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Trial registered on ANZCTR


Registration number
ACTRN12616001207404
Ethics application status
Approved
Date submitted
3/08/2016
Date registered
1/09/2016
Date last updated
28/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Spanish version of the Mental Health eClinic (MHeC-S) an e-health system for improving the mental health and wellbeing of Spanish-speaking young people based in Australia
Scientific title
Evaluating the Spanish version of the Mental Health eClinic (MHeC-S) an e-health system for improving the mental health and wellbeing of Spanish-speaking young people based in Australia
Secondary ID [1] 289707 0
X16-0193
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health
 299521 0
General health and wellbeing 299522 0
Condition category
Condition code
Mental Health 299500 299500 0 0
Depression
Mental Health 299704 299704 0 0
Anxiety
Public Health 299705 299705 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Spanish version of the Mental Health Clinic (MHeC-S) is currently comprised of five essential elements:
1. Landing page and triage system to ensure young people with high distress access urgent care immediately and appropriately
2. Comprehensive online self-report assessment.
3. A detailed dashboard of results
4. Booking system to make timely appointments with health professionals attached to MHeC and,
5. Video-visit to allow for short structured interviews. This element also allows the health
professional to suggest relevant apps and etools (including UBWELL) to the young person as a means to improve their symptoms as well as track their progress over time. The length of each video visit (online interview) will be approximately 15 minutes. Interviews in which participants disclose suicidal ideation will require more time in order to provide a safety plan and emergency contact numbers as per duty of care. These interviews will take approximately 25 minutes.

NATURALISTIC (CLINICAL TRIAL)
Potential participants will be screened for the study via the MHeC-S. On its landing page, participants can click the “GET STARTED” button. From here they are directed to a simple screening questionnaire, which confirms age (between 16 and 30 years), Spanish as native language, location currently based in Australia and then regular access to a smartphone (iPhone or Android) and the Internet. If potential participants meet all eligibility criteria, they are then redirected to the online Study Information Sheet and Participant Consent Form followed by “CREATE ACCOUNT (or enrolment)”
Participants will then complete a 45-minute self-reported assessment regarding their physical and mental health. On completion, the MHeC-S generates a comprehensive dashboard of results and recommends the user book a ‘video visit’ in the following days; in the meantime, a participant is encouraged to download and use UBWELL [UBWELL is an app developed by the Brain and Mind Centre, that allows users (participants) to track (or self-monitoring) their physical activity, sleep patterns, mood, energy, diet, weight and other behaviours. Participants can connect UBWELL with the MHeC-S, which displays their data on the MHeC-S dashboard. The participant would be invited to download the UBWELL app (currently available in the App Store and Google Play, free of charge), connect it to the MHeC-S platform and collect their data 4 times per day. This process is completely optional].
Participants will then have a ‘video visit’ with a native Spanish-speaking (research) child and adolescent psychiatrist , who will provide direct feedback about the participants’ results. Optionally, participants can book a second ‘video visit’ appointment where their progress, symptom reduction and share plan will be further assessed (and subsequent pathway to care established if so required).
At any time during the course of the study, if a participant is identified as being a significant risk of serious harm, they will automatically be provided with emergency service details as well as with specific advice as to how to access appropriate counselling, support or formal health care.

USER TESTING
One-on-one 90-minute user-testing sessions where young people/ supportive others and health professionals will be invited to test the MHeC-S using scenarios and lists of tasks.

FOCUS GROUPS
Finally a total of four (three-hour) focus groups will be conducted to explore SROI via Theory of Change (including inputs, activity, outputs, outcomes and impacts). Two focus groups will be conducted prior to the naturalistic (clinical trial) evaluation of the MHeC-S – one with young people/ supportive others and one with health professionals; and two focus groups will be conducted post the naturalistic (clinical trial) evaluation of the MHeC-S – one with young people/ supportive others and one with health professionals. The user testing sessions will run throughout the duration of the trial, as they are independent of the intervention (clinical trial) and focus groups.

It’s important to clarify that there are three types of research activity – focus group (pre and post trial), clinical trial and user testing. Invitation to participate in a research activity is as follows:
FOCUS GROUPS
Pre – trial: All participants (young people, health professionals and supportive others) will be invited to the pre-trial focus group.

Post – trial: Only young people who have participated in the clinical trial or user testing will be invited to the post – trial group. All of these young people would have used the online system and therefore can offer views/opinions about the system.

NATURALISTIC (CLINICAL TRIAL)
Young people will have the option of participating in the clinical trial or the user testing, but not both.

