Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000963426
Ethics application status
Approved
Date submitted
9/07/2025
Date registered
2/09/2025
Date last updated
2/09/2025
Date data sharing statement initially provided
2/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining novel digital single-session interventions addressing risk factors for self-harm and suicidal ideation in young people
Scientific title
Pilot feasibility trial of novel digital single-session interventions addressing risk factors for self-harm and suicidal ideation in young people
Secondary ID [1] 314867 0
Suicide Prevention Australia: RG00182
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicide prevention 338149 0
non-suicidal self-injury 338150 0
suicidal ideation 338151 0
Condition category
Condition code
Mental Health 334433 334433 0 0
Suicide
Public Health 334434 334434 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four novel digital single-session interventions (D-SSIs) have been developed, each to target one proximal risk factor/process to address risk for self-injurious thoughts and behaviours (SITBs).
1. Emotion regulation: teaches cognitive re-appraisal as the active therapeutic skill to increase access to strategies, reduce affective reactivity and experiential avoidance (i.e., increase emotion regulation self-efficacy). It is proposed that increasing emotion regulation self-efficacy will, in turn, reduce SITBs.
2. Self-criticism: teaches cognitive restructuring skills (e.g., thought challenging, learning about unhelpful thinking styles, etc.) with the aim of reduce cognitive biases, unhelpful thinking styles, and increasing self-compassion. It is proposed that reducing self-criticism and increasing a positive protective view of the self will in turn reduce SITBs.
3. Rumination: teaches decentering skills as the active therapeutic component, by introducing meta-awareness, promoting disidentification, and teaching cognitive diffusion. It is proposed that reducing ruminative processes will reduce reactivity to thought content, which will in turn reduce SITBs.
4. Hopelessness: teaches values-based, goal-driven behavioural activation as the active therapeutic strategy to increase state hope (pathways to goals and perceived agency), to reduce hopelessness, which in in turn is proposed to reduce SITBs.

The trial is a randomised, 2×2 factorial pilot feasibility trial, whereby random allocation is used to compare the effects of (a) intervention assignment method (free choice vs. clinician recommendation) and (b) post-intervention brief telephone check-in (yes vs. no) on adherence to the intervention and post-intervention daily skill use and brief self-assessments. For the first randomisation, in one arm, participants will be provided with the D-SSI that best aligns with their risk profile (‘personalised’ arm), and in the other arm, participants will be presented with the four D-SSIs and allowed to select the one that most appeals to them (‘free choice’ arm). Highest standardised score on one of the four pre-screening measures (mapping onto the risk factor targeted per D-SSI) will determine allocation to the most appropriate D-SSI in the personalised arm. This will result in two primary groups (choice, no choice), with unequal distribution of D-SSIs per arm. However, neither condition is a true control group as both groups are receiving an active intervention. Further, the randomisation to a supportive check-in (brief phone call to assess any difficulties with adherence vs. no call) at 7 days post-intervention is to examine whether this call increases participant adherence to daily skill use and completion of the brief daily self-assessments the month following completion of the D-SSI. This approach will allow us to determine the specific contribution of the phone call check-in to supporting engagement with the post-intervention daily skill practice. This will help inform the design of the study and treatment protocol for a future larger scale effectiveness trial.


