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
ACTRN12626001171303p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
25/08/2026
Date registered
Help: Date registered
21/09/2026
Date last updated
Help: Date last updated
21/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
21/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The Youth Service Integration Resource Kit Evaluation: Phase 2 Pilot Feasibility Randomised Control Trial (RCT) of headspace and Local Health District services.
Scientific title
The Youth Service Integration Resource Kit Evaluation: Phase 2 Pilot Feasibility Randomised Control Trial (RCT) of headspace and Local Health District services.
Additional trial identifiers [1] 318274 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Mental ill-Health 343368 0
Condition category
Condition code
Mental Health 339459 339459 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Resource Kit is a digital intervention targeted to mental health service providers strengthening integration of mental health services in order to deliver effective and timely integrated care to young people accessing headspace centres. Key components of the intervention target streamlining referral processes ensuring continuity of care, structured collaborations, sharing resources, and improving communication between providers to better meet the mental health needs of young people accessing care at headspace, aged 12–25. Our work with headspace has focused on enhancing integration within their centres in line with the Australian governments model of stepped care, integrating headspace and higher intensity services to address the continuum of needs seen among headspace clients. The Youth Integration Project (YIP) model will enhance headspaces standard clinical care by integrating services, so they seamlessly work together as one, to deliver care that is accessible through a single-site entry point and is personalised to each young person’s needs. Systematic improvement and integration of the youth mental health system are urgently required to improve access to specialist assessment, collaborative care planning, and streamlined referral pathways. In 2019, Mindgardens Neuroscience Network received federal funding for YIP, a novel translational research project exploring real-world barriers, enablers, and solutions to improve integrated care for youth mental health services in NSW. This project identified the key components of an integrated youth mental health care system and co-produced evidence-based solutions, including a digital Resource Kit, with young people and clinicians. The Resource Kit defines the critical elements of integrated youth mental health care and serves as a resource to enhance service integration. As part of YIP, our team conducted extensive consultations with young people aged 12–25, their families, and service providers across NSW to identify structural and systemic barriers and enablers to integration. We also employed journey mapping with young people to chronologically explore their trajectories through the youth mental health system, employing a strengths-based approach to engage sensitively with young people and families in complex contexts and from priority populations. The YIP model comprises of five core components of integration: 1. Service delivery; 2. Workforce; 3. Information systems and communication, 4. Financing; 5. Values, and leadership, governance and policy. Each component of integration is essential for effective integrated service delivery. We have developed a Youth Service Integration Resource Kit to strengthen each component of integration within mental health care systems relevant to youth populations.
The Resource Kit will be used online by consenting headspace and corresponding LHD sites and staff and starts with a questionnaire to help services identify how well they are currently working with other services in their area, and how they can boost their collaborations to help young people get back on track with work, study and relationships. Based on each response, the Resource Kit will direct providers to resources that can help improve how sites partner with and focus on supporting young clients. Content/modules include ‘Leadership and Governance’: Organisations that wish to offer a more integrated approach to youth mental health care can benefit from developing an explicit leadership, governance and policy framework. By articulating your values and ways of working, in line with findings from the Youth Integration Project, you can foster positive, transparent relationships with their leaders and staff, promoting trust and collaboration; ‘Service Delivery’: Integrated service delivery may take different forms. It can refer to continuity of support on the journey from screening to primary care and mental health treatment services. It might mean services are managed by one organisation, or it could be seamless management of transitions and referrals – so young people receive individual support and advice as they move between services, and do not have to tell their story again; ‘Workforce’: Many different professionals are involved in young people’s mental health care: psychiatrists, psychologists, primary care specialists, alcohol and drug workers, youth workers, peer workers, teachers and others. Youth mental health services need to integrate those functions within and across organisations if they are to get the best from their staff, promote retention and prevent stress and burnout. The Youth Integration Project has identified steps to address these issues and move towards more holistic mental health care for youth; ‘Communications’: Shared communication is the cornerstone of integration. It is essential to share information about clients – including treatment plans, referral pathways, case conferencing and shared care planning. Interpersonal communication builds team cohesion and trust and is just as vital, though its impact easily be underestimated. Communication between organisational partners requires thoughtful consideration and a deliberate allocation of time and effort; and ‘Finance’: Integrated services require money, infrastructure, time and skills. Fragmented funding models can frustrate mental health service integration, while collaboration that extends to shared financing can powerfully demonstrate impact and sustainability.
The Resource Kit includes resources that have been organised according to the core components of integration and include reflection worksheets, implementation guidance, action checklists, useful templates and additional reading. The Resource Kit will be delivered online but will be discussed with the LHD staff, headspace clinical teams and headspace clients to ensure up-take. There is no desired duration in terms of time usage of the Resource Kit. The initial survey as part of the Resource Kit takes approximately 5 minutes to complete, with results being made available to staff immediately as to what areas of improvement are suggested. In each of these domains (Leadership and Governance, Service Delivery, Workforce, Communications, and Finance) there are worksheets, implementation guidance, reading material, templates and action checklists to be used at each participants (staff) discretion. The Resource Kit can also be used more than once to check if levels of integration have improved or changed. In terms of time, this is a very low frequency participation in terms of hours per week (less than one hour).
Participants do not need any extensive training to be able to use the Resource Kit. Any issues that arise from the self-exploration of the Resource Kit will be able to be addressed in the monthly check-ins and also in the first focus group. We will recruit participants from ten sites from headspace and corresponding Local Health District's (LHD). Five of these sites will be randomly allocated to the Resource Kit, and five will have the control arm (usual headspace care). Sites will know after random allocation which arm they have been allocated to (intervention vs. control). Sites (including staff participants will not be blinded in this study).
From these sites we will recruit and consent staff, clinical managers and clinicians. Phase 2 will also include recruitment and focus groups with headspace clients. This trial will run for 6 months at consenting headspace sites (and corresponding LHDs). Staff participants will take part in two (one pre and one post) focus groups during this time period, and they will use the Resource Kit also. headspace client participants will participate on one post0intervention focus group. All focus groups go for 30-60 minutes and are available either online or person, depending on the site and staff capacity. During this 6-month activity period, researchers will also do monthly check-ins with sites and staff to give any opportunity for participants to ask questions or seek further support on the digital intervention (Resource Kit). There are no strategies used to assess or monitor adherence to the intervention.
The focus groups for headspace and LHD staff will explore the barriers and facilitators to the implementation of the Resource Kit, as well as it’s acceptability, adoption, appropriateness, feasibility, and fidelity we will use a mixed methods approach. Semi structured focus groups involving headspace providers at each site will be conducted exploring the barriers and enablers to implementing the Resource Kit, this will take place post implementation (that is, after the intervention has run at the corresponding headspace service (6 months). The areas of discussion will be broken down into the same domains as the Resource Kit (as previously mentioned - Leadership and Governance, Service Delivery, Workforce, Communications, and Finance). And further discussion points will include the following: identified barriers and possible solutions? Which solutions could realistically be implemented within existing resources? Which barriers seem insurmountable, and why? How might these solutions improve vertical or horizontal integration?

