Validation of the Developmental Check-In Tool for Low-Literacy Autism Screening.

BACKGROUND: Persistent disparities exist in early identification of autism spectrum disorder (ASD) among children from low-income families who are racial and/or ethnic minorities and where English is not the primary language. Parental literacy and level of maternal education may contribute to disparities. The Developmental Check-In (DCI) is a visually based ASD screening tool created to reduce literacy demands and to be easily administered and scored across settings. In a previous study, the DCI showed acceptable discriminative ability between ASD versus non-ASD in a young, underserved sample at high-risk for ASD. In this study, we tested the DCI among an unselected, general sample of young underserved children. METHODS: Six hundred twenty-four children ages 24 to 60 months were recruited through Head Start and Early Head Start. Parents completed the DCI, Modified Checklist for Autism in Toddlers, Revised with Follow-Up, and Social Communication Questionnaire. Children scoring positive on any measure received evaluation for ASD. Those screening negative on both Modified Checklist for Autism in Toddlers, Revised with Follow-Up and Social Communication Questionnaire were considered non-ASD. RESULTS: Parents were primarily Hispanic, reported high school education or less, and had public or no insurance. The DCI demonstrated good discriminative power (area under the curve = 0.80), performing well across all age groups, genders, levels of maternal education, primary language, and included ethnic and racial groups. Item-level analyses indicated that 24 of 26 DCI items discriminated ASD from non-ASD. CONCLUSIONS: The DCI is a promising ASD screening tool for young, underserved children and may be of particular value in screening for ASD for those with low literacy levels or with limited English proficiency.

Parental Concerns of Underserved Young Children at Risk for Autism.

Early identification of children at risk for autism spectrum disorder (ASD) is critical to promote optimal outcomes. However disparities in early recognition of ASD based on race, ethnicity, income, and English proficiency persist. Little is known regarding how parents from these groups describe concerns. The study aim was to understand how parents of children from underserved backgrounds at developmental risk describe concerns about child development and behavior. To address this gap, developmental concerns of 204 parents of children at-risk for ASD from underserved communities were analyzed. In this sample, the number and type of parental concerns differed based on parent primary language but not the presence of ASD or ethnicity. Parents whose primary language was Spanish were less likely to express concerns about their child's development or to express ASD-specific concerns. These findings have implications for how clinicians elicit and interpret developmental concerns from underserved families.

The Developmental Check-In: Development and initial testing of an autism screening tool targeting young children from underserved communities.

Children with autism spectrum disorder from low-income, minority families or those with limited English proficiency are diagnosed at a later age, or not at all, compared with their more advantaged peers. The Developmental Check-In is a new tool that could potentially be used to screen for autism that uses pictures to illustrate target behaviors. It was developed to enhance early identification of autism spectrum disorder in low literacy groups. The Developmental Check-In was tested in a sample of 376 children between the ages of 24 and 60 months, from underserved communities. It showed good ability to discriminate autism spectrum disorder from non-autism spectrum disorder (area-under-the-curve = 0.75) across the full age range represented in the sample. Twenty-six of the 28 Developmental Check-In items predicted the presence of autism spectrum disorder. Findings suggest that this pictorial tool may reduce linguistic and health literacy demands when screening for autism among vulnerable populations.

An Observational Study With the Janssen Autism Knowledge Engine (JAKE®) in Individuals With Autism Spectrum Disorder.

