Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001397707
Ethics application status
Approved
Date submitted
13/10/2022
Date registered
1/11/2022
Date last updated
2/06/2024
Date data sharing statement initially provided
1/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the impact of the #chatsafe social media intervention on young people’s ability to communicate safely online about suicide: a randomised-controlled trial
Scientific title
Testing the impact of the #chatsafe social media intervention on young people’s ability to communicate safely online about suicide: a randomised-controlled trial
Secondary ID [1] 307486 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicide 326885 0
sexual health 326886 0
Condition category
Condition code
Mental Health 324094 324094 0 0
Suicide
Reproductive Health and Childbirth 324903 324903 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention description
The 8-week intervention will comprise 24 pieces of content; three per week. The intervention group will receive the #chatsafe suicide prevention content. Participants will receive their content via text message once per week, with links to the weekly content hosted on Instagram. Because of the rolling recruitment used in the trial, all of the trial content is already on the trial Instagram page so appropriate links can be sent to participants as they move through the trial.
The campaign content educates participants across four core areas: a) talking safely about suicide online; b) sharing your own thoughts, feelings or experiences with suicide safely online; c) responding to someone who may be suicidal; and d) communicating safely about someone has died by suicide.
Content is in the form of 3 Instagram posts per week (sent together on one occasion), with posts having between 1-8 'tiles' with the caption containing further information for each topic. Throughout the campaign, different mediums are used including still image, video, digital art, animation, block text and mobile phone screen recordings. For example, the week 3, post 3 content uses a series of images describing how to create content warnings. The post has 4 tiles, that describe why content warnings are used, how to create a content warning, and support services that can be included in content warnings. The caption gives further context to the post.
Once per week, the text message will be sent containing a link to the content. Halfway through each survey period, a follow-up engagement text message will be sent either reminding participants to complete their survey or checking in and offering assistance with participation.
The trial content was co-designed with young people. First, the entire #chatsafe program of work has been conceptualised, designed, and conducted in partnership with young people. The guidelines themselves (that the trial content is based off) were created using the Delphi consensus method, with young people as an expert panel. The first #chatsafe social media campaign was co-created in partnership with over 140 young people, across a series of workshops each containing up to 20 young people. For the trial content specifically, two youth workshops (N = 26) were conducted to assist with the initial planning of the trial in April 2021. The study was then presented to the Orygen Youth Research Council (YRC) in November 2021 and feedback on intervention development and study conduct was obtained from 8 young people. Next, three co-design workshops were conducted in April and May 2022 (N = 46) to help create the trial content. These workshops were facilitated by creative agency Portable, who created the final Instagram posts that will be used.


Intervention code [1] 323938 0
Behaviour
Intervention code [2] 323939 0
Prevention
Comparator / control treatment
Control condition
The 8-week intervention will comprise 24 pieces of content; three per week. The control group will receive the PROSPEct social media content. The PROSPEct campaign content comprises still visual posts with anywhere between 1 and 3 tiles. Once per week, a text message will be sent containing a link to the content. Halfway through each survey period, a follow-up engagement text message will be sent either reminding participants to complete their survey or checking in and offering assistance with participation. Because of the rolling recruitment used in the trial, all of the trial content is already on the trial Instagram page so appropriate links can be sent to participants as they move through the trial.
The campaign educates young participants across 4 core areas: a) Understanding our bodies and the relationships with ourselves (e.g. pleasure & diversity); b) exploring the relationships we have with others e.g. consent, sexual activity, healthy relationships; c) staying safe online and in person e.g. online dating, STI awareness, contraceptive methods and d) owning our sexual wellbeing e.g. being self-aware and finding support services
The tiles include still image, digital art and block text to convey campaign messaging. Content is in the form of 3 Instagram posts per week, with posts having between 1-3 'tiles' with the caption containing further information for each topic. For example, the week 3, post 1 content outlines and describes the importance of sexual consent. The post and has 3 tiles, and together with the caption, it describes what consent is, discusses legal consent in the context of different states and territories in Australia, and the impact of intoxication on one’s capacity to consent to sex.
The control campaign content was drafted by the researchers, based on the learnings from the PROSPEct project (ACTRN12622000679785), which aimed to develop an intervention to promote sexual wellbeing in young people with mental ill-health before testing it in a clinical trial. These learnings came from collaboration from 29 key stakeholders including 8 young people with mental ill-health, 3 carers and 18 clinicians who provide mental health or sexual health support to young people with mental ill-health. A working group was convened with 4 young people, who were service users themselves and advocates for youth mental health to provide feedback on the first draft of the intervention. There was further feedback from 9 key stakeholders including 2 young people, one carer and six clinicians after making these changes. Consultation was sought from colleagues who undertook other projects to inform the development of LGBTQIA+ inclusive and gender affirming care training.
Control group
Active

