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ObjectivesEarly developmental assessment is crucial for effective support and intervention. This study examined factors that contribute to (a) older child age when caregivers first became concerned about their child’s development and (b) older child age at the point of entry into developmental and diagnostic assessment. We also quantified how factors contributed to risk of children not receiving an assessment by 5 years and considered the acceptability of electronic data capture for families.DesignThis cross-sectional study collected information about caregiver developmental concerns, family history and child characteristics.SettingChildren and families entered a large, publicly funded hospital-based paediatric developmental assessment service.ParticipantsConsecutively enrolled children (N=916) aged 6 months to 17 years with neurodevelopmental concerns and their caregivers.Main outcomes and measuresA developmental history questionnaire completed by caregivers.ResultsThe average age that caregivers identified developmental concerns was 3.0 years of age but the average age of a receiving a developmental assessment was 6.6 years. Only 46.4% of children received a diagnostic assessment by 5 years of age, even though 88.0% of caregivers were concerned about their child’s development by that age. Parental age, relationship status, education level, prior use of support services and being from a culturally and linguistically diverse background contributed to age at identification of concern, age at diagnostic assessment and the likelihood of receiving a diagnostic assessment by 5 years. Electronic data capture had high acceptability, with 88.2% of caregivers reporting a preference for electronic completion of questionnaires.ConclusionsThe study shows a substantial delay in diagnostic assessments that leaves most vulnerable children without an assessment by school age and highlights contributors to delays. These delays highlight the complexity of delivering early intervention and support policies that rely on swift and appropriate developmental assessment to vulnerable families.

Background A number of differences in joint attention behaviour between children with autism spectrum disorder (ASD) and typically developing (TD) individuals have previously been documented. Method We use eye-tracking technology to assess response to joint attention (RJA) behaviours in 77 children aged 31 to 73 months. We conducted a repeated-measures analysis of variance to identify differences between groups. In addition, we analysed correlations between eye-tracking and clinical measures using Spearman’s correlation. Results The children diagnosed with ASD were less likely to follow gaze compared to TD children. Children with ASD were less accurate at gaze following when only eye gaze information was available, compared to when eye gaze with head movement was observed. Higher accuracy gaze-following profiles were associated with better early cognition and more adaptive behaviours in children with ASD. Less accurate gaze-following profiles were associated with more severe ASD symptomatology. Conclusion There are differences in RJA behaviours between ASD and TD preschool children. Several eye-tracking measures of RJA behaviours in preschool children were found to be associated with clinical measures for ASD diagnosis. This study also highlights the construct validity of using eye-tracking measures as potential biomarkers in the assessment and diagnosis of ASD in preschool children.

Background Fragile X syndrome (FXS) is characterized by a range of developmental, neuropsychiatric, and behavioral symptoms that cause significant impairment in those with the disorder. Cannabidiol (CBD) holds promise as a potential treatment for FXS symptoms due to its safety profile and positive effects on a number of emotional and behavioral symptoms associated with FXS. The aim of the current study was to evaluate the safety, tolerability, and initial efficacy of ZYN002, a transdermal CBD gel, in a pediatric population with FXS. Methods Twenty children and adolescents (aged 6–17 years) with a diagnosis of FXS (confirmed through molecular documentation of FMR1 full mutation) were enrolled in an open-label, multi-site, trial of ZYN002. Transdermal CBD gel was administered twice daily for 12 weeks, titrated from 50 mg to a maximum daily dose of 250 mg. The primary efficacy endpoint was change from screening to week 12 on the Anxiety, Depression, and Mood Scale (ADAMS). Secondary endpoint measures included the Aberrant Behavior Checklist—Community for FXS (ABC-C FXS ), Pediatric Anxiety Rating Scale (PARS-R), Pediatric Quality of Life Inventory (PedsQL™), three Visual Analogue Scales (VAS), and the Clinical Global Impression Scale—Severity (CGI-S) and Improvement (CGI-I). Results The majority of treatment-emergent AEs (reported by 85% of participants) were mild in severity (70%), and no serious adverse events were reported. There was a statistically significant reduction in ADAMS total score from screening to week 12 and significant reductions on nearly all other secondary endpoints, including all ADAMS subscales (except depressed mood), all ABC-C FXS subscale scores (e.g., social avoidance, irritability), PARS-R total severity score, and PedsQL total score. Conclusions ZYN002 was well tolerated and produced clinically meaningful reductions in anxiety and behavioral symptoms in children and adolescents with FXS. These findings support further study of ZYN002 in a randomized, well-controlled trial for the treatment of behavioral symptoms of FXS. Trial registration ANZCTR, ACTRN12617000150347 Registered 27 January 2017