Focus groups will be run by two members of the research team (the research coordinator and implementation officer), they will take place in headspace sites or online using Microsoft Teams pending participant preference and will take between 30 and 60 minutes. The focus groups for headspace clients will be mid-way through the study (3 months) and at the end of the study (6 months). Focus groups (one group of three to five clients per site) for us to better understand each client’s experience of mental health care and using headspace services as a young person. Focus groups with young people attending headspace centres will explore their experiences of receiving care from headspace and other youth mental health services. Focus groups discussion stages include accessing the systems, how their experience with support was, what services have they accessed so far, what made access and support easier or harder. Feeling supported and understood, moving between services, and improving the system, what worked well in their journey, hat could be improved, how could services work better together.
Focus groups will be facilitated by the coordinating researcher and the implementational officer (research team). To ensure that all focus groups allow for all participants to fairly and comfortable be able to express their perspectives and taking into consideration varying numbers of staff and clients based on each site, we have set a cap of 5 participants per focus group. We will be recruiting as many participants (both headspace and LHD staff and headspace clients per site as are eager to participate). As this is between varying headspace sites (in person and online) and LHD sites (online) there are no clear numbers un terms of sample size for this project. We aim to be powered to assess feasible service integration improvement. This RCT aims to address sample size, rates of recruitment and retention, along with acceptability, effectiveness and engagement with the trial intervention and procedures. Sample size relates to primary feasibility outcomes. We aim to obtain data from 2 headspace sites in Phase 1, and 10 headspace sites in Phase 2; that is, 5 sites in each trial arm of Phase 2 and powered to assess service integration improvement. The minimum detectable difference of analysis will be at the site level. Power may be low with only 10 clusters in Phase 2; however, it is important to reiterate this is a pilot feasibility study justifying integration, effectiveness and feasibility.

