Table 1 TOBY Playpad Trial measures

Primary Measure

Autism Treatment Evaluation Checklist (ATEC) [64]

The ATEC is a parent rated measure consisting of four subtest scales: Scale I. Speech/Language/Communication (14 items—with scores ranging from 0 to 28); Scale II. Sociability (20 items— with scores ranging from 0 to 40); Scale III. Sensory/Cognitive Awareness (18 items— with scores ranging from 0 to 36), and Scale IV. Health/Physical Behaviour (25 items-with scores ranging from 0 to 75). The four subscale scores can be used to calculate a total score (with total scores ranging from 0 to 180). The higher the subscale and total score, the more impaired the participant. The lower the subscale and total score, the less impaired the participant.

Secondary Measures

Autism Diagnostic Observation Schedule-Generic (ADOS-G) [58]

T0, T3

The ADOS-G is a semi-structured standardised observational assessment that uses questions and activities to elicit the communicative, social, and repetitive behaviours relevant to ASD diagnosis. There are four modules which are age and language dependent. Therefore, this trial will use Module 1 (for pre-verbal children or those using single words/simple phrases (10 activities with 29 accompanying ratings) and Module 2 (children with flexible phrase speech (14 activities with 28 accompanying ratings). A standardised severity score is generated for respective modules. The lower the severity score, the less impaired the participant.

Mullen Scales of Early Learning (MSEL) [61]

The MSEL is a standardised developmental test for children (from birth to 68 months) which includes interactive tasks completed by the child to measure cognitive ability and motor development. The MSEL includes 124 items that measure five specific domains: 1) Gross Motor; 2) Fine Motor; 3) Visual Reception; 4) Expressive Language; and 5) Receptive Language. Four cognitive scales (Visual Reception, Fine Motor, Receptive Language, and Expressive Language) sum to represent an Early Learning Composite Score which measures overall cognitive functioning. A T-score, percentile, and age equivalent score can also be generated for each scale.

Symbolic Play Test (SPT) [66]

The SPT is a non-verbal standardised assessment of young children’s early concept formation and symbolisation. The SPT consists of four independent situations where the child is presented with sets of realistic representational toys and their spontaneous play is observed and recorded on a standardised checklist. The test is scored on the number of meaningful responses and connections made by the child when the objects are presented.

MacArthur-Bates Communicative Development Inventories (MCDI) [67]

The MCDI are parent report scales used to evaluate early language competence. There are two versions of the MCDI; 1) Words and Gestures (MCDI-WG) and 2) Words and Sentences (MCDI-WS). The MCDI-WG form is for 8–18 months old children while the MCDI-WS is for 16–30 months old toddlers. In both forms, parents report their child’s language development (i.e., vocabulary syntax). The MCDI were adapted for the Australian context with permission of the publishers, Paul H Brookes Publishing Co, (http://www.brookespublishing.com/customer-service/rights-permissions/)

Measure

Time points T0, T1, T2^a unless otherwise noted

Description

Communication and Symbolic Behaviour Scales - Developmental Profile (CSBS-DP) [68]

The CSBS-DP is a standardized assessment that measures communication and symbolic abilities as reported by a parent. The scale consists of a 24-item Infant-Toddler Checklist and assesses parents’ perceptions of their child’s communication and symbolic behaviour. The CSBS DP measures seven language predictors: Emotion and Eye Gaze, Communication, Gestures, Sounds, Words, Understanding, and Object Use. These predictors are summed to yield three Composite scores (Communication, Expressive Speech, and Symbolic). The composite scores are summed to yield a Total score.

Repetitive Behaviour Scale (RBS) [69]

The RBS is a parent questionnaire that characterizes the severity of repetitive behaviour. The RBS consists of 6 sub-domain scores: Stereotyped Behaviour (6 items - with scores ranging from 0 to 18), Self-injurious Behaviour (8 items - with scores ranging from 0 to 24), Compulsive Behaviour (8 items - with scores ranging from 0 to 24), Ritualistic Behaviour (6 items - with scores ranging from 0 to 18), Sameness Behaviour (11 items - with scores ranging from 0 to 33), and Restricted Behaviour (4 items - with scores ranging from 0 to 12). The six sub domains can be summed to yield a total score (total scores ranging from 0–129). Each item is rated on a four-point scale ranging from 0 (behaviour does not occur) to 3 (behaviour occurs and is a severe problem).