Participant will then be presented with one D-SSI [recommended/personalised or free-choice] and provided with instructions to complete the intervention online [Qualtrics] in a single sitting. A D-SSI should take 30 minutes to complete in a single setting. After intervention completion, as a part of the treatment protocol, participants will be instructed to practice the skill introduced in the session (at least) once daily for the subsequent 28 days. Participants will only complete one of four D-SSIs as a part of this trial. Each D-SSI has introduction to the session content, explanation of the structure and purpose of the session, including setting session expectations (i.e., getting into ‘single-session mindset’, and post-session skill engagement). Each includes psychoeducational validation statements (regarding those who struggle with similar difficulties), and a brief, clinician-led psychoeducation video about maladaptive cycles [ ‘what might be keeping you feeling stuck’]. This includes the defining the struggle in specific behavioural terms for the young person. Then, a matched, active therapeutic skill will be introduced to the young person (e.g., decentering to help reduce emotional reactivity to thought content). This will include an animation, examples, written exercises, reflective questions, and multiple-choice questions to support the young person’s understanding and practice of the active therapeutic technique. The session will also include encouraging testimonials from other young people to positively reinforce skill engagement post-session. At the end of the session, a personalised action plan is provided, including a clear strategy, guidelines and instructions for daily skill engagement for the 28-days post intervention, as well as supplemental resources and emergency contacts. All materials and resources used were developed for the present study. Only the participants who were randomised to the 'brief call' condition will receive 1 brief call 7 days post-intervention.

Intervention adherence will be assessed by examining if participants complete the intervention (in a single sitting), and if participants utilise the skill learned in the intervention for the subsequent 28 days. Regarding daily skill use, adherence to the intervention protocol means engaging in skill use on at least 75% of the days (at least 21/28 days). Given the possibility of daily assessment resulting in low response rates, opportunity will be given at follow-up to retrospectively report on daily skill use.
Intervention code [1] 331475 0
Behaviour
Intervention code [2] 331476 0
Prevention
Comparator / control treatment
Randomisation 1: Clinician recommended arm.

Randomisation 2: No phone call.
Control group
Active

Outcomes
Primary outcome [1] 342124 0
Acceptability
Timepoint [1] 342124 0
T1 (post-intervention)
Primary outcome [2] 342125 0
Feasibility (treatment completion)
Timepoint [2] 342125 0
T1 (post-intervention)
Primary outcome [3] 342567 0
Adherence to post-intervention treatment protocol
Timepoint [3] 342567 0
T2 (one-month follow-up)
Secondary outcome [1] 451435 0
Treatment credibility
Timepoint [1] 451435 0
T1 (post-intervention)

Eligibility
Key inclusion criteria
This pilot study aims to recruit a national community-based sample of Australian adolescents who have had a recent experience with self-injurious thoughts and/or behaviours.

1. 15 to 19 years of age (confirmed via video call from the researchers)
2. Living in Australia
3. Fluent in English
4. Own and have access to a computer/laptop or smartphone
5. Have experienced self-injurious thoughts or behaviours (excluding suicide attempt) in the past 14 days
Minimum age
15 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a current diagnosis of psychosis or bipolar
2. Current active suicidal ideation with specific plan and intent
3. Suicide attempt in the last 30 days
4. Self-reported learning difficulty, visual impairment, or other difficulty that would make it challenging to answer questions on a computer, laptop, tablet, or smartphone
5. Enrolled and participating in another research trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation 1: Intervention arm (Free choice vs. clinician recommended)
As all participants will receive access to a single D-SSI, we will maintain a blind-to-hypothesis approach regarding examining what role ‘choice’ may play in adherence to the intervention protocol (treatment completion).

Randomisation 2: Follow-up contact (brief warm post-intervention phone call vs. no call)
We will maintain a blind-to-hypothesis approach regarding examining what role the ‘brief call’ may play in adherence to the post-intervention protocol (28 day skill use).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation 1: Intervention arm (Free choice vs. reccomended)
Randomisation will be conducted via an automated process in Qualtrics (qualtrics randomiser), with a 1:1 allocation ratio to each intervention arm, so group allocation is conducted independently of members of the research team.

Randomisation 2: Follow-up contact (brief warm post-intervention phone call vs. no call)
A computer-generated random sequence will be used to assign each participant ID to either condition. This process will be conducted by an independent assessor.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Acceptability: PFS scores will be calculated both as a mean and by examining individual item scores. Mean and item scores will be considered acceptable using cut-off scores >3 (indicating positive endorsement and perceptions of the D-SSI; as per Schleider et al., 2022). The mean of individual items will inform specific acceptability domains (e.g., enjoyability, user ease, etc.). Open-ended acceptability questions will be analysed qualitatively using thematic analysis, for each novel D-SSI separately.

