Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000225819
Ethics application status
Approved
Date submitted
1/02/2021
Date registered
3/03/2021
Date last updated
14/03/2022
Date data sharing statement initially provided
3/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining the delivery of Smooth Sailing in Secondary Schools
Scientific title
Examining the Implementation of the Smooth Sailing Online Mental Health Service in Secondary Schools
Secondary ID [1] 303280 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12617000977370 was the Feasibility and Acceptability study which was a pre/post design (Phase 2).

ACTRN12618001539224 was the Randomised Control Trial (Phase 3).

Health condition
Health condition(s) or problem(s) studied:
Anxiety
 320480 0
Depression 320481 0
Condition category
Condition code
Mental Health 318360 318360 0 0
Anxiety
Mental Health 318361 318361 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Smooth Sailing is a web-based mental health service designed for secondary school students and administered by the Black Dog Institute. Smooth Sailing uses a website to register students, screen and monitor their mental health, allocate them to an appropriate level (or “step”) of care, engage them in youth-oriented evidence-based information and activities about mental health, depression, anxiety, and help-seeking, and connect them with a school counsellor when face-to-face support may be required. The service is delivered over a 12-week period in three classroom sessions spaced six weeks apart during which participating students complete several questionnaires. Between these classroom sessions, all participants are given access to an online learning platform called Bite Back during the first six-week period and complete a series of psychoeducation modules during the second six-week period. A member of the research team and/or a school staff member (e.g., teacher, school counsellor) will be present and available at each classroom session to discuss any questions or concerns and provide advice or assistance as required. Each school will be randomly allocated to receive the intervention in one of the following three arms:

1. Standard service: Smooth Sailing will be delivered over a 12-week period in three classroom sessions spaced six weeks apart (i.e., baseline, six weeks, and 12 weeks) and participating students will otherwise use the service in their own time.

2. Standard service with allocated class time: In addition to the standard service, participating students will be given two additional classroom sessions to use Smooth Sailing.

3. Standard service with financial incentive: In addition to the standard service, participating students will be given a financial incentive to use Smooth Sailing. Participants will be reimbursed $2.50 for completing the six- and 12-week classroom sessions and $3 for completing each of the five psychoeducation modules. Each participant can receive up to a total of $20 in reimbursements.

Further details are provided below.

1. Service registration and initial screening: Students will complete service registration and screening questionnaires online using a compatible device (e.g., desktop computer, laptop, tablet, or smartphone) during the first of three classroom sessions. To register, students will be asked to go to the Smooth Sailing website using a school specific URL (provided on a slide or on a sheet of paper), read and understand the online consent form and Gillick Competency Test, register to the service by entering a valid, active, and accessible school-administered email address (or personal email address is school email unavailable) and create a password. Initial screening involves the completion of several questionnaires, including validated self-report measures of depression, anxiety, and help-seeking intentions and behaviours. This will take one class period or up to 45 minutes to complete.

2. Delivery of universal program Bite Back: After completing initial screening, all participating students will be given access to and asked to use the online learning platform Bite Back that aims to improve the mental health and wellbeing of young people aged 13 to 16 years. Bite Back provides a range of information, resources, strategies, activities, quizzes, stories, and multimedia related to positive psychology topics including gratitude, mindfulness, social connections, character strengths, and meaning and purpose. A key feature of the program is the Bite Back Mental Fitness Challenge, which contains six modules. Bite Back aligns with the mental health and wellbeing focus area of the National Health and Physical Education Curriculum for schools in Australia and has been shown in a RCT to reduce symptoms of psychopathology and increase wellbeing in young people. Each module takes approximately 10 minutes to complete and students will be asked to complete one module per week in their own time unless they are allocated to the additional class time arm.

3. Midpoint screening: At the 6-week time point, midway through delivery of the Smooth Sailing service and during the second classroom session, researchers will revisit the schools either in person or via an online platform. Participants will be asked to complete several questionnaires, including some of the questionnaires completed as part of the initial screening session via link that will be sent to the email address they registered with. This will take approximately 30 minutes to complete and will be completed during class time.

4. Step allocation and delivery of care: An algorithm based on the level of depression and anxiety symptoms indicated by the questionnaires completed as part of the initial and midpoint screening sessions automatically allocates each student to one of five symptom severity categories and one of three steps of care in accordance with the Australian Clinical Practice Guidelines for Clinical Depression (McDermott et al., 2010). The level of care, or intensity of care, is matched to the level (i.e., severity) of symptoms and increases cumulatively.

