ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12622000486729

Ethics application status

Approved

Date submitted

16/03/2022

Date registered

28/03/2022

Date last updated

28/03/2022

Date data sharing statement initially provided

28/03/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Using speech characteristics to classify suicide risk in telehealth callers

Scientific title

Using speech characteristics to classify low versus high risk of suicide in 64 male and female telehealth counselling calls

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1275-8186

Trial acronym

RELIANCE (REaL tIme ANalysis of voiCE)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

suicide

Condition category

Condition code

Mental Health

Suicide

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Duration of observation is 1/7/2020 - 30/6/21
Call recordings made to a national telehealth suicide prevention service will be observed throughout the duration of each call. Callers identified as being at high risk of imminent suicide will be identified. Callers will by identified via screening questions ("are you at risk of suicide", and "do you have a plan that you will carry out"). High risk of suicide status will be initially assigned by the responding counsellor using an organisational risk framework, then confirmed retrospectively by a team of Associate Researchers and finally re-confirmed by the student investigator, using the Columbia Suicide Severity Risk rating (ratings 5 and 6). Calls are made form private homes, and in public spaces.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

Call recordings made to a national telehealth suicide prevention service will be observed throughout the duration of each call. Callers identified as being at low risk of imminent suicide will be identified. Callers will by identified via screening questions ("are you at risk of suicide", and "do you have a plan that you will carry out"). Low risk of suicide status will be initially assigned by the responding counsellor using an organisational risk framework, then confirmed retrospectively by a team of Associate Researchers and finally re-confirmed by the student investigator, using the Columbia Suicide Severity Risk rating (ratings 1 and 2). Calls are made form private homes, and in public spaces.

Control group

Active

Outcomes

Primary outcome [1]

High risk of suicide shall be determined via assessment using the Columbia Suicide Severity Rating Scale (CSSR-S) (Rating 5 and 6) (highest levels)

Timepoint [1]

Assessment of high risk of suicide will be made at the conclusion of each call, and after listening to each call recording in full.

Secondary outcome [1]

Emotional distress shall be assessed via the Distress Barometer (10 point Likert-style scale, 0=absence of emotional distress; 10 = highest level emotional distress).

Timepoint [1]

Emotional distress shall be assessed at various timepoints across each call recording. Timepoints shall correspond to a variety of emotional distress ratings within each recording.

Eligibility

Key inclusion criteria

English speaking; call made within Australia; 18+ years

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Calls made via teletext or requiring third party translation; speech difficulties (motor articulation); intoxication.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

Preprocessing of call recordings will include conversion to alternative format (8kHz; 16-bit PCM) compatible with RStudio. Recordings will be normalised and pre-emphasis applied to attenuate low frequencies and magnify high frequencies.
Analysis will involve:
1. L1-penalised Lasso Regression to reduce the number of extracted speech characteristics.
2. 3-level Mixed Effects Generalised Additive Modelling (GAMM) with speech characteristics extracted at within 40ms (50% overlapping) Blackman-windowed frames (level 1); Annotated Segments with Power Spectral Density characteristics (level 2); and individual callers with identified sex of caller (level 3). Binary regression with logit link will be used to discriminate between low and high risk of suicide response. AR1 autocorrelation will also be applied to level 1 predictors.
3. Component-wise Gradient Boosting well be used to automatically classify each recording to either low or high risk of suicide categories. The algorithm will be trained on 70% of the recordings, while the remaining 30% will be used for validation purposes.
The methods used at 2. and 3. will allow for significant non-linearity amongst the predictors by using splines to more accurately model the data.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

8/07/2021

Date of last participant enrolment

Anticipated

Actual

15/07/2021

Date of last data collection

Anticipated

Actual

15/07/2021

Sample size

Target

500

Accrual to date

Final

840

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

On The Line

Address [1]

PO Box 2339,
Footscray,
Vic 311

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Australian Federal Police

Address [2]

Cnr College Street and Benjamin Way, Belconnen ACT 2617

Country [2]

Australia

Primary sponsor type

University

Name

Swinburne University of Technology

Address

John Street
Hawthorn
Vic. 3122

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Swinburne University Human Research Ethics Committee

Ethics committee address [1]

John Street, 
Hawthorn
Vic. 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2020

Approval date [1]

22/01/2021

Ethics approval number [1]

20214340-5805

Summary

Brief summary

The primary hypothesis of the study is to automatically classify a sample of call recordings obtained from our telehealth partners according to risk of suicide. Risk of suicide is defined as low (levels 1 and 2 on the Columbia Suicide Severity Rating scale, CSSR-S) and High (levels 5 and 6 on the CSSR-R). Call recordings will be sourced from two industry partners including On The Line who administer the Suicide Call Back service and the Australian Federal Police who administer 000 emergency services in the Canberra, Australia region.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Denny Meyer

Address

Centre for Mental Health
Swinburne University of Technology
John Street
Hawthorn
Vic. 3122

Country

Australia

Phone

+61 03 9214 4824

Fax

dmeyer@swin.edu.au

Contact person for public queries

Name

Ravi Iyer

Address

Centre for Mental Health
Swinburne University of Technology
John Street
Hawthorn
Vic. 3122

Country

Australia

Phone

+61 456 565 575

Fax

raviiyer@swin.edu.au

Contact person for scientific queries

Name

Ravi Iyer

Address

Centre for Mental Health
Swinburne University of Technology
John Street
Hawthorn
Vic. 3122

Country

Australia

Phone

+61 456 565 575

Fax

raviiyer@swin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Call recordings contain personally identifiable information and relate to sensitive information being discussed in a counselling context.

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

Source	Title	Year of Publication	DOI
Embase	Using Voice Biomarkers to Classify Suicide Risk in Adult Telehealth Callers: Retrospective Observational Study.	2022	https://dx.doi.org/10.2196/39807

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically