Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001453178
Ethics application status
Approved
Date submitted
5/09/2019
Date registered
21/10/2019
Date last updated
21/10/2019
Date data sharing statement initially provided
21/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
tune.in: evaluation of an app to support adolescents with managing behavioural change.
Scientific title
tune.in: evaluation of an app to support adolescents with managing behavioural change.
Secondary ID [1] 299189 0
None
Universal Trial Number (UTN)
U1111-1238-0479
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 314288 0
Anxiety 314289 0
Substance use 314290 0
Condition category
Condition code
Mental Health 312639 312639 0 0
Addiction
Mental Health 312640 312640 0 0
Depression
Mental Health 312641 312641 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open, single arm trial aiming to test an app (tune.in) that has been co-designed with young people to support young people to make positive behavioural changes (i.e. goal attainment and emotional management).

The tune.in app is an interactive app designed to support emotional and behavioural management in young people. Tune.in achieves this by facilitating goal attainment via reminders and rewards. Goals can be chosen from a variety of options preloaded into the tune.in app and which young people will then be coached to breakdown into “daily tasks” - specific behavioural strategies and activities that will help them achieve their ultimate goal. Tune.in sends a daily notification to the young person to remind them to engage in their “daily task” and on successful completion the young person will be rewarded with a song selected by a New Zealand celebrity and an encouraging message explaining how the song may inspire them to feel, think and act positively.

Young people are able to use the tune.in app in conjunction with a health professional such as a mental health clinician. Goal planning is a key part of most psychological treatments and support, thus “goals” and “daily tasks” may be collaboratively decided upon and reviewed by the young person and health professionals in their sessions.

The tune.in app used co-design sessions with young people to ensure that the final version of the app would appeal and be helpful to young people, services uses, health professionals and the Maori and Pasifika community.

For this evaluation, the treatment period will be approximately four weeks.

The app is based on goal setting; young people pick their overall goal (journey), the strategy they will use to achieve that goal, including the specific activity they will do as part of that strategy. The only information provided is about phone lines that they can call for support, and they can enter the number of their own support person into that list

The app utilises important behaviour change elements of action planning and intentions. It enhances the opportunity for behaviour change by providing notifications each day (reminders) of the planned activity (steps) that the young person has chosen to help them achieve their goal. The app being highly customisable (young people choose their own goal and steps to achieve their goal). the app gives rewards for goal achievement in the form of songs young people can add to their play list that are accompanied by a message of encouragement from leading NZ artists, promoting a sense of connection to others who may have had similar experiences. Gamification to encourage and sustain behaviour change is provided via unlockable content (the next song on the playlist) that also includes an element of randomness via the name of the next song to be unlocked being hidden until is unlocked. The app is designed so that the support person of the young person (school counsellor, clinician etc…) can help the young person set up their goals etc…in the context of the therapeutic relationship they already have, and can check in regularly with how the young person is going with the app in their regular sessions

Examples of journeys/goals are: Looking after myself; Accepting myself; Getting a job;
Reduce substance use; Using substances safely; Managing my feelings; Reducing self-harm;
Getting better marks; Planning my future; Keeping relationships.

Choose the steps you will take – the things you choose to do (and how often you will do it).
Get active
1) Go to the gym
2) Jog or walk
3) Go cycling or mtbiking
4) play a team sport
5) Get into/onto the water
6) Do yoga/pilates
7) Do chores/housework
8) Go dancing
9) Get outside and muck about
10) Do another activity

Self care
Appreciate myself
Do something I love
Pamper myself
Do something creative
Practice mindfulness
Practice acceptance
Do the opposite
Turn off social media
Enjoy time out for myself
Be positive to myself

Get connected
Talk to someone
Hang out with people
Contact my supports
Connect with Whanau / friends
Join a team or group
Try something new
Explore/discover my culture
Cut conflict and arguments
Contribute and help others
Connect to my community

Sleep better
Stick to the same bed time
Avoid napping in the day
Decrease screen time
Reduce caffeine
Keep bed as a 'sleepzone'
Set an alarm and get up
Do some exercise
Turn off my phone
Practice steady breathing
Jot down worries

Party safe
Drink / use more slowly
Avoid driving
Be safe with sex
Plan ahead
Food and hydration
Stay with friends
Avoid mixing
Know what I'm taking
Use an alarm
Call it quits