Outcomes
Primary outcome [1] 331890 0
Changes in safety when communicating online about suicide, as measured via the purpose designed #chatsafe Online Safety Questionnaire.
Timepoint [1] 331890 0
Baseline (T1), 8 weeks post-intervention commencement (T2), follow-up 3 months post-intervention commencement (T3)
Secondary outcome [1] 411518 0
Confidence when communicating online about suicide, as measured via the purpose designed #chatsafe Online Safety Questionnaire.
Timepoint [1] 411518 0
Baseline (T1), 8 weeks post-intervention commencement (T2), 4 weeks post-intervention conclusion (T3)
Secondary outcome [2] 414655 0
Willingness to intervene against suicide online, as measured via the Willingness to Intervene Questionnaire.
Timepoint [2] 414655 0
Baseline (T1), 8 weeks post-intervention commencement (T2)', 4 weeks post-intervention conclusion (T3)
Secondary outcome [3] 414656 0
Internet self-efficacy, as measured by the Internet Self-Efficacy Questionnaire.
Timepoint [3] 414656 0
Baseline (T1), 8 weeks post-intervention commencement (T2), 4 weeks post-intervention conclusion (T3)
Secondary outcome [4] 414658 0
Safety of the weekly #chatsafe content, as measured by the purpose-built weekly evaluation and engagement survey.
Timepoint [4] 414658 0
Weekly for the 8-week duration of the intervention
Secondary outcome [5] 414659 0
Acceptability of the #chatsafe intervention, as measured by the purpose-built T2 evaluation questions.
Timepoint [5] 414659 0
8 weeks post-intervention commencement (T2)
Secondary outcome [6] 414739 0
Safety of the #chatsafe social media intervention (as a whole), as measured by the number of (or absence of) adverse events recorded throughout the trial.
Participant adverse events include:
1. Participant response to item 9 on the PHQ-9 survey at baseline (Time 1), Time 2 or Time 3
2. Participant response to the 9-item weekly evaluation survey indicates distress.
3. Participant response to T2 evaluation questionnaire indicates that a particular piece of campaign content made them feel distressed or at risk of suicide.
4. Participant directly contacts the research team via social media or email, and reports distress or risk of harm to self.
All adverse events will be responded to by the study team, in line with the study's safety management strategy.
Timepoint [6] 414739 0
Weekly for the 8-week duration of the intervention; and 8 weeks post-intervention commencement (T2)
Secondary outcome [7] 415197 0
Feasibility of the #chatsafe social media intervention as measured by campaign reach via social media analytics, and participant retention/attrition via audit of study enrolment and withdrawal logs.
Timepoint [7] 415197 0
Weekly for the 8-week duration of the intervention; 8 weeks post-intervention commencement (T2).
Secondary outcome [8] 415198 0
Self-reported evaluations of the acceptability of receiving the #chatsafe social media intervention, as measured by purpose-designed study questions.
Timepoint [8] 415198 0
Weekly for the 8-week duration of the intervention; 8 weeks post-intervention commencement (T2)