Background There are significant barriers to accessing assessments and supports for children with neurodevelopmental conditions and their families. This study examined the influence of elevated psychiatric symptoms in caregivers on delays to assessment and access to supports for their children and themselves. Methods This cross-sectional study from the Sydney Child Neurodevelopment Research Registry collected information about caregiver psychiatric symptoms, and access and barriers to supports. Participants were 187 children and their caregivers who presented to a tertiary diagnostic and assessment service. Results Children of caregivers with elevated psychiatric symptoms had a one-year delay in accessing developmental assessment, compared to children of caregivers without elevated psychiatric symptoms. This was despite there being no significant difference in the age at which caregivers first detected a developmental delay in children. Caregivers with elevated psychiatric symptoms also reported greater perceived support needs for themselves and their child, and increased barriers to accessing these supports. Conclusions This study highlights a complex inter-relationship between caregiver mental health and access to supports and intervention services for children with neurodevelopmental conditions. Caregivers with elevated psychiatric symptoms report greater service needs for themselves and their child, as well as reporting more barriers when accessing these services. Results suggest elevated caregiver psychiatric symptoms provide a useful indicator for enhanced support pathways and specialised care.

Background The application of telehealth in the paediatric setting is growing, and yet, limited research has focused on using telehealth in developmental diagnostic assessment and the consumers' perceptions of their telehealth experience. This study explored parents'/carers' and staff experiences of using telehealth as part of the developmental diagnostic assessment. Methods Parents/carers who attended an assessment between June 2020 and July 2021 that incorporated a telehealth component within a hybrid service delivery model were invited to provide feedback about their experience of telehealth appointments at a multidisciplinary developmental assessment service. All parents were invited to complete an online survey, with a sample of families being offered a telephone interview. Staff members were invited to a focus group to explore their experiences of delivering services via telehealth. Data obtained were analysed descriptively and thematically using a mixed method of analysis. Codes were categorized, enabling facilitators and barriers to be explored. Results The use of telehealth in the diagnostic assessment of complex developmental disorders received high levels of acceptance from parents/carers and staff, despite having limitations such as technical issues, difficulties building rapport between families/clinicians and limited direct observations of the child. Telehealth services are perceived to reduce costs and increase flexibility, including increased ability to accommodate family needs. Conclusions Results demonstrated that telehealth is a highly acceptable mode of service in a developmental assessment service. The current study informs the development of a hybrid service delivery model by enhancing facilitators and reducing barriers commonly reported by consumers and provides direction for future research. Patient or Public Contribution Parents or carers of children who attended a tertiary paediatric assessment unit for a diagnostic developmental assessment completed the online survey and were interviewed.

A pediatric assessment service for children with Intellectual Disability (ID) was established in a culturally diverse region of Sydney, Australia, to meet the health needs of children and young people with ID. This paper reports on parents’ and providers’ experiences using qualitative and quantitative analysis of surveys. The survey responses from the parents’ enumerated their key concerns and the practical help they received from the service. Responses from service providers reported a high level of satisfaction with the services and valued the quality of assessment reports. The service facilitated inter-agency collaboration and enhanced the access to quality health care.

Background Dysregulated endocannabinoid signaling is involved in Fragile X syndrome (FXS), suggesting a potential role for the endocannabinoid signaling modulator, cannabidiol, in treatment. ZYN002 is a synthetic cannabidiol that has been uniquely formulated as a gel for transdermal delivery and is currently under investigation for the treatment of behavioral symptoms associated with FXS. Design ZYN2-CL-017 is an ongoing, long-term, open-label extension (OLE) safety trial of ZYN002 in patients with FXS. We are enrolling patients from past and current ZYN002 clinical trials to evaluate the safety and tolerability of ZYN002 in patients with FXS. Methods Primary safety assessments were conducted in patients who enrolled into the OLE from 2 completed ZYN002 trials. Secondary analyses, conducted in a subgroup enrolled from a completed placebo-controlled trial of ZYN002, included the FXS-specific Aberrant Behavior Checklist-Community Social Avoidance and Irritability subscales (ABC-C FXS SA and ABC-C FXS Irr, examined change from baseline of the randomized study) and the Caregiver Global Impression of Change (CaGI-C, examined change from baseline of the OLE), in which caregivers were asked to rate the change in their child’s overall behavior. Results At the time of this interim analysis data cut (January 31, 2024), 240 patients had been enrolled from 2 completed ZYN002 trials. Mean age at entry to the OLE was 9.7 years (range 3-17 years), and the majority were male (76.3%) and White (80.4%). Mean exposure to ZYN002 during the initial trials and OLE was 28 months. Treatment-related adverse events (AEs) were reported in 12.9% of patients; the most common (6.7% of patients) was short-term application site pain. The highest degree of skin irritation reported by investigators was moderate erythema in 7 patients (2.9%). In the secondary analysis cohort (n=196 evaluable patients), patients demonstrated clinically meaningful changes in ABC-C FXS SA, ABC-C FXS Irr, and CaGI-C scores. Conclusions Interim analysis results of the ongoing OLE in children, adolescents, and young adults with FXS demonstrated that ZYN002 has a favorable long-term safety profile and is generally well tolerated. Clinically meaningful changes in behaviors from baseline continued to be observed during the OLE. These findings support further study of ZYN002 in patients with FXS. Trial registration ZYN2-CL-017 is registered on Clinicaltrials.gov (NCT03802799) on December 26, 2018.