Step One: Self-directed web-based psychoeducation. Participating students with nil to mild symptoms (i.e., symptom severity categories “0” and “1”) will be allocated to Step One comprising five 10-minute psychoeducation modules on i) general mental health, ii) depression, iii) anxiety, iv) seeking help for yourself, v) seeking help for a friend. Each of these modules provides youth-oriented information about mental health, depression, anxiety, and help-seeking. This content is complemented by youth-oriented graphics and hyperlinks to credible youth mental health services and websites. This content was created specifically for this service and was reviewed by clinicians. It is designed to be self-directed, such that the youth can read and return to it whenever they wish.

Step Two: Self-directed web-based CBT. Participating students with moderate symptoms (i.e., symptom severity category “2”) will be allocated to Step Two and, in addition to having access to the five psychoeducation modules, will have access to a sixth module which provides information about a selection of publicly available, free, evidence-based online CBT programs. The online CBT module consists of a single webpage that outlines two evidence-based self-directed online CBT programs: i) MoodGym (Australian National University), ii) The BRAVE Program (University of Queensland), and iii) one relationships-focused program WeClick (Black Dog Institute). MoodGym is an interactive program that helps identify mental health symptoms and learn and practice skills for managing symptoms of depression and anxiety. BRAVE is an online CBT program that helps young people learn how to identify anxiety and stress, develop relaxation skills, and replace negative thinking with more positive thinking. WeClick is a relationships-focused program that helps young people learn skills and strategies to improve friendships and other relationships.

Step Three: Face-to-face support from a school counsellor. Participating students with moderately severe to severe symptoms (i.e., symptom severity categories “3” and “4”) will be allocated to Step Three and, in addition to having access to all six Smooth Sailing modules, will be referred to a school counsellor for face-to-face support.

Any participant who reports thoughts that they would be better off dead or harming themselves in some way will also be referred to a school counsellor for face-to-face support.

Students will be asked to complete the modules and programs in their own time unless they are allocated to the additional class time arm.

5. Reminders and monitoring: Reminders will be sent to the registered email address (and mobile/cell phone number, if provided) of participating students to remind them to engage with the service. All participating students will receive three Bite Back program reminders (Day 8, 22 and 36) and three Smooth Sailing service reminders (Day 50, 64 and 78). Participating students in schools randomly allocated to the arm with a financial incentive will receive additional information about the financial incentive in the three Smooth Sailing service reminders. Following the 6-week assessment, participating students who are allocated to Step 2 and Step 3 (i.e., symptom severity categories “3” and “4”) will be asked to complete two monitoring assessments, spaced 14 days apart (Day 57 and 71). This consists of the PHQ-2 and GAD-2 and will be delivered via email or SMS and should take 2 minutes to complete. Participants are then reminded to use the program, with no symptom feedback given. These students will receive four reminders to complete the monitoring assessments (Day 59 and 61 for the first monitoring assessment and Day 73 and 75 for the second monitoring assessment).

6. Final screening: At the 12-week time point during the third classroom session, researchers will revisit the schools either in person or via an online platform. Participants will be asked to complete several questionnaires, including some of the questionnaires completed as part of the initial and midway screening sessions via link that will be sent to the email address they registered with. The final screening session will include a questionnaire to assess students’ satisfaction with Smooth Sailing. Participating students will have access to the Smooth Sailing modules for a further two-week period after the 12-week assessment. This will take approximately 30 minutes to complete and will be completed during class time.

7. School staff involved in delivering the service will be asked to complete a battery of questionnaires prior to service registration and baseline assessment and after the 12-week assessment. School staff will be invited to participate in a semi-structured phone interview to discuss their experiences.
Intervention code [1] 319581 0
Early detection / Screening
Intervention code [2] 319582 0
Behaviour
Intervention code [3] 319863 0
Prevention
Comparator / control treatment
The comparator/control arm is the “Core Intervention”. This arm delivers the Smooth Sailing service over a 12-week period in three classroom sessions spaced six week apart (i.e., baseline, six weeks and 12 weeks).