Feasibility: Completion rate of the D-SSI of >85% will indicate feasibility (as per the indicated mean from a systematic review of D-SSIs for SITBs and depression in young people; Hatoum et al., 2025). The completion rate of D-SSIs will be reported overall and for both intervention assignment method conditions (free choice vs. clinician recommendation). Regarding daily skill use, adherence to the intervention protocol means engaging in skill use on at least 75% of the days (at least 21/28 days). Adherence to the intervention protocol in terms of skill use will be reported overall and for both brief telephone check-in conditions (yes vs. no) for each intervention assignment method condition separately.

Several measures will also be given at baseline to assess if any individual and environmental factors affect adherence to the intervention protocol. This includes functional wellbeing (WHO-5; World Health Organisation, 2024), depressive symptoms, (Patient Health Questionnaire 9 – Adolescent [PHQ-9-A]; Johnson et al., 2002), attitudes towards digital health interventions (Attitudes towards Psychological Online Interventions scale [APOI]; Schröder et al., 2015), motivation (Motivation for Youth’s Treatment Scale [MYTS]; Breda & Riemer, 2012), treatment expectations (Credibility/Expectations Questionnaire [CEQ]; Devilly & Borkovec, 2000), any current treatment (psychotherapy and/or pharmacotherapy), family environment (Brief Family Relationship Scale [BFRS]; Fok et al., 2014), stigmatising attitudes towards suicidal thoughts and behaviours (Personal Suicide Stigma Questionnaire [PSSQ]; Rimkevicien et al., 2019), and perceptions of digital therapy (Perceptions of Computerized Therapy Questionnaire-Patient Version; PCTQ-P). The association between baseline individual- and environmental factors with adherence to the treatment protocol in terms of D-SSI completion will be examined by correlating each of the factors with completion of D-SSI (yes vs. no) across all study conditions. Missing baseline data will be handled via multiple imputation.

Stringent data quality criteria will be applied through several methods. For data quality assurance, at post-intervention one question will ask participants to select a pre-determined answer. Data will be excluded from participants who do not select the response indicated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/10/2025
Actual
Date of last participant enrolment
Anticipated
5/01/2026
Actual
Date of last data collection
Anticipated
10/02/2026
Actual
Sample size
Target
216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319426 0
Charities/Societies/Foundations
Name [1] 319426 0
Suicide Prevention Australia
Country [1] 319426 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 321916 0
None
Name [1] 321916 0
Address [1] 321916 0
Country [1] 321916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317996 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 317996 0
Ethics committee country [1] 317996 0
Australia
Date submitted for ethics approval [1] 317996 0
19/05/2025
Approval date [1] 317996 0
20/06/2025
Ethics approval number [1] 317996 0

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

Contacts
Principal investigator
Name 142822 0
A/Prof Michelle Tye
Address 142822 0
Prince Of Wales Hospital, Hospital Rd, Randwick, NSW, 2031
Country 142822 0
Australia
Phone 142822 0
+61415677477
Fax 142822 0
Email 142822 0
[email protected]
Contact person for public queries
Name 142823 0
Michelle Tye
Address 142823 0
Prince Of Wales Hospital, Hospital Rd, Randwick, NSW, 2031
Country 142823 0
Australia
Phone 142823 0
+61415677477
Fax 142823 0
Email 142823 0
[email protected]
Contact person for scientific queries
Name 142824 0
Michelle Tye
Address 142824 0
Prince Of Wales Hospital, Hospital Rd, Randwick, NSW, 2031
Country 142824 0
Australia
Phone 142824 0
+61415677477
Fax 142824 0
Email 142824 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Ethics approval stipulates participant confidentiality will be maintained by only reporting aggregate results and not including any individually identifying information in publications.



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.