Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001261505
Ethics application status
Approved
Date submitted
24/03/2024
Date registered
16/10/2024
Date last updated
16/10/2024
Date data sharing statement initially provided
16/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Stay Strong App, Use of a Digital Wellbeing App with Indigenous People in Prison: A Randomized Controlled Trial
Scientific title
Efficacy of the Stay Strong App, a Digital Wellbeing App targeting Wellbeing, Empowerment and Psychological Distress in Indigenous People in Prison: A Randomized Controlled Trial
Secondary ID [1] 311669 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychological distress 333129 0
empowerment 335131 0
wellbeing 335132 0
Condition category
Condition code
Mental Health 329826 329826 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Stay Strong App (SSA) is a culturally safe intervention tool, developed to enhance the wellbeing and mental health of Aboriginal and Torres Strait Islander peoples. It is an Android app delivered in conjunction with a therapist on tablet pcs, with administration of the SSA taking approximately 60 minutes. Therapeutic adherence is supported through practitioner supervision and training.
The SSA is an 11-step intervention involving (1) the collection of demographics, (2) “people who keep me strong” or the identification of support people and the nature of their relationship, (3) strengths or factors that support client well-being, (4) worries or factors that reduce client well-being , (5) setting the client’s first goal for change, (6) setting the client’s second goal for change, (7) well-being tips, (8) tips to reduce substance use, (9) “my support” or a description of professional supports and contact details for use upon release from prison, (10) “client summary” or a review of client information provided across the previous 9 steps, and (11) the provision of a client card to the client.
Items relating to the Stay Strong Tree (steps 3 and 4) provide descriptive data on the strengths and worries that were identified in the SSA sessions. The tree is divided into a 4-root system, representative of the four aspects of a client’s life: (1) spiritual and cultural; (2) physical; (3) family, social, and emotional; and (4) mental and emotional aspects. Each root system is then divided into individual strength or worry items (strengths: 16, including 4 open items idiosyncratic to clients; worries: 16 items, including 2 open items idiosyncratic to clients; steps 3 and 4). These items in the SSA represent the key determinants of SEWB for Aboriginal and Torres Strait Islander people.
The primary aim of the project was to conduct a randomized controlled trial (RCT) within Queensland prisons to determine the feasibility and effectiveness of the SSA with Indigenous female and male prisoners. The project was conducted through the Indigenous Mental Health Intervention Program (IMHIP), a social and emotional wellbeing (SEWB) and mental health service for Aboriginal and Torres Strait Islander people in custody. The SSA was added to existing IMHIP services immediately after a baseline assessment or after a 3-month delay, and wellbeing, empowerment and psychological distress were assessed at Baseline, 3 and 6 months. Delivery of the SSA was facilitated in-person by Indigenous practitioners, requiring no prior computer literature of clients. Indigenous participants were recruited from three high-security Australian prisons from January 2017 to September 2019. The outcome measures assessed wellbeing (Warwick-Edinburgh Mental Wellbeing Scale, WWS), empowerment (Growth and Empowerment Measure, GEM, giving Total, EE14 and 12S scores) and psychological distress (Kessler Psychological Distress Scale, K10). Intention-to-treat effects on these outcomes were analysed using Linear Mixed Models.
Clients were provided with 2 copies of their client cards, one for use while in prison and one for their prison property, which would become available to them upon release from prison. Each client card had a summary of the SSA, including professional supports and contact details. The laminated cards were folded in a way that allowed clients to display their support network, or “people who help me are,” in their prison cells.
Intervention code [1] 328133 0
Prevention
Intervention code [2] 329492 0
Behaviour
Comparator / control treatment
The trial compared Immediate and three month Delayed use of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 337774 0
Wellbeing
Timepoint [1] 337774 0
Baseline, 3months and 6 months post-baseline
Primary outcome [2] 337775 0
Empowerment
Timepoint [2] 337775 0
Baseline, 3 months and 6 months post-baseline
Primary outcome [3] 337776 0
Psychological Distress
Timepoint [3] 337776 0
Baseline, 3 months and 6 months post-baseline
Secondary outcome [1] 439667 0
Change in number of strengths identified within app
Timepoint [1] 439667 0
Comparison between baseline, 3 months post-baseline and 6 months post-baseline
Secondary outcome [2] 439668 0
Change in number of worries identified within app
Timepoint [2] 439668 0
Comparison between baseline, 3 months post-baseline and 6 months post-baseline

Eligibility
Key inclusion criteria
All Aboriginal and Torres Strait Islander peoples in custody who were engaged with Indigenous Mental Health Intervention Program (IMHIP), who had the capacity to consent were invited by IMHIP staff to participate in the study. This invitation involved both a written and verbal explanation of the study and consent forms.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who caused safety concerns for staff

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation created by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Outcome measures were administered by IMHIP practitioners to all available participants at baseline, 3 months, and 6 months at the beginning of treatment sessions. The immediate intervention group had SSA sessions after each assessment, while the delayed group had sessions only at 3 and 6 months.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat effects on these outcomes were analysed using Linear Mixed Models.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study complete with retrospective trial registration for publication
Date of first participant enrolment
Anticipated
Actual
9/01/2017
Date of last participant enrolment
Anticipated
Actual
30/09/2019
Date of last data collection
Anticipated
Actual
31/03/2020
Sample size
Target
200
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315996 0
Government body
Name [1] 315996 0
Queensland Health
Country [1] 315996 0
Australia
Funding source category [2] 317393 0
Government body
Name [2] 317393 0
Queensland Corrective Services
Country [2] 317393 0
Australia
Funding source category [3] 317394 0
University
Name [3] 317394 0
University of Queensland
Country [3] 317394 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318145 0
Government body
Name [1] 318145 0
Queensland Health
Address [1] 318145 0
Country [1] 318145 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314821 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314821 0
Ethics committee country [1] 314821 0
Australia
Date submitted for ethics approval [1] 314821 0
06/08/2014
Approval date [1] 314821 0
04/03/2015
Ethics approval number [1] 314821 0
HREC/14/QTDD/65
Ethics committee name [2] 314975 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [2] 314975 0
Ethics committee country [2] 314975 0
Australia
Date submitted for ethics approval [2] 314975 0
06/08/2014
Approval date [2] 314975 0
10/03/2015
Ethics approval number [2] 314975 0
2015000360

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

Contacts
Principal investigator
Name 132830 0
Dr Elke Perdacher
Address 132830 0
Queensland Forensic Mental Health Service, GPO Box 8161, Brisbane Qld 4001
Country 132830 0
Australia
Phone 132830 0
+617 3837 5820
Fax 132830 0
Email 132830 0
elke.perdacher@health.qld.gov.au
Contact person for public queries
Name 132831 0
Elke Perdacher
Address 132831 0
Queensland Forensic Mental Health Service, GPO Box 8161, Brisbane Qld 4001
Country 132831 0
Australia
Phone 132831 0
+617 3837 5820
Fax 132831 0
Email 132831 0
elke.perdacher@health.qld.gov.au
Contact person for scientific queries
Name 132832 0
Elke Perdacher
Address 132832 0
Queensland Forensic Mental Health Service, GPO Box 8161, Brisbane Qld 4001
Country 132832 0
Australia
Phone 132832 0
+617 3837 5820
Fax 132832 0
Email 132832 0
elke.perdacher@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data not approved to be made available publicly


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.