Control group
Active

Outcomes
Primary outcome [1] 326328 0
Reach/Service engagement (this is operationalized as the number of modules accessed by participating students). The Smooth Sailing service consisted of 7 modules: BiteBack, five psycho-education modules and one iCBT module. As the total number of modules available to students was dependent on their step allocation at 6-weeks, this outcome was reported as the proportion of available modules accessed. The number of modules accessed will be recorded automatically by the online platform hosting the service.
Timepoint [1] 326328 0
12-week follow up
Secondary outcome [1] 391069 0
Help-seeking attitudes, assessed using the General Help-Seeking Questionnaire (GHSQ) (Wilson et al., 2005).
Timepoint [1] 391069 0
Baseline, 6-week follow-up, and 12-week follow-up
Secondary outcome [2] 391255 0
Help-seeking behaviour, assessed using the Actual Help-Seeking Questionnaire (AHSQ) (Rickwood et al., 2005).
Timepoint [2] 391255 0
Baseline, 6-week follow-up, and 12-week follow-up
Secondary outcome [3] 391256 0
Anxiety, assessed using the Generalised Anxiety Disorder Scale (GAD-7) (Spitzer et al, 2006).
Timepoint [3] 391256 0
Baseline, 6-week follow-up, and 12-week follow-up
Secondary outcome [4] 391257 0
Depression, assessed using the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2006).
Timepoint [4] 391257 0
Baseline, 6-week follow-up, and 12-week follow-up
Secondary outcome [5] 391258 0
Satisfaction with the service: assessed using a purpose-designed 11-item questionnaire to assess three factors relating to enjoyment and ease of use, usefulness, and level of comfort with service requirements. Barriers and facilitators to use: assessed using an 18-item scale examining the barriers and facilitators of service access, and use of websites and programs recommended by the service. Helpfulness (usefulness) of the service: assessed using one item.
Timepoint [5] 391258 0
12-week follow-up
Secondary outcome [6] 391260 0
Uptake. This is operationalised as the proportion of eligible students who register for the service and will be recorded automatically by the online platform hosting the service.
Timepoint [6] 391260 0
Baseline
Secondary outcome [7] 392385 0
School contextual factors including: School location (rural, metropolitan) and socioeconomic status (Index of Community Socio-Educational Advantage [ICSEA] level) will be obtained from the Australian Curriculum, Assessment and Reporting Authority (ACARA) My School website (https://myschool.edu.au/).
Timepoint [7] 392385 0
Baseline
Secondary outcome [8] 392386 0
School specific factors including: School type (government, non-government) and school student gender (co-educational, gender selective) will be obtained from the Australian Curriculum, Assessment and Reporting Authority (ACARA) My School website (https://myschool.edu.au/). Year level of participating students (Year 8, Year 9) will be requested from school staff as part of the onboarding process.
Timepoint [8] 392386 0
Baseline
Secondary outcome [9] 392387 0
School promotion of mental health, assessed using the Survey of School Promotion of Emotional and Social Health (Dix et al., 2019) (13 items).
Timepoint [9] 392387 0
Pre-intervention
Secondary outcome [10] 392388 0
Relative priority, assessed using the Perceived Attributes of the Healthy School Approach Scale Perceived Attributes of the Healthy School Approach Scale (Deschesnes et al., 2009), adapted for this trial (2-tems).
Timepoint [10] 392388 0
Pre-intervention
Secondary outcome [11] 392389 0
Relative advantage, assessed using the Perceived Attributes of the Healthy School Approach Scale (Deschesnes et al., 2009), adapted for this trial (2-tems).
Timepoint [11] 392389 0
Pre-intervention
Secondary outcome [12] 392390 0
Evidence of strength and quality of the service, assessed using the Perceived Attributes of the Healthy School Approach Scale (Deschesnes et al., 2009), adapted for this trial (3 items).
Timepoint [12] 392390 0
Pre-intervention
Secondary outcome [13] 392391 0
School culture and support, assessed using the School Culture and Support Survey (2 items).
Timepoint [13] 392391 0
Pre-intervention
Secondary outcome [14] 392392 0
Implementation Climate (receptiveness), assessed using the Implementation Climate (Fernandez et al., 2018) (4 items).
Timepoint [14] 392392 0
Pre-intervention
Secondary outcome [15] 392393 0
Resource allocation for implementation and operations, assessed using the Implementation Climate adapted for the school context (Fernandez et al., 2018) (7 items).
Timepoint [15] 392393 0
Pre-intervention
Secondary outcome [16] 392394 0
Leadership commitment and involvement, assessed using the Implementation Climate adapted for the school context (Fernandez et al., 2018) (4 items).
Timepoint [16] 392394 0
Pre-intervention
Secondary outcome [17] 392395 0
Leadership, assessed using the Implementation Leadership Scale (Aarons et al., 2014) (6 items).
Timepoint [17] 392395 0
Pre-intervention, post-intervention
Secondary outcome [18] 392396 0
Barriers to implementation, assessed using a study specific questionnaire, the Barriers to Implementation questionnaire (28 items).
Timepoint [18] 392396 0
Post-intervention
Secondary outcome [19] 392397 0
Facilitators to implementation, assessed using a study specific questionnaire, the Facilitators to Implementation questionnaire (22 items).
Timepoint [19] 392397 0
Post-intervention
Secondary outcome [20] 392398 0
Implementation process, assessed using the Normalisation MeAsure Development questionnaire (NoMAD; Finch et al., 2015) (16 items).
Timepoint [20] 392398 0
Post-intervention
Secondary outcome [21] 392399 0
Acceptability/Appropriateness, assessed using the Acceptability of Intervention Measure (AIM) (4 items), the Intervention Appropriateness Measure (IAM) (4 items) and the Feasibility of Intervention Measure (FIM) (4 items) (Weiner, et al., 2017).
Timepoint [21] 392399 0
Pre-intervention, post-intervention

