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A targeted digital intervention for youth with suicidal thoughts and behaviours attending outpatient care

Pragmatic trial of the efficacy of a targeted digital intervention for reducing suicidal ideation in youth with suicidal thoughts and behaviours attending outpatient care

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001059651
Enrollment
129
Registered
2023-10-03
Start date
2025-01-28
Completion date
2027-05-03
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Affinity trial aims to assess the efficacy of an enhanced version of the moderated online social therapy (MOST) digital therapeutic social networking platform in reducing suicidal thoughts and behaviours in young people attending outpatient care. Participants randomized to the intervention condition will also have the option of participating in a fortnightly online psychosocial recovery group and to invite their caregivers to participate in caregiver online psychoeducation sessions. It is expected that the Affinity intervention condition will be faster at, and have greater maintained effects in, reducing levels of suicidal ideation than the treatment as usual condition. Effects of therapeutic mechanisms of action, as well as health economic aspects will also be assessed.

Interventions

Participation in the trial involves a 12 week intervention period, with a follow up at week 26 and 52. Participants randomised to the intervention condition will receive access to the Moderated Online Social Therapy (MOST) platform with additional content specifically designed to target theoretical constructs of the interpersonal theory of suicide. Engagement in the MOST platform and novel content is at the user's discretion. Participants in the intervention condition will also receive a carin

Participation in the trial involves a 12 week intervention period, with a follow up at week 26 and 52. Participants randomised to the intervention condition will receive access to the Moderated Online Social Therapy (MOST) platform with additional content specifically designed to target theoretical constructs of the interpersonal theory of suicide. Engagement in the MOST platform and novel content is at the user's discretion. Participants in the intervention condition will also receive a caring contact intervention via a digital postcard weekly during the 12-week intervention period. Additionally, they will have the opportunity to participate in a fortnightly psychosocial recovery group. As well they may allow their caregiver(s) to participate in a monthly psychoeducation session. Brief Summary of content on the MOST platform The MOST platform has content addressing a variety of mental health issues such as depression, anxiety, social skill development. It draws on a variety of psychological principles such as cognitive behavioural therapy, self-determination theory, behavioural activation. Users complete journeys. Journeys contain tracks with specific focuses. Tracks have activities that involve psychoeducation, behavioural activation, opportunities to communicate experiences with the broader platform, opportunities to reflect on experiences and journal thoughts. Brief summary of the novel additional content: - the novel additional content for the Affinity trial has been developed based on the interpersonal theory of suicide and targets experiences of perceived burdensomeness, thwarted belongingness and interpersonal hopelessness The mode of training used: - Content is delivered via psychoeducational material, behavioural activation tasks, visually and audio guided meditations. Strategies used to monitor adherence to the intervention: - certain content has the capacity for the participant to contribute a response / confirm completion. - all engagement with the MOST platform is captured as data and can be analysed to understand the way in which participants adhered to the intervention. - the caring contact intervention involves the clinical moderator sending a singular digital comic postcard to the participant each week with text content that will express care for the participant. The caring contact post card will be sent via the MOST platform. Details of the fortnightly psychosocial recovery group: - what it involves: Session 1: Introductions, guidelines for group sessions and group rules Psychoeducation about burdensomeness Discussion and sharing activity Vignette analysis and advice provision Session 2: Introductions, guidelines for group sessions and group rules Psychoeducation about belongingness Discussion and sharing activity Vignette analysis and advice provision Session 3: Introductions, guidelines for group sessions and group rules, Psychoeducation about interpersonal hopelessness Discussion, sharing and activity. Vignette analysis and advice provision Session 4: Introductions, guidelines for group sessions and group rules, Psychoeducation about mood monitoring Vignette analysis, and advice provision Session 5: Introductions, guidelines for group sessions and group rules, Psychoeducation about interpersonal skills problem solving Vignette analysis, roleplay, advice provision Session 6: Introductions, guidelines for group sessions and group rules, Psychoeducation about emotional regulation Vignette analysis, roleplay, and advice provision Duration of the sessions: 1 hour The group size: minimum group size is 2, maximum is 10 The mode of administration: over Zoom Who will be facilitating the sessions: psychologist or social worker. Brief description of any strategies used to monitor adherence to the intervention: session attendance checklist Details of the monthly psychoeducation session: What it involves, including a description of each of the procedures, activities, and/or processes used: Session 1 Reduce shame and stigma among caregivers Reframing and understanding suicidality in young people Psychoeducation regarding burdensomeness and belongingness Session 2 Psychoeducation and activities focussed on increasing emotional attunement to young person Session 3 Changing contingencies within the home environment Caregiver skills coaching Duration of the sessions: 1 hour Delivery format: minimum one attendee, no maximum attendees The mode of administration: Zoom Who will be facilitating the sessions, psychologist, social worker, or family therapy clinician Description of any strategies used to monitor adherence to the intervention: Session attendance checklists