Each core component of integration is broken down into varying resources.
Leadership, governance and policy includes:
(1a) Reflection Worksheet - helps organisations reflect on their leadership, governance and policy framework and articulate their values and ways of working. Develop common agendas and policies; information of embedded values into service and useful links.
(1b) Implementation Guidance - provides guidance on the process of reflection and implementation
(1c) Leadership, Governance and Policy Checklist - template checklist for actionable items with example prompts
(1d) Standardised Agreement Template - template of Standardised Agreement that providers can work from, etc.
Service Delivery includes:
(2a) Implementational and stratified care guidance - Integrated service delivery is formed around the principles of continuity of care between screening, primary and mental health treatment services. This may mean services are managed and/or provided by one organisation/health service. It may also involve supported transition and seamless referrals
(2b) Service Delivery Checklist - template checklist for actionable items with example prompts
Workforce includes:
(3a) Health Workforce and Practitioner care guidance - Integrated health workforces involved internal multidisciplinary workforce of providers working together who are trained and skilled in different professions and partnerships with external organisations, such as other mental health services, primary care, alcohol and other drug services, research entities and other sectors like education or justice.
(3b) Health Workforce Checklist - template checklist for actionable items with example prompts, checklist as a guide for possible action items towards improving integration for Health Workforce.
Communication includes:
(4a) Implementation Guidance in Information Systems and Communication/ Products and technology - provides guidance on the process of reflection and implementation. Shared communication is the cornerstone of integration, with shared treatment plans and regular communication, either formally through team meetings or informally, in-person or via phone or electronic medical record. Information sharing and communication involves formal and informal activities. Referral pathways are a key component of information sharing, but so are case conferencing and shared care planning. Communication about clients is important, but so is the interpersonal communication that builds team cohesiveness and trust. All these things require thoughtful consideration and the allocation of time and effort.
(4b) Actions Checklist - template checklist for actionable items with example prompts. This checklist is a guide for possible action items towards improving integration for Information Systems and Communication.
(4c) Youth Mental Health Referral Pathways Template - Template for Youth Mental Health Referral Pathways. Referral protocols for youth mental health partners.
Finance includes:
(5a) Implementational guidance - Integrated models require money, infrastructure, time and skills to be coordinated and balanced across different services. Funding models and regimes have been cited as a key barrier to service integration in mental health largely related to the erratic and piecemeal nature of mental health funding. This includes checklists and readings to support and consider the sustainability of your funding model & future funding structures.
(5b) Health Financing Checklist - This checklist is a guide for possible action items towards improving integration for Health Financing, and to support current and future funding models.
Intervention code [1] 335168 0
Behaviour
Description of the comparator or control
The control in this study is usual headspace care. That is, each headspace and Youth Mental Health Initiative (LHD) sites standard care. Each headspace site has its own standard of care based on each individual who presents to their service. This can differ based on, for example, area (metropolitan or rural), relationship with their Local Health District, access they have to certain programs and or/support structures (for example early intervention programs, early psychosis programs, work and study support, family support etc). headspace centres represent the largest provider of community-based integrated youth mental health care in Australia for youth aged 12-25 years with over 160 centres nationwide. headspace’s model of care integrates services to address individual needs, providing care that includes support for mental health, vocational and educational needs, physical and sexual health, and alcohol and drugs. Since 2006, this model has been delivered within primary care funded primarily through the Primary Health Networks and Commonwealth’s Medicare Benefit Scheme faced by headspace centres is that they have limited provision for youth with specialist care needs. These youth may have access to state or territory funded specialist services with some who do not meet this threshold often unable to access care. To enable referral pathways between primary and specialist care services, the Australian government has scaled up a population health model of stepped care which aims to support and facilitate joint implementation of integrated pathways between headspace and state and territory funded mental health services at a regional level to ensure individuals access the right level of care at the right time. Once this pilot feasibility RCT is completed, the Resource Kit will be available to all services.
Control group
Active

