Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000279820
Ethics application status
Approved
Date submitted
7/10/2020
Date registered
12/03/2021
Date last updated
12/03/2021
Date data sharing statement initially provided
12/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Multimodal Approach to Preventing Suicide in Schools (MAPSS): A regionally-based trial of safeTALK and Reframe IT among secondary school students (Reframe IT component)
Scientific title
Multimodal Approach to Preventing Suicide in Schools (MAPSS): A regionally-based trial of safeTALK and Reframe IT among secondary school students (Reframe IT component)
Secondary ID [1] 302489 0
Nil known
Universal Trial Number (UTN)
NA
Trial acronym
MAPSS
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Depression 319341 0
Suicide 319342 0
Condition category
Condition code
Mental Health 317297 317297 0 0
Depression
Mental Health 317298 317298 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Reframe IT intervention comprises eight modules to be delivered during a 10-week intervention period. Each module is takes approximately 15-20 minutes to complete.
The program takes the form of an adult ‘host’ character who delivers the therapy verbally, and a series of video diaries made by young people. There are two activities per week plus suggested homework (homework tasks take approximately 5-10 minutes per day to complete). The activities and homework tasks are based on standard CBT commonly used with young people and have a specific focus on suicidal thinking and behaviours. The content covered by the modules is as follows:
• Week 1 - problem identification
• Week 2 - emotion recognition and distress tolerance
• Week 3 - thought recognition
• Week 4 - help-seeking
• Week 5 - activity scheduling (including relaxation)
• Week 6 - problem solving
• Week 7 - cognitive restructuring
• Week 8 - summary of Reframe IT program, create coping cards

Each participant will have access to their own personalised webpage accessed via secure login. To maximise the chances of follow-up in the unlikely event that Reframe IT is associated with any adverse events, each self-administered module will be completed in the participant’s school, in the presence of the student wellbeing staff member. Once each individual module has been completed in the presence of the school staff member, participants will be able to access it from home, 24 hours a day. The program has no social networking function.

Reframe IT has a message board through which the participants can communicate with the site moderator/s. It is moderated once a day on weekdays by a member of the research team, who will monitor the site for any communication from participants and respond accordingly if required. It also contains links to a series of factsheets covering a range of related topics. The factsheets are those developed for general use by mental health organisations such as headspace and Orygen, and were not specifically developed for the Reframe IT platform (e.g., the fact sheet on suicidal thoughts is located at https://headspace.org.au/assets/Uploads/Resource-library/Health-professionals/suicidal-ideation-mythbusterv2.pdf). As the weeks progress, additional items are added to the site, (e.g. an activity diary).

Finally, there is a ‘Getting help’ tab, which lists a range of local and national helplines and services that the participant can access if in crisis.

Log-ins, time spent logged in, modules completed and progress within modules are automatically tracked by the Reframe IT system and will be used to monitor adherence to the intervention.
Intervention code [1] 318785 0
Behaviour
Intervention code [2] 319569 0
Prevention
Comparator / control treatment
Treatment as Usual (TAU): Participants allocated to TAU will receive standard care as determined by their school wellbeing coordinator. Their use of health services will be assessed through the Resource Use Questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 325358 0
Suicidal ideation, assessed using the Suicidal Ideation Attributes Scale (SIDAS)
Timepoint [1] 325358 0
Twelve weeks (Time 3) and 24 weeks (Time 4) post-baseline, as compared to two weeks post-baseline (Time 2).
Secondary outcome [1] 387624 0
Symptoms of depression, assessed using the Patient Health Questionnaire – 9 item (PHQ-9)
Timepoint [1] 387624 0
Twelve weeks (Time 3) and 24 weeks (Time 4) post-baseline, as compared to two weeks post-baseline (Time 2).
Secondary outcome [2] 387625 0
Hopelessness, assessed using the Hopelessness Scale for Children (HSC)
Timepoint [2] 387625 0
Twelve weeks (Time 3) and 24 weeks (Time 4) post-baseline, as compared to two weeks post-baseline (Time 2).
Secondary outcome [3] 387626 0
Problem-solving, assessed using the Negative Problem Orientation Questionnaire (NPOQ)
Timepoint [3] 387626 0
Twelve weeks (Time 3) and 24 weeks (Time 4) post-baseline, as compared to two weeks post-baseline (Time 2).
Secondary outcome [4] 387627 0
Health-service use, assessed using the Resource Use Questionnaire (RUQ)
Timepoint [4] 387627 0
Twelve weeks (Time 3) and 24 weeks (Time 4) post-baseline, as compared to two weeks post-baseline (Time 2).
Secondary outcome [5] 387636 0
Acceptability of Reframe IT, assessed using a purpose-designed questionnaire
Timepoint [5] 387636 0
Twelve weeks post-baseline (Time 3)

