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Trial registered on ANZCTR


Registration number
ACTRN12618001539224
Ethics application status
Approved
Date submitted
24/08/2018
Date registered
14/09/2018
Date last updated
14/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Smooth Sailing: Evaluating an online service for student wellbeing
Scientific title
Smooth Sailing: Evaluating an online service for student wellbeing
Secondary ID [1] 295842 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). The current application is for a Randomised Controlled Trial (Phase 3).

Health condition
Health condition(s) or problem(s) studied:
Depression 309292 0
Anxiety 309293 0
Condition category
Condition code
Mental Health 308165 308165 0 0
Depression
Mental Health 308166 308166 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Smooth Sailing (Arm 1)

Smooth Sailing is an online mental health service designed and administered by the Black Dog Institute. It is based on the principles of stepped care such that the intensity of the recommended interventions is matched to individuals’ symptom severity and individuals will step up if they have not responded to treatment after a set period of time. Smooth Sailing involves:

1. Registration & Baseline Assessment. In class time, participants are given a slip of paper with the service URL and their unique identification code. Using a school or personal internet device, students visit this website and undertake registration. Before registration commences, participants are also asked to complete the Gillick Competency Test. Upon correct completion of this, participants are invited to create a personal profile (name, age, email address, mobile phone number, gender, history of mental health issues, and use of the internet for mental health information). Once a personal profile is created, a series of questionnaires will be used to measure the presence of depression, anxiety, and help-seeking attitudes/ behaviours (see Table 4 in attached protocol for more detail). This will take approximately 30 minutes to complete.

2. Step allocation. Based on the answers inputted during registration, Smooth Sailing allocates each participant to one of five steps. This is automatic and based on a clinical algorithm which accounts for the severity levels of the anxiety and depression symptoms as reported by the participant on the Generalised Anxiety Disorder Scale (GAD-7) and the Patient Health Questionnaire (PHQ-9). Each step matches a severity level and is based on Clinical Practice Guidelines for Adolescent Depression. The step allocations are: Nil/minimal (Step 0), Mild (Step 1), Moderate (Step 2), Moderately Severe (Step 3), and Severe (Step 4). Please see Table 1 in attached protocol for more detail.

3. Delivery of tailored program. After step allocation, Smooth Sailing delivers a program of content that is tailored to each step. Steps 0 and 1 receive online psychoeducation. Step 2 receive online psychoeducation + online self-directed Cognitive Behavioural Therapy (CBT). Steps 3 and 4 receive online psychoeducation + online self-directed CBT + additional support from the School Counsellor. Any participant who is allocated to Step 3 or 4 or reports thoughts that they would be better off dead or harming themselves in some way triggers an electronic notification alert, which is automatically sent to the school counsellor for further investigation. This allows the school counsellor to facilitate a face-to-face session to provide the student with counselling, or them refer on to external services. The online psychoeducation consists of five 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 contains information about definitions of mental health terms, signs and symptoms, causes of mental health problems, what to do if needing help, and strategies and tips for what a young person can do immediately. Each module is complemented by animations and illustrations to depict key messages as well as hyperlinks to other credible youth mental health services and websites, including Headspace, Reachout, and Kids Helpline. 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. The online CBT module consists of a single webpage that outlines two evidence-based self-directed online CBT programs: i) MoodGym (Australian National University) and ii) The BRAVE Program (University of Queensland). MoodGym is an interactive self-help, online program which helps to learn and practise skills for managing symptoms of depression and anxiety. It consists of five modules alongside questionnaires, summaries and a personal workbook. BRAVE was developed for children and teenagers who experience Separation Anxiety Disorder, Social Phobia, Specific Phobia and Generalised Anxiety Disorder. This program helps young people to learn new ways to manage their anxiety and fears. It consists of 10 sessions and is effective for reducing social worries, anxiety about separating from loved ones, fears of specific objects or situation, worries about friendships, school performance or other everyday worries. Please see Table 2 in attached protocol for more detail.

4. Monitoring. At four time points in the study (Day 15, Day 29, Day 57 and Day 71) participants receive an automated 4-item monitoring questionnaire to assess how they are doing. This consists of the PHQ-2 and GAD-2 and will be delivered via email or SMS. Students are then reminded to use the program, with no symptom feedback given.