Outcomes
Primary outcome [1] 346663 0
Implementation and feasibility of the Resource Kit (this will be assessed as a composite outcome)
Timepoint [1] 346663 0
Implementation and feasibility of the Resource kit assessed at 6-months post-intervention commencement
Secondary outcome [1] 466931 0
Barriers and facilitators to implementation assessed as a single composite outcome
Timepoint [1] 466931 0
Barriers and facilitators to implementation assessed as a single composite outcome will be assessed at 6-months post-intervention commencement
Secondary outcome [2] 467304 0
Implementation evaluation
Timepoint [2] 467304 0
Implementation evaluation will be assessed at 6-months post-intervention commencement

Eligibility
Key inclusion criteria
headspace site: (i) Readiness to participate to trial end; (ii) Located in NSW.

headspace site focus groups: (i) Works at a site that has agreed to participate in this project; (ii) Holds a position as a service leader or clinician at this headspace site.

LHD site: (i) Located in NSW; and (ii) Works at an LHD site that has agreed to participate in this project

LHD site focus group: (i) Is willing to participate under your corresponding LHD site staff role.

headspace client focus group: (i) Young people aged 16-25 years who attended headspace during the intervention study period.

Please note there is only a minimum age for the headspace client focus groups. All other focus groups are with headspace and LHD staff.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
headspace site: (i) Unable to participate to trial end; (ii) Located in NSW.

headspace site focus groups: (i) Unable to participate to trial end

LHD site focus groups: (i) Unable to participate to trial end

headspace client focus group: (i) Young people aged 12-16 years (in accordance with the National Statement on Ethics (2025). Young people of developing maturity are able to understand relevant information at differing levels. headspace clients between the ages of 12 and 16 years may be more vulnerable and need additional consent from a parent or guardian (see Sections 4 and 5 for additional information)).

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)
Participating sites will be allocated to the intervention v control. There is not concealment to the sites and staff once allocated. Two-stage randomisation process where clusters are first grouped into strata based on the socio-economic classification of a given geographic area, measured using the Socio-Economic Indexes for Areas (SEIFA), and then randomised to intervention or control groups within each stratum. Blinding will be completed by statisticians and implemented after the baseline assessment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Socio-Economic Indexes for Areas (SEIFA)
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
Randomisation will occur at the cluster-level (i.e., headspace site) and be stratified. Stratified randomisation of clusters will involve a two-stage randomisation process where clusters are first grouped into strata based on the socio-economic classification of a given geographic area, measured using the Socio-Economic Indexes for Areas (SEIFA), and then randomised to intervention or control groups within each stratum. This method ensures that specific subgroups (for example age and gender) are equally represented in each group by randomising within these strata. It is also particularly useful for small studies and helps ensure that key prognostic factors are balanced across intervention groups, increasing the precision and power of the study.

