Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000978167
Ethics application status
Approved
Date submitted
26/06/2019
Date registered
9/07/2019
Date last updated
27/05/2022
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Work and spinal cord injury: developing a vocational service for job-seekers living in the community
Scientific title
Preliminary evaluation of a return-to-work assessment and counselling service for injured job-seekers living in the community
Secondary ID [1] 298353 0
None
Universal Trial Number (UTN)
U1111-1234-2524
Trial acronym
Linked study record
Pilot evaluations of the education control condition used in the current study have previously been undertaken (ACTRN12617000728336, ACTRN12616000812493).

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 313009 0
Condition category
Condition code
Neurological 311514 311514 0 0
Other neurological disorders
Injuries and Accidents 311955 311955 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention participants will receive assessment and coaching by a certified vocational counsellor for 8 weeks. Sessions will target participants' knowledge of, and ability to engage in, job search activities. The delivery and format of sessions will be tailored to participant need and preference but will likely involve up to 60 minutes of individual counselling delivered in-person or via telephone, email and/or videochat (i.e. secure online meetings accessible by password) on a regular (e.g. fortnightly) basis.

In addition, all participants (intervention and control) will have access to a 6-module written educational resource titled ‘Work and SCI’ previously developed and tested by our team. The ‘Work and SCI’ modules will be emailed to participants following enrolment. Modules 1–3 relate to the job-seeking process (e.g. reviewing/recognising one’s vocational skills/interests, knowledge of the labour market. Modules 4–5 relate to job interviewing (e.g. resume writing, interviewing skills). Module 6 focuses on career development and coping with work issues in relation to SCI. Each module contains informative webpages and interactive materials. The modules were designed to be brief, with each taking no more than 15-20 minutes to complete. The modules are self-directed and can be completed at the individual's own pace.

Session attendance and duration with the vocational counsellor will be recorded, with reminder emails/text messages provided to participants (as required).

Sample attrition rate (no. of participants who withdraw from the study) will also be recorded.

All participants will be asked to indicate which of the 6 written 'Work and SCI' modules they accessed during the study.
Intervention code [1] 314594 0
Rehabilitation
Comparator / control treatment
Control participants will be emailed the 6-module ‘Work and SCI’ written resource on enrolment. Control participants will be offered the opportunity to undertake vocational counselling following 8 weeks of data collection (i.e. when pre and post-intervention data has been collected).
Control group
Active

Outcomes
Primary outcome [1] 320217 0
Job Search Behaviour Scale (JSBS). This validated self-report measure, developed by Blau (2004) examines the time and frequency with which participants engage in job search activities.
Timepoint [1] 320217 0
On study enrollment (baseline) and 8 weeks thereafter (i.e. immediately post-intervention)
Secondary outcome [1] 370898 0
Job Search Self-efficacy Scale). This validated scale, developed by Saks et al (2015), examines confidence in one’s ability to perform skills involved in seeking employment.
Timepoint [1] 370898 0
On study enrollment (baseline) and 8 weeks thereafter (i.e. immediately post-intervention)
Secondary outcome [2] 370899 0
Current employment status will be self-reported. This will involve a single survey item asking participants to indicate whether they are currently engaged in paid-employment (i.e. full, part-time or casual work) or whether they are unemployed.
Timepoint [2] 370899 0
On study enrollment (baseline) and 8 weeks thereafter (i.e. immediately post-intervention).

Eligibility
Key inclusion criteria
Adults of working age residing in Australia with a traumatic or non-traumatic spinal cord injury or disorder who are currently unemployed, of working age (<65 years) and want to return to the workforce, with English fluency and access to a computer, tablet or smartphone with internet connection are eligible.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The criteria for exclusion will include those who are medically retired, given the focus is on individuals who have the capacity to work. It is anticipated that people with major cognitive impairments will self-exclude as they are unlikely to access, or benefit from, the study materials.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (e.g. computerised sequence generation: randomizer.org).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be performed on an intention-to-treat basis. Differences in outcomes between groups, at each time point, will be expressed as a standardised mean difference with 95% confidence interval and p value: the comparison at 2 months will be considered primary.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/10/2019
Actual
20/10/2019
Date of last participant enrolment
Anticipated
29/01/2021
Actual
22/04/2020
Date of last data collection
Anticipated
1/04/2021
Actual
22/04/2020
Sample size
Target
30
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296464 0
Government body
Name [1] 296464 0
Lifetime Support Authority of South Australia
Country [1] 296464 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Parapegic and Quadriplegic Association of SA (PQSA)
Address
225 Greenhill Rd, Dulwich SA 5065
Country
Australia
Secondary sponsor category [1] 302845 0
None
Name [1] 302845 0
Address [1] 302845 0
Country [1] 302845 0
Other collaborator category [1] 280713 0
University
Name [1] 280713 0
University of Adelaide
Address [1] 280713 0
North Terrace campus
Hughes Building
Adelaide SA 5005
Country [1] 280713 0
Australia
Other collaborator category [2] 280714 0
University
Name [2] 280714 0
University of Sydney
Address [2] 280714 0
Kolling Institute of Medical Research
Corner Reserve Road & First Avenue
Royal North Shore Hospital
St Leonards NSW 2065
Country [2] 280714 0
Australia
Other collaborator category [3] 280715 0
University
Name [3] 280715 0
University of Technology Sydney
Address [3] 280715 0
15 Broadway
Ultimo NSW 2007 (PO Box 123)
Country [3] 280715 0
Australia
Other collaborator category [4] 280716 0
University
Name [4] 280716 0
La Trobe University
Address [4] 280716 0
School of Psychology and Public Health
Plenty Rd & Kingsbury Dr
Bundoora VIC 3086
Country [4] 280716 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297688 0
University of Adelaide Human Research Ethics committee
Ethics committee address [1] 297688 0
Ethics committee country [1] 297688 0
Australia
Date submitted for ethics approval [1] 297688 0
10/03/2019
Approval date [1] 297688 0
10/04/2019
Ethics approval number [1] 297688 0
H-2019-050

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

Contacts
Principal investigator
Name 74830 0
Dr Diana Dorstyn
Address 74830 0
School of Psychology
Faculty of Health and Medical Sciences
University of Adelaide
North Terrace campus
Level 5 Hughes Building
Adelaide SA 5000
Country 74830 0
Australia
Phone 74830 0
+61 8 8313 0649
Fax 74830 0
Email 74830 0
[email protected]
Contact person for public queries
Name 74831 0
Diana Dorstyn
Address 74831 0
School of Psychology
Faculty of Health and Medical Sciences
University of Adelaide
North Terrace campus
Level 5 Hughes Building
Adelaide SA 5000
Country 74831 0
Australia
Phone 74831 0
+61 8 8313 0649
Fax 74831 0
Email 74831 0
[email protected]
Contact person for scientific queries
Name 74832 0
Diana Dorstyn
Address 74832 0
School of Psychology
Faculty of Health and Medical Sciences
University of Adelaide
North Terrace campus
Level 5 Hughes Building
Adelaide SA 5000
Country 74832 0
Australia
Phone 74832 0
+61 8 8313 0649
Fax 74832 0
Email 74832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval requires that only de-identifiable (group) data, be made publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2947Ethical approval    Confirmation of ethics approval 372943-(Uploaded-09-07-2019-13-54-49)-Study-related document.pdf



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.