interventions include housing and employment assistance, or referral to a range of support services, such as education and training, legal support, Centrelink, drug and alcohol and family work intervention.
HOPE clinicians also work collaboratively with the young person’s support system (family/carers, educational/vocational, healthcare and community support providers) to understand, respond to and meet the wellbeing needs of the young person.
Intervention code [1] 324865 0
Prevention
Comparator / control treatment
Historical control group of young people who have accessed the emergency department (ED) of the Royal Melbourne Hospital (RMH) for self-harm and/or suicidal ideation related presentations in the period prior to the establishment of HOPE aftercare (specifically January 2012 to December 2021)
Control group
Historical

Outcomes
Primary outcome [1] 333110 0
Effectiveness and Maintenance 1: Self-reported episodes of suicidal ideation assessed using the Suicide Ideations Attributes Scale (SIDAS)
Timepoint [1] 333110 0
Change in self-reported symptoms across 3 time points: T1 (Pretreatment/Intake), T2 (Posttreatment/Discharge) and T3 (3-months following discharge)

Primary endpoint: T2 (Posttreatment/Discharge)
Secondary outcome [1] 416026 0
Effectiveness and Maintenance 2: Self-harm assessed with purpose-developed questions
Timepoint [1] 416026 0
Change in self-reported symptoms across 3 time points: T1 (Pretreatment/Intake), T2 (Posttreatment/Discharge) and T3 (3-months following discharge)
Secondary outcome [2] 416027 0
Effectiveness and Maintenance 3: suicide attempts assessed using the Youth Risk Behaviour Survey (YRBS)
Timepoint [2] 416027 0
Change in self-reported symptoms across 3 time points: T1 (Pretreatment/Intake), T2 (Posttreatment/Discharge) and T3 (3-months following discharge)
Secondary outcome [3] 416028 0
Effectiveness and Maintenance 4: depressive symptoms assessed with Patient Health Questionnaire 9 items (PHQ9)
Timepoint [3] 416028 0
Change in self-reported symptoms across 3 time points: T1 (Pretreatment/Intake), T2 (Posttreatment/Discharge) and T3 (3-months following discharge)
Secondary outcome [4] 416033 0
Effectiveness and Maintenance 5: psychological distress assessed with Kessler 10 (K-10)
Timepoint [4] 416033 0
Change in self-reported symptoms across 3 time points: T1 (Pretreatment/Intake), T2 (Posttreatment/Discharge) and T3 (3-months following discharge)
Secondary outcome [5] 429525 0
Effectiveness and Maintenance 6: generalised anxiety disorder assessed using GAD7
Timepoint [5] 429525 0
Change in self-reported symptoms across 3 time points: T1 (Pretreatment/Intake), T2 (Posttreatment/Discharge) and T3 (3-months following discharge)
Secondary outcome [6] 430127 0
Cost-effectiveness - value for money
The cost-effectiveness evaluation will involve collation of program delivery costs, other costs incurred or saved (e.g., reductions in hospitalisations or increases in psychological treatment use) and other health benefits (e.g., quality adjusted life years).
Data will be obtained from the self-reported Resource Use Questionnaire (RUQ) and Child Health Utility (CHU9), as well as data from hospital records (e.g., presentation rates).


Timepoint [6] 430127 0
Participants will complete self-reported surveys across 3 time points: T1 (Pretreatment/Intake), T2 (Posttreatment/Discharge) and T3 (3-months following discharge)

Hospital based data will be extracted from the hospital records every six months, for the duration of the project.
Secondary outcome [7] 430146 0
The Scalability or the potential population level impact of the service on rates of suicide, self-harm hospitalisations, and ED presentations when modelled to scale, will be assessed using the dynamic systems modelling.

Dynamic systems modelling incorporates a variety of information sources, as well as expert and local knowledge, and practice experience, in order to develop a computerised model that can be used to forecast the short- and longer-term impacts of different combinations of suicide prevention interventions and mental health service improvements on reducing suicidal behaviour,

Data sources for model parameterisation: Model development will leverage project data collected from participants directly as outlined in each primary/secondary outcomes, a range of routinely collected administrative/hospital datasets, and research evidence to deliver an interactive decision support tool that provides a safe virtual environment to explore the optimal timing, scale and intensity of assertive aftercare needed to achieve the greatest population-level impacts.

Timepoint [7] 430146 0
As per above nominated outcomes and corresponding timepoint.

Eligibility
Key inclusion criteria
Young people aged 12-25 who reside in north-west metropolitan Melbourne and who following presentation to Emergency Department for severe self-harm and/or suicidal ideation, are referred to HOPE aftercare service.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312658 0
Charities/Societies/Foundations
Name [1] 312658 0
Future Generations Global
Country [1] 312658 0
Australia
Funding source category [2] 312659 0
Charities/Societies/Foundations
Name [2] 312659 0
William Buckland Foundation
Country [2] 312659 0
Australia
Funding source category [3] 313401 0
Government body
Name [3] 313401 0
NHMRC
Country [3] 313401 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen
Address
35 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 314270 0
University
Name [1] 314270 0
University of Melbourne
Address [1] 314270 0
Parkville VIC 3010
Country [1] 314270 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311966 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 311966 0
Ethics committee country [1] 311966 0
Australia
Date submitted for ethics approval [1] 311966 0
16/11/2022
Approval date [1] 311966 0
08/08/2023
Ethics approval number [1] 311966 0

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

Contacts
Principal investigator
Name 122994 0
Prof Jo Robinson
Address 122994 0
Orygen 35 Poplar Rd, Parkville VIC 3052
Country 122994 0
Australia
Phone 122994 0
+61 3 9966 9318
Fax 122994 0
Email 122994 0
[email protected]
Contact person for public queries
Name 122995 0
Jo Robinson
Address 122995 0
Orygen 35 Poplar Rd, Parkville VIC 3052
Country 122995 0
Australia
Phone 122995 0
+61 3 9966 9318
Fax 122995 0
Email 122995 0
[email protected]
Contact person for scientific queries
Name 122996 0
Jo Robinson
Address 122996 0
Orygen 35 Poplar Rd, Parkville VIC 3052
Country 122996 0
Australia
Phone 122996 0
+61 3 9966 9318
Fax 122996 0
Email 122996 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


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.