Participation in the trial involves a 12-week intervention period, with a follow up at week 18, 26 and 52. Participants randomised to the intervention condition will receive access to the Moderated Online Social Therapy (MOST) platform with additional content specifically designed to target theoretical constructs of the interpersonal theory of suicide. Engagement in the MOST platform and novel content is at the user's discretion. Participants in the intervention condition will also receive a c

Participation in the trial involves a 12-week intervention period, with a follow up at week 18, 26 and 52. Participants randomised to the intervention condition will receive access to the Moderated Online Social Therapy (MOST) platform with additional content specifically designed to target theoretical constructs of the interpersonal theory of suicide. Engagement in the MOST platform and novel content is at the user's discretion. Participants in the intervention condition will also receive a caring contact intervention via a digital postcard weekly during the 12-week intervention period. Additionally, they will have the opportunity to participate in a fortnightly psychosocial recovery group. As well they may allow their caregiver(s) to participate in a monthly psychoeducation session. Brief Summary of content on the MOST platform The MOST platform has content addressing a variety of mental health issues such as depression, anxiety, social skill development. It draws on a variety of psychological principles such as cognitive behavioural therapy, self-determination theory, behavioural activation. Users complete journeys. Journeys contain tracks with specific focuses. Tracks have activities that involve psychoeducation, behavioural activation, opportunities to communicate experiences with the broader platform, opportunities to reflect on experiences and journal thoughts. Brief summary of the novel additional content: - the novel additional content for the Affinity trial has been developed based on the interpersonal theory of suicide and targets experiences of perceived burdensomeness, thwarted belongingness and interpersonal hopelessness The mode of training used: - Content is delivered via psychoeducational material, behavioural activation tasks, visually and audio guided meditations. Strategies used to monitor adherence to the intervention: - certain content has the capacity for the participant to contribute a response / confirm completion. - all engagement with the MOST platform is captured as data and can be analysed to understand the way in which participants adhered to the intervention. - the caring contact intervention involves the clinical moderator sending a singular digital comic postcard to the participant each week with text content that will express care for the participant. The caring contact post card will be sent via the MOST platform. Details of the fortnightly psychosocial recovery group: - what it involves: Session 1: Introductions, guidelines for group sessions and group rules Psychoeducation about burdensomeness Discussion and sharing activity Vignette analysis and advice provision Session 2: Introductions, guidelines for group sessions and group rules Psychoeducation about belongingness Discussion and sharing activity Vignette analysis and advice provision Session 3: Introductions, guidelines for group sessions and group rules, Psychoeducation about interpersonal hopelessness Discussion, sharing and activity. Vignette analysis and advice provision Session 4: Introductions, guidelines for group sessions and group rules, Psychoeducation about mood monitoring Vignette analysis, and advice provision Session 5: Introductions, guidelines for group sessions and group rules, Psychoeducation about interpersonal skills problem solving Vignette analysis, roleplay, advice provision Session 6: Introductions, guidelines for group sessions and group rules, Psychoeducation about emotional regulation Vignette analysis, roleplay, and advice provision Duration of the sessions: 1 hour The group size: minimum group size is 2, maximum is 10 The mode of administration: over Zoom Who will be facilitating the sessions: psychologist or social worker. Brief description of any strategies used to monitor adherence to the intervention: session attendance checklist Details of the monthly psychoeducation session: What it involves, including a description of each of the procedures, activities, and/or processes used: Session 1 Reduce shame and stigma among caregivers Reframing and understanding suicidality in young people Psychoeducation regarding burdensomeness and belongingness Session 2 Psychoeducation and activities focussed on increasing emotional attunement to young person Session 3 Changing contingencies within the home environment Caregiver skills coaching Duration of the sessions: 1 hour Delivery format: minimum one attendee, no maximum attendees The mode of administration: Zoom Who will be facilitating the sessions, psychologist, social worker, or family therapy clinician Description of any strategies used to monitor adherence to the intervention: Session attendance checklists

Sponsors

Orygen
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

(i) Age 15-25 years inclusive (ii) Client of either headspace or the Youth Mood Clinic (iii) At least moderate or higher depressive symptomology as measured by the Quick Inventory of Depression (QIDS) (iv) Current or recent (within 4 weeks) suicidal thoughts or behaviours (v) Engagement in outpatient or community-based care (vi) Internet and smartphone or computer access

Exclusion criteria

(i) Intellectual disability (ii) Inability to read English (iii) Participation in concurrent intervention or trial targeting suicidal thoughts or behavior (iv) Unwillingness to engage in safety planning and crisis supports

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026