Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000310460p
Ethics application status
Submitted, not yet approved
Date submitted
31/03/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Rehabilitation Participation for People with Brain Injuries
Scientific title
Assessing the Impact of Bespoke Rehabilitation Activity Delivery for People with Brain Injuries
Secondary ID [1] 314093 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain injury 336871 0
Condition category
Condition code
Neurological 333343 333343 0 0
Other neurological disorders
Injuries and Accidents 333459 333459 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Observational data: The study will begin with a stage of data collection, associated with baseline (or initial) information gathering. This will involve researchers observing (watching) the behaviours of consented participants (individuals with brain injury and/or care or support people) and recording behaviours (e.g., indices of happiness and unhappiness, choice behaviour, vocal verbal responses) using pen and paper methods or unobtrusive technology (i.e., through the use of an iPad or similar) at various times. No specific actions will be required of participants at this stage. Baseline observational data will be collected during 20 minute periods at different times of the day across a one to week period to capture the majority of behaviours,

Assessment (1): This stage will involve gathering information by asking informants (participants who support an individual with a brain injury, including whanau and/or staff) to comment on the person's engagement with rehabilitation. This will be achieved through a short (no longer than 20 minutes) interview (modality may vary depending on the preference of the research team and participants, i.e., online, in person, pen and paper survey).

Assessment (2): This stage will involve brief assessments where the research team modifies rehabilitation activities in response to participant behaviour (e.g., such as adding access to reassurance upon refusal to engage) and measures any change to behaviours of interest after the change. The purpose of this assessment is to identify possible reasons why the person does / does not engage with their rehabilitation activities. The assessments will comprise multiple sessions lasting no longer than 20 minutes, and have structured protocols and ending-session criteria to protect participants and to minimise disturbance of their time. The session-ending criteria will be yoked to the rehabilitation activity involved (e.g., physiotherapy session finishing) or will be a maximum of 20 min. A session may also be ended if behaviours of discomfort in the participant are observed. These will be determined in advance with each participant and their support people (e.g., walking away from the area, verbal aggression). This phase will occur after the completion of Assessment 1. Data-based decision making will be used, which means that the specific number of sessions and total duration will vary individual-by-individual. The predicted number of sessions is 3 to 20 per participant.

Intervention (1): This element of the research will involve using information (gathered using methods listed above) to identify likely effective and best-practice intervention approaches that are matched to engagement and are minimally intrusive/promote quality of life. This stage will involve working with individuals with brain injury. These interventions will be yoked to data analysis, and so cannot be explicitly stated at this stage of the project, but may include: enriching the participant's lived environment, providing participants with choice of activities, providing memory aids or other environmental prostheses, and other empirically-supported evidence-based treatments common in behaviour-analytic intervention. Data collection through observation will continue at this stage.

The changes implemented will be selected by the CI, using their clinical judgement and the data collected in the assessment phases (i.e., based on participant preferences, mobility, any medical contraindications, feasibility, available resource). Proposed changes will be presented to the organisation (i.e., their multi-disciplinary team) for their approval prior to implementation and to provide an additional check for safety and feasibility (for example, we will not suggest a change in location for a participant whose mobility would make it unsafe to move them to another room in the space). The changes will be implemented by the CI (registered psychologist), supporting staff (e.g., occupational therapists, rehabilitation assistants), and other members of the research team. A researcher will interact with an individual participant in a shared space where other patients with brain injury may be present, or in private quarters (depending on the change to be implemented). Sessions will be between 10 and 20-min in duration, implemented up to five times per week for up to 2 months. This stage will be implemented upon completion of the assessment phases.

Examples of potential changes include:
• Embedding rehabilitation tasks (e.g., physical stretches) in preferred leisure activities (e.g., a sport)
• Embedding choice in and between tasks to give people a sense of control and autonomy
• Altering the way an invitation to participate in a rehabilitation task is framed or presented
• Providing bespoke ways for the person to track their progress or track their scheduled tasks

A second observer will be present in approximately 30% of sessions to record treatment integrity data.

Intervention (2): This step of the study involves teaching and supporting consented care and support staff to modify the approaches they use when interacting with individuals they support to increase participation in rehabilitation activities. Again, the specific intervention technologies will be tied to baseline data and specific to each participant, but may include the use of behavioural skills training (such as didactic instruction, modelling, rehearsal and feedback). Data will be collected at this stage through observation of consented participant behaviour (that of care support people and individuals with brain injury). The teaching and support will be delivered by the research team and will include both analogue and in-situ components (i.e., in training rooms and during interactions with participants with a brain injury). This stage will be implemented upon completion of Intervention 1. Sessions will be between 10 and 30-min in duration and will be delivered up to 3 times per week for up to a month.

A second observer will be present in approximately 30% of sessions to record treatment integrity data.

