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Trial registered on ANZCTR


Registration number
ACTRN12620000491965p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2020
Date registered
20/04/2020
Date last updated
20/04/2020
Date data sharing statement initially provided
20/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Carer's Way Ahead: Helping Families Manage with Challenging Behaviour following Traumatic Brain Injury
Scientific title
The Carer's Way Ahead: An Randomised Control Trial for an Online Psychoeducational Program for Families Managing Challenging Behaviours following Traumatic Brain Injury
Secondary ID [1] 300872 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 316796 0
challenging behaviour 316797 0
emotional well-being 316799 0
carer distress 316800 0
Condition category
Condition code
Neurological 315009 315009 0 0
Other neurological disorders
Mental Health 315010 315010 0 0
Other mental health disorders
Injuries and Accidents 315011 315011 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
'The Carer's Way Ahead' program is a 7-module internet based program specifically tailored for Australian carers managing adult family members with a traumatic brain injury. The program includes two psychoeducational modules: (1) ‘Understanding TBI – the impact on emotions, thinking and behaviour’ (2) ‘The ABCs of behaviour’, which ideally all carers should work through. Four subsequent modules address specific challenging behaviours: (3) ‘Apathy’, (4) ‘Disinhibition’, (5) ‘Social difficulties’ and (6) ‘Irritability/Aggression’. Finally, it contains (7) a self-care module to assist carers manage stress, low mood and other emotional states.

Each module is comprised of around 50 colour slides depicting characters from the four families, a psychologist and narrator. Text in word bubbles is simple with readability at a 12-year-old level. Each module takes about 30 minutes. Each module ends with a lesson summary that can be downloaded upon completing the module. Participants will be encouraged to complete one module per week, and reminded to complete modules through automated emails. Clinical guidance will be provided in the form of email and/or phone contact from clinical psychologists. The participant is also able to contact the clinical at any point during the intervention.
Intervention code [1] 317196 0
Treatment: Other
Intervention code [2] 317197 0
Behaviour
Intervention code [3] 317198 0
Rehabilitation
Comparator / control treatment
The control group consists of a waitlist-control group whereby participants allocated to this condition will receive the treatment but at a later date compared to those in the active condition. The waitlist group will be offered the intervention after they complete the post-assessment, typically after a minimum of 10 weeks from the pre-assessment.
Control group
Active

Outcomes
Primary outcome [1] 323314 0
Changes to the severity of challenging behaviour in the family member with traumatic brain injury (as measured by The Overt Behaviour Scale)
Timepoint [1] 323314 0
A pre-intervention assessment will be done at the time of enrolment and a post-assessment will be completed after the completion of the intervention at 10 weeks. Follow-up will be completed at 6 months and 12 months post intervention.
Secondary outcome [1] 381529 0
Changes to the strategies used by family members in addressing challenging behaviour for their family member with Traumatic Brain Injury (as measured by The Strategy Use Measure - Carers Version)
Timepoint [1] 381529 0
A pre-intervention assessment will be done at the time of enrolment and a post-assessment will be completed after the completion of the intervention at 10 weeks. Follow-up will be completed at 6 months and 12 months post intervention.
Secondary outcome [2] 381530 0
Changes to family strain (as measured by the Carer Strain Index)
Timepoint [2] 381530 0
A pre-intervention assessment will be done at the time of enrolment and a post-assessment will be completed after the completion of the intervention at 10 weeks. Follow-up will be completed at 6 months and 12 months post intervention.
Secondary outcome [3] 381531 0
Changes to symptoms of psychological distress for carers as indexed by the self-report of symptoms of depression, anxiety and stress (as measured by the Depression, Anxiety, and Stress Scale)
Timepoint [3] 381531 0
A pre-intervention assessment will be done at the time of enrolment and a post-assessment will be completed after the completion of the intervention at 10 weeks. Follow-up will be completed at 6 months and 12 months post intervention.
Secondary outcome [4] 381532 0
Changes to social problem solving for the carers of an individual with traumatic brain injury (as measured by the Social Problem Solving Inventory - Short form)
Timepoint [4] 381532 0
A pre-intervention assessment will be done at the time of enrolment and a post-assessment will be completed after the completion of the intervention at 10 weeks. Follow-up will be completed at 6 months and 12 months post intervention.
Secondary outcome [5] 381533 0
Changes to global life satisfaction for the carers of those with traumatic brain injury (as measured by the Satisfaction with Life Scale)
Timepoint [5] 381533 0
A pre-intervention assessment will be done at the time of enrolment and a post-assessment will be completed after the completion of the intervention at 10 weeks. Follow-up will be completed at 6 months and 12 months post intervention.
Secondary outcome [6] 381534 0
Changes to family relations (as measured by the Family Environment Scale)
Timepoint [6] 381534 0
A pre-intervention assessment will be done at the time of enrolment and a post-assessment will be completed after the completion of the intervention at 10 weeks. Follow-up will be completed at 6 months and 12 months post intervention.
Secondary outcome [7] 381535 0
Changes to quality of life (as indexed by the 36 item Short Form Health Questionnaire)
Timepoint [7] 381535 0
A pre-intervention assessment will be done at the time of enrolment and a post-assessment will be completed after the completion of the intervention at 10 weeks. Follow-up will be completed at 6 months and 12 months post intervention.
Secondary outcome [8] 381536 0
Changes to estimated economic benefit associated with improved quality of life for carers (as measured by healthy economic analysis using the CIDI Health Service Use Module & the number of hours of care)
Timepoint [8] 381536 0
A pre-intervention assessment will be done at the time of enrolment and a post-assessment will be completed after the completion of the intervention at 10 weeks. Follow-up will be completed at 6 months and 12 months post intervention.

