Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001982202
Ethics application status
Approved
Date submitted
3/12/2018
Date registered
10/12/2018
Date last updated
15/09/2021
Date data sharing statement initially provided
10/12/2018
Date results provided
15/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
WeClick: Evaluating a mobile app to improve young people's relationships
Scientific title
WeClick: Evaluating a mobile app to improve young people's relationships
Secondary ID [1] 296768 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 310658 0
Anxiety 310660 0
Psychological Distress 310661 0
Condition category
Condition code
Mental Health 309367 309367 0 0
Depression
Mental Health 309414 309414 0 0
Anxiety
Mental Health 309415 309415 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
WeClick is a mobile app developed by researchers at the Black Dog Institute. The app is designed to reduce mental health problems associated with relationship issues. It is available on both iOS and Android operating devices and is based on the principles of Cognitive Behavioural Therapy. The app consists of four characters, each facing different relationship issues including family conflict, peer conflict, intimate relationships, as well as other adolescent issues including substance use, self-esteem, low mood, and anxiety. The user selects a character and then works through a series of interactive activities. The app is based on the social learning model which aims to teach the user skills by observing what occurs in others’ relationships. By completing each of the stories, the user builds their own character profile which outlines who they can turn to for help, what they can do to keep on top of things, how they would seek help, and what they do to stay calm. In the current study, participants are given 4 weeks access to the app. During this time, they are free to use the app at their discretion. Participants are notified to use the app weekly by an in-app reminder. App usage is measured by the start time and completion time of the stories within the app. This is recorded by the app and sent back to the Black Dog Institute e-health platform. From this, time spent on app will be calculated.
Intervention code [1] 313079 0
Treatment: Other
Comparator / control treatment
A 4-week wait-list control condition.
Control group
Active

Outcomes
Primary outcome [1] 308324 0
Depression: This will be measured by a change in total scores on the Patient Health Questionnaire-9 (PHQ-9) for Adolescents.
Timepoint [1] 308324 0
4-weeks post-randomisation
Secondary outcome [1] 354610 0
Psychological distress: This will be measured by a change in total scores on the Distress Questionnaire-5 (DQ5).
Timepoint [1] 354610 0
4-week post-randomisation and again at 3 months post completion of treatment.
Secondary outcome [2] 354737 0
Separation Anxiety: This will be measured by a change in total scores on the Separation Anxiety Disorder (SAD) subscale.
Timepoint [2] 354737 0
4-week post-randomisation and again at 3 months post completion of treatment.
Secondary outcome [3] 354738 0
Wellbeing: This will be measured by a change in total scores on the short-form of the Warwick Edinburgh Mental Wellbeing Scale.
Timepoint [3] 354738 0
4-week post-randomisation and again at 3 months post completion of treatment.
Secondary outcome [4] 354739 0
Help-seeking intentions: This will be measured by a change in total scores on the General Help-Seeking Questionnaire.
Timepoint [4] 354739 0
4-week post-randomisation and again at 3 months post completion of treatment.
Secondary outcome [5] 354740 0
Belongingness: This will be measured by a change in total scores on the Thwarted Belongingness Scale.
Timepoint [5] 354740 0
4-week post-randomisation and again at 3 months post completion of treatment.
Secondary outcome [6] 354741 0
Social Self-efficacy: This will be measured by a change in total scores on the Social Self-efficacy Scale.
Timepoint [6] 354741 0
4-week post-randomisation and again at 3 months post completion of treatment.
Secondary outcome [7] 354813 0
Generalized Anxiety: This will be measured by a change in total scores on the Spence Children's Anxiety Scale for Generalized Anxiety.
Timepoint [7] 354813 0
4-week post-randomisation and again at 3 months post completion of treatment.

Eligibility
Key inclusion criteria
This study targeted young people aged between 12 to 16 years who are living in Australia, fluent in English, have access to the Internet, have an active email address, and mobile phone access (iOS or Android). Participants are also required to provide their parents’ consent.
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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 Black Dog Institute e-health platform was used to randomly allocate participants to the treatment or control arm. Researchers were not involved in the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation was employed to ensure equal representation of gender and age was made across the two study arms. Stratification accounted for gender (male vs. female) and age (12-14 vs. 15-16 years).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
At 4-weeks post-test, participants in the control arm are given access to the intervention. Therefore, at the 3-month follow-up datapoint, all participants have had access to the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This trial is a pilot randomised controlled trial and was not powered to detect small effects on the primary outcome. Instead, the trial was calculated based on detecting an initial effect size of 0.50, which is similar to that obtained in prior youth relationship intervention programs on wellbeing, distress, and help-seeking. The statistical power level is set at 0.8, a=0.05 (two-tailed). Based on this, the minimum target sample size for this pilot trial is 166, with 83 participants in each arm. The estimated sample size accommodates for a 30% attrition rate based on previous Internet trials. In addition, because this trial is also designed to examine the feasibility and acceptability of this type of intervention among young people and their parents, recruitment into the trial will remain open for two months and we will accept all enrolments during this time. This will give a measure of the interest and engagement in this type of intervention.

Data is collected using the Black Dog Institute e-health platform. Data is downloaded into Microsoft Excel and exported to SPSS Version 22.0 (SPSS Inc., Chicago, Il, USA) for analysis. Primary analyses are undertaken on an intention to treat basis, including all participants randomised, regardless of treatment received. Effectiveness of the WeClick app will be established by a change on the PHQ-9 scale between baseline and 4-weeks using a mixed-effects model repeated-measures analysis. Similar models will be conducted to examine effects on the secondary outcomes, controlling for baseline scores where appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/10/2018
Date of last participant enrolment
Anticipated
19/12/2018
Actual
12/12/2018
Date of last data collection
Anticipated
26/04/2019
Actual
8/04/2019
Sample size
Target
166
Accrual to date
Final
196
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301347 0
Other
Name [1] 301347 0
Black Dog Institute
Country [1] 301347 0
Australia
Primary sponsor type
Other
Name
Black Dog Institute
Address
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 301016 0
None
Name [1] 301016 0
Address [1] 301016 0
Country [1] 301016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302086 0
University of New South Wales Human Research Ethics Commitee
Ethics committee address [1] 302086 0
Ethics committee country [1] 302086 0
Australia
Date submitted for ethics approval [1] 302086 0
18/06/2018
Approval date [1] 302086 0
05/07/2018
Ethics approval number [1] 302086 0
HC180460

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

Contacts
Principal investigator
Name 89074 0
Dr Bridianne O'Dea
Address 89074 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 89074 0
Australia
Phone 89074 0
+61 2 93828509
Fax 89074 0
Email 89074 0
[email protected]
Contact person for public queries
Name 89075 0
Bridianne O'Dea
Address 89075 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 89075 0
Australia
Phone 89075 0
+61 2 93828509
Fax 89075 0
Email 89075 0
[email protected]
Contact person for scientific queries
Name 89076 0
Bridianne O'Dea
Address 89076 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick, NSW, 2031
Country 89076 0
Australia
Phone 89076 0
+61 2 93828509
Fax 89076 0
Email 89076 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
Participants have not agreed to this condition in the current consent forms.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
592Ethical approval    376504-(Uploaded-03-12-2018-12-32-17)-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
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial of a relationship-focussed mobile phone application for improving adolescents' mental health.2020https://dx.doi.org/10.1111/jcpp.13294
N.B. These documents automatically identified may not have been verified by the study sponsor.