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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001112358p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
30/07/2026
Date registered
Help: Date registered
8/09/2026
Date last updated
Help: Date last updated
8/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
8/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
NAVIGATE: Transition Coaching to build health literacy, self-advocacy and healthy lifestyle behaviours for Queensland Adolescents with Aacquired Brain Injury and their caregivers.
Scientific title
NAVIGATE: Transition Coaching to build health literacy, self-advocacy and healthy lifestyle behaviours for Queensland Adolescents with ABI and their caregivers.
Additional trial identifiers [1] 317930 0
Nil known
Universal Trial Number (UTN)
Trial acronym
NAVIGATE
Related trial records

Health condition
Health condition(s) studied:
Acquired Brain Injury 342880 0
Condition category
Condition code
Physical Medicine / Rehabilitation 338997 338997 0 0
Other physical medicine / rehabilitation
Neurological 339333 339333 0 0
Other neurological disorders
Injuries and Accidents 339334 339334 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Phase 1: Information Gathering - a comprehensive needs assessment will be undertaken with young people with ABI, caregivers, clinicians and stakeholders to understand transition experiences, identify service gaps and inform the development of a Queensland specific ABI transition model and resources. Please note Phase 1 is NOT an intervention.

Phase 2: Co-Design. (Please note Phase 2 is not an intervention).

Phase 2 is a structured co-design process to adapt evidence-based ABI transition programs for the Queensland context and develop the Queensland ABI Transition Model, Transition Protocol Toolkit, training resources, and implementation strategies.

Who delivers it and their relevant expertise? - Project investigators and facilitators with expertise in ABI rehabilitation, co-design methodology, implementation science, and transition care. Participants include young people with ABI, caregivers, clinicians, service providers, and consumer representatives.

How is it delivered? - Structured co-design workshops involving collaborative discussion, prioritisation activities, review of evidence, and adaptation of program components.

How often and for how long?
Three co-design workshops.
Each workshop is anticipated to run for approximately 2 to 4 hours.
Delivered over a 2-month period (Months 4-6 of the project).

Where is it delivered? - Face-to-face at participating health service or community venues, online via videoconference, or using a hybrid format.

Adherence (e.g. reminders, monitoring) - Workshop attendance will be monitored and participants will receive meeting invitations, agendas, and reminders. Workshop outputs and participation will be documented by the research team.

Participants in Phase 2 will not be involved in Phase 3.

Phase 3: Transition Program Implementation
What is the intervention? - The Queensland ABI Transition Program, comprising structured transition support for adolescents with moderate-to-severe ABI moving from paediatric to adult services. The program is expected to include transition coaching, transition planning, educational resources, care coordination processes, clinician support, and use of the Queensland ABI Transition Toolkit developed during Phases 1 and 2.

Who delivers it and their relevant expertise? - Paediatric Rehabilitation allied health clinicians with expertise in acquired brain injury and transition care, Providers will receive training in the Queensland ABI Transition Model and associated resources.

How is it delivered?

Individual transition coaching and planning sessions

Care coordination activities - Individualised transition planning, referral facilitation, liaison with paediatric and adult healthcare providers, coordination of community supports, service navigation support, and monitoring of progress towards transition goals. Delivered throughout the intervention period as required

Educational and self-management resources - study-specific educational materials and self-management resources developed through a co-design process, including worksheets, visual aids, transition planning tools, session summaries and health education materials to support transition readiness, self-management and service navigation. Provided throughout the intervention period.

Communication and support involving adolescents, caregivers, and clinicians - Motivational Interviewing-based transition coaching, health education, goal setting, self-advocacy training, family support, service liaison and, where required, targeted psychological support. Delivered through one initial session, up to 12 coaching sessions over 6 months, and one follow-up session 3 months post-intervention.

Delivery may occur face-to-face, by telehealth, or through a combination of both.

How often and for how long? - The duration of the transition program for participants is approximately 9 months in total. The final frequency and duration will be determined through the co-design process. At this stage, participants will receive 1 initial session (up to 2 hours), up to 12 transition coaching sessions (typically 45-60 minutes with flexibility up to 1-2 hours per session) and ongoing care coordination, education and support activities as needed. There will also be 1 follow up session approximately 3 months after completion of the intervention period. The number and duration of contacts will be recorded and monitored during implementation.

Where is it delivered? - Queensland Health outpatient and rehabilitation services, community settings, and participants' homes via telehealth where appropriate.

Adherence (e.g. reminders, monitoring) - Participant engagement will be monitored through attendance records, completion of transition planning activities, and utilisation of program resources. Appointment reminders, follow-up contact from clinicians and Nurse Navigators, and routine monitoring of intervention fidelity will be used to support adherence.

