Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000745640
Ethics application status
Not yet submitted
Date submitted
26/06/2014
Date registered
14/07/2014
Date last updated
14/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The TOBY playpad intervention study in rural Western Australia: Examining its effectiveness as a complementary therapy for 2-6 year olds recently diagnosed with Autism Spectrum Disorder
Scientific title
The TOBY playpad intervention study in rural Western Australia: Examining its effectiveness as a complementary therapy for 2-6 year olds recently diagnosed with Autism Spectrum Disorder
Secondary ID [1] 284859 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 292257 0
Condition category
Condition code
Mental Health 292604 292604 0 0
Autistic spectrum disorders
Physical Medicine / Rehabilitation 292605 292605 0 0
Occupational therapy
Physical Medicine / Rehabilitation 292606 292606 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TOBY Playpad is a unique, therapist-and-parent designed Early Intervention application for children with Autism. TOBY’s iPad tasks co-ordinate with off-iPad tasks to help your child learn skills in the real world. TOBY stands for Therapy Outcomes By You, because it aims to empower parents to commence early intervention to maximize your child’s development.

Children will be provided with an i-Pad with the TOBY Playpad App installed. Parents will be required to attend an interactive parent information session providing training on the effective use of the TOBY App.

For the length of the trial, the parent and child will be asked to complete at least 20 minutes of therapy from the TOBY App each day for 6-months. This will be in addition to any other therapy the child is already undergoing outside of this study.


The Playpad software will monitor adherence to the intervention.

At the conclusion of the trial (at 6 months), the parent will be asked to return the iPad to the research team at Curtin University.
Intervention code [1] 289660 0
Rehabilitation
Intervention code [2] 289786 0
Treatment: Devices
Comparator / control treatment
Routine Therapy is used to refer to any other therapy the child is already undergoing outside of this study.

The control group will be offered the intervention after 6 months
Control group
Active

Outcomes
Primary outcome [1] 292452 0
Social -Communicative skills using the The MacArthur Communicative Development Inventories (CDIs) and the Communication and Symbolic Behavior Scale (CSBS)
Timepoint [1] 292452 0
Baseline, 3, 6 and 9 months
Primary outcome [2] 292615 0
Cognitive and motor abilities using the Mullen Scales of Early Learning (D)
Timepoint [2] 292615 0
Baseline, 6 and 9 months
Primary outcome [3] 292616 0
Repetitive behaviour using the Repetitive Behaviour Scale
Timepoint [3] 292616 0
Baseline, 3, 6 and 9 months
Secondary outcome [1] 308985 0
Parental Satisfaction with TOBY app using a specially designed questionnaire
Timepoint [1] 308985 0
Baseline
Three, Six, and Nine months post intervention
Secondary outcome [2] 309345 0
Parental Stress using the Parental Stress Inventory
Timepoint [2] 309345 0
Baseline
Three, Six, and Nine months post intervention

Eligibility
Key inclusion criteria
Families with a child aged between 2-6 years who has recently been diagnosed with Autism Spectrum Disorder (ASD); and
residing in the rural regions of the South West, Greater Southern, Wheatbelt, and Goldfieds-Esperance.
Minimum age
2 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children without an ASD diagnosis, and greater than 6 years in age at the time of entry into the study
Families residing in metropolitan Perth

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A randomized, wait-list controlled clinical trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289473 0
Charities/Societies/Foundations
Name [1] 289473 0
Val Lishman Health Research Foundation Inc
Country [1] 289473 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Occupational Therapy and Social Work
GPO Box U1987, Perth
Western Australia. 6845
Country
Australia
Secondary sponsor category [1] 288160 0
None
Name [1] 288160 0
Address [1] 288160 0
Country [1] 288160 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291230 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291230 0
Ethics committee country [1] 291230 0
Australia
Date submitted for ethics approval [1] 291230 0
27/06/2014
Approval date [1] 291230 0
Ethics approval number [1] 291230 0

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

Contacts
Principal investigator
Name 49422 0
Prof Torbjorn Falkmer
Address 49422 0
Curtin University
School of Occupational Therapy and Social Work
Kent Street, Bentley, Perth
Western Australia 6102
Country 49422 0
Australia
Phone 49422 0
+ 61 8 9266 9051
Fax 49422 0
+61 8 9266 3636
Email 49422 0
[email protected]
Contact person for public queries
Name 49423 0
Sharmila Vaz
Address 49423 0
Curtin University
School of Occupational Therapy and Social Work
Kent Street, Bentley, Perth
Western Australia 6102
Country 49423 0
Australia
Phone 49423 0
+ 61 8 9266 1849
Fax 49423 0
+61 8 9266 3636
Email 49423 0
[email protected]
Contact person for scientific queries
Name 49424 0
Sharmila Vaz
Address 49424 0
Curtin University
School of Occupational Therapy and Social Work
Kent Street, Bentley, Perth
Western Australia 6102
Country 49424 0
Australia
Phone 49424 0
+ 61 8 9266 1849
Fax 49424 0
+61 8 9266 3636
Email 49424 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
No additional documents have been identified.