Eligibility
Key inclusion criteria
All schools in New South Wales (NSW) and independent schools in South Australia (SA) and Queensland (QLD) with a Year 8 or Year 9 cohort are eligible to participate in the trial, which requires the support of both the School Principal and School Counsellor. Inclusion criteria for participants (students) are being enrolled in Year 8 or Year 9 at a participating school and the provision of personal consent or parental consent if from a participating Catholic school. Participating students will be required to have a valid, active, and accessible school-administered email address (or personal email if a school email address is unavailable) as well as internet access for the duration of the trial. The school will be required to provide internet access for the duration of the trial. There will be no participant eligibility criteria for age, although it is expected that the age range of participants will be between 12 and 16 years at baseline. There are no participant exclusion criteria regarding sex, gender, mental health status or current treatment for mental health.

Participants in this study will also include school staff who are currently employed in a participating high school, have internet access for questionnaire completion, are involved in the Smooth Sailing service implementation and must be willing to provide informed consent.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those not willing or able to provide informed consent will be excluded from participating.

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)
Allocation concealment will be ensured as the holder of the allocation schedule was off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation (at the school level) will be employed to avoid contamination (Donner & Klar, 2000) and for administrative feasibility within schools. Each school will be allocated to receive the intervention in one of its three forms: (1) core intervention; (2) core intervention with allocated class time; and (3) core intervention with financial incentive. Assignment of schools to one of three arms will be carried out in accordance with ICH guidelines (Lewis, 1999). Schools will be assigned to the interventions in a 1:1 ratio, using a minimisation approach (Taves, 2010; Altman & Bland, 2005) using the with school socioeconomic status (Index of Community Socio-Educational Advantage [ICSEA] level: <1,000; >1,000), school student gender (co-educational; gender selective), and Year level of students (Year 8; Year 9) as balancing factors. Minimisation will be undertaken in Stata version 14.2 using the rct_minim procedure (Ryan, 2018). The pool of already-available schools will be sorted in a random order using the Microsoft Excel data analysis random number generator and then entered into the minimisation routine in ascending order using the balancing variables specified above. Subsequent schools will be assigned to an arm of the trial using rct_minim in the order that they join the trial and provide complete information.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Cluster randomisation, conducted at the school level, will be employed to avoid contamination, such that each school will be randomly allocated to receive the intervention in one of its three forms: (1) core intervention; (2) core intervention with allocated class time; and (3) core intervention with financial incentive.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size:
The target sample size for this three-arm trial was calculated based on detecting a relatively small effect size (0.30) on a continuous primary outcome with alpha set at .05 and a 20% attrition rate.

A conservative intraclass correlation (ICC) of 0.02 was assumed. This is slightly higher than the ICC of 0.017 estimated from previous trial data. The number of participants consenting per school was estimated at 85, as observed in the previous trial (O’Dea, Subotic-Kerry, King, Mackinnon, Achilles, Anderson, Parker, Werner-Seidler, Torok, Cockayne, Baker, & Christensen, unpublished). Based on this, the required sample is 450 participants per condition, and therefore 1,350 participants in total. Based on our prior study, on average, a total of 85 students consented per school; therefore, we will require at least 15 schools, with 5 schools allocated to each arm.

