Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000686606
Ethics application status
Approved
Date submitted
20/06/2014
Date registered
30/06/2014
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Using an app for suicide prevention amongst young Indigenous people: A randomised controlled trial
Scientific title
A randomised controlled trial to evaluate the effect of a self-managed acceptance and commitment therapy based app for Indigenous youths with suicidal ideation compared against wait list control.
Secondary ID [1] 284752 0
None
Universal Trial Number (UTN)
U1111-1158-2820
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 292120 0
Condition category
Condition code
Mental Health 292454 292454 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The self-paced tablet app is largely based on Acceptance and Commitment Therapy. It consists of several modules designed to help individuals become more aware of their unhelpful thoughts and behaviours and helps then identify guiding principles for their life. The time it takes to complete each module will differ for each person and is dependent on individual needs. Participants are given 6 weeks to complete the modules at their own pace. The app provides users with tools and strategies to better manage their emotions and helps them to set goals in order to move their life in valued directions. The app collects data on overall usage and time spent in each module.
Intervention code [1] 289543 0
Treatment: Devices
Intervention code [2] 289544 0
Behaviour
Intervention code [3] 289678 0
Prevention
Comparator / control treatment
A wait list control group will receive the same intervention 6 months after the intervention group completes the program.
Control group
Active

Outcomes
Primary outcome [1] 292318 0
Screening, baseline, 6 weeks, 6 months, 12 months.
Timepoint [1] 292318 0
Screening, baseline, 6 weeks, 6 months, 12 months, 24 months.
Primary outcome [2] 298227 0
Quick Inventory of Depressive Symptomatology- suicide intent and suicide plans questions
Timepoint [2] 298227 0
Screening, baseline, 6 weeks, 6 months, 12 months.
Secondary outcome [1] 308711 0
Depression symptoms as measured by Patient Health Questionnaire-9
Timepoint [1] 308711 0
Screening, baseline, 6 weeks, 6 months, 12 months.
Secondary outcome [2] 308762 0
Distress tolerance as measured by the Distress Tolerance Scale
Timepoint [2] 308762 0
Baseline, 6 weeks, 6 months
Secondary outcome [3] 308764 0
Perceived burdensomeness and thwarted belonging as measured by the Interpersonal Needs Questionnaire
Timepoint [3] 308764 0
Baseline, 12 months.
Secondary outcome [4] 308766 0
Help seeking as measured by the General Help Seeking Questionnaire
Timepoint [4] 308766 0
Screening, baseline, 6 weeks, 6 months, 12 months.
Secondary outcome [5] 323592 0
Resource Use Questionnaire
Timepoint [5] 323592 0
Baseline, 6 weeks, 6 months.
Secondary outcome [6] 323593 0
Assessment of Quality of Life
Timepoint [6] 323593 0
Screening, baseline, 6 weeks, 6 months, 12 months.

Eligibility
Key inclusion criteria
Participants must:

* Be at least 16 years of age
* Be a resident of Australia
* Be of Indigenous background
* Have the ability to navigate a basic app
* Give consent to take part in the trial
* Be willing to make contact with Suicide Call Back Service (SCBS).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not:

*Be actively suicidal
* Currently experiencing symptoms associated with a psychotic disorder such as schizophrenia

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2016
Actual
6/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
570
Accrual to date
350
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,WA

Funding & Sponsors
Funding source category [1] 289402 0
Government body
Name [1] 289402 0
National Health and Medical Research Council
Country [1] 289402 0
Australia
Primary sponsor type
University
Name
Black Dog Institute / University of New South Wales
Address
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 288084 0
None
Name [1] 288084 0
Address [1] 288084 0
Country [1] 288084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291162 0
University of New South Wales Human Research Ethics Committee (HREC)
Ethics committee address [1] 291162 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 291162 0
Australia
Date submitted for ethics approval [1] 291162 0
01/08/2014
Approval date [1] 291162 0
27/08/2014
Ethics approval number [1] 291162 0

Summary
Brief summary
This project aims to investigate whether a self-help interactive program delivered via tablet devices can help Indigenous youth to reduce their suicidal ideation. Participants will be randomly assigned to either the intervention group, which includes therapeutic activities grounded in acceptance and commitment therapy or a wait list control group. We predict those using the intervention program for 6 weeks will report reduced suicidal ideation, a reduction of reported suicide plans, and lower symptoms of depression, anxiety, hopelessness and impulsivity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49034 0
Dr Fiona Shand
Address 49034 0
Black Dog Institute
University of New South Wales
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 49034 0
Australia
Phone 49034 0
+61 2 9382 9291
Fax 49034 0
Email 49034 0
fionas@unsw.edu.au
Contact person for public queries
Name 49035 0
Dr Fiona Shand
Address 49035 0
Black Dog Institute
University of New South Wales
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 49035 0
Australia
Phone 49035 0
+61 2 9382 9291
Fax 49035 0
Email 49035 0
fionas@unsw.edu.au
Contact person for scientific queries
Name 49036 0
Dr Fiona Shand
Address 49036 0
Black Dog Institute
University of New South Wales
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 49036 0
Australia
Phone 49036 0
+61 2 9382 9291
Fax 49036 0
Email 49036 0
fionas@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be available however group level data will be published


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
SourceTitleYear of PublicationDOI
EmbaseThe iBobbly Aboriginal and Torres Strait Islander app project: Study protocol for a randomised controlled trial.2019https://dx.doi.org/10.1186/s13063-019-3262-2
N.B. These documents automatically identified may not have been verified by the study sponsor.