Eligibility
Key inclusion criteria
Current year 10 or 11 student at a secondary school in North West Melbourne who has consented to participate in the broader MAPSS trial and reports suicidal ideation within the past four weeks.

Past-four-week suicidal ideation past four-week suicidal ideation will be indicated by either a score of 21 or higher on the Suicidal Ideation Attributes Scale (SIDAS), or a score of 1-20 confirmed by a screening interview with a researcher.
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Intellectual disability;
2. Inability to converse in, or read English.

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)
Eligible students will be identified via their responses to the baseline assessment for the broader MAPSS study. In the two-week period following the baseline assessment, eligible students will be informed about the trial and invited to participate. This may occur via two ways: 1) a research assistant will contact eligible students via phone; or 2) school wellbeing staff will have this conversation face-to-face with the student at school. This will be determined on a school-by-school basis.

Those who consent to participate will then be randomised to the intervention group (Reframe IT plus TAU) or to the control group (TAU only) using REDCap database management software. A member of the study team will inform schools of the outcome of randomisation; school wellbeing staff will then inform the relevant students.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was generated by the study statistician (HPY) and then loaded into REDCap for use
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be a linear regression, conducted using an intention-to-treat approach. Multiple imputation techniques will be considered if the amount of missing values is substantial. The key predictors will be study arm (IX vs TAU) and T2 SIDAS score (i.e., baseline for Reframe IT). The primary outcome will be SIDAS score at T4. Sensitivity analyses will employ a random effects model to control for baseline covariates and clustering within schools. These will be repeated for secondary analyses, which will involve SIDAS score at T4 as the outcome variable. Additional variables such as hopelessness and help-seeking will also be explored in secondary analyses, as will acceptability (see hypotheses).

Economic evaluation:
This will employ a “within-trial” design whereby the individual level costs and outcomes of the randomised participants in the schools will be included in the evaluation over the duration for which costs and outcomes are measured. However, because this may not capture the full costs and consequences of the intervention, a modelled evaluation will also be undertaken using the results of this trial and relevant epidemiological literature.

The economic evaluation will comprise a cost-consequences analysis whereby the incremental costs of the intervention will be compared to the full spectrum of outcomes included in the study. This means that a series of cost-effectiveness ratios will be determined rather than just one, an approach that has been found useful by decision-makers. The inclusion of a multi-attribute utility measure (the CHU 9D) will also enable a cost-utility analysis to be undertaken, thereby allowing practical judgements regarding value for money of the intervention to made. The economic analysis will be primarily from the perspective of the health care sector though and a secondary analysis from the broader societal perspective will also be undertaken. The evaluation will first measure and value any change to the use of health care resources over the period of the study between the two arms of the trial (intervention and control) and then compare any additional costs to other outcomes achieved.