Eligibility
Key inclusion criteria
- Are aged between 16 and 25 years;
- Live in Australia;
- Have used social media to communicate about suicide or self-harm or have seen suicide or self-harm related information on social media;
- Have not previously participated in a research study that was focused on evaluating suicide prevention or sexual health related content on social media;
- Consider themselves to be active social media users; and
- Are willing to share their mobile number with the research team so that they can be contacted.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Allocation is concealed as the randomisation schedule is computer generated by independent Information Technology (IT) personnel with guidance from the study statistician. The schedule will then be implemented by a member of the study team (other than the statistician) into the REDCap database management software for allocating treatments to individual participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with varying block sizes with an allocation ratio of 1:1 will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
At baseline, state of residence, postcode, age, Aboriginal and/or Torres Strait Island status, gender identity, sexual orientation, primary language spoken at home, cultural background, educational and occupational background will be reported using descriptive statistics and will be checked for imbalance between trial arms. The moderating effect of gender (male, female, trans and gender diverse), age group (i.e., 16-20 and 21-25), time spent on social media, psychological distress, and previous experience of suicide and self-harm will be considered in analyses as covariates.

Analyses will be done on an intention-to-treat basis, where all individuals randomised will be included in the analysis by their allocated trial arm status regardless of whether they received all, part or none of the intended treatments. For the primary analysis, we will use linear regression to estimate the difference in the mean changes between the intervention and control arms at T2 in the outcome safety when communicating online about suicide, as measured via the #chatsafe Online Safety Questionnaire. This analysis will adjust for T1 scores. Multiple imputation will be used to address attrition bias, with 50 imputation samples generated using chained equations. We will conduct two sensitivity analyses. One sensitivity analysis will be undertaken using complete cases only (i.e., repeating the primary analysis but only analysing participants who have complete T1 and T2 data). The second sensitivity analysis will use multiple imputation and include the following potential moderating factors as covariates: gender (male, female, trans and gender diverse), age group (i.e., 16-20 and 21-25), time spent on social media, psychological distress, and previous experience of suicide and self-harm.

Our secondary outcomes at T2 and T3 will be analysed on the same basis as our primary analysis and the two sensitivity analyses. We will use linear regression for continuous outcomes, logistic regression for binary outcomes and negative binomial regression for counts.

Potential iatrogenic effects will be analysed on a weekly basis and will serve as an interim analysis throughout the course of the study. If the weekly content is assessed as ‘very distressing’ by more than 20% of participants per week the Safety Monitoring Committee (SMC) will be consulted, and the content may be withdrawn. The acceptability of each week’s content will be analysed and reported as descriptive statistics (frequencies and percentages).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/11/2022
Actual
7/11/2022
Date of last participant enrolment
Anticipated
8/11/2023
Actual
31/01/2024
Date of last data collection
Anticipated
9/05/2024
Actual
9/05/2024
Sample size
Target
400
Accrual to date
Final
908
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311765 0
Government body
Name [1] 311765 0
Australian Research Council
Country [1] 311765 0
Australia
Primary sponsor type
Other
Name
Orygen
Address
Orygen
35 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 313229 0
None
Name [1] 313229 0
Address [1] 313229 0
Country [1] 313229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311207 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 311207 0
Ethics committee country [1] 311207 0
Australia
Date submitted for ethics approval [1] 311207 0
08/07/2022
Approval date [1] 311207 0
07/10/2022
Ethics approval number [1] 311207 0
2022-24238-32907-3

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

Contacts
Principal investigator
Name 120330 0
Prof Jo Robinson
Address 120330 0
Orygen
35 Poplar Rd, Parkville VIC 3052
Country 120330 0
Australia
Phone 120330 0
+61 412 999 140
Fax 120330 0
Email 120330 0
[email protected]
Contact person for public queries
Name 120331 0
Jo Robinson
Address 120331 0
Orygen
35 Poplar Rd, Parkville VIC 3052
Country 120331 0
Australia
Phone 120331 0
+61 412 999 140
Fax 120331 0
Email 120331 0
[email protected]
Contact person for scientific queries
Name 120332 0
Jo Robinson
Address 120332 0
Orygen
35 Poplar Rd, Parkville VIC 3052
Country 120332 0
Australia
Phone 120332 0
+61 412 999 140
Fax 120332 0
Email 120332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16526Study protocol https://www.researchprotocols.org/2023/1/e44300[email protected] Accepted for publication 384318-(Uploaded-14-03-2023-14-37-57)-Study-related document.pdf
23758Statistical analysis plan    384318-(Uploaded-14-05-2024-11-18-28)-Study-related document.pdf



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.