Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000169347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/10/2025
Date registered
Help: Date registered
10/02/2026
Date last updated
Help: Date last updated
28/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/02/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A peer-supported recovery planning program to help young people experiencing early psychosis build confidence, skills, and self-management
Scientific title
A hybrid II implementation-effectiveness randomised controlled trial of a peer supported self-management intervention “My Personal REcovery Plan” (MyPREP-ED) for young people in Early Psychosis Services
Additional trial identifiers [1] 316194 0
MYPREP-ED
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Schizophrenia 339136 0
Schizophrenia-related Disorders 339137 0
Early Psychosis 339138 0
Condition category
Condition code
Mental Health 335420 335420 0 0
Schizophrenia
Mental Health 335421 335421 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Our research team has used a co-production and co-design approach to translate the CORE Study self-management resources (now called My Personal REcovery Plan for Early Psychosis Service Discharge [MyPREP-ED]) from the United Kingdom to an Australian youth Early Intervention in Psychosis Service (EIPS) context. This has included the adaptation of both paper-based and digital resources for use by peer coaches supporting young people transitioning out of EIPS.

Over a 12-week period, trained peer coaches from the participating EIPS site will support individuals accessing the service to work through the MyPREP-ED intervention. MyPREP-ED consists of a series of self-management modules, each combining psychoeducation and structured activities. Participants may choose which modules to complete based on their personal needs and preferences.

MyPREP-ED Modules and Content

Introduction to the tool and peer worker
Introduces the purpose of MyPREP-ED, outlines how peer support works, and establishes shared expectations, goals, and boundaries for the sessions.

Recovery (connectedness, hope, identity, meaning, empowerment)
Explores personal understandings of recovery, focusing on strengths, values, identity beyond illness, and what a meaningful life looks like for the participant.

Psychoeducation
Provides accessible information about mental health, early psychosis, recovery, and common experiences following discharge, tailored to the participant’s interests and level of understanding.

Relapse strategies
Supports participants to identify early warning signs, triggers, and protective factors, and to develop personalised strategies to manage setbacks.

Crisis planning
Guides participants in creating a simple, practical plan outlining what helps during times of distress, who to contact, and preferred supports.

Wellness planning
Focuses on maintaining wellbeing through routines, self-care strategies, social supports, and activities that support mental health.

Goal setting
Assists participants to identify short- and medium-term goals related to education, employment, relationships, health, or personal development, and to break these into achievable steps.

Links to tools and resources
Connects participants with relevant community, digital, and service-based supports that align with their goals and needs.

EIPS graduation / closure
Supports reflection on the transition out of EIPS, consolidates learning from the program, and reinforces confidence in ongoing self-management and help-seeking.

Delivery Format and Duration

The MyPREP-ED intervention is flexibly delivered based on participant preference, including:

Which modules are completed, depending on relevance to the participant

Mode of delivery, including digital tools, paper-based materials, verbal discussion, or a combination

Format of sessions, including face-to-face, telephone, digital conferencing platforms, or mixed formats

Frequency and timing, with sessions scheduled at mutually agreed times

Sessions are typically held approximately weekly, for up to 10 sessions.

Each session is expected to last approximately 30 minutes,

Sessions may extend to up to 60 minutes where clinically appropriate or preferred by the participant.

Participants may engage with individual modules across one or more sessions depending on their needs.

Use of Digital and Paper-Based Tools

Participants in the intervention arm who wish to use the interactive digital support tools will be supported by their peer coach to log in and navigate the platform. Participants may access and use the digital tool as often as they wish during the intervention period.

If participants prefer not to use paper-based or digital materials, the intervention will be delivered through verbal discussion facilitated by the peer coach across the scheduled sessions.

Participants will be considered to have received the intervention according to protocol if they complete at least three sessions with their peer coach.

At the conclusion of each session, the peer worker will record session delivery and tool use with the study research team.

Co-designed Consent e-Resources

As part of the study, we are also trialling co-designed electronic resources to support informed consent. This tool uses natural language processing to transform complex medical information into simple text, images, audio, or video formats.

The prototype has been developed by the trial investigator team in collaboration with TechLab (Faculty of Information Technology, University of Sydney) as part of the broader co-design of the MyPREP-ED intervention.

Regulatory Clarification

MyPREP-ED is a non-clinical self-management support tool delivered with peer coach support to assist young people transitioning out of EIPS at discharge. It is not intended to diagnose, prevent, monitor, or treat medical conditions and does not replace clinical care.

The intervention consists of educational materials, guided reflection exercises, and structured peer support, designed to complement usual care. Safety concerns are managed through established clinical pathways.

MyPREP-ED does not involve automated decision-making, physiological monitoring, or clinical-grade assessments and does not meet the criteria for a medical device under regulatory definitions. The intervention is an adapted youth version of the original adult My-PREP tool, which was previously confirmed by SLHD HREC and RGO not to be a medical device and did not require a CTN.
Intervention code [1] 332158 0
Prevention
Description of the comparator or control
CONTROL CONDITION: USUAL CARE

Participants allocated to the control condition will receive usual care provided by staff within the participating Early Intervention in Psychosis Service (EIPS).

