Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000349448
Ethics application status
Approved
Date submitted
31/03/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
TIPS: Trans-Tasman Internet-delivered Prevention of (youth) Suicide
Scientific title
TIPS (The Trans-Tasman Internet-delivered Prevention of (youth) Suicide): A four-arm superiority randomised controlled trial of three New Zealand and Australian developed apps to determine their effectiveness in reducing suicidal ideation in young people
Secondary ID [1] 313359 0
HRC: 23/302/A University of Auckland: 9123-3726811
Universal Trial Number (UTN)
Trial acronym
TIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 335717 0
Condition category
Condition code
Mental Health 332283 332283 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TIPS is a four-arm superiority RCT of mobile apps.
1 – Tune In (NZ); 2 – Bro (NZ); 3 – LifeBuoy (Australian); 4 – Mood tracking (attention-matched) control app (NZ).
The RCT will be delivered by the Tirohia Platform, a configurable Web portal and suite of Web services that facilitates rapid and concurrent field trials.

Young people will have uninterrupted access to their app for the duration of the trial until the final participant has completed the 90-day follow-up. At 30 and 90 days, the Tirohia Platform will send a URL for the assessment survey via SMS or email based on the information provided by the participant. The Web services provide an Application Programming Interface (API) that also allows apps to log event data (passive logging e.g., sessions of use, modules completed, as per relevant to each app), which is linked with assessments in the Tirohia Platform database for subsequent analysis. After downloading an app from the app store, on initial invocation the participant will be presented with a login to match to their identity in the Tirohia Platform (we expect young people will usually opt for this to be their phone number). This will cause the app to invoke the Tirohia Platform API and exchange a security token. The token will persist on the device and be renewable such that further logins are unnecessary (unless the participant chooses to logout, e.g. to secure their session if they share a device with others).

1. Tune In
Tune in, is an app co-designed with young people in NZ that helps young people set and achieve personally relevant goals to reduce suicidal ideation and self-harm by incorporating health behaviour change theory and evidence to encourage behaviours to enhance wellness.
Tune In uses goal setting - a key component of Cognitive Behaviour Therapy (CBT), Dialectical Behaviour Therapy (DBT) and Acceptance and Commitment Therapy (ACT) to encourage behaviours that enhance wellbeing.

It incorporates the ability to quickly connect with a nominated support person if needed. The nominated support person is someone that the user adds to their app (with the emergency contact number) to call if the user ever feels they need help. The call is made by using the phone button within the app but uses the phone(i.e. the call is not part of the app). A list of helplines is also provided in the user account, which again the user can call/text but not from within the app.

In Tune In, users can choose their own goals, as well as the strategies to achieve their goals, which are specific behavioural strategies focused on improving coping capacities and promoting well-being and self-care from a strengths-based perspective to facilitating goal attainment. Further, Tune In provides feedback to reinforce goal attainment, scaffolds young people to access their existing support and provides rewards for adhering to and achieving goals.

Once goals are set, the user is expected to engage with the app daily to indicate if the daily strategy has been completed and, if desired, to change that daily strategy (~2 minutes of engagement per day). On completion of each day, the young person is rewarded with a song selected by a New Zealand celebrity or peer, accompanied by an encouraging message explaining how the song may inspire them to feel, think and act positively.

Co-design included rangatahi Maori, pilot testing included 20% Maori, and a further study examined how Tune In could be more culturally responsive for Maori (paper submitted), resulting in an update to Tune In to address the findings.

2. Bro
Bro is a Chatbot that delivers safety planning via a customisable and personal experience, that engages a young person in a dialogue. Bro is fully scripted. Chatbot dialogue is used to connect and develop safety plan and wall of strength. As required use for instances where distress is increasing. Develop safety plan and wall of strength; review plan and wall of strength up to five times over four weeks.

Bro was co-designed with rangatahi Maori, engaging them in the active participation as co-designers throughout the design process, to ensure that the app is accessible to Maori. Safety planning is an evidence based intervention that is very commonly used in face-to-face clinical settings and the co-designed Chatbot includes the core features of a plan with ideas about how a young person can notice they are becoming more upset and distressed, how they can make their environment safe, and pre-prepared coping strategies to them less upset and distressed, including social and crisis support as well as emotion regulation activities. A key feature is ‘the wall of strength’ that provides a reminder for the young person of those aspects of their lives that enhance their wellbeing, including a sense of meaning and purpose, people who support them.

Chatbot dialogue to connect and develop safety plan and wall of strength. As required use for instances where distress is increasing. Develop safety plan and wall of strength; review plan and wall of strength up to five times over four weeks. The experience is customised based on user input.
Bro is hybrid. The dialog is principally scripted with generative AI integrated principally to improve conversationally.

3. LifeBuoy
LifeBuoy is an app co-designed in Australia for young people with suicidal ideation using dialectical behaviour therapy skills that aim to improve distress tolerance.

LifeBuoy is a mix of CBT and third-wave (DBT and ACT)
CBT (psychoeducation, calm breathing, cognitive reappraisal, problem-solving); DBT (grounding, distress tolerance, distraction, “PLEASE”, ); ACT (mindfulness, value direction)
LifeBuoy includes text-based content, audio files (e.g., scripted mindfulness meditations), and interactive exercises.