5. Six-week Reassessment (6-week follow-up): At Day 43, researchers revisit the schools, where participants are asked to log into the service using the same URL and unique ID codes, and are delivered the follow-up questionnaires. The results of these questionnaires are used to determine whether a participant had responded to care or needs to be “stepped up”. In accordance with the Clinical Practice Guidelines for the Treatment of Depression in Young Adults, if a participant has not responded to their care within 6 weeks of their baseline allocation, they would be “stepped up” to the next level of care. See Table 3 in attached protocol for the stepping matrix. The matrix was designed such that a participant would not be stepped down, instead will either remain at the same step or step up.

6. 12-week Reassessment (Post-test/final endpoint): At Day 85, researchers revisit the schools. Participants again log into the service using the same URL and unique ID codes, and are delivered the final endpoint questionnaires. School Counsellors will receive the same types of automated alerts as scheduled in baseline assessment when a student rates their symptoms to be severe or indicative of self-harm or thoughts of dying.

Throughout the trial, participating students will use Smooth Sailing at pre-test (for registration and baseline measure collection), at 6-weeks (for reassessment) and at 12-weeks (for final endpoint). Any students who could not access the website at 6-weeks or 12-weeks due to IT issues will be given a paper copy of questionnaires to complete and the research team will input that data electronically into the dataset. Researchers will use a paper scoring method to calculate participants’ step at these timepoints and will inform the school counsellor verbally if the student required follow-up. The online portal will be immediately updated once the research team has entered the data by hand.

Service use/ adherence to the intervention will also be measured by analysing the number of online modules accessed by participants, and the number of monitoring questionnaires completed.
Intervention code [1] 312178 0
Early detection / Screening
Intervention code [2] 312179 0
Treatment: Other
Comparator / control treatment
Control - Waitlist.

Schools that are allocated into the control condition will be placed on a waitlist to receive the Smooth Sailing program after the trial data collection has been completed and analysed. As such, students from control schools will receive treatment as usual during the initial 12-week study period. This means they will still be able to access the school counsellor when needed and permitted to participate in any mental health education or activities initiated by the school. During this time, students from control schools will complete a series of questionnaires at baseline, 6- and 12-week follow-up. Upon completion of the study period, control schools will be given the option to implement the Smooth Sailing program in their school. If the school goes ahead, students from control schools will be able to register to the Smooth Sailing service. Once consent is obtained, students in the control condition will be asked to visit the control website to complete the screening assessment. At 6-weeks and 12-weeks, students will be asked to complete another set of online questionnaires during class time. Access to the service will cease after 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 307133 0
Help-seeking attitudes, as measured by the General Help-Seeking Questionnaire (GHSQ).
Timepoint [1] 307133 0
Baseline, 6-week follow-up, and 12-week follow-up [primary timepoint]
Primary outcome [2] 307134 0
Help-seeking behaviour, measured using the Actual Help-Seeking Questionnaire (AHSQ).
Timepoint [2] 307134 0
Baseline, 6-week follow-up, and 12-week follow-up [primary timepoint]
Secondary outcome [1] 350797 0
Depression levels as measured by the Patient Health Questionnaire (PHQ-9), and the Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Timepoint [1] 350797 0
Baseline, 6-week follow-up, and 12-week follow-up
Secondary outcome [2] 350798 0
Anxiety levels as measured by the Generalised Anxiety Disorder Scale (GAD-7)
Timepoint [2] 350798 0
Baseline, 6-week follow-up, and 12-week follow-up
Secondary outcome [3] 350799 0
Psychological distress, as measured by the Distress Questionnaire-5 (DQ5)
Timepoint [3] 350799 0
Baseline, 6-week follow-up, and 12-week follow-up
Secondary outcome [4] 350800 0
Barriers to help-seeking as measured by the Barriers to Seeking Help Questionnaire (BASH-Brief).
Timepoint [4] 350800 0
Baseline, and 12-week follow-up
Secondary outcome [5] 350801 0
Mental health literacy, as measured by the Mental Health Literacy Scale
Timepoint [5] 350801 0
Baseline, and 12-week follow-up
Secondary outcome [6] 350802 0
Satisfaction with the service: to be measured using a purpose-designed questionnaire consisting of 3 questionnaires: 1) An 11 item scale (answered "agree" vs "disagree") assessing young people's experience and satisfaction with the service; 2) An 18 item scale (answered "yes" or "no" examining the barriers and facilitators of service access); 3) An 8 item questionnaire asking about participants' use of Smooth Sailing, whether it was helpful and how it could be improved. This includes 2 short answer questions, allowing participants to elaborate in their own words.
Timepoint [6] 350802 0
12-week follow-up

