Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000914369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
23/06/2026
Date registered
Help: Date registered
24/07/2026
Date last updated
Help: Date last updated
13/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot of a novel co-produced supported and shared decision-making model relating to medication for early psychosis (Choices)
Scientific title
Pilot of a novel co-produced supported and shared decision-making model relating to medication for early psychosis (Choices)
Additional trial identifiers [1] 317068 0
ORY-P16-26-06
Additional trial identifiers [2] 317069 0
MRF2045630
Universal Trial Number (UTN)
Trial acronym
Choices
Related trial records

Health condition
Health condition(s) studied:
Psychosis 341589 0
Condition category
Condition code
Mental Health 337658 337658 0 0
Psychosis and personality disorders
Public Health 337659 337659 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study will be conducted at two headspace Early Psychosis program sites (Bentleigh and Narre Warren), which are governed by Bayside Health (Alfred Care Group) in Victoria, Australia. Participants will be young people, aged 12-25, who have been diagnosed with a psychotic disorder and are currently receiving mental health treatment at headspace. This is a cluster randomised pilot randomised controlled trial. This means that sites (not participants) will be randomised to the intervention groups.

The aim of this study is to evaluate the acceptability, feasibility, and possible effectiveness of a supported and shared decision-making model related to decisions about medication in early psychosis care (i.e., the Choices model). Decisions may relate to commencing medication, changing medication (dose or type), and safely reducing or discontinuing medication. The Choices model will be compared to standard care (control). We will recruit 56 people into this study (i.e., 28 participants in each group). Participants in both groups will receive the 16 core components of the Australian early psychosis treatment model (EPPIC) as part of standard care. Participants in Choices will also have access to essential decision-support tools, such as patient decision aids, advance statements, nominated person forms, and structured frameworks for eliciting values and preferences (which are expected to be used less frequently in standard care). The Choices protocol will not dictate the exact type of treatment that young people will receive in their group. This will remain a clinical decision. However, there is an expectation that young people in Choices will receive treatment that is more closely aligned with shared/supported decision making principles (including access to specific decision-making tools) than participants in standard care (e.g., young people will be explained the benefits and harms of each treatment including not taking medication, they will know they can seek advice from trusted others to help them decide about treatment, they will know they can nominate another person to help them make decisions if they become unwell and be given options to do so, etc.). Clinicians who are based at the site allocated to Choices will receive training in shared/supported decision making prior to recruitment of the first participant, with the model to be supported by senior management at that site. We expect that most participants will attend headspace face-to-face every 1-2 weeks, but frequency of clinical contacts and the format (face-to-face vs telehealth) will remain a decision for the young person and their treating team. The Choices model will be delivered to participants over 12-months by their clinical team at headspace Early Psychosis during standard consultation sessions at headspace. Fidelity to the model will be evaluated throughout the trial using a study-specific fidelity tool.

This trial will also explore the acceptability and feasibility of implementation strategies trialled in this study (e.g., proposed clinician training model) as well as facilitators and barriers to the delivery of Choices in the real-world as part of an exploratory implementation study. These objectives will be explored using a semi-structured qualitative interview with key stakeholders (e.g., young people, caregivers, clinicians, service leaders), which will be led by approved interview guides. Qualitative interviews will be audio-recorded and may take up to 90 minutes to complete. This component of the trial is optional and will involve a separate consent process.
Intervention code [1] 333826 0
Treatment: Other
Description of the comparator or control
The Choices model will be compared to a control group receiving standard care. The headspace Early Psychosis Program delivers the 16 core components of the EPPIC model of care. Clients (and their families) work with a specialist case manager and psychiatrist who develop an individual treatment plan and provide support throughout the episode of care. The service provides peer support, family and vocational workers who work with young people and families to achieve their goals. MAT teams also provide assessment, community outreach and crisis support after hours.
Control group
Active