Phase 4: Translation and Evaluation
The Queensland ABI Transition Program will be evaluated to assess its implementation, acceptability, feasibility and potential for wider adoption, with findings used to refine transition pathways, workforce training and future service delivery. Please note Phase 4 is NOT an intervention.
Intervention code [1] 334780 0
Rehabilitation
Intervention code [2] 334781 0
Lifestyle
Intervention code [3] 334782 0
Behaviour
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346236 0
Management of Participant Health and Healthcare. This will be assessed as a composite outcome.
Timepoint [1] 346236 0
TRAQ will be administered at baseline (T0) prior to receiving transition coaching, 6 months after T0 and following transition coaching (T1), and 9 months after T0 (T2).
Secondary outcome [1] 465130 0
Depression, Anxiety, Stress. This will be assessed as a composite outcome.
Timepoint [1] 465130 0
DASS-21 will be administered at baseline (T0) prior to receiving transition coaching, 6 months after T0 and following transition coaching (T1), and 9 months after T0 (T2).
Secondary outcome [2] 465131 0
Health Literacy. This will be assessed as a composite outcome.
Timepoint [2] 465131 0
HELMA will be administered at baseline (T0) prior to receiving transition coaching, 6 months after T0 and following transition coaching (T1), and 9 months after T0 (T2).
Secondary outcome [3] 465132 0
General ability to cope with life challenges. This will be assessed as a composite outcome.
Timepoint [3] 465132 0
Generalized self-efficacy scale will be administered at baseline (T0) prior to receiving transition coaching, 6 months after T0 and following transition coaching (T1), and 9 months after T0 (T2).
Secondary outcome [4] 465133 0
Parenting Stress. This will be measured as a composite outcome.
Timepoint [4] 465133 0
PIP will be administered at baseline (T0) prior to receiving transition coaching, 6 months after T0 and following transition coaching (T1), and 9 months after T0 (T2).
Secondary outcome [5] 465134 0
Health related quality of life. This will be assessed as a composite outcome.
Timepoint [5] 465134 0
Kidscreen-27 will be administered at baseline (T0) prior to receiving transition coaching, 6 months after T0 and following transition coaching (T1), and 9 months after T0 (T2).
Secondary outcome [6] 465135 0
Identification of skills achieved and not yet achieved.
Timepoint [6] 465135 0
Preparing for Adulthood Knowledge Checklist will be administered at baseline (T0) prior to receiving transition coaching, 6 months after T0 and following transition coaching (T1), and 9 months after T0 (T2).
Secondary outcome [7] 465136 0
Acceptability of NAVIGATE Transition Program to clinicians working with older adolescents and their families
Timepoint [7] 465136 0
22 months after baseline (T0) following completion of intervention and follow up periods.
Secondary outcome [8] 465137 0
Acceptability of NAVIGATE Transition Program to youth with ABI and their caregivers who have completed the program
Timepoint [8] 465137 0
Following completion of intervention (T1), 6 months post baseline.
Secondary outcome [9] 465139 0
Feasibility of NAVIGATE Transition Program
Timepoint [9] 465139 0
Collected throughout study duration.
Secondary outcome [10] 465140 0
Appropriateness which is understanding the perceived fit including NAVIGATE transition program relevant and suitability for clinicians working with older adolescents and their caregivers. This will be assessed as a composite outcome.
Timepoint [10] 465140 0
22 months after baseline (T0) following completion of intervention and follow up periods.
Secondary outcome [11] 465141 0
Appropriateness which is understanding the perceived fit including NAVIGATE Transition program relevance and suitability for youth with ABI and their families. This will be assessed as a composite outcome.
Timepoint [11] 465141 0
Following completion of intervention (T1), 6 months post baseline.
Secondary outcome [12] 465143 0
Acceptability of the NAVIGATE transition program including aspects of delivery, content and complexity for clinicians working with older adolescents and their caregivers. This will be assessed as a composite outcome.
Timepoint [12] 465143 0
22 months after baseline (T0) following completion of intervention and follow up periods.
Secondary outcome [13] 465149 0
Acceptability of the NAVIGATE transition program including aspects of delivery, content and complexity for youth with ABI and their families. This will be assessed as a composite outcome.
Timepoint [13] 465149 0
Following completion of intervention (T1), 6 months post baseline.

Eligibility
Key inclusion criteria
Phase 1 and Phase 2
Young adults with lived experience of paediatric-acquired brain injury (ABI).
Parents, caregivers or family members of individuals with paediatric-acquired ABI.
Clinicians and service providers involved in paediatric or adult ABI care, rehabilitation or transition services.
Community stakeholders with experience relevant to ABI transition care.

Phase 3
Adolescents and young adults aged 15 to 19 years with moderate to severe paediatric-acquired ABI.
Receiving or transitioning from paediatric ABI services in Queensland.
Able to provide informed consent/assent, or have parent/guardian consent where required.