Eligibility
Key inclusion criteria
Secondary students will be aged between 11–19 years, and currently attending high school at one of the participating schools. Both males and females will be eligible. As well as including participants that are well, this trial will include adolescents with current depressive symptoms or any adolescents with a history of depression or anxiety. This trial will also include adolescents with current suicidality or a history of suicidality. Participants will be required to have an active email address for the duration of the trial as well as internet access either at home or at school (the school will provide internet access for the duration of the trial). Only those who provide signed written consent will be included. Participating school counsellors are required to be i) working in a participating high school for at least two days per week for the duration of the trial; ii) involved in the service; and iii) have phone and internet access for questionnaire completion and follow-up interview.
Minimum age
11 Years
Maximum age
19 Years
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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of schools to control or intervention will be carried out according to ICH guidelines (Lewis, 1999). Schools will be allocated to a single condition (cluster design) to avoid contamination and for administrative convenience (Donner & Klar, 2000). A minimisation approach (Taves, 2010; Altman & Bland, 2005) will be used to ensure balance across conditions in terms of the Index of Community Socio-Educational Advantage (ICSEA) level (less than 1000 versus greater or equal to 1000), gender mix (co-educational versus single sex) and year level involved (year 9 students only versus multiple or other years).

Minimisation was undertaken in Stata version 14.2 using the rct_minim procedure (Phillip, 2017). The pool of already-available schools was sorted in a random order using the Excel 2003 data analysis random number generator and entered into the minimisation routine in ascending order using the factors specified above. Subsequent schools were assigned to an intervention arm using rct_minim in the order that they joined the trial and provided 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 schools will be randomly allocated to receive the intervention or the control condition.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample size is 1600 participants. This calculation was based on detecting an effect size of 0.20, which is similar to that obtained in prior school-based depression intervention programs. Power was set at 0.8, a = 0.05 (two-tailed) and correlation of 0.5 assumed between baseline and endpoint scores. To allow for possible clustering effects, a design effect was calculated assuming an Intra-Class Correlation (ICC) of 0.02 and an average school size of 300 students. This estimate was derived from previous Australian school-based studies. The estimated sample size also accommodates for a 20% attrition rate based on previous school-based trials. To achieve the desired sample size, 16 schools will be selected for study inclusion, based on approximately 100 participating students per school.

Data will be collected using the Black Dog Institute e-health platform. Participant data will then be exported to SPSS statistical software for analyses. Statistical analyses will be performed using SPSS 21.0 (SPSS Inc., Chicago, Il, USA). The outcome measures will be analysed using mixed modelling with intention to treat. This type of analysis will determine any significant differences in the scores reported at time 1 (baseline) and at time 2 (6-week) and time 3 (12-week post). The primary hypothesis will be evaluated by differences in pre and post scores on help-seeking questionnaires, with secondary hypotheses relating to depression, anxiety, and distress symptoms.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/02/2018
Date of last participant enrolment
Anticipated
Actual
5/04/2018
Date of last data collection
Anticipated
Actual
29/06/2018
Sample size
Target
1600
Accrual to date
Final
1802
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23735 0
2722 - Gundagai
Recruitment postcode(s) [2] 23736 0
2193 - Canterbury
Recruitment postcode(s) [3] 23737 0
2131 - Ashfield
Recruitment postcode(s) [4] 23738 0
2558 - Eagle Vale
Recruitment postcode(s) [5] 23739 0
2151 - North Parramatta
Recruitment postcode(s) [6] 23740 0
2327 - Kurri Kurri
Recruitment postcode(s) [7] 23741 0
2036 - Chifley
Recruitment postcode(s) [8] 23742 0
2289 - Adamstown
Recruitment postcode(s) [9] 23743 0
2528 - Warilla
Recruitment postcode(s) [10] 23744 0
2452 - Toormina
Recruitment postcode(s) [11] 23745 0
2360 - Inverell
Recruitment postcode(s) [12] 23746 0
2227 - Gymea
Recruitment postcode(s) [13] 23747 0
2170 - Casula
Recruitment postcode(s) [14] 23748 0
2264 - Morisset
Recruitment postcode(s) [15] 23749 0
2533 - Kiama
Recruitment postcode(s) [16] 23750 0
2284 - Booragul
Recruitment postcode(s) [17] 23751 0
2502 - Warrawong
Recruitment postcode(s) [18] 23752 0
2292 - Broadmeadow
Recruitment postcode(s) [19] 23753 0
2567 - Narellan
Recruitment postcode(s) [20] 23754 0
2750 - Emu Plains
Recruitment postcode(s) [21] 23756 0
2033 - Kensington
Recruitment postcode(s) [22] 23757 0
2214 - Milperra