It is acknowledged that these estimates provide guidance only. The primary outcome is a count variable and will not be available for participants who fail to register to use the system. In the absence of reliable estimates of the proportion failing to register and knowledge of the distribution of counts, more reliable estimates of the required sample are not feasible. In response to this, we plan to maximize recruitment within the constraints of resources available.

Analyses:
The primary outcome – reach – is measured by the number of modules accessed at 12 weeks. As a bounded count variable, a variety of types of model are appropriate depending on the observed distribution of the number of modules accessed. These include binomial, Poission and negative binomial models with and without inflation components to accommodate any excess zero counts. The form of the model on which the performance of the interventions will be judged will be chosen by evaluating the fit of the model to the observed distribution of modules completed and testing whether more complex components (zero inflation, negative binomial/Poisson) are required to adequately represent the observed data (Hilbe, 2011). If these models fail to fit the data, alternative generalized linear mixed models will be considered.

Models will include intervention arm as the main factor of interest with balance factors used in minimisation provisionally entered into models and retained only if significant. Mixed model formulations will be used to accommodate school as a random factor. Any model for zero inflation will also include these factors. As the ‘timing’ and ‘incentive’ interventions are essentially independent manipulations of the core intervention, they will be compared to the core intervention in separate contrasts with no adjustment of alpha level.

As it is hypothesized that both manipulations will have a positive effect it is acknowledged that power to detect differences between these arms is low and uncertain. These arms will be compared within a broad ‘equivalence’ framework. This will involve comparison of confidence intervals rather than the setting of a non-inferiority margin as this would not be appropriate (see Dunn, Copas & Brocklehurst, 2018). It may be that useful comparisons between these arms lie in the identification of subgroups of participants who respond best to one form of enhancement compared to the other in exploratory analyses.

The ‘reach’ outcome is meaningful only for students who register on the system. It will be possible to impute a zero count to students who do not register and even to those who drop out, however, this conflates the two outcomes of engagement and reach: one intervention arm might show a lower average reach due to fewer registrations even if those who register actually do complete more modules. Nevertheless, this appropriate will be implemented as secondary analysis as it is, arguably, more consistent with the intention to treat principle and analysis of all participants as randomised. The outcomes of this approach will be compared to that obtained for module completion of students who register to use the system.

Results for secondary outcomes will be undertaken using comparable methods as the primary measure with the model type depending on the nature of the data. Where comparable measures are available on multiple occasions, all available data will be used in measured-measures models incorporating factors for intervention arm and occasion of measurement and their interaction. The test of the effectiveness of each intervention enhancement will be a planned comparison comparing change in the measure from baseline relative to change in the core intervention. For outcomes yielding continuous scores, linear mixed model repeated measures analysis of variance (MMRM) will be used with an unstructured variance-covariance matrix used to account for associations between occasions. If necessary, variables may be transformed to address distributional assumption. Analogous generalized mixed models will be used for binary and count outcomes. All models will incorporate school as a random factor.

Exploratory analyses will seek to identify moderators of outcomes. For example, effects of contextual factors on outcomes will be explored using linear and generalized linear models according to outcome type.

Thematic analysis following Braun and Clarke’s (2006, 2019) six-phase model approach will be used to identify, analyse, and report the themes present in the qualitative semi-structured telephone interview data about experiences using the Smooth Sailing service.

