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Trial registered on ANZCTR


Registration number
ACTRN12621001430820
Ethics application status
Approved
Date submitted
24/08/2021
Date registered
22/10/2021
Date last updated
3/03/2023
Date data sharing statement initially provided
22/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the SignPost Study: a mobile phone messaging intervention to support people bereaved by suicide
Scientific title
SignPost: Randomised controlled trial of a mobile phone messaging intervention to support people bereaved by suicide
Secondary ID [1] 305127 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide bereavement 323364 0
Grief 323712 0
Condition category
Condition code
Mental Health 320934 320934 0 0
Suicide
Mental Health 321247 321247 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SignPost study is an evidence-informed brief contact intervention comprising a series of text messages for people bereaved by suicide. Messages will be sent over a six-week period to participants (18 years or over) bereaved by suicide and will contain information and links to readily available supports and psychoeducation about grief following suicide.

A randomised controlled trial will be used to investigate the efficacy of the intervention. Participants will be randomly allocated to either an intervention group or the control (i.e., treatment-as-usual) group. The intervention group will receive a series of SMS brief contacts over a six-week period, provided in addition to treatment as usual. The messages will link to a Webpage hosted on Qualtrics and include a links to Factsheets relevant to the topic of the message. The specific content and framing of the messages and the type of content provided have been developed through a two-phase collaborative method. First, international experts in suicide prevention provided input into the issues and timing of these issues, and second, the outcomes of this were reviewed through focus groups with people with lived experience of suicide bereavement to finalise the message content.

This study will use a mixed-methods approach to evaluate the effectiveness of the intervention with survey assessments conducted at baseline (T1) and six-week post-baseline (T2), with qualitative interviews conducted after the intervention period with a subset of participants.

Messages are sent via SMS at the following timepoints across a six week period, with the subject identified:
Message 1 @T1 + 1 day - grief after suicide
Message 2 @ T1 + 8 days - practical challenges
Message 3 @ T1 + 15 days - relationships after a suicide
Message 4 @ T1+22 days - I need help now
Message 5 @ T1 + 25 days - returning to well-being
Message 6 @ T1 + 29 days - peer support
Message 7 @ T1+ 26 days - professional support
Link to T2 @T1 + 39 days

The length of the messages is between 100-150 words, taking 1-2 minutes to read.

The development of the messages was two-phased. First, a group of international suicide bereavement experts completed a survey indicating the issues/challenges associated with suicide bereavement, and what supports were required at differing timeframes following the death. This informed focus groups undertaken with people bereaved by suicide who then developed and tested the messages and landing website information. Further information for the website was sourced through existing services, primarily the national suicide postvention program, StandBy Support After Suicide (https://standbysupport.com.au/resources/) to refer specifically to the content of the message. The information designed specifically for the study is not yet publicly available, until after the trial so that the control condition do not have access. Post this study the information will become publicly available and will be hosted on the Life in Mind website (www.Lifeinmind.org.au). As the landing website is designed specifically for this study, general tracking analytics of the website use are being collected.

The qualitative interview participants will be purposively sampled based on the initial quantitative analysis to ensure maximum variation sampling to ensure insights into those who used the messages and website, and those who did not based on changes to the primary and secondary outcome measures.


Intervention code [1] 321536 0
Treatment: Other
Comparator / control treatment
The control group do not receive any messages, and only at the completion of the T2 survey (seven weeks post engagement with the project) do they gain access to the website with the information that the intervention group were being linked with. For the purposes of this study, treatment as usual refers to any services or supports the individual locates and accesses for their bereavement related to suicide.
Control group
Active

Outcomes
Primary outcome [1] 328717 0
Primary outcome 1: Psychological distress - Clinically significant improvement and deterioration in symptoms assessed via K-10 (Kessler et al., 2003)
Timepoint [1] 328717 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [1] 400105 0
Secondary outcome 1: Suicide exposure (Maple & Sanford, 2020)
Timepoint [1] 400105 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [2] 400106 0
Secondary outcome 2: Help seeking intentions and behaviours as measured by General Help Seeking Questionnaire (GHSQ; Wilson et al., 2005) and factors associated with these outcomes
Timepoint [2] 400106 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [3] 400107 0
Secondary outcome 3: Suicidal ideation and attempts as measured by SIDAS (van Spijker et al., 2014)