Phase 4
Clinicians involved in delivery of the Queensland ABI Transition Program.
Young people with ABI and caregivers who participated in and completed the Transition Program during Phase 3.
Minimum age
15 Years
Maximum age
60 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Phases 1-2 and 4
Inability to communicate perspectives and experiences, either verbally or through augmentative and alternative communication (AAC).
Insufficient English language proficiency to participate in interviews, focus groups or co-design activities.

Phase 3
Not client of Queensland Paediatric Rehabilitation Service (QPRS) care based on service eligibility requirements.
Age under 15 years
Does not have moderate-severe ABI (as confirmed by QPRS doctors)
Unable to meet program participation requirements

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A convergent mixed methods design will be used to evaluate the Transition Program, whereby both quantitative data (adolescent and caregiver outcomes) and qualitative data will be used to identify themes around elements of effectiveness and implementation (e.g., satisfaction, feasibility, acceptability, appropriateness).
Quantitative analyses: Data for each measure from each timepoint will be summarised and descriptive statistics calculated. Changes between baseline and each timepoint will be compared using paired t-tests or non-parametric equivalent, dependent on data distribution.
Qualitative analyses: Qualitative data will be analysed inductively and deductively using interpretive description. Qualitative and quantitative data will be triangulated to report on the implementation outcomes. Trustworthiness will be maintained using member checking of interview transcripts and analysis summaries, oversight by experienced researchers in qualitative and mixed methods, and reflection by the research team with consideration given to power relations.
Sample size and statistical power
This project will likely use repeated measures ANOVAs to evaluate the impact of the clinic on patient outcomes. Statistical significance will be set at p <0.05. Where appropriate effect sizes will also be calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
31/05/2027
Actual
Date of last data collection
Anticipated
28/04/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 29876 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 46231 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 322474 0
Government body
Name [1] 322474 0
National Insurance Injury Scheme - Queensland, REACH Grant
Country [1] 322474 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 325660 0
None
Name [1] 325660 0
Address [1] 325660 0
Country [1] 325660 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320957 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 320957 0
Ethics committee country [1] 320957 0
Australia
Date submitted for ethics approval [1] 320957 0
06/07/2026
Approval date [1] 320957 0
Ethics approval number [1] 320957 0

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

Contacts
Principal investigator
Name 152198 0
Ms Janet Danielson
Address 152198 0
Queensland Paediatric Rehabilitation Service; c/- Queensland Children’s Hospital; Level 12, 501 Stanley St, South Brisbane, QLD, 4101
Country 152198 0
Australia
Phone 152198 0
+61 7 431 526 155
Fax 152198 0
Email 152198 0
[email protected]
Contact person for public queries
Name 152199 0
Janet Danielson
Address 152199 0
Queensland Paediatric Rehabilitation Service; c/- Queensland Children’s Hospital; Level 12, 501 Stanley St, South Brisbane, QLD, 4101
Country 152199 0
Australia
Phone 152199 0
+61 7 431 526 155
Fax 152199 0
Email 152199 0
[email protected]
Contact person for scientific queries
Name 152200 0
Janet Danielson
Address 152200 0
Queensland Paediatric Rehabilitation Service; c/- Queensland Children’s Hospital; Level 12, 501 Stanley St, South Brisbane, QLD, 4101
Country 152200 0
Australia
Phone 152200 0
+61 7 431 526 155
Fax 152200 0
Email 152200 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:
• The study team are available to collaborate with other research teams upon receipt of a reasonable request to access non-identifiable study data.

Conditions for requesting access:
• The study team are available to collaborate with other research teams upon receipt of a reasonable request to access non-identifiable study data.

What individual participant data might be shared?
• The study team are available to collaborate with other research teams upon receipt of a reasonable request to access non-identifiable study data. Expressions of interest to access study data (all of the individual participant data collected during the trial), made out to the Principal Investigator (Ms Janet Danielson) will be considered and the group level or individual level deidentified data could be shared if appropriate.

What types of analyses could be done with individual participant data?
• Expressions of interest to access study data, made out to the Principal Investigator, Ms Janet Danielson, will be considered and the group level or individual level de-identified data could be shared as appropriate for IPD meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
On completion of data collection

To:
5 years after data collection is complete.

Where can requests to access individual participant data be made, or data be obtained directly?
• Expressions of interest to access study data, made out to the Principal Investigator, Ms Janet Danielson, will be considered. Postal address: Ms Janet Danielson, Queensland Paediatric Rehabilitation Service; c/- Queensland Children’s Hospital; Level 12, 501 Stanley St, South Brisbane, QLD, 4101
E:[email protected]

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


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.