Family Empowerment Scale (FES) [70]

The FES is a 34-item rating scale assessing a family’s empowerment status, which is measured across two dimensions. The dimensions include the level of empowerment (family, service system, and community/political) and the ways empowerment is expressed (attitudes, knowledge, and behaviours). Each item is rated from on a 5-point Likert scale from 1 (not true at all) to 5 (very true). For example, parents will rate the following item: “I help other families get the services they need”.

Parenting Stress Index - Short Form (PSI-SF) [71]

The PSI-SF is a 36-item rating scale measuring the overall stress within the parent–child system. The PSI consists of three subscales: Parental Distress, Parent–child Dysfunction Interaction, and Difficult Child. Each subscale consists of 12 items rated from 1 (strongly agree) to 5 (strongly disagree), with subscale scores ranging from 12 to 60. The three domains combined form a Total Stress score (with a total score ranges from 36 to 180). A high score on the subscales and total stress score indicates increased levels of stress.

Parenting Sense of Competence Scale (PSCS) [72]

The PSCS is a 17-item scale that measures two dimensions of parenting self-esteem: Efficacy (scores range from 7 to 42) and Satisfaction (scores range from 9 to 54). A sample item includes “Being a good mother is a reward in itself”. Each item is rated on a 6-point scale from 1 (strongly agree) to 6 (strongly disagree). The total score of the 17-items represent parental confidence, with a higher score indicating a higher parenting sense of competency.

Measure

Time points T0, T1, T2^a unless otherwise noted

Description

Vineland Adaptive Behaviour Scale - Parent Version (VABS) [73]

The VABS is a standardized norm-referenced assessment tool used to measure adaptive behaviour. The Parent/Caregiver form includes 376-items. The VABS consists of five domains (each with 2–3 sub domains): Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behaviour. An adaptive behaviour composite can also be calculated (with scores ranging from 20 to 160). Percentile ranks, adaptive levels, stanines, age equivalents, V-scale score, and standard scores can also be calculated from the raw scores

Behaviour Flexibility Rating Scale (BFRS) [74]

The BFRS is a 16-item scale assessing the behavioural flexibility in individuals with developmental disabilities. The BFRS consists of three subscales: Position/Location, Interruption/Disruption, and Interpersonal Mishaps. Using a 4-point scale, ranging from 0 (not a problem at all) to 3 (the situation causes severe problems); parents rate the severity of situations that can could be problematic to the individual. Higher total and subscale scores indicate greater behavioural inflexibility.

TOBY Playpad Intake Questionnaire

T0

The TOBY intake questionnaire consists of seven sections and is tailored to obtain parental report on children’s listening, communication, language and play skills. Items about children’s electronic media use and parents’ self-efficacy and confidence in assisting children to communicate are featured.

TOBY Playpad Follow-up & Satisfaction Questionnaire

T1, T2

The TOBY Playpad follow-up questionnaire version is as above. In addition, it contains 10 items and asks the treatment group parents (only) about the TOBY-App experience and satisfaction.

Case History Questionnaire (CHQ)

T0

The CHQ consists of eight sections and is tailored to gather socio-demographics of participants; birth; medical and developmental history of children with ASD. In addition, thinking styles of both biological parents in the form of Autism Quotient is asked.

TOBY therapy and therapy as usual Diary

T1, T2

Over 24 weeks of the intervention, both, intervention and control group parents report their children’s ‘therapy as usual’. In addition, the treatment group parents report TOBY App use termed as TOBY therapy. Both groups record relevant information at the end of each day in a diary format as featured in Fig. 3. Two diaries are provided to participants; 1) week 1–12 and 2) week 13–24.