Timepoint [3] 400107 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [4] 400108 0
Secondary outcome 4: Functioning as measured by a HRQOL-14 survey item (Newschaffer, 1998) and factors associated with these outcomes
Timepoint [4] 400108 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [5] 400109 0
Secondary outcome 5: Complicated grief as measured by Inventory of Complicated Grief (Prigerson et al., 1995) and factors associated with these outcomes
Timepoint [5] 400109 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [6] 400110 0
Secondary outcome 6: Resilience as measured by Resilience Appraisal Scale 12 (Johnson et al., 2010) and factors associated with these outcomes
Timepoint [6] 400110 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [7] 400111 0
Secondary outcome 7: Alcohol use as measured by AUDIT-C (Bush et al., 1998) and factors associated with these outcomes
Timepoint [7] 400111 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [8] 401525 0
Impact of suicide (Maple and Sanford, 2020)
Timepoint [8] 401525 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [9] 401526 0
Actual Help Seeking Questionnaire AHSQ; Wilson et al., 2005)
Timepoint [9] 401526 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [10] 401527 0
Single item Wellbeing as measured by a HILDA survey item and factors associated with these outcomes
Timepoint [10] 401527 0
Timepoint: baseline (T1), at six-week post-baseline (T2)
Secondary outcome [11] 401528 0
Semi-structured interview with sub-sample of 20 participants via video-conferencing (zoom) at a time that is mutually convenient. Content of the interview focused on the outcome measures of interest, and participants will be purposively sampled via initial quantitative analysis for maximum variation sampling to be achieved.
Timepoint [11] 401528 0
Mutually convenient time - invitation to participate one month following T2 (six weeks post-baseline).

Eligibility
Key inclusion criteria
To be eligible to take part in this study, participants will need to be:
- 18 years or over
- Bereaved by suicide (self-identified) in the last year
- Living in Australia
- Proficient in English language
- Access to a personal mobile phone
- Not currently considering suicide
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a small-moderate difference (d=0.4) between the intervention and control groups with 90% power, a sample of 266 is required. To account for up to 50% attrition (based on prior, like projects), we aim to recruit 266 per condition for a total sample of 532.

Mixed-model repeated measures ANOVA will test the efficacy of the intervention compared to the control group, with an intention-to-treat analysis using all available data. Interaction terms will be examined to identify moderators and mediators of efficacy and engagement, to assist in better targeting the intervention and potential scaling up the delivery of the intervention in the community following the study. To establish the safety of the intervention, we will investigate clinically significant improvement and deterioration in symptoms between the two arms, and factors associated with these outcomes.

Latent profile analysis will be applied to baseline measures to generate a typology of groups who share similar attitudes/beliefs to suicide risk and protective factors, enabling development of targeted interventions for high-risk groups.

A subsample of approximately 20 individuals from the intervention group will participate in qualitative interviews. A socio-ecological theoretical model will determine the psychosocial influences on lived experience of suicide exposure using the qualitative data. Thematic analysis will be applied to the transcripts of the qualitative interviews

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
31/03/2022
Actual
2/06/2022
Date of last data collection
Anticipated
31/05/2022
Actual
25/07/2022
Sample size
Target
532
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309489 0
Charities/Societies/Foundations
Name [1] 309489 0
Suicide Prevention Research Fund via Suicide Prevention Australia
Country [1] 309489 0
Australia
Primary sponsor type
University
Name
University of New England
Address
Elm Ave
Armidale, NSW, 2351
Country
Australia
Secondary sponsor category [1] 310459 0
University
Name [1] 310459 0
Australian National University
Address [1] 310459 0
95 Daley Road Canberra ACT 2601
Country [1] 310459 0
Australia
Secondary sponsor category [2] 310500 0
Other
Name [2] 310500 0
Everymind
Address [2] 310500 0
72 Watt St Newcastle, NSW 2300
Country [2] 310500 0
Australia
Other collaborator category [1] 281957 0
Other
Name [1] 281957 0
Life in Mind
Address [1] 281957 0
PO Box 833 Newcastle NSW 2300
Country [1] 281957 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309274 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 309274 0
Ethics committee country [1] 309274 0
Australia
Date submitted for ethics approval [1] 309274 0
28/07/2021
Approval date [1] 309274 0
13/08/2021
Ethics approval number [1] 309274 0
HE21-175

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

Contacts
Principal investigator
Name 113586 0
Prof Myfanwy Maple
Address 113586 0
School of Health (C013), University of New England
Elm Ave
Armidale NSW 2351
Country 113586 0
Australia
Phone 113586 0
+61 2 6773 3661
Fax 113586 0
Email 113586 0
mmaple2@une.edu.au
Contact person for public queries
Name 113587 0
Myfanwy Maple
Address 113587 0
School of Health (C013), University of New England
Elm Ave
Armidale NSW 2351
Country 113587 0
Australia
Phone 113587 0
+61 2 6773 3661
Fax 113587 0
Email 113587 0
mmaple2@une.edu.au
Contact person for scientific queries
Name 113588 0
Myfanwy Maple
Address 113588 0
School of Health (C013), University of New England
Elm Ave
Armidale NSW 2351
Country 113588 0
Australia
Phone 113588 0
+61 2 6773 3661
Fax 113588 0
Email 113588 0
mmaple2@une.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case by case basis at the discretion of the principal investigator, based on a methodologically sound proposal and relevant ethics approval being received.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access will be subject to approvals by principal investigator via contacting:
Professor Myfanwy Maple
School of Health
University of New England
NSW 2351 Australia
Email: mmaple2@une.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12979Ethical approval  mmaple2@une.edu.au Available from principal investigator via contacti... [More Details] 382632-(Uploaded-24-08-2021-14-51-37)-Study-related document.pdf
13415Study protocol  mmaple2@une.edu.au Study protocol available from: Professor Myfanwy ... [More Details]



Results publications and other study-related documents

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