Be calm
Practice steading breathing
Watch TV or movies or read
Listen to positive music
Talk to someone
Tap into culture or spirituality
Practice relaxation
Be with Whanau or family
Take a bath or shower
Do something creative
Be with nature and the land

Get sorted
Talk to my teacher
Write a list of things to do
Look for a job
Volunteer
Plan my time
Have a study plan
Problem solve
Keep up to date with study
Put my screen aside
Get more sleep

Cut down on substance use
Delay my use
See my non-using friends
Monitor my use
Avoid triggers to using
Plan alternative activities
Let cravings pass
Go to a meeting
Use less
Save or spend money
Contact my supports

Be present
Engage my senses
Do something I love
Practice gratitude
Do something creative
Take time out alone
Schedule a quiet moment
Fully enjoy the present
Eat something delicious
Read quietly or out loud
Turn off my phone

Manage distress
Wait it (urge/distress) out
Contact my support people
Change my environment
Hang with positive people
Do intense physical exercise
Listen to music
Write about it
Do alternative actions
Be mindful of my triggers
Be accepting

There is no correspondance between clinician/support person and the young person via the app. The apps designed to be set up/customised by the young person according to what goal they want to set and the steps they want to take to achieve that goal. However, we are instructing support people to scaffold/support young people in this process and to check in with the young person at their regular sessions about how their app usage is going. The clinician can check the ‘activity log’ in the app, if the young person choses to show them this – this records achievement of steps.

The young person spend up to ten minutes with their clinician/support person, in their regular session talking about their app usage during the week and showing the clinician/support person their activity log. There is no prescribed frequency or duration of sessions with a clinician/support person but we have suggested that for the period of time the young person is using the app (4 weeks) that there is a weekly check in.

We are asking clinicians/support people to check in with the young person, preferably in their regular sessions, once a week about app usage.
Intervention code [1] 315483 0
Behaviour
Intervention code [2] 315484 0
Lifestyle
Intervention code [3] 315485 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321292 0
Data regarding participant usage collected passively by the tune.in app via the HABITs IT platform (setting and achieving 1 goal)
Timepoint [1] 321292 0
Collected at 4 weeks and 8 weeks after being given access to the app.
Primary outcome [2] 321293 0
PHQ-ADS combined scales assessing depression
Timepoint [2] 321293 0
Baseline & 4 weeks (post intervention) and 8 weeks (follow-up)
Secondary outcome [1] 374541 0
WHO (Five) Wellbeing Index
Timepoint [1] 374541 0
Baseline & 4 weeks (post intervention) and 8 weeks (follow-up)
Secondary outcome [2] 374542 0
SACS alcohol and drug use measure - a composite measure of alcohol and drug use
Timepoint [2] 374542 0
Baseline & 4 weeks (post intervention) and 8 weeks (follow-up)
Secondary outcome [3] 374543 0
App rating scale designed for this study
Timepoint [3] 374543 0
Baseline & 4 weeks (post intervention)
Secondary outcome [4] 374544 0
Clinician feedback using a questionnaire designed for this study
Timepoint [4] 374544 0
4 weeks (post intervention)