Funding & Sponsors
Funding source category [1] 300437 0
Commercial sector/Industry
Name [1] 300437 0
HSBC Bank Australia
Country [1] 300437 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Black Dog Institute
Address
Hospital Road, Prince of Wales Hospital, Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 299902 0
None
Name [1] 299902 0
Address [1] 299902 0
Country [1] 299902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301239 0
University of New South Wales Human Research Ethics (UNSW HREC)
Ethics committee address [1] 301239 0
Ethics committee country [1] 301239 0
Australia
Date submitted for ethics approval [1] 301239 0
18/10/2017
Approval date [1] 301239 0
24/11/2017
Ethics approval number [1] 301239 0
HC17910

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3023 3023 0 0
/AnzctrAttachments/375821(v23-08-2018-10-58-11)-UNSW Approval - NOV 2017.Pdf (Ethics approval)
Attachments [2] 3024 3024 0 0
/AnzctrAttachments/375821-SERAP_2016471_Approved_Letter.pdf (Ethics approval)
Attachments [3] 3025 3025 0 0
/AnzctrAttachments/375821-Maitland Diocese Approval Letter.pdf (Ethics approval)
Attachments [4] 3026 3026 0 0
/AnzctrAttachments/375821-SCS Approval Letter 2018.pdf (Ethics approval)
Attachments [5] 3027 3027 0 0
/AnzctrAttachments/375821(v23-08-2018-11-00-53)-Phase 3 Clinical Trial Protocol_Final.pdf (Protocol)
Attachments [6] 3028 3028 0 0
/AnzctrAttachments/375821-Appendix G_Student PICF_Intervention (V.4 updated 19.02.2018).pdf (Participant information/consent)
Attachments [7] 3029 3029 0 0
/AnzctrAttachments/375821-Appendix H_Student PICF_Control (V.4 updated 19.02.2018).pdf (Participant information/consent)
Attachments [8] 3034 3034 0 0
/AnzctrAttachments/375821(v23-08-2018-11-31-02)-Appendix I_School Counsellors PICF (V.2 updated 12.12.2017).pdf (Participant information/consent)
Attachments [9] 3035 3035 0 0
/AnzctrAttachments/375821(v23-08-2018-11-31-37)-Appendix S_ Catholic_Parent & Student PICF Intervention.pdf (Participant information/consent)
Attachments [10] 3036 3036 0 0
/AnzctrAttachments/375821(v23-08-2018-11-32-22)-Appendix T_ Catholic_Parent & Student PICF Control.pdf (Participant information/consent)
Attachments [11] 3037 3037 0 0
/AnzctrAttachments/375821(v23-08-2018-11-32-50)-Appendix M - Gillick Competency Test_RCT.pdf (Supplementary information)

Contacts
Principal investigator
Name 86342 0
Dr Bridianne O'Dea
Address 86342 0
Black Dog Institute
Hospital Rd, Prince of Wales Hospital,
Randwick, NSW 2031
Country 86342 0
Australia
Phone 86342 0
+61 2 9382 8509
Fax 86342 0
Email 86342 0
b.odea@blackdog.org.au
Contact person for public queries
Name 86343 0
Bridianne O'Dea
Address 86343 0
Black Dog Institute
Hospital Rd, Prince of Wales Hospital,
Randwick, NSW 2031
Country 86343 0
Australia
Phone 86343 0
+61 2 9382 8509
Fax 86343 0
Email 86343 0
b.odea@blackdog.org.au
Contact person for scientific queries
Name 86344 0
Bridianne O'Dea
Address 86344 0
Black Dog Institute
Hospital Rd, Prince of Wales Hospital,
Randwick, NSW 2031
Country 86344 0
Australia
Phone 86344 0
+61 2 9382 8509
Fax 86344 0
Email 86344 0
b.odea@blackdog.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA cluster randomised controlled trial of a web-based youth mental health service in Australian schools.2021https://dx.doi.org/10.1016/j.lanwpc.2021.100178
N.B. These documents automatically identified may not have been verified by the study sponsor.