Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000757314p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
5/06/2026
Date registered
Help: Date registered
25/06/2026
Date last updated
Help: Date last updated
25/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/06/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Story-ABI-lity: Evaluating a story-based speech pathology intervention for people with traumatic brain injury in the hospital setting.
Scientific title
Story-ABI-lity feasibility trial: Evaluating a co-designed cognitive-communication intervention for people with traumatic brain injury in the hospital setting.
Additional trial identifiers [1] 317451 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Traumatic Brain Injury 342149 0
Condition category
Condition code
Neurological 338267 338267 0 0
Other neurological disorders
Injuries and Accidents 338448 338448 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
What is the intervention?
Story-ABI-lity is a manualised, narrative-based speech pathology intervention designed to support cognitive-communication recovery in adults with traumatic brain injury (TBI) during inpatient rehabilitation. The intervention targets storytelling and narrative discourse skills through structured, supported activities delivered by a speech pathologist. Story-ABI-lity was co-designed with people with TBI, clinicians and researchers, developed for the hospital setting.

Story-ABI-lity is informed by pragmatic communication principles, including Gricean maxims, and hierarchical storytelling approaches. Participants are supported to produce organised, relevant and contextually appropriate narratives using visual and conversational prompts, clinician modelling, scaffolding and guided practice.

Gricean maxims are rules that guide effective and cooperative communication (Grice, 1975). These domains are Quality, Quantity, Relation and Manner, areas that guide conversations to be informative, truthful, relevant, and clear. Participants practice storytelling and are then guided to reflect on the informativeness, truthfulness, relevance and clarity of their communication using a simple Likert scale. Participants work with the therapist to identify a suitable strategy to address areas of concern.
Hierarchical storytelling approaches begin with simple narrative organisation (e.g. beginning, middle, end) and build to more complex narrative components (e.g. orientation - who, where, when), and more elaborate story episodic structure.

Visual and conversational prompts (e.g. use of photos, “what happened in the beginning”), clinician modelling (e.g. "You could start by talking about when it happened - Last week?”), scaffolding (e.g. visual scaffold with sections labelled beginning, middle and end) and guided practise (e.g. “Now have a go telling your story using the ‘stop, think, check’ strategy”).

Who delivers it and their relevant expertise.
The intervention is delivered by qualified speech pathologists trained in the Story-ABI-lity program, following a clinician manual and structured treatment protocol.

How is it delivered?
The intervention is delivered individually, face to face, within specialist inpatient brain injury rehabilitation service at Westmead Hospital.

How often and for how long?
Up to ten treatment sessions (minimum 30 minutes, maximum 1 hour/session). These will be scheduled to fit around the patient and therapists' schedules and will be a minimum of one and a maximum of four sessions per week. The maximum duration of the treatment will be 10 weeks.

Data will be collected on planned sessions, session attendance, completion of key tasks, reasons for any tasks not completed, planned session duration and actual session duration.

Clinician Training
The program is manualised with each session based on a tailored session plan. The manual and materials will be provided at least 2 weeks prior to participant enrolment. Training includes clinical preparation time for the speech pathologist to independently review the treatment manual and materials (approximately 2 hours). The clinician will have the opportunity to ask the research team any questions about the treatment program, with a 1 hour online meeting offered by the research team for any further discussion of the treatment.
Intervention code [1] 334244 0
Behaviour
Intervention code [2] 334404 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345624 0
Acceptability
Timepoint [1] 345624 0
Post-treatment (within one week post-treatment)
Primary outcome [2] 345625 0
Feasibility
Timepoint [2] 345625 0
Post-treatment (within one week post-treatment)
Primary outcome [3] 345626 0
Appropriateness
Timepoint [3] 345626 0
Post-treatment (within one week post-treatment)
Secondary outcome [1] 462486 0
Communication
Timepoint [1] 462486 0
Pre and within one week post-treatment
Secondary outcome [2] 462487 0
Psychosocial outcome
Timepoint [2] 462487 0
Pre and within one week post-treatment

Eligibility
Key inclusion criteria

Adult (over 18 years) with diagnosed traumatic brain injury (Any severity mild-severe)
Between 2 weeks and 1-year post-injury at time of recruitment

Medically stable and able to participate as determined by treating medical team.

Able to provide self-consent (We will develop easy-read consent forms)

Adequate alertness, English language and communication skills to participate in minimum 30-minute sessions as determined by managing speech pathologist (We will include people with comorbid language or motor speech disorders i.e. aphasia or dysarthria)

Identified or suspected cognitive-communication disorder as screened by treating speech pathologist or team

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Less than 18 years of age
Greater than 1-year post-injury at time of recruitment
Medically unstable
Any history of dementia or previous documented conditions affecting communication e.g. intellectual disability, schizophrenia.
History of previous TBI or stroke, hypoxia etc. related to TBI.
Hearing or visual impairments (which could not be compensated for) preventing ability to see pictures and hear instructions
Unable to sustain adequate alertness or inadequate English language or communication skills to participate in the intervention as determined by treating team
Severe aggression or agitation
Unable to tolerate therapy for a minimum of 30 minutes. Non-verbal or very limited capacity for verbal output
No cognitive-communication disorder


Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



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
31/07/2026
Actual
Date of last participant enrolment
Anticipated
29/01/2027
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322023 0
University
Name [1] 322023 0
The University of Newcastle
Country [1] 322023 0
Australia
Funding source category [2] 322031 0
University
Name [2] 322031 0
The University of Sydney
Country [2] 322031 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Country
Australia
Secondary sponsor category [1] 324901 0
University
Name [1] 324901 0
The University of Sydney
Address [1] 324901 0
Country [1] 324901 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320556 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 320556 0
Ethics committee country [1] 320556 0
Australia
Date submitted for ethics approval [1] 320556 0
22/06/2026
Approval date [1] 320556 0
Ethics approval number [1] 320556 0

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

Contacts
Principal investigator
Name 150862 0
Dr Joanne Steel
Address 150862 0
School of Health Sciences, ICT building, The University of Newcastle, Callaghan, NSW, 2308
Country 150862 0
Australia
Phone 150862 0
+61240553011
Fax 150862 0
Email 150862 0
[email protected]
Contact person for public queries
Name 150863 0
Joanne Steel
Address 150863 0
School of Health Sciences, ICT building, The University of Newcastle, Callaghan, NSW, 2308
Country 150863 0
Australia
Phone 150863 0
+61240553011
Fax 150863 0
Email 150863 0
[email protected]
Contact person for scientific queries
Name 150864 0
Joanne Steel
Address 150864 0
School of Health Sciences, ICT building, The University of Newcastle, Callaghan, NSW, 2308
Country 150864 0
Australia
Phone 150864 0
+61240553011
Fax 150864 0
Email 150864 0
[email protected]

Data sharing statement
Will the study consider sharing 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.