Standardised economic evaluation techniques including incremental analysis of mean differences and bootstrapping to determine confidence intervals will be employed. If the intervention is found to be effective, the lifetime and population budgetary impacts and cost-effectiveness of the intervention will be determined using modelling techniques.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/03/2021
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
268
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306915 0
Government body
Name [1] 306915 0
National Health and Medical Research Council (NHMRC)
Country [1] 306915 0
Australia
Funding source category [2] 306916 0
Charities/Societies/Foundations
Name [2] 306916 0
Lifeline Australia
Country [2] 306916 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Centre for Youth Mental Health
35 Poplar Road
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 307474 0
None
Name [1] 307474 0
Address [1] 307474 0
Country [1] 307474 0
Other collaborator category [1] 281503 0
University
Name [1] 281503 0
Deakin University
Address [1] 281503 0
School of Health & Soc. Dev.
Deakin University
221 Burwood Highway
Burwood VIC 3125
Australia
Country [1] 281503 0
Australia
Other collaborator category [2] 281504 0
University
Name [2] 281504 0
University of Auckland
Address [2] 281504 0
Auckland Hospital - Bldg 599
Level 12, Room 12003
2 Park Road
Grafton
Auckland 1023
New Zealand
Country [2] 281504 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307065 0
The University of Melbourne Psychology Health and Applied Sciences Human Ethics Sub-Committee
Ethics committee address [1] 307065 0
Office of Research Ethics & Integrity
Level 4, 161 Barry Street
The University of Melbourne
VIC 3010
Ethics committee country [1] 307065 0
Australia
Date submitted for ethics approval [1] 307065 0
25/01/2019
Approval date [1] 307065 0
22/02/2019
Ethics approval number [1] 307065 0
Ethics committee name [2] 307066 0
Research, Evaluation and Analytics Branch, Performance and Evaluation Division, Department of Education and Training
Ethics committee address [2] 307066 0
Research, Evaluation and Analytics Branch, Performance and Evaluation Division
Department of Education and Training
Level 3, 33 St Andrews Place
GPO Box 4367
Melbourne
VIC 3001
Ethics committee country [2] 307066 0
Australia
Date submitted for ethics approval [2] 307066 0
31/01/2019
Approval date [2] 307066 0
29/03/2019
Ethics approval number [2] 307066 0

Summary
Brief summary
This study involves the evaluation of an online CBT-based intervention (Reframe IT) delivered to secondary school students in North-West Melbourne. This study forms part of a larger study (the MAPSS project) which also involves delivery of educational workshops to school students. The educational workshops will be evaluated using a pre-test post-test study design.

Participants in the current trial will be students who have experienced suicidal ideation in the past four-weeks, identified via their responses to the baseline questionnaire for the MAPSS project. Eligible participants will be invited to participate, and those who consent will be randomised to either Reframe IT or TAU conditions. The intervention period occurs between 2- and 12-weeks post-baseline assessment. The primary outcome is change in suicidal ideation; secondary outcomes are change in depression, hopelessness, and problem-solving skills.
Trial website
https://www.orygen.org.au/Research/Currently-recruiting/Multimodal-approach-to-preventing-suicide-in-schoo
Trial related presentations / publications
Public notes
Time 1 (Week 0) relates to the primary outcomes for the pre-test/post-test evaluation component of the broader MAPSS project. It is also used to identify potentially eligible students for this study.

Contacts
Principal investigator
Name 105906 0
A/Prof Jo Robinson
Address 105906 0
Centre for Youth Mental Health
35 Poplar Road
Parkville
VIC 3052
Country 105906 0
Australia
Phone 105906 0
+61 412 999 140
Fax 105906 0
Email 105906 0
[email protected]
Contact person for public queries
Name 105907 0
A/Prof Jo Robinson
Address 105907 0
Centre for Youth Mental Health
35 Poplar Road
Parkville
VIC 3052
Country 105907 0
Australia
Phone 105907 0
+61 412 999 140
Fax 105907 0
Email 105907 0
[email protected]
Contact person for scientific queries
Name 105908 0
A/Prof Jo Robinson
Address 105908 0
Centre for Youth Mental Health
35 Poplar Road
Parkville
VIC 3052
Country 105908 0
Australia
Phone 105908 0
+61 412 999 140
Fax 105908 0
Email 105908 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?

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.