For the purposes of this study, usual care is defined as the standard, routinely available clinical and psychosocial supports offered by the EIPS as part of normal service delivery. This may include, but is not limited to:

Ongoing case management by clinical staff

Psychiatric review and medication management, where indicated

Psychological and psychosocial interventions as clinically appropriate

Support with discharge planning and referral to community services

Access to multidisciplinary team support in line with service protocols

As part of usual care, some service users may have access to peer support or peer workers where this is routinely available within the service. However, participants in the control condition will not receive the structured MyPREP-ED self-management intervention
Control group
Active

Outcomes
Primary outcome [1] 342995 0
mental health-related recovery
Timepoint [1] 342995 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Primary outcome [2] 342996 0
feasibility
Timepoint [2] 342996 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [1] 453055 0
Acceptability of intervention
Timepoint [1] 453055 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [2] 453056 0
Appropriateness of intervention
Timepoint [2] 453056 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [3] 453057 0
System usability
Timepoint [3] 453057 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [4] 453058 0
Adoption, engagement (composite)
Timepoint [4] 453058 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [5] 453059 0
Sustainability & scalability (composite)
Timepoint [5] 453059 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [6] 453060 0
Economic evaluation
Timepoint [6] 453060 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [7] 453061 0
Health care resource use
Timepoint [7] 453061 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [8] 453062 0
Health literacy
Timepoint [8] 453062 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [9] 453064 0
Qualitative process evaluation
Timepoint [9] 453064 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [10] 453066 0
Self-management skills / activation (composite)
Timepoint [10] 453066 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [11] 453071 0
Social inclusion
Timepoint [11] 453071 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [12] 453072 0
Service satisfaction
Timepoint [12] 453072 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [13] 453073 0
Health status / physical & mental component (composite)
Timepoint [13] 453073 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [14] 453074 0
Psychological distress
Timepoint [14] 453074 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [15] 453075 0
Social and occupational functioning (SOFAS) (this will be assessed as a composite outcome)
Timepoint [15] 453075 0
Baseline, Post-intervention (3 months post-baseline), Follow up (9 months post-baseline)
Secondary outcome [16] 453076 0
Self-reported change in medication
Timepoint [16] 453076 0
Follow up (9 months post-baseline)
Secondary outcome [17] 456055 0
My life tracker (MLT-5)
Timepoint [17] 456055 0
Follow up (9 months post-baseline)

Eligibility
Key inclusion criteria
Group 1 – Service Users

Aged 16 years and older

On the caseload of a participating Early Intervention in Psychosis Service (EIPS) for First Episode Psychosis or Ultra-high risk support

Within 6 months of discharge from the EIPS

Group 2 - Staff

Adult aged 18 years of age and older

Staff of participating Early Psychosis Intervention Services who deliver or support the intervention

Group 3 – Parent or Guardians

Adults aged 18 years of age and older

This refers to parent or guardian who have been invited by the participant to be present and assist with the research process. They may also provide proxy consent on behalf of the participant if the participant wishes them to do so. This authority is specific to participation in this study and does not extend to general service provision or other decision-making areas. The participant has chosen to have their parent or guardian representative involved in this capacity, ensuring that their preferences and needs are respected throughout the research process.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Group 1 – Service Users

People who, in the view of the clinical/treating team, lack capacity to consent to take part in the study.

People who, in the view of the mental health team, present such a high risk of harm to others, or it would be unsafe for researchers or a support worker to meet with them even in a mental health service setting

People who cannot understand the intervention when delivered in English

Group 2 – Staff

None

Group 3 – Parent or Guardian

No verbal or CNF authorisation to act on behalf of the person they represent. All participants will be informed when scheduling that they can invite a representative if they are unable to provide informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is at the central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
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
1/10/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2028
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 320129 0
Government body
Name [1] 320129 0
Australian Department of Health, Disability and Ageing, Medical Research Future Fund (MRFF) - Clinician Researchers Initiative - 2023 Clinician Researchers: Applied Research in Health Grant
Country [1] 320129 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 322691 0
None
Name [1] 322691 0
Address [1] 322691 0
Country [1] 322691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318676 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 318676 0
Ethics committee country [1] 318676 0
Australia
Date submitted for ethics approval [1] 318676 0
18/03/2025
Approval date [1] 318676 0
15/05/2025
Ethics approval number [1] 318676 0
2025/ETH00610

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

Contacts
Principal investigator
Name 144898 0
A/Prof Alyssa Milton
Address 144898 0
The University of Sydney, Professor Marie Bashir Centre, 67-73 Missenden Road, CAMPERDOWN NSW 2050
Country 144898 0
Australia
Phone 144898 0
+61 2 9515 1593
Fax 144898 0
Email 144898 0
[email protected]
Contact person for public queries
Name 144899 0
Alyssa Milton
Address 144899 0
The University of Sydney, Professor Marie Bashir Centre, 67-73 Missenden Road, CAMPERDOWN NSW 2050
Country 144899 0
Australia
Phone 144899 0
+61 2 9515 1593
Fax 144899 0
Email 144899 0
[email protected]
Contact person for scientific queries
Name 144900 0
Alyssa Milton
Address 144900 0
The University of Sydney, Professor Marie Bashir Centre, 67-73 Missenden Road, CAMPERDOWN NSW 2050
Country 144900 0
Australia
Phone 144900 0
+61 2 9515 1593
Fax 144900 0
Email 144900 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Statistical analysis plan    MyPREP-ED SAP_FINAL2_Signed_2-12-2025.pdf


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Statistical analysis planNo MyPREP-ED SAP_FINAL2_Signed_2-12-2025.pdf

Documents added automatically
No additional documents have been identified.