Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001283965
Ethics application status
Approved
Date submitted
16/09/2020
Date registered
27/11/2020
Date last updated
3/12/2020
Date data sharing statement initially provided
27/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the effect of a counselling training module on speech pathologists’ self­-efficacy and self-­report of competence for counselling in post­-stroke aphasia? A Pilot Randomised Controlled Trial.
Scientific title
What is the effect of a counselling training module on speech pathologists’ self­-efficacy and self-­report of competence for counselling in post­-stroke aphasia? A Pilot Randomised Controlled Trial.
Secondary ID [1] 302176 0
None
Universal Trial Number (UTN)
U1111-1257-6289
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Psychological wellbeing 318840 0
Stroke 318841 0
Aphasia 318842 0
Condition category
Condition code
Stroke 316845 316845 0 0
Ischaemic
Mental Health 316846 316846 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 316847 316847 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 317505 317505 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Counseling training to support psychological wellbeing in post-stroke aphasia will be delivered online and completed over two weeks. Participants will be encouraged to complete the four hours of self-directed learning (delivered via La Trobe Univerisity's Learning Management System-LMS) in the first week and are required to attend 2 x 2-hour workshops (via teleconference) scheduled during the 2nd week of the course. Participant activity including login to LMS, completion of sections (ascertained by a short knowledge quiz), and attendance to the online workshops will be used to monitor adherence.
Counselling training will be based on low-level (Level 1 and 2) approaches of the Stepped Psychological Care for Stroke model (Gilham & Clarke, 2011; Kneebone, 2016). Psychological issues at Level 1 pertain to transient and sub-threshold (subclinical) psychological issues common to most or all stroke survivors. Psychological intervention and support at Level 1 may be provided by stroke survivor peers and all members of the stroke multidisciplinary team including speech pathologists (Gilham & Clarke, 2011; Kneebone, 2016). Level 2 approaches include brief psychological approaches such as problem-solving and motivational interviewing. Appropriately trained speech pathologists may utilize these approaches to support psychological wellbeing with the support from stroke mental health professionals. Principles of adult learning will be used in the counselling training. The training will be conducted by a speech pathologist with experience in stroke rehabilitation and with training in Level 1 approaches who is supervised by a specialist stroke clinical psychologist, and speech pathologists with specialization in aphasia, cognitive linguistics, counselling, and psychology.
Data will be collected at 3­ time points for the experimental group (A) and at 4­ time points for the control group (B) using online surveys from the La Trobe University REDCap platform.
Intervention code [1] 318620 0
Prevention
Intervention code [2] 318621 0
Rehabilitation
Comparator / control treatment
A matched control group will receive the intervention after a delay of two weeks.
Control group
Active

Outcomes
Primary outcome [1] 325148 0
The primary outcome will be speech pathologists' perceived self­-efficacy for counselling in post­-stroke aphasia using the Self­ Efficacy for Counselling in Communication Disorders Scale which consists of 35 closed questions rated on a 6-point ranked scale (Victorino and Hinkle, 2019).
Timepoint [1] 325148 0
Data will be collected at 3­ time points for the experimental group (A) and at 4­ time points for the control group (B) (with 2 x pre-training data points) using online surveys from the La Trobe University REDCap platform. Time points include pre-training, post-training, and at follow up four weeks post-training.
Secondary outcome [1] 387001 0
A secondary outcome, self-­rated competency for counselling in post-stroke aphasia will be assessed using an 8-item checklist developed specifically for this study (Sekhon et al., 2019).
Timepoint [1] 387001 0
Data will be collected at 3­ time points for the experimental group (A) and at 4­ time points for the control group (B) (with 2 x pre-training data points) using online surveys from the La Trobe University REDCap platform. Time points include pre-training, post-training, and at follow up four weeks post-training.
Secondary outcome [2] 387002 0
A secondary outcome of maintained training effects will be measured using the Self­-Efficacy for Counselling in Communication Disorders Scale (Victorino and Hinkle, 2019) and a checklist of self-­rated competency or counselling in post-stroke aphasia developed specifically for this study (Sekhon et al., 2019).
Timepoint [2] 387002 0
Data will be collected at 3­ time points for the experimental group (A) and at 4­ time points for the control group (B) (with 2 x pre-training data points) using online surveys from the La Trobe University REDCap platform. Time points include pre-training, post-training, and at follow up four weeks post-training.