USER TESTING
Young people (who have not participated in the clinical trial), health professionals and supportive others will be invited to the user testing sessions.
Intervention code [1] 295334 0
Treatment: Other
Intervention code [2] 295521 0
Lifestyle
Intervention code [3] 295522 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298980 0
Percentage (%) change in item measuring general health and wellbeing: “How would you rate your overall health?” (five-point Likert scale response ‘very bad’ to ‘very good’).
Timepoint [1] 298980 0
Baseline (or Day 1) and Day 30
Primary outcome [2] 298981 0
Percentage (%) change in item measuring overall mental health: “How would you rate your overall mental health?” (five-point Likert scale response ‘very bad’ to ‘very good’).
Timepoint [2] 298981 0
Baseline (or Day 1) and Day 30
Primary outcome [3] 298982 0
Mean score on item measuring overall rating of the system: “What is your overall (star) rating of the Spanish version of the Mental Health eClinic?” (‘1’ [One of the worst tools I’ve used] to ‘5’ [One of the best tools] I've used star rating).
Timepoint [3] 298982 0
Day 30 only
Secondary outcome [1] 325812 0
Percentage (%) change over time as measured on analytics including on measures of mental health: 10-item Kessler Psychological Distress Scale (K-10)
Timepoint [1] 325812 0
Baseline (or Day 1) and Day 30
Secondary outcome [2] 325813 0
Mean system usability score as measured by the System Usability Scale (five-point Likert scale response ‘strongly disagree’ to ‘strongly agree’).
Timepoint [2] 325813 0
Day 30 only
Secondary outcome [3] 325814 0
Google Analytics
1. The number of participants.
2. Geographical location (postcode) of participant’s IP address.
3. The average number of page views per participant – a high number would indicate that the
average participants go deep inside the site, possibly because they like it or find it useful.
4. Average visit duration – the total length of a participant’s visit.
5. Average page duration – how long a page is viewed for.
6. Busy times – the most popular viewing time of the site.
7. Most requested pages – the most popular pages.
8. Most requested entry pages – the entry page is the first page viewed by a visitor and shows
which are the pages most attracting visitors.
9. Most requested exit pages – the most requested exit pages could help find bad pages or the
exit pages may have a popular external link.
10. Top paths – a path is the sequence of pages viewed by visitors from entry to exit, with the
top paths identifying the way most visitors go through the site.
Timepoint [3] 325814 0
Day 30
Secondary outcome [4] 325815 0
Social Return on Investment analysis. SROI analysis is conducted by determining value using financial proxies to estimate the social value of non-traded goods, arriving at an estimate of the total social value created by an intervention.
Timepoint [4] 325815 0
End of focus groups
Secondary outcome [5] 325816 0
Composite secondary outcome: User testing qualitative analysis regarding the general usability of the MHeC-S (via scenarios); and, quantitative analysis of the Single Ease Question (SEQ) after performing a list of tasks.
Each one-on-one 90-minute user testing session will be facilitated using a facilitator’s guide. The participant’s reactions and comments to each task will be transcribed during the user testing session. The content of the user testing sessions will be analysed using Nvivo. The results form the SEQ will be analysed with simple descriptive statistics.
Timepoint [5] 325816 0
End of User (acceptance) testing sessions
Secondary outcome [6] 327318 0
Percentage (%) change over time as measured on analytics including on measures of mental health: Suicidal Behaviours Questionnaire—Revised (SBQ-R)
Timepoint [6] 327318 0
Day 1 (baseline) and day 30
Secondary outcome [7] 327319 0
Percentage (%) change over time as measured on analytics including on measures of mental health: Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR16)
Timepoint [7] 327319 0
Baseline (or Day 1) and Day 30

Eligibility
Key inclusion criteria
Young people:
Each participant must meet all of the following criteria to be enrolled in the study:
*Aged 16 to 30 years old;
*Spanish as a first language and currently based in Australia;
*Regular access to a smartphone (iPhone or Android) and the Internet; and,
*Willingness to give online informed consent and willingness to comply with study protocol.

Health professionals and supportive others should have experience in mental health.
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Due to the naturalistic research design, this study does not have defined exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
NATURALISTIC (CLINICAL TRIAL)
Utilising a naturalistic research design, the MHeC-S will be evaluated by using a range of descriptive and multivariate statistical analyses, which will essentially look at baseline vs post-test outcomes; and, where combinations of influential variables are identified, regression analyses will be used to identify the unique variance associated with different factors.
The naturalistic (clinical trial) evaluation allows engagement to be analysed by interrogating Google Analytics; efficacy by assessing baseline vs post health outcomes; and effectiveness by a combination of engagement and efficacy as well as participants assessment of the actual system (including design and technology).
A total of 100 naturalistic (clinical trial) evaluation participants which is ample given calculations predict a total of 68 participants based on a medium effect size (d=0.4) for two groups, an alpha level of 0.05 and 90% power for a repeated measures MANOVA design as well as accounting for an anticipated attrition rate of 30%.

