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Trial registered on ANZCTR


Registration number
ACTRN12614000738628
Ethics application status
Approved
Date submitted
1/07/2014
Date registered
11/07/2014
Date last updated
26/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapy Outcomes By You - TOBY Playpad an early intervention trial for children with autism.
Scientific title
Multi-site single-blind randomised controlled trial of an iPad delivered intervention to complement therapy for children with an autism spectrum disorder: The TOBY Playpad Clinical Trial
Secondary ID [1] 284886 0
Nil
Universal Trial Number (UTN)
U1111-1158-6423
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 292324 0
Condition category
Condition code
Mental Health 292662 292662 0 0
Autistic spectrum disorders
Public Health 292663 292663 0 0
Health promotion/education
Physical Medicine / Rehabilitation 299947 299947 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is primarily delivered by parents using an iPad based application for at least 20-30 minutes per day over 6 months. The intervention follows a early learning curriculum based on evidence-based practices about childhood development. The curriculum covers learning areas such as imitation skills; sensory discrimination; early joint attention skills; early receptive and expressive language skills. The curriculum is delivered in two ways 1) On-iPad activities are designed for children to complete, 2) Off-iPad activities are designed for parents to implement as part of Natural Environment Tasks during routine adaptive routines and play times with their child affected by autism.
This intervention can be used as a complement to any other community therapy a child might be receiving. Intervention adherence is monitored using an objective - electronic report upload system through the App and parent-report diaries of TOBY and other community therapy frequency and duration.
Intervention code [1] 289718 0
Behaviour
Intervention code [2] 295748 0
Treatment: Other
Comparator / control treatment
Any early intervention or community therapy 'as usual' - as part of standard care.
Control group
Active

Outcomes
Primary outcome [1] 292527 0
Autism Treatment Evaluation Checklist (ATEC).
Timepoint [1] 292527 0
Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).
Secondary outcome [1] 309153 0
Mullen Scale of Early Learning (MSEL).
Timepoint [1] 309153 0
Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).
Secondary outcome [2] 309269 0
MacArthur Communicative Development Inventory (MCDI) Words & Gestures and Words & Sentences.
Timepoint [2] 309269 0
Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).
Secondary outcome [3] 309270 0
Communication and Symbolic Behaviour Scales (CSBS)
Timepoint [3] 309270 0
Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).
Secondary outcome [4] 309271 0
Repetitive Behaviour Scale (RBS).
Timepoint [4] 309271 0
Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).
Secondary outcome [5] 309272 0
Behaviour Flexibility Rating Scale (BRFS).
Timepoint [5] 309272 0
Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).
Secondary outcome [6] 309273 0
Parenting Stress Index (PSI- SF).
Timepoint [6] 309273 0
Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).
Secondary outcome [7] 309274 0
Parenting Sense of Competence Scale (PSCS).
Timepoint [7] 309274 0
Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).
Secondary outcome [8] 309275 0
Family Empowerment Scale (FES).
Timepoint [8] 309275 0
Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).

Eligibility
Key inclusion criteria
Males or females with a diagnosis of an Autism Spectrum Disorder (Autistic Disorder, PDD-NOS or Asperger’s Disorder) based on DSM-IV-TR guidelines, and confirmed with the Autism Diagnostic Observation Schedule (ADOS):
1) Within the past 12 months of initial diagnosis
2) 4 years of age or younger
Minimum age
No limit
Maximum age
51 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of Rett’s Disorder, Childhood Disintegrative Disorder or a neurodevelopmental disorder of known aetiology (e.g., Fragile X)
1) Significant sensory or motor impairment
2) Major physical problems
3) Unstable seizure disorder
4) Use of psychoactive medication
5) History of head injury and/or neurologic disease
6) Alcohol or drug exposure in utero

