Early detection of autism in toddlers within General Practice in Australia

INTERVENTION: Intervention: ASD (Autism Spectrum Disorder) surveillance pathway Initially a parent of the participant aged between 18 and 24 months will complete the following ‘surveillance’ instruments in the General Practice waiting room using either an online link on a tablet or on paper based questionnaires (if internet is not available): Participant Information and Consent form, brief demographics, Learn The Signs. Act Early (LTSAE) developmental check from Centres for Disease Control and Prevention (CDC), The Parents’ Evaluation of Developmental Status (PEDS) and the Quantitative Checklist for Autism in Toddlers‐10 item (Q‐CHAT‐10). These questionnaires will take approximately 10‐15 minutes. Then during a consultation on the same day, the General Practitioner (GP) or Practice Nurse (PN) will complete a face to face observational ‘surveillance’ instrument: the Social Attention and Communication Surveillance – online (SACS Online), which takes approximately 3‐5 minutes. The assessor completing the SACS Online (GP or PN) will be noted. Parents of participants who are identified as 'at developmental risk' on both the LTSAE and PEDS or 'at risk' of autism using the SACS Online or Q‐CHAT‐10 will then complete the Ages and Stages Questionnaire (ASQ) which will take approximately 10 minutes to complete (there will be the option to complete this at home). Participants identified 'at risk' on the ASQ or 'at risk' of autism on the SACS Online or Q‐CHAT and 10% of those determined 'not at risk' (randomly selected) will be invited to undergo a “Gold Standardâ€? diagnostic confirmation assessment at approximately 24 months of age. This assessment will take approximately 3‐4 hours and will occur at the local university by research staff trained in the administration of the assessment. This assessment will include the Autism Diagnostic Observation Schedule (ADOS), the Autism Diagnostic Interview‐Revised (ADI‐R), Mullen Scales of Early Learning (MSE CONDITION: Autism; ; Autism Mental Health ‐ Autistic spectrum disorders Public Health ‐ Health service research SECONDARY OUTCOME: The proportion assigned as 'at probable risk' of autism using the Social Responsiveness Scale, Second Edition (SRS‐2), Preschool form (2.5 to 4.5 years) compared with the proportion of children who were diagnosed with autism using the ADOS. ; ; ; [30 months of age] The proportion of children aged 18‐24 months attending a participating primary health care General Practice clinic during the study duration who complete the developmental surveillance assessments ('uptake'). ; ; This outcome will be assessed using General Practice records to identify the number of children between 18 and 24 months attending the practice during the study and the number of children who undergo the developmental surveillance assessments. [Duration of study] The proportion of children previously identified as ‘at risk’ of developmental concerns or autism using the developmental surveillance assessments who are later diagnosed with autism using the Autism Diagnostic Interview‐Revised (ADI‐R). INCLUSION CRITERIA: Any toddler between the ages of approximately 18‐24 months taken to their General Practitioner for any reason, including for an immunisation, will be part of the trial (a “universal approachâ€�). PRIMARY OUTCOME: The proportion of children between 18 and 24 months identified as ‘at risk’ of developmental concerns or autism using the developmental surveillance assessments. The surveillance assessments included as a composite screen are Parents’ Evaluation of Developmental Status (PEDS), Learn The Signs. Act Early (LTSAE), Quantitative Checklist for Autism in Toddlers‐10 item (Q‐CHAT‐10), Social Attention and Communication Surveillance – online (SACS Online), Ages and Stages Questionnaire (ASQ) & ASQ– Social Emotional scale (ASQ‐SE)).; [Baseline; ] The proportion of children previously identified as ‘at risk’ of developmental concerns or autism using the developmental surveillance assessments who are later diagnosed with autism using the Autism Diagnostic Observation Schedule (ADOS). [24 months of age] ; [24 months of age.] The proportion of children previously identified as ‘at risk’ of developmental concerns using the screening assessments who are later confirmed as being developmentally delayed using the Mullen Scales of Early Learning (MSEL)[24 months of age] The proportion of children previously identified as ‘at risk’ of developmental concerns using the screening assessments who are later confirmed as having developmental delays using the Vineland Adaptive Behavior Scales, Third Edition (VABS‐3) (care giver self‐report form)[24 months of age] The proportion of children who received referrals following identification of at risk of developmental concerns or autism. GP Practice records will be used to determine those who received referrals.[Baseline] To compare the intervention arm who received assessments and recommendations using the National Autism Guideline with those in the comparator arm who received routine care. This composite outcome will be assessed using a study‐specific, written semi structured questionnaire to evaluate the uptake of recommendations from doctors at the baseline visit, experience of assessment/service use including National Disability Insurance Scheme (NDIS), disability supports, early intervention received and parental satisfaction with the services. [30 months of age] Parents of participating toddlers are also included for the purpose of completing screening instruments and questionnaires about their toddler, and an evaluation survey at follow‐up when toddler is 30 months of age.