Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001287426
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
17/09/2025
Date registered
Help: Date registered
19/11/2025
Date last updated
Help: Date last updated
19/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
19/11/2025
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Feasibility and acceptability of EDBridge: A brief contact intervention for adolescents at risk of suicide and their parents
Scientific title
Feasibility and acceptability of EDBridge: A multi-component brief contact intervention program involving safety planning, psycho-educative resources, and automated follow-up text message support for adolescents at risk of suicide and their parents/caregivers, investigating the impact on suicide risk, suicide-related coping, parent mental health and self-efficacy in managing adolescent suicide risk, and community treatment engagement.
Additional trial identifiers [1] 313577 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Suicidal ideation and behaviour 336104 0
Condition category
Condition code
Mental Health 332658 332658 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
EDBridge involves three intervention components including safety planning (for teen participants), a psychoeducative factsheet (for parent participants), and an automated text message support program (for teen and parent participants). All teens who enrol in this study will be given access to the safety planning and text message intervention components. All parents who enrol in this study will be given access to the psychoeducative factsheet and text message intervention components. All intervention components will be delivered in the participating ED for seven months.

1. Safety planning (for adolescents)
Adolescent participants will develop a collaborative safety plan with a trained paediatric emergency psychiatry clinician during their routine assessment in the Paediatric Emergency Department (ED). Adolescents will first be offered to develop a safety plan using the Beyond Now smartphone app, with a paper or verbal safety plan offered as alternatives. Beyond Now is a suicide safety planning smartphone application initially developed by Beyond Blue (now owned by Lifeline) that is freely available to the public on all major app stores. It has not been specifically designed for this study. The Beyond Now safety planning app contains seven steps for managing a suicidal crisis, including 1. identifying warning signs of a suicidal crisis, 2. making the environment safe (e.g., removing access to lethal means), 3. reasons for living, 4. internal coping strategies, 5. social contacts and places for distraction, 6. social support for help with a suicidal crisis, and 7. professional supports. The paper based safety plan will follow the same format as Beyond Now. If adolescents already have a safety plan developed, they will have the option to transition the plan to Beyond Now or an alternative.

After developing a safety plan (with or without Beyond Now), adolescent participants will engage with their safety plan at their own discretion and will not be asked to use the app or their safety plan for any minimum duration once discharged from the ED (however some text messages as part of the text message intervention will encourage engagement with their safety plan). Clinicians will receive training on developing safety plans using Beyond Now two weeks prior to the anticipated first enrolment. Clinicians will record whether a participant safety plan was developed with Beyond Now, paper-based format, or verbally. Adherence to app usage will not be directly monitored (e.g., via app analytics). Adolescent participants will be surveyed on their engagement with their safety plan during follow up surveys at Week 2 and Week 12 post enrolment. Because participants are only eligible for the study if they are discharged out of the hospital system, and there is no follow up appointments with the ED clinician (due to the nature of cross-sectional ED assessments), participants will not have their safety plan reviewed by ED clinicians unless they return to the ED or discuss their safety plan with a community-based clinician (e.g., private psychologist). Reviewing of safety plans is not within the scope of the current research protocol.

2. Parent/caregiver psychoeducative factsheet (for parents/carers)
Parents/caregivers of adolescents presenting to the ED will receive a paper-based psycho-educative factsheet resource from the trained paediatric emergency psychiatry clinician (or a researcher) upon discharge from the ED. The two-sided A4 factsheet includes strategies for managing adolescent suicide risk in the 24-48 hours post-discharge, options for seeking treatment and caregiver support, and psycho-education. The factsheet is tailored to the recruitment site and was co-designed by researchers, young people with lived experience and their parents, and clinicians.

3. Text message support (for adolescents and parents)
Both adolescents and parents will receive a one-way, automated follow-up text message support program post-discharge from the ED. The trained paediatric emergency psychiatry clinician will activate the text message program using a web platform developed for the trial. Participants will be randomly allocated to one of two text-message intervention arms: a short-term (2-week) or long-term (3-month) arm. Parents in the short-term arm will receive 14 messages and adolescents in the short-term arm will receive 12 messages.

