Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000771651
Ethics application status
Approved
Date submitted
11/07/2014
Date registered
21/07/2014
Date last updated
30/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding Successful Employment for Adults with High Functioning Autism/ Asperger's Syndrome.
Scientific title
Understanding successful employment for adults with high functioning autism/ Asperger's Syndrome: Development of the Integrated Employment Success Tool.
Secondary ID [1] 284960 0
Nil
Universal Trial Number (UTN)
Trial acronym
Trial acrynom is IEST (Integrated Employment Success Tool).
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 292450 0
Condition category
Condition code
Mental Health 292767 292767 0 0
Autistic spectrum disorders
Physical Medicine / Rehabilitation 292768 292768 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention that will be used is called the Integrated Employment Success Tool (IEST). The IEST is a ‘protocol’/ ’checklist’ tool to be used by employers of adults with HFA/AS to create an awareness of the characteristics of adults with HFA/AS and subsequently identifies possible areas of environmental workplace difficulties that may occur. It highlights what possible actions and/or modification are required to resolve these difficulties and recommends services, products or educational training courses that can be accessed to assist in creating a suitable workplace environment for the adult with HFA/AS, employers and co-workers.
Intervention code [1] 289789 0
Rehabilitation
Comparator / control treatment
The control/comparator group is referred to as the 'Treatment As Usual' Group. This group will receive the treatment/intervention that is typically issued by Disability Employment Service Providers for adults with HFA/AS. This may include: on-the-job support, training and/or counselling for job seekers.
Control group
Active

Outcomes
Primary outcome [1] 292617 0
Successful employment for adults with HFA/AS. This will be measured through the evaulation of the IEST tool.
Timepoint [1] 292617 0
Baseline measurements will occur and then repeated at 1, 3, 6 and 18 months.
Primary outcome [2] 292619 0
Employer Satisfaction will be measured through a survey.
Timepoint [2] 292619 0
Baseline measurements will occur and then repeated at 1, 3, 6 and 18 months.
Secondary outcome [1] 322310 0
Employer attitudes toward employees with disabilities in the workplace. Employer attitudes will be measured using the Workers Scale.
Timepoint [1] 322310 0
This will be measured at baseline, 3, 6 and 18 months.

Eligibility
Key inclusion criteria
Employers/managers/supervisors (N=80) who support and/or assist employees with HFA/ASD in their workplace on a regular basis. Adults with a diagnosis of HFA/AS who are seeking open employment.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults with HFA/AS and co-morbid conditions including: Attention Deficit Hyperactivity Disorder (ADHD), epilepsy, major depression and psychotic disorders.

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)
A cluster RCT will be undertaken with adults with HFA/AS and their prospective workplace. Instead of the participants being allocated to an intervention, randomisation of the workplaces will occur. Therefore, once participants seeking employment through Centrelink and/or Disability Employment Services are employed, clustering and randomising of the workplaces will occur. Participants will then either be allocated to the ‘IEST Intervention’ group or the ‘Treatment as Usual’ group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants who go through a Disability Employment Service (DES) provider, will be allocated a workplace as per normal procedure. The DES will be unaware as to which group the participants will be allocated to, i.e., either the IEST group workplace or the TreatmentAs Usual group workplace. DES will be concealed from this group allocation process. Allocation will involve contacting the holder of the allocation schedule who is 'off-site'.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Group equivalence at baseline will be determined on type of employment and/or workplace. The sample size of 80 will allow for the effect size of 0.6 or larger with a ß-level of 0.2 and an a-level of 0.05. This sample size allows for expected attrition rate that may occur throughout the period of the study trial. ANOVA will be used to analyse the difference; within individuals, within groups and between the groups

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
23/11/2015
Date of last participant enrolment
Anticipated
16/09/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NT,SA,TAS

Funding & Sponsors
Funding source category [1] 289583 0
Commercial sector/Industry
Name [1] 289583 0
Autism Cooperative Research Centre (Autism CRC)
Country [1] 289583 0
Australia
Funding source category [2] 289584 0
University
Name [2] 289584 0
Curtin University
Country [2] 289584 0
Australia
Primary sponsor type
Individual
Name
Professor Torbjorn Falkmer
Address
Level 3 Building 401
School of Occupational Therapy and Social Work
Curtin University
Kent Street
Bentley
Western Australia
6102
Country
Australia
Secondary sponsor category [1] 288268 0
Individual
Name [1] 288268 0
Dr Marita Falkmer
Address [1] 288268 0
Level 2 Building 400
School of Occupational Therapy and Social Work
Curtin University
Kent Street
Bentley
Western Australia
6102
Country [1] 288268 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291320 0
Human Research Ethics Committee Curtin University
Ethics committee address [1] 291320 0
Ethics committee country [1] 291320 0
Australia
Date submitted for ethics approval [1] 291320 0
27/05/2014
Approval date [1] 291320 0
15/07/2014
Ethics approval number [1] 291320 0
HR 141/2014

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

Contacts
Principal investigator
Name 49854 0
Prof Torbjorn Falkmer
Address 49854 0
Level 3 Building 401
School of Occupational Therapy and Social Work
Curtin University
Kent Street
Bentley
Western Australia
6102
Country 49854 0
Australia
Phone 49854 0
+61 8 9266 9051
Fax 49854 0
Email 49854 0
[email protected]
Contact person for public queries
Name 49855 0
Marita Falkmer
Address 49855 0
Level 2 Building 400
School of Occupational Therapy and Social Work
Curtin University
Kent Street
Bentley
Western Australia
6102
Country 49855 0
Australia
Phone 49855 0
+61 8 9266 3605
Fax 49855 0
Email 49855 0
[email protected]
Contact person for scientific queries
Name 49856 0
Torbjorn Falkmer
Address 49856 0
Level 3 Building 401
School of Occupational Therapy and Social Work
Curtin University
Kent Street
Bentley
Western Australia
6102
Country 49856 0
Australia
Phone 49856 0
+61 8 9266 9051
Fax 49856 0
Email 49856 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEvaluating the Effectiveness of an Autism-Specific Workplace Tool for Employers: A Randomised Controlled Trial.2018https://dx.doi.org/10.1007/s10803-018-3611-0
N.B. These documents automatically identified may not have been verified by the study sponsor.