Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000377134
Ethics application status
Approved
Date submitted
27/02/2019
Date registered
11/03/2019
Date last updated
3/11/2020
Date data sharing statement initially provided
11/03/2019
Date results provided
5/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of a youth mobile help-seeking ToolKit
Scientific title
Evaluation of the effectiveness of a youth mobile help-seeking ToolKit
A Randomised Controlled Trial, Testing the Efficacy of the ToolKit app on the mental health and wellbeing of young Australians.
Secondary ID [1] 297554 0
nil
Universal Trial Number (UTN)
Trial acronym
KHLTKRCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
'Anxiety' 311777 0
'Depression' 311978 0
'Distress' 311979 0
'Wellbeing' 311980 0
Condition category
Condition code
Mental Health 310390 310390 0 0
Anxiety
Mental Health 310391 310391 0 0
Depression
Mental Health 310392 310392 0 0
Other mental health disorders
Mental Health 310393 310393 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project investigates the effectiveness, acceptability and usability of a newly developed Toolkit "Niggle" app in conjunction with the Kids Helpline (KHL) services treatment as usual (TAU) compared to TAU in young people accessing KHL services.

The Toolkit encompasses support and intervention in five steps.
Step 1: Users are invited to reflect on their current mental and physical condition and to select up to three problems (called "Niggles" within the app) they are currently dealing with. This step aims to promote self-reflection and to offer mood- and problem-tracking over time.
Step 2: Users are provided with support information (tip sheets, videos, audios-podcasts, health apps and personal stories from previous KHL clients. The Tipsheets and Health apps are also available on the Kids Helpline website - https://kidshelpline.com.au/ The Podcasts, and Videos are only available through the app. The Personal stories presented in the app have been modified from the version appearing on the website to be more concise and associated with specific issues.
Step 3: Upon choosing the sources that are most relevant to their 'niggle', an automated customised Kids Helpline-specific activities list is proposed allowing users to schedule activities to deal with their 'niggle'. Those activities are only available within the app and not on the Kids Helpline website. They include issue-specific actions such as "Write a list of our strengths"; "Ask someone you trust how they cope with setbacks"; "Call the Police in an emergency if you or someone is getting hurt"; "Write down a list of people you feel safe around", etc.
Step 4: Users are invited to regularly track their activities, as compared to issues/moods logs. Visual feedback provides users with the opportunity to verify which activities are associated with the least amount of issues and the most positive moods. Users are invited to submit their own recovery story aiming to promote reflection and peer-support.
Step 5: The app offers four validated mental health scales for symptom tracking of Depression, Anxiety, Resilience and Wellbeing.

Issues including suicidality, severe depression and anxiety trigger a warning message stating “It sounds like you’re having a really tough time. We think it would be a good idea for you to chat to a counsellor” promoting contact with Kids Helpline Services (telephone/chat/email) or emergency hotline 000 for high-risk issues.

Participants allocated to the app condition will use the app as often as they choose to for three months and will complete follow-up assessment measures monthly (1, 2 and 3 months post Baseline)
They will receive automated SMS messages to remind them to use the app 7, 14 and 21 days after recruitment.
Automatic 'Backend' app usage data capture is implemented which will capture each individual's app use. The backend data will include time of app access, screens viewed, moods logged, support resources viewed, activities scheduled, activities completed, etc.
Intervention code [1] 313790 0
Treatment: Other
Intervention code [2] 313791 0
Lifestyle
Comparator / control treatment
Kids Helpline Counselling Treatment as Usual, provided via telephone, email or online chat.
Participants who are referred to the trial and randomly allocated to the control condition will continue to use Kids Helpline's services on a needs basis. The Participant Information and Consent Form also contains Kids Helpline's contact details, allowing access to support for all participants,
Through an automatically-generated 'welcome email' participants are also provided with contact details for Kids Helpline, as well as other mental health and crisis support organisations, such as Lifeline.
Control group
Active

Outcomes
Primary outcome [1] 319275 0
Depression symptom severity, measured using the Patient Health Questionnaire (PHQ-9)
Timepoint [1] 319275 0
Baseline, 1 month (primary endpoint), 2 months, 3 months
Primary outcome [2] 319277 0
Anxiety severity, measured using the Generalized Anxiety Disorder scale (GAD-7)
Timepoint [2] 319277 0
Baseline, 1 month (primary endpoint), 2 months, 3 months
Primary outcome [3] 319278 0
Psychological Distress, measured using the Kessler Psychological Distress Scale (K-10)
Timepoint [3] 319278 0
Baseline, 1 month (primary endpoint), 2 months, 3 months
Secondary outcome [1] 367538 0
General functioning, measures using the Multidimensional Adolescent Functioning Scale (MAFS)
Timepoint [1] 367538 0
Baseline, 1 month, 2 months, 3 months
Secondary outcome [2] 367544 0
Wellbeing using the brief 14-item version of the Mental Health Continuum – Short Form (MHC-SF)
Timepoint [2] 367544 0
Baseline, 1 month, 2 months, 3 months
Secondary outcome [3] 367546 0
Behavioural activation using the 9-item short form of the Behavioural Activation for Depression Scale (BADS-SF)
Timepoint [3] 367546 0
Baseline, 1 month, 2 months, 3 months
Secondary outcome [4] 367548 0
Self-efficacy using The General Self-Efficacy Scale (GSE)
Timepoint [4] 367548 0
Baseline, 1 month, 2 months, 3 months
Secondary outcome [5] 367549 0
Situational Coping using the 26-item Brief (COPE) scale
Timepoint [5] 367549 0
Baseline, 1 month, 2 months, 3 months
Secondary outcome [6] 367550 0
Health related quality of life, measured using the 5 level version of EuroQoL (EQ-5D-5L)
Timepoint [6] 367550 0
Baseline, 1 month, 2 months, 3 months