Eligibility
Key inclusion criteria
Speech pathologists working with clients affected by post-stroke aphasia in Australia.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Speech pathologists who are not working in a clinical role with people affected by post-stroke aphasia.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Stratification and randomisation of groups conducted using REDCap software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification employed using previous counselling training and co-work with mental health professionals.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Waitlisted control where the control group receives the intervention after two weeks delay.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be analysed using t-tests to compare mean scores. Independent (between-group) t-tests will be used for answering the primary question: What is the effect of an online counselling training module for supporting psychological wellbeing (IV) on speech pathologists’ self-efficacy for counselling in post-stroke aphasia (DV)? and the secondary question What is the effect of an online counselling training module for supporting psychological wellbeing (IV) on speech pathologists' self-rated competency for counselling in post-stroke aphasia (DV)? Effect size using Cohen’s d and standard deviations will be reported.

Dependent (within group) t-test will be used to compare mean scores to answer the secondary question: Are training effects are maintained after 4 weeks (at follow up)?

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
31/05/2021
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC

Funding & Sponsors
Funding source category [1] 306600 0
University
Name [1] 306600 0
La Trobe University
Country [1] 306600 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive, Bundoora, Vic 3083
Country
Australia
Secondary sponsor category [1] 307311 0
University
Name [1] 307311 0
University of Technology Sydney
Address [1] 307311 0
Graduate School of Psychology, 15 Broadway, Ultimo, New South Wales, 2007
Country [1] 307311 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306785 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 306785 0
Ethics committee country [1] 306785 0
Australia
Date submitted for ethics approval [1] 306785 0
Approval date [1] 306785 0
12/08/2020
Ethics approval number [1] 306785 0
HEC20293
Ethics committee name [2] 307208 0
UTS Human Research Ethics Committee
Ethics committee address [2] 307208 0
Ethics committee country [2] 307208 0
Australia
Date submitted for ethics approval [2] 307208 0
Approval date [2] 307208 0
19/10/2020
Ethics approval number [2] 307208 0
ETH20-5453

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

Contacts
Principal investigator
Name 105014 0
Prof Miranda Rose
Address 105014 0
School of Allied Health, Human Services & Sport, La Trobe University, Kingsbury Drive, Bundoora, Vic 3083
Country 105014 0
Australia
Phone 105014 0
+61 3 94792088
Fax 105014 0
Email 105014 0
[email protected]
Contact person for public queries
Name 105015 0
Miranda Rose
Address 105015 0
School of Allied Health, Human Services & Sport, La Trobe University, Kingsbury Drive, Bundoora, Vic 3083
Country 105015 0
Australia
Phone 105015 0
+61 3 94792088
Fax 105015 0
Email 105015 0
[email protected]
Contact person for scientific queries
Name 105016 0
Miranda Rose
Address 105016 0
School of Allied Health, Human Services & Sport, La Trobe University, Kingsbury Drive, Bundoora, Vic 3083
Country 105016 0
Australia
Phone 105016 0
+61 3 94792088
Fax 105016 0
Email 105016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified analyzed group information and results.
When will data be available (start and end dates)?
Data will be available approximately 6 months after the study ends and available for 5 years after publication.
Available to whom?
Only non-identifiable data will be shared upon request to the research team and approved by the Human Ethics Committee of La Trobe University. Data will be shared using the secure CloudStor FileSender tool, which allows for client-side file encryption option and set expiry date. All files shared will be locked to editing.
Available for what types of analyses?
Data is available to achieve the aims in the approved proposal and related projects, which includes a proposed nested qualitative study evaluating the feasibility and acceptability of this training module.
How or where can data be obtained?
By emailing the principal investigator, Professor Miranda Rose, ([email protected]) and subject to approval from La Trobe Universities Human Ethics Committee.


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.