Descriptive statistics will be computed on a range of data/outcomes, including personal characteristics (demographics) of participating school staff and students, students’ help-seeking intentions and behaviours and mental health outcomes, and related service outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/02/2020
Date of last participant enrolment
Anticipated
Actual
29/10/2020
Date of last data collection
Anticipated
31/03/2021
Actual
31/03/2021
Sample size
Target
1350
Accrual to date
Final
1295
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment postcode(s) [1] 32866 0
2173 - Holsworthy
Recruitment postcode(s) [2] 32867 0
2015 - Alexandria
Recruitment postcode(s) [3] 32868 0
2482 - Mullumbimby
Recruitment postcode(s) [4] 32869 0
2452 - Toormina
Recruitment postcode(s) [5] 32870 0
2048 - Stanmore
Recruitment postcode(s) [6] 32871 0
2440 - Kempsey
Recruitment postcode(s) [7] 32872 0
2360 - Inverell
Recruitment postcode(s) [8] 32873 0
5290 - Mount Gambier
Recruitment postcode(s) [9] 32874 0
2422 - Gloucester
Recruitment postcode(s) [10] 32875 0
2440 - South Kempsey
Recruitment postcode(s) [11] 32876 0
2500 - Wollongong
Recruitment postcode(s) [12] 32878 0
2576 - Bowral
Recruitment postcode(s) [13] 32879 0
2541 - Nowra
Recruitment postcode(s) [14] 32880 0
2540 - Vincentia
Recruitment postcode(s) [15] 32881 0
2007 - Ultimo
Recruitment postcode(s) [16] 32882 0
2300 - Newcastle
Recruitment postcode(s) [17] 32883 0
2284 - Argenton
Recruitment postcode(s) [18] 32884 0
2325 - Cessnock
Recruitment postcode(s) [19] 32885 0
2428 - Tuncurry
Recruitment postcode(s) [20] 32886 0
2324 - Raymond Terrace
Recruitment postcode(s) [21] 32887 0
2317 - Salamander Bay
Recruitment postcode(s) [22] 32888 0
2131 - Ashfield
Recruitment postcode(s) [23] 32889 0
4810 - Townsville
Recruitment postcode(s) [24] 32890 0
2161 - Guildford
Recruitment postcode(s) [25] 32891 0
2135 - Strathfield
Recruitment postcode(s) [26] 32892 0
2390 - Narrabri
Recruitment postcode(s) [27] 32893 0
2761 - Plumpton
Recruitment postcode(s) [28] 32894 0
2680 - Griffith
Recruitment postcode(s) [29] 32895 0
2782 - Wentworth Falls
Recruitment postcode(s) [30] 32896 0
2753 - Richmond
Recruitment postcode(s) [31] 32897 0
2155 - Kellyville
Recruitment postcode(s) [32] 32898 0
2120 - Pennant Hills
Recruitment postcode(s) [33] 32899 0
2420 - Dungog

Funding & Sponsors
Funding source category [1] 307692 0
Government body
Name [1] 307692 0
The Commonwealth of Australia represented by the Department of Health
Country [1] 307692 0
Australia
Funding source category [2] 307695 0
Charities/Societies/Foundations
Name [2] 307695 0
Graf Family Foundation
Country [2] 307695 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW Sydney)
Address
UNSW, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 308390 0
None
Name [1] 308390 0
Address [1] 308390 0
Country [1] 308390 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307726 0
University of New South Wales Human Research Ethics
Ethics committee address [1] 307726 0
Ethics committee country [1] 307726 0
Australia
Date submitted for ethics approval [1] 307726 0
20/05/2019
Approval date [1] 307726 0
26/07/2019
Ethics approval number [1] 307726 0
HC190382

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

Contacts
Principal investigator
Name 108290 0
Dr Mirjana Subotic-Kerry
Address 108290 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick, NSW 2031
Country 108290 0
Australia
Phone 108290 0
+61290659153
Fax 108290 0
Email 108290 0
m.subotic-kerry@blackdog.org.au
Contact person for public queries
Name 108291 0
Mirjana Subotic-Kerry
Address 108291 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick, NSW 2031
Country 108291 0
Australia
Phone 108291 0
+61290659153
Fax 108291 0
Email 108291 0
m.subotic-kerry@blackdog.org.au
Contact person for scientific queries
Name 108292 0
Mirjana Subotic-Kerry
Address 108292 0
Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick, NSW 2031
Country 108292 0
Australia
Phone 108292 0
+61290659153
Fax 108292 0
Email 108292 0
m.subotic-kerry@blackdog.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This will not be available as per the conditions of our ethical approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10406Ethical approval    381308-(Uploaded-01-02-2021-13-20-14)-Study-related document.pdf
10407Informed consent form    381308-(Uploaded-01-02-2021-13-58-22)-Study-related document.pdf
10408Informed consent form    381308-(Uploaded-01-02-2021-14-00-00)-Study-related document.pdf
10409Informed consent form    381308-(Uploaded-01-02-2021-14-00-26)-Study-related document.pdf
10410Informed consent form    381308-(Uploaded-01-02-2021-14-00-45)-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.