Eligibility
Key inclusion criteria
Young people will be included if:
• They are 12-25 years of age (on the day of consent);
• They have been identified by a health professional as potentially benefitting from app-based support for improving their wellbeing, learning strategies to regulate their feelings, and making positive behaviour change;
• They have access to a smart phone, tablet or Chromebook that is able to run tune.in.
will be included if:
• They are 12-25 years of age (on the day of consent);
• They have been identified by a health professional as potentially benefitting from app-based support for improving their wellbeing, learning strategies to regulate their feelings, and making positive behaviour change;
• They have access to a smart phone, tablet or Chromebook that is able to run tune.in.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if:
• They are unable to sufficiently understand the nature of study involvement or to provide online informed consent;
• They have, in the judgement of the referring health practitioner, an acute risk of harm to themselves requiring urgent intervention (i.e. suicidal ideation with a current plan and intent to enact this plan) or a level of emotional distress or current situation that warrants weekly risk monitoring.
• Parental consent is not obtained if aged 12-15 years of age.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No sequence generation required
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
Sample size and power
We plan to include up to 120 young people in the open trial. Power calculations are not deemed necessary due to the main research question being related to feasibility and usability of the app rather than efficacy.
Statistical methods
Baseline data will be summarised using standard descriptive statistics including means, medians, ranges and standard deviations and frequencies and percentages, as appropriate.
Descriptive summaries including means, medians, ranges and standard deviations and frequencies and percentages will be used to describe app usage behaviour and responses provided in the app rating scale. These descriptive summaries include the number of times the app is accessed, the average time spent on each module and in each level within the module.
Descriptive data, including means and standard deviations, will be used to describe responses to the wellbeing measures. Changes over time will be estimated by calculating effect sizes for the Likert scales and wellbeing measures.
The app rating and usage data will be summarised for the all those completing these scales and additionally will be summarised for Maori/Pasifika and non-Maori, non-Pasifika participants and compared between these two groups. These comparisons will be made using non-parametric Mann-Whitney-U tests and chi-square tests, as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/10/2019
Actual
Date of last participant enrolment
Anticipated
1/03/2020
Actual
Date of last data collection
Anticipated
26/04/2020
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 21835 0
New Zealand
State/province [1] 21835 0
North Island

Funding & Sponsors
Funding source category [1] 303728 0
Government body
Name [1] 303728 0
The Ministry of Business, Innovation and Employment
Country [1] 303728 0
New Zealand
Funding source category [2] 303730 0
Charities/Societies/Foundations
Name [2] 303730 0
The Auckland Medical Research Foundation
Country [2] 303730 0
New Zealand
Funding source category [3] 303731 0
Charities/Societies/Foundations
Name [3] 303731 0
Cure Kids.
Country [3] 303731 0
New Zealand
Primary sponsor type
Hospital
Name
The University of Auckland
Address
The Research Office
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 303847 0
None
Name [1] 303847 0
None
Address [1] 303847 0
None
Country [1] 303847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304253 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 304253 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
New Zealand
Ethics committee country [1] 304253 0
New Zealand
Date submitted for ethics approval [1] 304253 0
Approval date [1] 304253 0
05/09/2019
Ethics approval number [1] 304253 0

Summary
Brief summary
This is an open trial aiming to test an app designed to support young people to make positive behavioural changes (i.e. goal attainment and emotional management). We will assess how well young people engage with the app, its acceptability to young people, and its potential efficacy.
Participant referral via school counsellors or mental health services is designed to maximise recruitment, particularly for Maori and Pasifika young people. The enrolment process will be the same for all volunteers and all study procedures will be carried out online to time reduce burden. Participants will provide informed consent, eligibility screening and complete baseline assessments electronically.
Participants will be included in the study if they are twelve to twenty-five years old at the time of consent/assent, have been identified by a health professional as potentially benefiting from the proposed app, and have access to a smart phone that can run the proposed app.
Participants will be excluded if they are not able to sufficiently understand the nature of study involvement or can provide online informed consent; if they are at an acute risk of harm or distress, or parental consent is not obtained for participants aged twelve to fifteen years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96298 0
A/Prof Sarah Hetrick
Address 96298 0
The Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
85 Park Road
Grafton 1142
Auckland
New Zealand
Country 96298 0
New Zealand
Phone 96298 0
+64 211733878
Fax 96298 0
Email 96298 0
[email protected]
Contact person for public queries
Name 96299 0
A/Prof Sarah Hetrick
Address 96299 0
The Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
85 Park Road
Grafton 1142
Auckland
New Zealand
Country 96299 0
New Zealand
Phone 96299 0
+64 211733878
Fax 96299 0
Email 96299 0
[email protected]
Contact person for scientific queries
Name 96300 0
A/Prof Sarah Hetrick
Address 96300 0
The Department of Psychological Medicine
Faculty of Medical and health Scriences
The University of Auckland
85 Park Road
Grafton 1142
Auckland
New Zealand
Country 96300 0
New Zealand
Phone 96300 0
+64 211733878
Fax 96300 0
Email 96300 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
We are currently assessing engagement and acceptability. IPD data will be shared when we test the app in a RCT.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4554Study protocol  [email protected]
4555Informed consent form  [email protected]
4556Clinical study report  [email protected]
4557Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.