USER TESTING
The one-on-one 90-minute user-testing sessions will aim to recruit 10 young people/ supportive others and five health professionals. A qualitative analysis of their scenario observations will be performed as well as a quantitative analysis assessing the difficulty of the list of tasks performed.
A total sample of 15 user testing participants is considered adequate to reach the level of saturation

SROI FOCUS GROUPS
The focus groups exploring SROI will aim to recruit 10 young people/ supportive others and five health professionals. A qualitative analysis of SROI via Theory of Change will be conducted (as well as a quantitative economic analysis including inputs, activity, outputs, outcomes and impacts).
A total sample of 30 focus group participants is considered enough to reach the required in qualitative research.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/09/2016
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 9132 0
Colombia
State/province [1] 9132 0

Funding & Sponsors
Funding source category [1] 294088 0
University
Name [1] 294088 0
The University of Sydney
Country [1] 294088 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Brain and Mind Centre
100 Mallett Street
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 293053 0
None
Name [1] 293053 0
Address [1] 293053 0
Country [1] 293053 0
Other collaborator category [1] 279667 0
University
Name [1] 279667 0
University Autonoma of Bucaramanga
Address [1] 279667 0
Avenida 42 No. 48 – 11, Bucaramanga - Colombia.
Country [1] 279667 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295504 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 295504 0
Research Integrity & Ethics Administration Research Portfolio
Level 2, Margaret Telfer Building (K07) The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 295504 0
Australia
Date submitted for ethics approval [1] 295504 0
22/03/2016
Approval date [1] 295504 0
30/06/2016
Ethics approval number [1] 295504 0
2016/487

Summary
Brief summary
Synergy-enabled Spanish version of the Mental Health eClinic is a real-time primary care online clinic that offers young people immediate self-report assessment, as well as timely support and programs, via a ‘video-visit’ with a health professional that results in a share plan. By using the Internet, this online clinic aims to deliver best practice clinical services to native Spanish-speaking young people (aged 16 to 30 years) currently living in Australia.
Primary objective: To naturalistically evaluate (engagement, efficacy and effectiveness) the MHeC-S.
Secondary objectives: To inform the beta build of the MHeC-S (which in turn informs the original version of the MHeC); and, to evaluate social return on investment (SROI) of the MHeC-S.

The study design includes three parts:
1. The naturalistic (clinical trial) evaluation wherein potential participants (n=100 young people aged 16 to 30 years; native Spanish speakers currently living in Australia; with regular access to a smartphone [iPhone or Android] and the Internet) will be given access to the MHeC-S to use of their own accord for a period of up to 30 days. Participants are then able to navigate the online clinic at their own accord, naturally engaging with the self-report assessment, dashboard of results, ‘video visit’ and recommended apps, etools and other resources. At two time points (Day 1 and Day 30) participants will be asked to complete a pre/post- questionnaire using LimeSurvey – this questionnaire will include items regarding engagement with, efficacy and effectiveness of, the MHeC-S.


2. One-on-one 90-minute user-testing sessions where young people/ supportive others and health professionals will be invited to test the MHeC-S using scenarios and lists of tasks. (n= 15)
3. A total of four (three-hour) focus groups will be conducted to explore SROI via Theory of Change (including inputs, activity, outputs, outcomes and impacts). Two focus groups will be conducted prior to the naturalistic (clinical trial) evaluation of the MHeC-S – one with young people/ supportive others and one with health professionals; and two focus groups will be conducted post the naturalistic (clinical trial) evaluation of the MHeC-S – one with young people/ supportive others and one with health professionals. (n= 15)
Trial website
TBC
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67514 0
Prof Ian Hickie
Address 67514 0
Brain and Mind Centre
The University of Sydney
Building F, Level 4
94 Mallett Street
Camperdown NSW 2050
Country 67514 0
Australia
Phone 67514 0
+61 2 9351 0810
Fax 67514 0
Email 67514 0
[email protected]
Contact person for public queries
Name 67515 0
Laura Ospina Pinillos
Address 67515 0
Brain and Mind Centre The University of Sydney Building G, Shops 1-3, 66-70 Parramatta Road. Camperdown NSW 2050
Country 67515 0
Australia
Phone 67515 0
+61 28 627 6946
Fax 67515 0
Email 67515 0
[email protected]
Contact person for scientific queries
Name 67516 0
Ms Tracey Davenport
Address 67516 0
Brain and Mind Centre The University of Sydney Building G, Shops 1-3, 66-70 Parramatta Road. Camperdown NSW 2050
Country 67516 0
Australia
Phone 67516 0
+61 2 9114 4220
Fax 67516 0
Email 67516 0
[email protected]

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

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