For adolescents, text messages contain information and strategies about managing a suicidal crisis, safety planning, transitioning back to school/work, problem solving, places to get support (e.g., online support, crisis support, longer term mental health treatment), and psychoeducation about suicide and suicide risk factors (e.g., self-harm). Parents will receive information and strategies about safety planning for their teen, how to monitor for and respond to changes in suicide risk, connecting with their teen, places their teen can get mental health support (including crisis support), and options for parent/caregiver support. The long-term intervention arm does not contain additional or new information for parents or adolescents but rather involves reminders about previously delivering strategies and information. Text message delivery will be monitored via Twilio, a cloud-based communication service that is being used to deliver text messages.
Intervention code [1] 330359 0
Prevention
Intervention code [2] 330360 0
Treatment: Other
Description of the comparator or control
Participants receiving the text message support program will be randomly allocated to receive text messages for either two weeks or three months. This random allocation has been included to seek participant preferences regarding the duration of the text message program, as this was unclear during the development phase of the intervention. When parent and adolescent participants are recruited as a dyad (e.g., parents and adolescents in the same family who consent to receive the text messages), both will be allocated to the same arm. The long-term message arm (3-month) is considered the comparator arm for this study. Parents in the long-term arm will receive 20 messages and adolescents in the long-term arm will receive 18 messages.

Additionally, the trial includes a two week observation-control period prior to the five month intervention period. This has been included to assess the feasibility and acceptability of an observation-control condition (e.g., as part of a stepped-wedge design) for a future definitive clinical trial of EDBridge. During the observation-control period, adolescents will receive routine care including a mental health assessment and referral to public or private mental health support, and may involve a safety plan (typically paper-based or verbal) and single follow up text message with information about their recommended treatment plan. Parents will also be involved in an assessment about their teen's mental health and may receive some form of psychoeducation (delivered verbally or with pamphlets), and a single text message with information about their teen's treatment plan. Parents will not receive the EDBridge parent/caregiver factsheet. Any text messages sent with information about a treatment plan will not be delivered with the software program develop for this study (i.e., clinicians will use their regular software). Clinicians may use the Beyond Now safety plan with an adolescent.
Control group
Active

Outcomes
Primary outcome [1] 340444 0
Feasibility of intervention
Timepoint [1] 340444 0
Conclusion of trial
Primary outcome [2] 340445 0
Acceptability of intervention
Timepoint [2] 340445 0
Conclusion of trial
Secondary outcome [1] 444104 0
Adolescent suicidal ideation and behaviour
Timepoint [1] 444104 0
At study enrolment (during ED assessment; clinician rating) and Week 1, 2, and 12 post study enrolment in both observation-control and intervention period
Secondary outcome [2] 444105 0
Adolescent suicide-related coping skills
Timepoint [2] 444105 0
At study enrolment (during ED assessment) and Week 1, 2, and 12 post study enrolment in both observation-control and intervention period
Secondary outcome [3] 444106 0
Adolescent hospital re-presentation for suicidal ideation or behaviour (assessed together as composite outcome)
Timepoint [3] 444106 0
Week 1, Week 2, Week 12 post enrolment into study (during both observation-control period and intervention period)
Secondary outcome [4] 444107 0
Adolescent non-suicidal self injury
Timepoint [4] 444107 0
Baseline (at study enrolment during ED assessment in control-observation and intervention period), and Week 2, Week 12 post enrolment
Secondary outcome [5] 444949 0
Community treatment engagement indicators (parent) e.g., scheduling mental health appointment in community setting
Timepoint [5] 444949 0
Baseline (at study enrolment during ED assessment), and Week 1, 2, and 12 post study enrolment in observation-control period and intervention period
Secondary outcome [6] 444950 0
Parent psychological distress
Timepoint [6] 444950 0
Baseline (at study enrolment during ED assessment), and Week 2, and 12 post study enrolment in observation-control period and intervention period
Secondary outcome [7] 444951 0
Parent impressions of teen mental health
Timepoint [7] 444951 0
At study enrolment (during ED assessment) and Week 1, 2, and 12 post study enrolment in both observation-control and intervention period
Secondary outcome [8] 444952 0
Parent self-efficacy in managing adolescent suicide risk
Timepoint [8] 444952 0
At study enrolment (during ED assessment) and Week 2 and 12 post study enrolment in both observation-control and intervention period
Secondary outcome [9] 452171 0
Intervention evaluation
Timepoint [9] 452171 0
Weeks 2 and 12 post study enrolment in intervention period only
Secondary outcome [10] 453981 0
Community treatment engagement indicators (adolescent)
Timepoint [10] 453981 0
Baseline (at study enrolment during ED assessment), and Week 1, 2, and 12 post study enrolment in observation-control period and intervention period
Secondary outcome [11] 453982 0
Impressions of Patient Mental Health Status & Improvement (adolescent self-report)
Timepoint [11] 453982 0
At study enrolment (during ED assessment) and Week 1, 2, and 12 post study enrolment in both observation-control and intervention period
Secondary outcome [12] 453985 0
Feasibility of intervention (secondary)
Timepoint [12] 453985 0
Conclusion of trial
Secondary outcome [13] 454014 0
Feasibility of intervention (secondary)
Timepoint [13] 454014 0
Conclusion of trial
Secondary outcome [14] 454052 0
Collection of outcome measures
Timepoint [14] 454052 0
Conclusion of trial
Secondary outcome [15] 454053 0
Feasibility of intervention procedures
Timepoint [15] 454053 0
Week 2 and Week 12 post enrolment in intervention period
Secondary outcome [16] 454054 0
Feasibility of intervention procedures
Timepoint [16] 454054 0
Conclusion of trial
Secondary outcome [17] 454055 0
Acceptability of intervention
Timepoint [17] 454055 0
Week 2 and Week 12 post study enrolment in intervention period
Secondary outcome [18] 454057 0
Acceptability of intervention (secondary)
Timepoint [18] 454057 0
Week 2 and Week 12 post study enrolment in intervention period
Secondary outcome [19] 454058 0
Acceptability of intervention (secondary)
Timepoint [19] 454058 0
Conclusion of trial