Social validity: The perspectives and opinions of consented whanau, care and support people will be recorded using informant methods (as described in Assessment: 1). Care will be taken to minimise the response time and effort required for this task. Data will be analysed using quantitative and qualitative methods. Consented individuals with brain injury may also be asked to provide their perspectives of participation through a modified tool, aligned with the cognitive skills of participants and in line with participant preference.

The overall duration of the project for each participant is 6 months from enrolment to completion of final sessions.
Intervention code [1] 330668 0
Behaviour
Comparator / control treatment
The baseline measurement of behaviour during care as usual will act as the control condition. In this small-N design, each participant acts as their own control and is exposed to all conditions of intervention.
Control group
Active

Outcomes
Primary outcome [1] 340917 0
Engagement with rehabilitation activities - defined objectively for each individual participant.
Timepoint [1] 340917 0
Repeated measures - data collected in every baseline, functional assessment, and intervention session that occurs for 6 months from enrolment.
Primary outcome [2] 340918 0
Indices of affect (including facial expression, vocalisations, body language). Behaviours to be operationally defined for each participant - composite outcome.
Timepoint [2] 340918 0
Repeated measures - data collected in every baseline, functional assessment, and intervention session that occurs for 6 months from enrolment.
Secondary outcome [1] 445438 0
Acceptability of assessment and intervention (participant) - composite outcome.
Timepoint [1] 445438 0
At the time of enrolment, after assessment phases and after the last intervention session,
Secondary outcome [2] 445439 0
Acceptability of assessment and intervention (whanau and professional carer) - composite outcome.
Timepoint [2] 445439 0
At the time of enrolment, after assessment phases, and after the last intervention session.

Eligibility
Key inclusion criteria
Group 1: People diagnosed with a brain injury prior to participating in the study (i.e., have an existing, independent diagnosis).
Group 2. Whanau/ family members of participants with a brain injury.
Group 3. Professional caregivers or support staff members who provide care to participants with a brain injury.

Participants must be over 16 years old in order to be included as a legal adult in NZ.

We also do not have a criterion for specific diagnosis (e.g., type brain injury). We are not seeking to make broad generalisations about people with a specific diagnosis, but start to understand some of the factors that should be considered helping people get the most out of rehabilitation. As such, and due to our small-N design approach, we are not seeking an homogenous sample.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with a brain injury who are unable to provide informed consent.

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
Behaviour-analytic approaches will be employed. The majority of the data will be collected by direct observational measurement of behaviours and environmental variables, operationally defined, and collected via pen-and-paper methods (e.g., Johnson & Pennypacker, 2009; Sharp, Mudford, & Elliffe, 2015). Experimental control will be demonstrated with small-N designs, which do not require statistical analyses. In a small-N design, each participant serves as their own control, and is exposed to all conditions.
Comparisons of behaviour are made within a participant rather than across participants and we conduct repeated measures of our behaviour of interest (i.e., we measure behaviour throughout each session and phase rather than just pre- and post-intervention). We will use visual inspection of graphed data (based on baseline logic; Kazdin, 1982), a common method of data analysis employed in most of behaviour-analytic research. This involves tracking data visually on graphs, and making data-based decisions during the
study. Under this approach, small samples can be highly informative. A key component of small-N design is that we publish our methods in detail (principle of technological). This enables replication; as a field, we are more likely to conduct 20 studies including 5 participants in each rather than one study with 100 participants. This approach allows for a nuanced evaluation of the individual factors that contribute to the effectiveness of an intervention. When working with people with major neurocognitive disorder, a small-N
approach is useful because experimental control is unaffected by individual differences in behaviour (see Steingrimsdottir & Artnzen, 2015 for a detailed discussion).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2027
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26924 0
New Zealand
State/province [1] 26924 0

Funding & Sponsors
Funding source category [1] 318601 0
University
Name [1] 318601 0
The University of Auckland
Country [1] 318601 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321002 0
None
Name [1] 321002 0
Address [1] 321002 0
Country [1] 321002 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317203 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317203 0
Ethics committee country [1] 317203 0
New Zealand
Date submitted for ethics approval [1] 317203 0
30/01/2025
Approval date [1] 317203 0
Ethics approval number [1] 317203 0

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

Contacts
Principal investigator
Name 140330 0
Dr Rebecca Sharp
Address 140330 0
Science Centre, Symonds Street, Auckland, 1010, The University of Auckland
Country 140330 0
New Zealand
Phone 140330 0
+64 09 923 2073
Fax 140330 0
Email 140330 0
[email protected]
Contact person for public queries
Name 140331 0
Rebecca Sharp
Address 140331 0
Science Centre, Symonds Street, Auckland, 1010, The University of Auckland
Country 140331 0
New Zealand
Phone 140331 0
+64 09 923 2073
Fax 140331 0
Email 140331 0
[email protected]
Contact person for scientific queries
Name 140332 0
Rebecca Sharp
Address 140332 0
Science Centre, Symonds Street, Auckland, 1010, The University of Auckland
Country 140332 0
New Zealand
Phone 140332 0
+64 09 923 2073
Fax 140332 0
Email 140332 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.