We aim to be powered to assess feasible service integration improvement. This RCT aims to address sample size, rates of recruitment and retention, along with acceptability, effectiveness and engagement with the trial intervention and procedures. Sample size relates to primary feasibility outcomes. We aim to obtain data from ten headspace sites in Phase 2; that is, 5 sites in each trial arm of Phase 2 and powered to assess service integration improvement. The minimum detectable difference of analysis will be at the site level. Power may be low with only 10 clusters in Phase 2; however, it is important to reiterate this is a pilot feasibility study justifying integration, effectiveness and feasibility. To ensure that all focus groups allow for all participants to fairly and comfortable be able to express their perspectives and taking into consideration varying numbers of staff and clients based on each site, we have set a cap of 5 participants per focus group.

This is an intraclass cluster correlation (ICC) for a randomised trial. An ICC supports determining the sample size and continuous outcomes needed to detect a treatment effect. Descriptive statistics will be first used to present the pre-implementation measures collected and to describe the pre-and post-implementation change in outcomes following the intervention. Objective 1 and 2 will be evaluated using qualitative data and quantitative surveys descriptive to inform intervention refinement and assessment of larger scale pilot feasibility RCT. Objective 3 will be examined using descriptive analysis of the pre-and post-implementation change in levels of service integration between Phase 2: Pilot feasibility RCT headspace sites and local health services. Objective 4 will be examined using appropriate regression analyses to compare changes in the outcome measures pre- and post-implementation of the intervention. Analyses will be completed using generalised estimating equations (GEE) modelling to control for clustering by headspace site and repeated measures within the same client, while adjusting for plausible confounding factors (e.g., sociodemographic, clinical severity).

Survey and questionnaire responses to validated measures will be analysed using descriptive statistics. Qualitative feedback from focus groups will be collected as observations and interviews following the Phase 2 pilot feasibility RCT. Qualitative focus group data will be analysed using a thematic analysis approach to identify major themes representing recommendations for improved practice, feasibility of intervention, and health care journey. Any relevant findings, feedback, analyses and reports generated through the project would be made available to all participating LHD and headspace sites for review and consideration.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322823 0
Government body
Name [1] 322823 0
NSW Health
Country [1] 322823 0
Australia
Primary sponsor type
Government body
Name
NSW Health (Ministry of Health)
Address
Country
Australia
Secondary sponsor category [1] 325758 0
None
Name [1] 325758 0
Address [1] 325758 0
Country [1] 325758 0
Other collaborator category [1] 284066 0
Other
Name [1] 284066 0
headspace National (a Primary Health Network (not for profit Australian government funding mental health organisation)
Address [1] 284066 0
Country [1] 284066 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321265 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 321265 0
Ethics committee country [1] 321265 0
Australia
Date submitted for ethics approval [1] 321265 0
11/09/2026
Approval date [1] 321265 0
Ethics approval number [1] 321265 0

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

Contacts
Principal investigator
Name 153194 0
Prof Raghu Lingam
Address 153194 0
UNSW Medicine & Health Building C29, Health Translation Hub, Level 355 Botany St Kensington 2033 NSW
Country 153194 0
Australia
Phone 153194 0
+61466985160
Fax 153194 0
Email 153194 0
[email protected]
Contact person for public queries
Name 153195 0
Dr Ashleigh Tickell
Address 153195 0
UNSW Medicine & Health Building C29, Health Translation Hub, Level 355 Botany St Kensington 2033 NSW
Country 153195 0
Australia
Phone 153195 0
+61466985160
Fax 153195 0
Email 153195 0
[email protected]
Contact person for scientific queries
Name 153196 0
Dr Ashleigh Tickell
Address 153196 0
UNSW Medicine & Health Building C29, Health Translation Hub, Level 355 Botany St Kensington 2033 NSW
Country 153196 0
Australia
Phone 153196 0
+61466985160
Fax 153196 0
Email 153196 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No



What supporting documents are/will be available?



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.