Outcomes
Primary outcome [1] 345145 0
Primary feasibility. The primary feasibility outcome will be the proportion of consented participants who complete the study protocol. This is defined as the number of people completing the baseline and primary endpoint (12-month) assessments with complete usable data and receiving the allocated intervention.
Timepoint [1] 345145 0
Four-months, eight-months and 12-months post-commencement of the intervention (deemed to have started once the baseline assessment is complete).
Secondary outcome [1] 460622 0
Acceptability of Choices
Timepoint [1] 460622 0
12-months post-commencement of the intervention.
Secondary outcome [2] 460623 0
Self-efficacy
Timepoint [2] 460623 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [3] 460624 0
Basic Psychological Need Satisfaction
Timepoint [3] 460624 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [4] 460625 0
Antipsychotic Side-Effects
Timepoint [4] 460625 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [5] 460626 0
Quality of Life
Timepoint [5] 460626 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [6] 460627 0
Productivity
Timepoint [6] 460627 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [7] 460628 0
Perceived involvement in shared decision-making
Timepoint [7] 460628 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [8] 460629 0
Decisional Conflict
Timepoint [8] 460629 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [9] 460630 0
Participant experience related to medication use
Timepoint [9] 460630 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [10] 460631 0
Working Alliance
Timepoint [10] 460631 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [11] 460632 0
Illness Identity
Timepoint [11] 460632 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [12] 460633 0
Medication Adherence
Timepoint [12] 460633 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [13] 460639 0
Clinical/psychotic symptoms
Timepoint [13] 460639 0
Baseline and 12-months post-commencement of the intervention.
Secondary outcome [14] 460640 0
Social and role functioning
Timepoint [14] 460640 0
Baseline and 12-months post-commencement of the intervention.
Secondary outcome [15] 460641 0
Quality of life
Timepoint [15] 460641 0
Baseline, four-months, eight-months and 12-months post-commencement of the intervention.
Secondary outcome [16] 460642 0
Acceptability of the implementation strategies used in this trial.
Timepoint [16] 460642 0
Interviews will occur throughout the duration of the study. We expect that 6-10 people from each stakeholder group will be required. Clinicians will complete the survey after completing training.
Secondary outcome [17] 464055 0
Feasibility of the implementation strategies used in this trial.
Timepoint [17] 464055 0
Interviews will occur throughout the duration of the study. We expect that 6-10 people from each stakeholder group will be required. Clinicians will complete the survey after completing training.
Secondary outcome [18] 464056 0
Completion of advance statements (part of secondary feasibility)
Timepoint [18] 464056 0
Baseline, four-months, eight-months, and 12-months post-commencement of the intervention.
Secondary outcome [19] 464057 0
Use and number of medical reviews (part of secondary feasibility). This will be assessed as a composite outcome.
Timepoint [19] 464057 0
Baseline, four-months, eight-months, and 12-months post-commencement of the intervention.
Secondary outcome [20] 464058 0
Medication use and medication decisions (part of secondary feasibility). This will be assessed as a composite outcome.
Timepoint [20] 464058 0
Baseline, four-months, eight-months, and 12-months post-commencement of the intervention.
Secondary outcome [21] 464059 0
Consent rate (part of secondary feasibility)
Timepoint [21] 464059 0
Baseline, four-months, eight-months, and 12-months post-commencement of the intervention.
Secondary outcome [22] 464060 0
Emergency psychiatry service contacts (part of health economic outcomes)
Timepoint [22] 464060 0
Baseline, four-months, eight-months, and 12-months post-commencement of the intervention.
Secondary outcome [23] 464061 0
External mental health resources use
Timepoint [23] 464061 0
Twelve months post-commencement of the intervention.
Secondary outcome [24] 465258 0
Completion of nominated person forms (part of secondary feasibility)
Timepoint [24] 465258 0
Baseline, four-months, eight-months, and 12-months post-commencement of the intervention.
Secondary outcome [25] 465259 0
Use and number of case management appointments (part of secondary feasibility).
Timepoint [25] 465259 0
Baseline, four-months, eight-months, and 12-months post-commencement of the intervention.
Secondary outcome [26] 465260 0
Refusal/withdrawal rate (part of secondary feasibility)
Timepoint [26] 465260 0
Baseline, four-months, eight-months, and 12-months post-commencement of the intervention.

Eligibility
Key inclusion criteria
Participants are eligible for the study if they are:
1. Aged between 12 and 25 years inclusive,
2. Receiving treatment from one of two Alfred headspace Early Psychosis sites (sites to be chosen from five potential locations: Bentleigh, Narre Warren, Frankston, Dandenong, and Elsternwick).
3. Diagnosed with a current (or past) psychotic disorder (as verified by a treating psychiatrist),
4. Able to provide informed consent.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants are ineligible for the study if they are participating in another clinical trial or discharge from their treatment service is planned in the next nine months. People with comorbid conditions such as substance use, affective, or neurodevelopmental conditions will not be excluded from this study.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table determined by the study statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 321656 0
Government body
Name [1] 321656 0
Department of Health, Disability and Ageing - Medical Research Future Fund (MRFF), 2025 Clinical Trials Activity Grant (Steam 1, incubator).
Country [1] 321656 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen
Address
Country
Australia
Secondary sponsor category [1] 324478 0
None
Name [1] 324478 0
Address [1] 324478 0
Country [1] 324478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320190 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 320190 0
Ethics committee country [1] 320190 0
Australia
Date submitted for ethics approval [1] 320190 0
10/04/2026
Approval date [1] 320190 0
20/07/2026
Ethics approval number [1] 320190 0
124759

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

Contacts
Principal investigator
Name 149714 0
Prof Kelly Allott
Address 149714 0
Orygen, 35 Poplar Road, Parkville, Victoria, 3052
Country 149714 0
Australia
Phone 149714 0
+61 407365600
Fax 149714 0
Email 149714 0
[email protected]
Contact person for public queries
Name 149715 0
Kelly Allott
Address 149715 0
Orygen, 35 Poplar Road, Parkville, Victoria, 3052
Country 149715 0
Australia
Phone 149715 0
+61 407365600
Fax 149715 0
Email 149715 0
[email protected]
Contact person for scientific queries
Name 149716 0
Kelly Allott
Address 149716 0
Orygen, 35 Poplar Road, Parkville, Victoria, 3052
Country 149716 0
Australia
Phone 149716 0
+61 407365600
Fax 149716 0
Email 149716 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data will include sensitive/personal health information obtained from young people (including minors) who have lived experience of mental illness.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected]
Ethical approval  [email protected] When approved.


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.