Eligibility
Key inclusion criteria
1. aged 13-25,
2. accessing Kids Helpline telephone- or web-services for support.
Minimum age
13 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insufficient English language fluency

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)
The chief investigators, follow-up assessors and trial statistician will be blind to treatment group allocation, and any violations of blindness will be recorded.
Allocation concealment will be achieved as central randomisation will be done by a automated computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The assessment will use a secure, automated web-based project and data management system for RCTs. The computerized random number sequence program installed in the system, incorporates random permuted blocks allocating participants to (i) KHL TAU or (ii) KHL TAU + ToolKit app. Stratification will be by gender, age (16 – 20 years, 21 – 25 years) and previous KHL service use. The randomization sequence concealed within the secure website, allocate automatically and released when full eligibility criteria is met.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:

Previous similar trials, testing the efficacy of new eHealth interventions, conducted by this research team comprise of samples of young people between 150 and 280 participants.
To measure a small to moderate effect size of f=.20, alpha (a) set at 0.025 and power set at 0.95, we would require 173 participants per group. We predict a 20% attrition rate at 3 months based on previous work and will therefore need to randomize a total of 380 participants.


Analysis:

Preliminary one-way analyses of variance and Chi-square analyses will be undertaken to check for baseline group differences on demographic, primary and secondary outcomes and diagnostic status. To determine whether there are group differences on the primary and secondary outcome measures at 1, 2, and 3 months a series of mixed effects model repeated measures analyses of variance (MMRM) will be employed. The within groups factor will be time (baseline, 1, 2, 3 months) and group will be the between subjects factor. This technique can also control for potential confounds (e.g. frequency of service use) and identify moderators (e.g., age, gender, Connor-Davidson Resilience Scale 25, General Self-Efficacy Scale, Situational Coping) of treatment outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/03/2019
Date of last participant enrolment
Anticipated
31/05/2019
Actual
23/05/2019
Date of last data collection
Anticipated
31/08/2019
Actual
31/08/2019
Sample size
Target
380
Accrual to date
Final
702
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 302107 0
Government body
Name [1] 302107 0
Australian Research Council
Country [1] 302107 0
Australia
Funding source category [2] 302114 0
Charities/Societies/Foundations
Name [2] 302114 0
Yourtown - Kids Helpline
Country [2] 302114 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George St,
Brisbane City
QLD 4000
Australia
Country
Australia
Secondary sponsor category [1] 301946 0
None
Name [1] 301946 0
Address [1] 301946 0
Country [1] 301946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302786 0
Queensland University of Technology (QUT) Human Research Ethics Committee (UHREC)
Ethics committee address [1] 302786 0
Ethics committee country [1] 302786 0
Australia
Date submitted for ethics approval [1] 302786 0
12/11/2018
Approval date [1] 302786 0
03/12/2018
Ethics approval number [1] 302786 0
1800001096

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

Contacts
Principal investigator
Name 91398 0
Mr Stoyan Stoyanov
Address 91398 0
Queensland University of Technology
Gardens Point D Block, Level 5, Room D 505
2 George Street,
Brisbane, QLD 4000
Country 91398 0
Australia
Phone 91398 0
+61 7 3138 0316
Fax 91398 0
Email 91398 0
[email protected]
Contact person for public queries
Name 91399 0
Stoyan Stoyanov
Address 91399 0
Queensland University of Technology
Gardens Point D Block, Level 5, Room D 505
2 George Street,
Brisbane, QLD 4000
Country 91399 0
Australia
Phone 91399 0
+61 7 3138 0316
Fax 91399 0
Email 91399 0
[email protected]
Contact person for scientific queries
Name 91400 0
Stoyan Stoyanov
Address 91400 0
Queensland University of Technology
Gardens Point D Block, Level 5, Room D 505
2 George Street,
Brisbane, QLD 4000
Country 91400 0
Australia
Phone 91400 0
+61 7 3138 0316
Fax 91400 0
Email 91400 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.