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)
An initial eligibility screening phone call (10 minutes) will be based on the inclusion and exclusion criteria. Upon meeting the eligibility screening and willingness to take part in the trial, pre trial - baseline assessments (3 hours) will be conducted. Random allocation by computer will be generated. Participants will be advised of group allotment (therapy as usual - comparison group) or (therapy as usual plus TOBY App - intervention group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified permuted block randomisation using a random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Single-blind
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be performed on an intention-to-treat basis including all participants with outcomes data available. The primary outcome- total score on the ATEC (range 0-180) at Time Point 1, 2 and 3 will be analysed using a repeated measures ANOVA method. Based on the study investigator's clinical judgment in managing children with autism, a score of 72 (50th centile) and a difference of 1SD=32 (30th-70th centile)) on the ATEC can represent clinically important improvement in autism symptoms. This intervention aims to find a moderate effect size of 0.5 with 80% power and two-sided alpha of 0.05. This will require a sample of 64 participants per treatment group. Allowing for a 10% drop-out rate, 70 participants will be required per treatment group, thus, the trial aims to recruit a total of 140 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
15/07/2013
Date of last participant enrolment
Anticipated
31/10/2014
Actual
31/10/2014
Date of last data collection
Anticipated
15/07/2015
Actual
15/07/2015
Sample size
Target
140
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment postcode(s) [1] 8422 0
3086 - La Trobe University
Recruitment postcode(s) [2] 8423 0
3217 - Deakin University
Recruitment postcode(s) [3] 8399 0
3800 - Monash University
Recruitment postcode(s) [4] 8398 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 289525 0
Charities/Societies/Foundations
Name [1] 289525 0
Australian Children's Trust
Country [1] 289525 0
Australia
Funding source category [2] 289526 0
Charities/Societies/Foundations
Name [2] 289526 0
Helen MacPherson Smith Trust
Country [2] 289526 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
100 Roberts Road
Subiaco Western Australia 6008
Country
Australia
Secondary sponsor category [1] 288212 0
University
Name [1] 288212 0
Monash University
Address [1] 288212 0
Krongold Building
Faculty of Education
Clayton, Victoria, 3800
Australia
Country [1] 288212 0
Australia
Other collaborator category [1] 278024 0
University
Name [1] 278024 0
La Trobe University
Address [1] 278024 0
Olga Tennison Autism Research Centre
School of Psychological Science
Bundoora 3086 Victoria Australia
Country [1] 278024 0
Australia
Other collaborator category [2] 278025 0
University
Name [2] 278025 0
Deakin University
Address [2] 278025 0
Centre for Pattern Recognition and Data Analytics (PRaDA), Geelong Campus at Waurn Ponds, Victoria 3217 Australia
Country [2] 278025 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291267 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 291267 0
35 Stirling Hwy
Crawley, WA 6009
Ethics committee country [1] 291267 0
Australia
Date submitted for ethics approval [1] 291267 0
Approval date [1] 291267 0
22/11/2012
Ethics approval number [1] 291267 0
RA415656

Summary
Brief summary
There is now a substantial evidence base for a range of treatment strategies that target the core features of autism spectrum disorders (ASD). Educational and behavioural interventions in particular have been the focus of several well-designed studies that have reported benefits of intense and sustained therapy. However, the effectiveness of these interventions depends on significant therapy time with trained clinicians, and come at considerable financial cost. Thus, a significant proportion of families are unable to access these therapies. Any activities that can improve the time- and cost-effectiveness of early intervention, and are proven to enhance the longer-term outcomes among individuals with ASD, will provide enormous benefit to the community.
TOBY (Therapy Outcomes By You) Playpad, an iPad App developed by a team of computer scientists, psychologists and speech pathologists, is one such tool that may enable a more cost-effective way to provide therapy to children with ASD. The TOBY curriculum covers social skills, language, sensory discrimination, and cognitive skills, using Applied behavioural analysis (ABA) principles. While TOBY was not designed to replace one-on-one therapy with clinicians, it may provide an affordable (RRP: $27.99AUD) and easily accessible intervention method to complement existing therapy. Anecdotal reports suggest that TOBY may be an effective intervention method for children with ASD, and also a means of positively empowering parents by giving them greater control over their child’s therapy. However TOBY is yet to be subjected to a randomized controlled trial.

1.To determine the effectiveness of the TOBY Playpad app as a complement to early behavioural intervention using a multi-site single-blind, randomized controlled design.
2.To examine whether the use of TOBY influences parental empowerment in relation to therapy.

Further information on TOBY Playpad, can be found at: http://tobyplaypad.com/
Trial website
http://tobyplaypad.com/latest-news/
Trial related presentations / publications
http://telethonkids.org.au/news-events/media-releases/2013/august/app-for-autism/

http://autism.telethonkids.org.au/our-research/toby-trial/
Public notes

Contacts
Principal investigator
Name 44910 0
Prof Andrew Whitehouse
Address 44910 0
Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008
Country 44910 0
Australia
Phone 44910 0
61 8 9489 7770
Fax 44910 0
Email 44910 0
andrew.whitehouse@telethonkids.org.au
Contact person for public queries
Name 44911 0
Mrs Joanna Granich
Address 44911 0
Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008
Country 44911 0
Australia
Phone 44911 0
61 8 9489 7749
Fax 44911 0
Email 44911 0
joanna.granich@telethonkids.org.au
Contact person for scientific queries
Name 44912 0
Mrs Joanna Granich
Address 44912 0
Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008
Country 44912 0
Australia
Phone 44912 0
61 8 9489 7749
Fax 44912 0
Email 44912 0
joanna.granich@telethonkids.org.au

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
EmbaseRandomised controlled trial of an iPad based early intervention for autism: TOBY playpad study protocol.2016https://dx.doi.org/10.1186/s12887-016-0704-9
N.B. These documents automatically identified may not have been verified by the study sponsor.