Eligibility
Key inclusion criteria
1. Adults aged 18 years or over,
2. Identify as a family member or carer of an individual who has experienced a traumatic brain injury
3. Identify as caring for that person
4. Have access to a computer and printer,
5. Prepared to provide your name, phone number, address, and informed consent.
6. Fluent English.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Do not have access to a computer or the internet.
2. Living outside of Australia.
3. Insufficient fluency in English to read materials.

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)
Allocation will be completed by contacting a person off-site who will allocate the participant using sealed opaque envelopes.Allocation will be concealed from the study investigators and the applicant until they meet inclusion criteria for the study and have completed the application questionnaires. The assessor will have no role in randomizing the participant, and randomization will not take place until the participant has been accepted into the trial. Due to the nature of the treatments, allocation cannot be concealed form the participant once they have been allocated to the group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation numbers will be generated using random.org using simple randomisation by a research assistant independent from the study and placed within the opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The control condition will be offered the online training program after a delay and after the completion of the post-intervention assessment.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Post-intervention results will be analysed between active and waitlist-control groups across primary and secondary outcomes, controlling for baseline performance. This will be completed using mixed linear models or analysis of covariance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 29699 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 305323 0
Government body
Name [1] 305323 0
National Health Medical and Research Council
Address [1] 305323 0
16 Marcus Clarke Street Canberra City ACT 2600
Country [1] 305323 0
Australia
Funding source category [2] 305324 0
Commercial sector/Industry
Name [2] 305324 0
iCare NSW
Address [2] 305324 0
321 Kent St, Sydney NSW 2000
Country [2] 305324 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Mathews Building, School of Psychology, University of New South Wales, Kensington, NSW 2051
Country
Australia
Secondary sponsor category [1] 305691 0
Commercial sector/Industry
Name [1] 305691 0
iCare NSW
Address [1] 305691 0
321 Kent St, Sydney NSW 2000
Country [1] 305691 0
Australia
Secondary sponsor category [2] 305693 0
Other
Name [2] 305693 0
Ingham Institute of Applied Medical Research, Liverpool Hospital, Sydney Australia.
Address [2] 305693 0
1 Campbell St, Liverpool NSW 2170
Country [2] 305693 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305662 0
The University of New South Wales Research Ethics Committee
Ethics committee address [1] 305662 0
Human Research Ethics Committee
The University of New South Wales
High Street, Kensington
NSW 2052 Australia
Ethics committee country [1] 305662 0
Australia
Date submitted for ethics approval [1] 305662 0
03/04/2020
Approval date [1] 305662 0
Ethics approval number [1] 305662 0

Summary
Brief summary
Managing challenging behaviour in the home is very difficult for families dealing with an adult relative with a brain injury. It is often difficult to access specialist support, and assistance from a psychologist can be costly and represent a barrier to accessing useful treatment, particularly for those with geographical limitations. In light of this, we recently developed ‘The Carers' Way Ahead’, an internet based program specifically tailored for Australian carers managing adult family members with traumatic brain injury. It is a step by step program, training carers how to implement an treatment approaches to behaviour management. We aim to determine if the program is effective in:
1. Reducing the frequency and intensity of challenging behaviours in the family member with brain injury
2. Improving the well-being of carers compared to families who are not receiving clinical input, including greater social problem solving, decreased strain, increased mood, improved satisfaction with life and improved family relations
3. Yielding health benefits in terms of quality of life and economic benefit

Participants will complete a baseline assessment where they will be asked to fill out various questionnaires. They will then be randomly allocated to receive ‘immediate treatment’ or ‘deferred treatment’ (i.e., waitlist control group). Treatment will involve the family member completing 'The Carer's Way Ahead' program. These include two psychoeducational modules, four modules addressing specific challenging behaviours (i.e., apathy, disinhibition, social difficulties, and aggression) and a self-care module to assist carers manage stress, low mood and other emotional states. Participants will complete these modules over a six to eight week period with support by a clinical psychologist (accessed remotely). They will then complete a post-assessment In the waitlist/deferred condition, participants will be asked to wait 10 weeks before gaining access to the online platform. They will attend a second assessment prior to commencement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101134 0
Prof Skye McDonald
Address 101134 0
1010 Mathews Building
School of Psychology
University of New South Wales
Kensington
NSW 2052
Country 101134 0
Australia
Phone 101134 0
+61 2 9385 3029
Fax 101134 0
Email 101134 0
s.mcdonald@unsw.edu.au
Contact person for public queries
Name 101135 0
Dr Travis Wearne
Address 101135 0
1309 Mathews Building
School of Psychology
University of New South Wales
Kensington
NSW 2052
Country 101135 0
Australia
Phone 101135 0
+61 2 9385 3310
Fax 101135 0
Email 101135 0
t.wearne@unsw.edu.au
Contact person for scientific queries
Name 101136 0
Dr Travis Wearne
Address 101136 0
1309 Mathews Building
School of Psychology
University of New South Wales
Kensington
NSW 2052
Country 101136 0
Australia
Phone 101136 0
+61 2 9385 3310
Fax 101136 0
Email 101136 0
t.wearne@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy concerns
What supporting documents are/will be available?
No other documents available
Summary results
No Results