Eligibility
Key inclusion criteria
Adolescent group
Inclusion criteria
1. Aged 12-18 years
2. Presents to the trial site paediatric Emergency Department (ED) with suicidal ideation or behaviour and is discharged home/to community-based services.
3. Presents to the trial site with a parent/caregiver

Parents/caregiver
Inclusion criteria
1. Attends project site paediatric ED with an adolescent who meets eligibility criteria and for whom they have legal guardianship over

Clinicians
Inclusion criteria
1. Registered health practitioner e.g., psychologist, social worker, psychiatrist, psychiatry registrar, mental health nurse, occupational therapist
2. Assesses paediatric patients aged 12-18 with mental health concerns at the project site paediatric ED.
3. Trained in administering EDBridge.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Adolescents
Exclusion criteria
1. No suicidal ideation or behaviour at presentation to site ED. Justification: intervention designed for adolescents with suicidal ideation or behaviour.
2. Under 12 years old or over 18 years old. Justification: Intervention designed for adolescent patients aged 12-18. Patients over 18 are assessed by different services.
3. Adolescent presents without parent/caregiver. Justification: Parent/caregiver is needed to provide consent for adolescent to participate, and seeking parent consent via follow up is not feasible or appropriate as the intervention is designed to begin during ED mental health assessment.
4. Contraindication according to clinical judgement. Justification: Clinicians recruiting participants may obtain information via medical records (e.g., patient history) or assessment that suggests intervention is not suitable for some participants e.g., due to developmental difficulties, risk of harm to clinician, frequent ED presentations (requiring more tailored intervention that is outside the scope of this intervention), psychotic symptoms, manic symptoms or intoxication that impairs capacity to provide assent.
5. Transferred to another unit/ward. Justification: the intervention is designed to be received upon discharge outside of the hospital system where there is not continuous monitoring of patient available (e.g., if transferred to an inpatient unit).
6. No mobile phone. Rationale: Text message intervention requires a mobile phone to be received.
7. Out of home care status. Rationale: Seeking relevant approval to include young people living in out of home care is outside the scope of this feasibility study.
8. Unable to read English. Justification: all study materials are only available in English at this stage. Translation is out of the scope of the pilot trial but is being considered for future adaptations.

