ANZCTR - Registration

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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]

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

Stroke

Aphasia

Condition category

Condition code

Stroke

Ischaemic

Mental Health

Studies of normal psychology, cognitive function and behaviour

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

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]

Prevention

Intervention code [2]

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]

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]

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]

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]

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,TAS,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

La Trobe University

Address [1]

Kingsbury Drive, Bundoora, Vic 3083

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Kingsbury Drive, Bundoora, Vic 3083

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Technology Sydney

Address [1]

Graduate School of Psychology, 15 Broadway, Ultimo, New South Wales, 2007

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University Human Ethics Committee

Ethics committee address [1]

Kingsbury Drive, Bundoora, Vic 3083

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/08/2020

Ethics approval number [1]

HEC20293

Ethics committee name [2]

UTS Human Research Ethics Committee

Ethics committee address [2]

The University Of Technology Sydney, 15 Broadway, Ultimo, New South Wales, 2007

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

19/10/2020

Ethics approval number [2]

ETH20-5453

Summary

Brief summary

Aphasia, an acquired language disorder affecting everyday communication, most commonly occurs after stroke with an incidence of approximately 30% of stroke survivors. Aphasia is associated with poor mental health with a high prevalence of anxiety and depression in both stroke survivors and their families. 
Speech pathology services include the provision of informational and personal adjustment counselling with regard to communication disorders. Speech pathologists frequently report providing counselling to support the psychological wellbeing in this client group but the majority report low knowledge, skills, confidence, and satisfaction in this practice (Rose et al, 2014).
A systematic review of counselling training for speech pathologists working with people affected by poststroke aphasia found that prequalification counseling training is variable and limited with some speech pathology training courses not offering any. Where offered, counselling training for working in poststroke aphasia is limited to less than three hours of counselling observation, coursework, and practicum.
After qualification, speech pathologists seek a wide range of counselling training and approaches from external sources ranging from short courses to doctorates in counselling and psychology in an array of approaches including in motivational interviewing, solution-focused brief training, narrative therapy, and basic counselling skills (Sekhon, Oates, Kneebone & Rose, 2019).
Some stroke services provide lowlevel training (by clinical psychologists) to support the psychological needs of stroke survivors. This can include, for example, person centered, solution-focused, and problem-solving approaches. However, a majority of these studies are of low quality with a variety of outcomes and unvalidated measures (checklists) used in evaluating counseling training. Counselling training (of one day or more) is significantly and positively associated with speech pathologists' selfreported confidence and competence in counselling for managing psychological concerns in stroke survivors with aphasia and their carers (Sekhon, Oates, Kneebone & Rose, 2019).
Research questions: 
1) What is the effect of an online counselling training module for supporting psychological wellbeing (IV) on 
a) speech pathologists’ self-efficacy (DV) for counselling in post-stroke aphasia? 
b) speech pathologists’ self-reported confidence (DV) for 8 counselling skills (including self-reported competence for counselling) relevant in post-stroke aphasia?
2) Are effects of the training maintained at 4-weeks post-training?

If this training module is effective, speech pathologists who feel they have low knowledge, skills, or confidence in supporting psychological wellbeing in post-stroke aphasia rehabilitation may gain confidence and self-efficacy from undertaking this training.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Miranda Rose

Address

School of Allied Health, Human Services & Sport, La Trobe University, Kingsbury Drive, Bundoora, Vic 3083

Country

Australia

Phone

+61 3 94792088

Fax

m.rose@latrobe.edu.au

Contact person for public queries

Name

Miranda Rose

Address

School of Allied Health, Human Services & Sport, La Trobe University, Kingsbury Drive, Bundoora, Vic 3083

Country

Australia

Phone

+61 3 94792088

Fax

m.rose@latrobe.edu.au

Contact person for scientific queries

Name

Miranda Rose

Address

School of Allied Health, Human Services & Sport, La Trobe University, Kingsbury Drive, Bundoora, Vic 3083

Country

Australia

Phone

+61 3 94792088

Fax

m.rose@latrobe.edu.au

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, (M.Rose@latrobe.edu.au) 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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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