title: Randomised controlled trial of an iPad based early intervention for autism: TOBY playpad study protocol.
abstract: Evidence for early intensive behavioural interventions (EIBI) by therapists as an effective treatment for children with an Autism Spectrum Disorder (ASD) is growing. High-intensity and sustained delivery of quality EIBI is expensive. The TOBY (Therapy Outcomes by You) Playpad is an App-based platform delivering EIBI to facilitate learning for young children with ASD, while enabling parents to become co-therapists. Intervention targets include increasing joint attention, imitation and communication of children with ASD. The primary aim of the study presented in this protocol is to determine the effectiveness of the TOBY App in reducing ASD symptoms when used as a complement to conventional EIBI. The secondary aim is to examine parental attributes as a result of TOBY App use.
  
  
  
  Children aged less than 4;3 years diagnosed with ASD and parents will be recruited into this single-blind, randomised controlled trial using a pragmatic approach. Eligible participants will be randomised to the treatment group 'TOBY therapy + therapy as usual' or, the control group 'therapy as usual' for six months. The treatment will be provided by the TOBY App and parent where a combination of learning environments such as on-iPad child only (solo), partner (with parent) and off-iPad - Natural Environment (with parent) Tasks will be implemented. Parents in the treatment group will participate in a TOBY training workshop. Treatment fidelity will be monitored via an App-based reporting system and parent diaries. The primary outcome measure is the Autism Treatment Evaluation Checklist. The secondary outcome measures involve diagnostics, functional and developmental assessments, including parent questionnaires at baseline (T0), three months (T1) and six months (T2).
  
  
  
  This trial will determine the effectiveness of the TOBY App as a therapeutic complement to other early interventions children with ASD receive. The trial will also determine the feasibility of a parent delivered early intervention using the iPad as an educational platform, and assess the impact of the TOBY App on parents' self-efficacy and empowerment in an effort to reduce children's ASD symptoms. The outcomes of this trial may have EIBI services implications for newly diagnosed children with ASD and parents.
  
  
  
  ACTRN12614000738628 retrospectively registered on 1stof July, 2014. UTN: U1111-1158-6423.
authors.affiliation: Telethon Kids Institute, The University of Western Australia, Perth, Australia. joanna.granich@telethonkids.org.au.|Telethon Kids Institute, 100 Roberts Rd, Subiaco, 6008, WA, Australia. joanna.granich@telethonkids.org.au.
authors.forename: Joanna
authors.initials: J
authors.lastname: Granich
authors.affiliation: Telethon Kids Institute, The University of Western Australia, Perth, Australia.
authors.forename: Alena
authors.initials: A
authors.lastname: Dass
authors.affiliation: Krongold Centre, Faculty of Education, Monash University, Melbourne, Australia.
authors.forename: Margherita
authors.initials: M
authors.lastname: Busacca
authors.affiliation: Krongold Centre, Faculty of Education, Monash University, Melbourne, Australia.
authors.forename: Dennis
authors.initials: D
authors.lastname: Moore
authors.affiliation: Krongold Centre, Faculty of Education, Monash University, Melbourne, Australia.
authors.forename: Angelika
authors.initials: A
authors.lastname: Anderson
authors.affiliation: Centre for Pattern Recognition and Data Analytics (PRaDA), Deakin University, Geelong, Australia.
authors.forename: Svetha
authors.initials: S
authors.lastname: Venkatesh
authors.affiliation: Centre for Pattern Recognition and Data Analytics (PRaDA), Deakin University, Geelong, Australia.
authors.forename: Thi
authors.initials: T
authors.lastname: Duong
authors.affiliation: Centre for Pattern Recognition and Data Analytics (PRaDA), Deakin University, Geelong, Australia.
authors.forename: Pratibha
authors.initials: P
authors.lastname: Vellanki
authors.affiliation: Olga Tennison Autism Research Centre, School of Psychology and Public Health, La Trobe University, Bundoora, Australia.
authors.forename: Amanda
authors.initials: A
authors.lastname: Richdale
authors.affiliation: Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Trembath
authors.affiliation: The Charles Street Clinic, North Perth, Australia.
authors.forename: Darin
authors.initials: D
authors.lastname: Cairns
authors.affiliation: Autism West, Mosman Park, Australia.
authors.forename: Wendy
authors.initials: W
authors.lastname: Marshall
authors.affiliation: Autism West, Mosman Park, Australia.
authors.forename: Tania
authors.initials: T
authors.lastname: Rodwell
authors.affiliation: Telethon Kids Institute, The University of Western Australia, Perth, Australia.
authors.forename: Madeleine
authors.initials: M
authors.lastname: Rayner
authors.affiliation: Telethon Kids Institute, The University of Western Australia, Perth, Australia.
authors.forename: Andrew J O
authors.initials: AJ
authors.lastname: Whitehouse
mesh_terms: D001294:Attitude to Health; D000067877:Autism Spectrum Disorder / Q000628:therapy*; D001521:Behavior Therapy / Q000379:methods*; D002675:Child, Preschool; D002985:Clinical Protocols; D034201:Computers, Handheld; D018479:Early Intervention, Educational / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008297:Male; D063731:Mobile Applications; D010290:Parents / Q000523:psychology; D012107:Research Design; D016037:Single-Blind Method; D016896:Treatment Outcome
keywords: App; Autism spectrum disorder; Children; Early therapy; Intervention; Parents; TOBY; Technology; Treatment; iPad