IntroductionAttention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder which affects 5% of children globally. In Australia, it is estimated that 4.1% of children and adolescents have ADHD. While research has examined the treatment and outcomes of children with ADHD attending public mental health services during their time in the public system in Australia, it is not known what treatment they received before and after these treatment episodes, which will provide a more complete understanding of these children’s treatment journey.Methods and analysisWe will link clinical data from cohorts of children and adolescents treated in the public child and youth mental health and/or child development services in Brisbane, Melbourne and Sydney to the Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS) and National Death Index. MBS data will demonstrate the treatment journey with respect to clinicians seen, and treatment episodes from the public health service data sets will be examined to assess if the type and intensity of treatment are related to treatment outcomes. PBS data will reveal all psychotropic medications prescribed, allowing an examination of not just ADHD medications, but also other psychotropics which may indicate co-occurring conditions (eg, anxiety and mood disorders). Statistical analyses will include descriptive statistics to describe the rates of specific medications and clinician specialties seen. Linear and logistic regression will be used to model how treatment and sociodemographic variables relate to routinely collected outcome measures in the public health system while controlling for covarying factors.Ethics and disseminationThis study has been approved by the following institutional ethics committees: (1) Children’s Health Queensland Hospital and Health Service (HREC/21/QCHQ/76260), (2) The University of Queensland (2021/HE002143) and (3) The Australian Institute of Health and Welfare (EO2021/4/1300). Findings will be disseminated through peer-reviewed journals, conferences, professional associations and to public mental health services that treat ADHD.

Background The identification of reproducible subtypes within autistic populations is a priority research area in the context of neurodevelopment, to pave the way for identification of biomarkers and targeted treatment recommendations. Few previous studies have considered medical comorbidity alongside behavioural, cognitive, and psychiatric data in subgrouping analyses. This study sought to determine whether differing behavioural, cognitive, medical, and psychiatric profiles could be used to distinguish subgroups of children on the autism spectrum in the Australian Autism Biobank (AAB). Methods Latent profile analysis was used to identify subgroups of children on the autism spectrum within the AAB (n = 1151), utilising data on social communication profiles and restricted, repetitive, and stereotyped behaviours (RRBs), in addition to their cognitive, medical, and psychiatric profiles. Results Our study identified four subgroups of children on the autism spectrum with differing profiles of autism traits and associated comorbidities. Two subgroups had more severe clinical and cognitive phenotype, suggesting higher support needs. For the ‘Higher Support Needs with Prominent Language and Cognitive Challenges’ subgroup, social communication, language and cognitive challenges were prominent, with prominent sensory seeking behaviours. The ‘Higher Support Needs with Prominent Medical and Psychiatric and Comorbidity’ subgroup had the highest mean scores of challenges relating to social communication and RRBs, with the highest probability of medical and psychiatric comorbidity, and cognitive scores similar to the overall group mean. Individuals within the ‘Moderate Support Needs with Emotional Challenges’ subgroup, had moderate mean scores of core traits of autism, and the highest probability of depression and/or suicidality. A fourth subgroup contained individuals with fewer challenges across domains (the ‘Fewer Support Needs Group’). Limitations Data utilised to identify subgroups within this study was cross-sectional as longitudinal data was not available. Conclusions Our findings support the holistic appraisal of support needs for children on the autism spectrum, with assessment of the impact of co-occurring medical and psychiatric conditions in addition to core autism traits, adaptive functioning, and cognitive functioning. Replication of our analysis in other cohorts of children on the autism spectrum is warranted, to assess whether the subgroup structure we identified is applicable in a broader context beyond our specific dataset.

IntroductionResearch highlights the importance of early intervention for children with autism spectrum disorder with better outcomes associated with earlier access to early intensive intervention (EII) programmes. However, there is significant variability in response to EII despite children receiving the same programmes.Methods and analysisA prospective, multisite cohort study using a pre–post design assesses the predictors of early intervention outcomes for children who receive EII through six early intervention services (Autism Specific Early Learning and Care Centres, ASELCCs) across Australia. Child and family characteristics at entry to and exit from ASELCCs are ascertained using measures of autism symptoms (Autism Diagnostic Observation Schedule-2; Social Communication Questionnaire); cognitive, language and developmental skills (Mullen Scale of Early Learning); adaptive function (Vineland Adaptive Behaviour Scale—second Edition); behaviours (Child Behaviour Checklist—1.5 to 5 years; Restricted Repetitive Behaviour Scale); parental stress (Parent Stress Index-4 Short Form); quality of life (Quality of Life in Autism Scale) and a semistructured family history questionnaire for sociodemographic, family and psychosocial characteristics. Characteristics at entry are used as predictors of outcome at exit following EII approximately 12 months later. The change in score from baseline to exit will be the primary outcome of interest. The mediating role of family and psychosocial factors will also be considered.Ethics approvalUniversity of New South Wales Human Research Ethics Committee (HC14267).Dissemination of resultsFindings will be published in peer-reviewed journals and presented at conferences. A report summarising data and the interpretation of data will be published.