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Trial registered on ANZCTR


Registration number
ACTRN12620000241932p
Ethics application status
Not yet submitted
Date submitted
16/01/2020
Date registered
26/02/2020
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Study protocol: It takes a village: Development and testing of 'Village' a communication application for young people who are experiencing low mood and suicidal ideation to obtain real-time support from a network of family and friends
Scientific title
Assessing the acceptability of Village - a communication app for supporting young people with low mood and suicidal ideation
Secondary ID [1] 300140 0
Nil
Universal Trial Number (UTN)
U1111-1245-7131
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicide
315865 0
Condition category
Condition code
Mental Health 314149 314149 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Village is an innovative communication application (app) co-designed with young people and families/whanau that aims to help young people obtain regular and timely support from a network of ‘buddies’ (family/whanau or peers) who are in turn educated and supported via information modules within the app to respond appropriately. The app is independently used without external therapist support. Young people will be encouraged to complete a daily 'check in' regarding their mood (quick mood rating using a sliding scale) and they will be encouraged to identify and use a range of self-management strategies about which they will be educated while using the app (within a self-help module). They will also be contacted by their buddies on a daily-weekly basis, so that they can let them know how they are doing and what help they need. Buddies are educated in how to respond to young people using a combination of validation and appropriately supportive messages. They are also provided with additional education about wellbeing, self-harm and common mental health issues such as anxiety and depression. The app consists of modules for mood rating, communication with buddies and education about common mental health problems, self-help strategies and communication strategies (the last one being for buddies only). Education modules were developed by an experienced child psychiatrist and modified during co-design sessions with a range of young people and adults.

The app will be downloaded onto participants' smartphones and used in a therapist- unsupported manner by them as many times as they wish over a 4 week period (no specific frequency). If concerning messages (regarding risk/suicidal ideation) within the app are detected by inbuilt AI software, participants may be contacted by a real-life telephone support service (Youthline). Frequency, duration and components of app use will be evaluated via app analytics at the end of the trial.

Link to explainer video: https://www.youtube.com/watch?v=hokq9F3ecYs

Intervention code [1] 316556 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322534 0
Acceptability of VIllage app with young people and support people (buddies) using qaulitative interviews and the uMARS scale
Timepoint [1] 322534 0
4 weeks following the start of the intervention
Secondary outcome [1] 378853 0
Change in level of suicidal ideation measured via the SIQ-JR scale
Timepoint [1] 378853 0
4 and 12 weeks following start of intervention
Secondary outcome [2] 378854 0
Change in level of depression measured via the PHQ-A scale
Timepoint [2] 378854 0
4 and 12 weeks following start of intervention
Secondary outcome [3] 378855 0
Change in level of functioning measured using the CAFAS scale
Timepoint [3] 378855 0
4 and 12 weeks following start of intervention

Eligibility
Key inclusion criteria
Participants will include 20 young people aged 13-18 years of any gender who have presented to acute or community mental health services with suicidal ideation (frequent or with a plan), a suicide attempt or both within the past 4 weeks. Eligible participants will have access to an iPhone or an-droid mobile telephone, reside in the ADHB catchment area (i.e. Auckland), be undertaking any kind of routine care (including psychotherapy and medication), speak adequate English and be able to provide informed consent.
Minimum age
13 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who do not meet all the inclusion criteria will be excluded.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Quantitative data from questionnaires will be analysed using Microsoft Excel and SPSS (Statistical Package for Social Sciences). Analyses will include basic descriptive statistics (e.g. changes in scores on validated scales, demo-graphic characteristics of the sample and aspects of app use). Pai-red t Tests and McNemar’s chi-square tests will be used to assess the statistical significance of changes in scores over time. A p-value of <0.05 will be taken to indicate statistical significance and 95% confidence intervals will be used to establish the extent of any difference between pre and post measures.

Qualitative data from semi-structured interviews will be analysed using Braun and Clarke’s method of thematic analysis (REF) with collated text being analysed to identify emerging themes, 30% being cross-coded by a second researcher and consensus reached by adjudication.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22234 0
New Zealand
State/province [1] 22234 0
Auckland

Funding & Sponsors
Funding source category [1] 304576 0
Charities/Societies/Foundations
Name [1] 304576 0
Starship Foundation
Address [1] 304576 0
Level 15 Support Block, Auckland Hospital, 2 Park Road, Grafton, Auckland 1142, New Zealand
Country [1] 304576 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Starship Foundation
Address
Level 15 Support Block, Auckland Hospital, 2 Park Road, Grafton, Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 305022 0
None
Name [1] 305022 0
Address [1] 305022 0
Country [1] 305022 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305002 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 305002 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
New Zealand
Ethics committee country [1] 305002 0
New Zealand
Date submitted for ethics approval [1] 305002 0
15/02/2020
Approval date [1] 305002 0
Ethics approval number [1] 305002 0

Summary
Brief summary
Vilage is a communication app that is designed to help young people experiencing suicidal ideation receive support from a small network of up to 5 'buddies' that are selected from their family/friends. These buddies will be able to check in on the young peope and they will be provided with help to effectively communicate with the young people.

Study hypotheses are as follows:
1. Village is acceptable to its intended audience (both young people and buddies)
2. Village helps to reduce levels of mental distress, rates of self-harm and rates of hospital presentations in young people using the app

Ethics approval will be obtained from the Health and Disability Ethics Committee (HDEC) and lo-cality approval will be secured by the ADHB. Recruitment of participants will be carried out in con-sultation with health professionals at Starship Children’s Hospital and ADHB community mental health services to ensure the young people and their families are able to participate, and supported throughout the type and phase of illness. Both young people and at least one support person per young person will be enrolled so that qualitative data can be collected from both types of users of the app. Paired parental consent and individual assent will be obtained for participants under 16 years of age. All participants will be free to withdraw from the study at any stage. Regardless of the duration of their involvement, all enrolled young people and support people will be offered $20 as koha for their participation
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 98926 0
Dr Hiran Thabrew
Address 98926 0
Department of Psychological Medicine, University of Auckland
Level 12 Support Block
Auckland Hospital
2 Park Road
Grafton
Auckland 1142
New Zealand
Country 98926 0
New Zealand
Phone 98926 0
+64 21402055
Fax 98926 0
Email 98926 0
h.thabrew@auckland.ac.nz
Contact person for public queries
Name 98927 0
Dr Hiran Thabrew
Address 98927 0
Department of Psychological Medicine, University of Auckland
Level 12 Support Block
Auckland Hospital
2 Park Road
Grafton
Auckland 1142
New Zealand
Country 98927 0
New Zealand
Phone 98927 0
+64 21402055
Fax 98927 0
Email 98927 0
h.thabrew@auckland.ac.nz
Contact person for scientific queries
Name 98928 0
Dr Hiran Thabrew
Address 98928 0
Department of Psychological Medicine, University of Auckland
Level 12 Support Block
Auckland Hospital
2 Park Road
Grafton
Auckland 1142
New Zealand
Country 98928 0
New Zealand
Phone 98928 0
+64 21402055
Fax 98928 0
Email 98928 0
h.thabrew@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not in study protocol. No resourcing available to provide this facility.
What supporting documents are/will be available?
No other documents available
Summary results
No Results