Examples include

Technique (DBT): Distraction
Popping bubbles: user plays against timer to pop as many bubbles as possible

Technique (ACT): Mindfulness
Mindful breath: interactive audio track to practice mindfulness technique - grounding, centering oneself away from unconscious autopilot mindfulness

Technique (DBT): Distress tolerance
TIPP: TIPP (temperature, intense exercise, paced breathing, paired muscle relaxation) user is guided by a timer to practice 'IPP'


Intervention code [1] 330735 0
Behaviour
Intervention code [2] 329943 0
Treatment: Other
Comparator / control treatment
Mood tracking (attention-matched) control app

The My Mood App is a simple daily mood-tracking tool designed to help users monitor their emotional wellbeing. It prompts users to log their mood each day and offers an optional journal-style reflection feature. The app also includes a curated collection of support resources and helpful links relevant to common mental health concerns in both New Zealand and Australia. Primarily, the app is intended for use in research settings as a control app, supporting studies that compare it with other feature-based or intervention-focused apps.

An attention control app using mood tracking has been chosen because: 1. it will be more effective in engaging young people through to assessment time points; 2. all three apps have an element of mood tracking; 3. mood tracking has some evidence of efficacy meaning it is an active control therapeutically; 4. it controls for the action of logging into an app and brief engagement; and, 5) it aligns with robust RCTs in this field
Control group
Active

Outcomes
Primary outcome [1] 339858 0
Suicidal ideation
Timepoint [1] 339858 0
baseline, post intervention (30-days) and follow-up (90-days)
Secondary outcome [1] 441670 0
Acceptability
Timepoint [1] 441670 0
post intervention (30-days) and follow-up (90-days)
Secondary outcome [2] 441668 0
Mental wellbeing
Timepoint [2] 441668 0
baseline, post intervention (30-days) and follow-up (90-days)
Secondary outcome [3] 441669 0
Engagement
Timepoint [3] 441669 0
post intervention (30-days) and follow-up (90-days)

Eligibility
Key inclusion criteria
Study inclusion criteria are young people:

aged 16 - 24 years old;

lives in either Australia or New Zealand;

of any ethnicity;

who own/have access to a smartphone;

who have current (last month) suicidal ideation as per Suicidal Ideation Attributes Scale (SIDAS),

with or without self-harm.
Minimum age
16 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

Having used the app before

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)
Once participants have registered and completed baseline assessment, the Tirohia Platform will randomly assign a unique number to study participants using a pre-generated randomisation list embedded in the system. Only the independent statistician will have access to this list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Tirohia Platform will allocate participants to study-arms (1:1:1:1 ratio using a block design [4 participants per block], stratified by site [New Zealand vs Australia])and present the app download URL to participants. Tirohia Platform ensures allocation concealment, and allows for protection against selection bias.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The aim is to enrol 1,480 participants. Sample size calculations are based on the primary hypothesis that will ultimately be tested for each site. This ensures adequate power to detect expected site-specific treatment effects. Based on an initial efficacy randomised trial of LifeBuoy, an effect size of 0.45 (Cohen’s d) is expected post-intervention (30-days) for suicidal ideation measured on the SIDAS for each individual app versus control. Assuming this is the smallest effect size for any of the intervention apps relative to the control app, and assuming an attrition rate of 35% (as is typical in RCTs in mental health generally, including digital mental health trials), a 0.50 correlation between scores on the repeated administrations of the SIDAS (a conservative estimate in case of a large correlation), and considering alpha adjustment for multiple comparisons (alpha = 0.01/3 intervention vs control comparisons = 0.003), a sample size for one site of n = 185 per trial arm (total site n = 740) will detect expected effect sizes with power = 0.90. A such, a total study sample size of 1,480 will be required. Effect sizes of the magnitude expected would equate to differential changes of about 3.5/4 points on the SIDAS, which is considered a minimally clinically significant effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
1480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26722 0
New Zealand
State/province [1] 26722 0

Funding & Sponsors
Funding source category [1] 317802 0
Government body
Name [1] 317802 0
Health Research Council (HRC) of New Zealand
Country [1] 317802 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 320136 0
None
Name [1] 320136 0
Address [1] 320136 0
Country [1] 320136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316485 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316485 0
Ethics committee country [1] 316485 0
New Zealand
Date submitted for ethics approval [1] 316485 0
09/11/2024
Approval date [1] 316485 0
26/02/2025
Ethics approval number [1] 316485 0
2025 EXP 21500

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

Contacts
Principal investigator
Name 138046 0
A/Prof Sarah Hetrick
Address 138046 0
The University of Auckland Private Bag 92019 Auckland 1142 New Zealand
Country 138046 0
New Zealand
Phone 138046 0
+64 09 3737599 89100
Fax 138046 0
Email 138046 0
[email protected]
Contact person for public queries
Name 138047 0
Sarah Hetrick
Address 138047 0
The University of Auckland Private Bag 92019 Auckland 1142 New Zealand
Country 138047 0
New Zealand
Phone 138047 0
+64 09 3737599
Fax 138047 0
Email 138047 0
[email protected]
Contact person for scientific queries
Name 138048 0
Sarah Hetrick
Address 138048 0
The University of Auckland Private Bag 92019 Auckland 1142 New Zealand
Country 138048 0
New Zealand
Phone 138048 0
+64 09 3737599
Fax 138048 0
Email 138048 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be available only researchers who provide a methodologically sound proposal. These proposals will be assessed on a case-by-case basis by the data request committee. Our data set will include Maori data and therefore any requests to access the data need to describe how data will be handled and interpreted through a cultural lens.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
• De-identified data can be requested by other researchers for future research to be added to data from other sources to form larger datasets. The data request committee will review applications for data use.

What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
• For purposes approved by the data request committee

When can requests for individual participant data be made (start and end dates)?
From:
Beginning 12 months and ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Before data can be obtained a proposal and request must be sent to the chair of the data request committee and co-lead investigator Dr Tania Cargo [email protected]
Requests for access can also be sent to Sarah Hetrick [email protected], who will direct requests to the committee

Are there extra considerations when requesting access to individual participant data?
No


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.