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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]

Nil

Universal Trial Number (UTN)

U1111-1158-6423

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autism

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Public Health

Health promotion/education

Physical Medicine / Rehabilitation

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]

Behaviour

Intervention code [2]

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]

Autism Treatment Evaluation Checklist (ATEC).

Timepoint [1]

Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).

Secondary outcome [1]

Mullen Scale of Early Learning (MSEL).

Timepoint [1]

Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).

Secondary outcome [2]

MacArthur Communicative Development Inventory (MCDI) Words & Gestures and Words & Sentences.

Timepoint [2]

Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).

Secondary outcome [3]

Communication and Symbolic Behaviour Scales (CSBS)

Timepoint [3]

Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).

Secondary outcome [4]

Repetitive Behaviour Scale (RBS).

Timepoint [4]

Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).

Secondary outcome [5]

Behaviour Flexibility Rating Scale (BRFS).

Timepoint [5]

Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).

Secondary outcome [6]

Parenting Stress Index (PSI- SF).

Timepoint [6]

Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).

Secondary outcome [7]

Parenting Sense of Competence Scale (PSCS).

Timepoint [7]

Time point 1 (at baseline); Time point 2 (at 3 months) and Time point 3 (at 6 months).

Secondary outcome [8]

Family Empowerment Scale (FES).

Timepoint [8]

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]

6008 - Subiaco

Recruitment postcode(s) [2]

3800 - Monash University

Recruitment postcode(s) [3]

3086 - La Trobe University

Recruitment postcode(s) [4]

3217 - Deakin University

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Children's Trust

Address [1]

PO Box 3155
Broadway, Nedlands
Perth Western Australia 6009

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Helen MacPherson Smith Trust

Address [2]

27 Windsor Place
Melbourne Victoria 3000

Country [2]

Australia

Primary sponsor type

Other

Name

Telethon Kids Institute

Address

100 Roberts Road
Subiaco Western Australia 6008

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Monash University

Address [1]

Krongold Building
Faculty of Education
Clayton, Victoria, 3800
Australia

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

La Trobe University

Address [1]

Olga Tennison Autism Research Centre
School of Psychological Science
Bundoora 3086 Victoria Australia

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Deakin University

Address [2]

Centre for Pattern Recognition and Data Analytics (PRaDA), Geelong Campus at Waurn Ponds, Victoria 3217 Australia

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Western Australia Human Research Ethics Committee

Ethics committee address [1]

35 Stirling Hwy
Crawley, WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/11/2012

Ethics approval number [1]

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

Prof Andrew Whitehouse

Address

Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008

Country

Australia

Phone

61 8 9489 7770

Fax

Email

andrew.whitehouse@telethonkids.org.au

Contact person for public queries

Name

Joanna Granich

Address

Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008

Country

Australia

Phone

61 8 9489 7749

Fax

Email

joanna.granich@telethonkids.org.au

Contact person for scientific queries

Name

Joanna Granich

Address

Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008

Country

Australia

Phone

61 8 9489 7749

Fax

Email

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

Source	Title	Year of Publication	DOI
Embase	Randomised controlled trial of an iPad based early intervention for autism: TOBY playpad study protocol.	2016	https://dx.doi.org/10.1186/s12887-016-0704-9

N.B. These documents automatically identified may not have been verified by the study sponsor.