Parents
Exclusion criteria
1. Unable to provide informed consent for adolescent. Justification: Intervention must be offered to both parents and adolescents, and adolescents require parent consent to participate.
2. Unable to read or understand English. Justification: all study materials are only available in English at this stage. Translation is out of the scope of the pilot trial but is being considered for future adaptations.
3. No mobile phone. Rationale: Text message intervention requires a mobile phone.
4. Contraindication according to clinical judgement e.g., due to aggressive behaviours. Rationale: clinicians may discern during assessment or EMR that the parent it is not appropriate to offer the intervention or poses a risk to clinician safety.

Clinicians
1. Not trained in administering EDBridge.

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)
The allocation of text message intervention (i.e., two week vs three month duration of text messages) will be concealed to clinicians delivering the intervention with central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Baseline characteristics including demographic and mental health information (e.g., suicidal ideation, psychological distress) will be summarised using descriptive statistics (means, standard deviations, and frequencies). Descriptive statistics will also be used to assess the feasibility and acceptability of the intervention. This will include primary outcomes such as recruitment rate, attrition/retention, data collection, and intervention adherence.

Between-group differences for the text-message intervention groups at Timepoint 1, Timepoint 2, and Timepoint 3 (immediately post-intervention) will be assessed with the following outcomes: treatment engagement indicators (no. of participants with appointments booked, intention to book appointment), mental health outcomes including suicidal ideation and behaviour (C-SSRS), suicide-related coping skills, psychological distress (K6), parent self-efficacy in managing adolescent suicide risk, and re-presentation rate.

For continuous outcomes (e.g., parent psychological distress, suicide-related coping skills, parent self-efficacy in managing adolescent suicide risk) measured at baseline, 1 week, 2.5 weeks, and 12.5 weeks, we will use Mixed Models of Repeated Measures (MMRM) to examine Condition*Time interaction effects. For categorical outcomes (e.g., suicidal ideation, suicidal behaviour, attrition, re-presentation rate) measured at all timepoints, a mixed-effects logistic regression model will be used. Random intercepts for subject will be used to account for baseline differences, and at each post-baseline timepoint, between-groups comparisons will be examined through post-hoc t-tests for continuous outcomes and Wald tests otherwise.

Qualitative interview data collected at Week 2 and Week 12 (i.e., the end of the text-message intervention for each arm) will be transcribed using a professional transcription service and analysed using Reflexive Thematic Analysis. Interviews will first be read and re read by the analytic team, with initial coding thoughts and themes discussed in light of the research questions. Initial coding will be completed by one team member, with these then organised into thematic groups with input from the analytic team. These will be written up and discussed by the analytic team for fidelity with the data set.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/11/2025
Date of last participant enrolment
Anticipated
29/05/2026
Actual
Date of last data collection
Anticipated
28/08/2026
Actual
Sample size
Target
144
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27643 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 43815 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 318043 0
Government body
Name [1] 318043 0
The Commonwealth of Australia, Million Minds Mission, Medical Research Future Fund (MRFF)
Country [1] 318043 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 320705 0
None
Name [1] 320705 0
Address [1] 320705 0
Country [1] 320705 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316697 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 316697 0
Ethics committee country [1] 316697 0
Australia
Date submitted for ethics approval [1] 316697 0
20/11/2024
Approval date [1] 316697 0
02/07/2025
Ethics approval number [1] 316697 0
RES-24-0000-794B

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

Contacts
Principal investigator
Name 138706 0
A/Prof Michael Gordon
Address 138706 0
Monash Health, 246 Clayton Rd, Clayton 3168
Country 138706 0
Australia
Phone 138706 0
+61 3 9594 1300
Fax 138706 0
Email 138706 0
[email protected]
Contact person for public queries
Name 138707 0
Glenn Melvin
Address 138707 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 138707 0
Australia
Phone 138707 0
+61 3 924 45625
Fax 138707 0
Email 138707 0
[email protected]
Contact person for scientific queries
Name 138708 0
Glenn Melvin
Address 138708 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 138708 0
Australia
Phone 138708 0
+61 3 924 45625
Fax 138708 0
Email 138708 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:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Coordinating Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
Yes: Qualitative data will not be available for sharing.



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.