Objective: The Janssen Autism Knowledge Engine (JAKE®) is a clinical research outcomes assessment system developed to more sensitively measure treatment outcomes and identify subpopulations in autism spectrum disorder (ASD). Here we describe JAKE and present results from its digital phenotyping (My JAKE) and biosensor (JAKE Sense) components. Methods: An observational, non-interventional, prospective study of JAKE in children and adults with ASD was conducted at nine sites in the United States. Feedback on JAKE usability was obtained from caregivers. JAKE Sense included electroencephalography, eye tracking, electrocardiography, electrodermal activity, facial affect analysis, and actigraphy. Caregivers of individuals with ASD reported behaviors using My JAKE. Results from My JAKE and JAKE Sense were compared to traditional ASD symptom measures. Results: Individuals with ASD (N = 144) and a cohort of typically developing (TD) individuals (N = 41) participated in JAKE Sense. Most caregivers reported that overall use and utility of My JAKE was "easy" (69%, 74/108) or "very easy" (74%, 80/108). My JAKE could detect differences in ASD symptoms as measured by traditional methods. The majority of biosensors included in JAKE Sense captured sizable amounts of quality data (i.e., 93-100% of eye tracker, facial affect analysis, and electrocardiogram data was of good quality), demonstrated differences between TD and ASD individuals, and correlated with ASD symptom scales. No significant safety events were reported. Conclusions: My JAKE was viewed as easy or very easy to use by caregivers participating in research outside of a clinical study. My JAKE sensitively measured a broad range of ASD symptoms. JAKE Sense biosensors were well-tolerated. JAKE functioned well when used at clinical sites previously inexperienced with some of the technologies. Lessons from the study will optimize JAKE for use in clinical trials to assess ASD interventions. Additionally, because biosensors were able to detect features differentiating TD and ASD individuals, and also were correlated with standardized symptom scales, these measures could be explored as potential biomarkers for ASD and as endpoints in future clinical studies. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02668991 identifier: NCT02668991.

JAKE® Multimodal Data Capture System: Insights from an Observational Study of Autism Spectrum Disorder.

Objective: To test usability and optimize the Janssen Autism Knowledge Engine (JAKE®) system's components, biosensors, and procedures used for objective measurement of core and associated symptoms of autism spectrum disorder (ASD) in clinical trials. Methods: A prospective, observational study of 29 children and adolescents with ASD using the JAKE system was conducted at three sites in the United States. This study was designed to establish the feasibility of the JAKE system and to learn practical aspects of its implementation. In addition to information collected by web and mobile components, wearable biosensor data were collected both continuously in natural settings and periodically during a battery of experimental tasks administered in laboratory settings. This study is registered at clinicaltrials.gov, NCT02299700. Results: Feedback collected throughout the study allowed future refinements to be planned for all components of the system. The Autism Behavior Inventory (ABI), a parent-reported measure of ASD core and associated symptoms, performed well. Among biosensors studied, the eye-tracker, sleep monitor, and electrocardiogram were shown to capture high quality data, whereas wireless electroencephalography was difficult to use due to its form factor. On an exit survey, the majority of parents rated their overall reaction to JAKE as positive/very positive. No significant device-related events were reported in the study. Conclusion: The results of this study, with the described changes, demonstrate that the JAKE system is a viable, useful, and safe platform for use in clinical trials of ASD, justifying larger validation and deployment studies of the optimized system.

Screening for autism spectrum disorder in underserved communities: Early childcare providers as reporters.

Early diagnosis of autism typically is associated with earlier access to intervention and improved outcomes. Daycares and preschools largely have been ignored as possible venues for early identification. This may be especially important for minority children in the United States who are typically diagnosed with autism later than White children, limiting their access to early specialized interventions and possibly resulting in poorer outcomes. Early childcare providers within underserved communities completed autism screening tools for a sample of low-risk young children (n = 967) in their programs. Early childcare providers returned screening tools for 90% of the children for whom parental consent had been received. A total of 14% of children screened positive for autism spectrum disorder and 3% of the sample met criteria for autism spectrum disorder. Among those who screened positive, 34% were lost to follow-up. Findings suggest that early childcare providers can effectively screen young children for autism spectrum disorder in preschool/daycare settings, thus improving access to early diagnosis and reducing potential healthcare disparities among underserved populations.

Aripiprazole in children and adolescents: clinical experience.

Despite few supportive data, aripiprazole was being administered to children and adolescents for management of mood instability, aggression, and psychosis. Using a retrospective review (n = 11) and prospective recruitment (n = 6), 17 children and adolescents received aripiprazole 5 to 20 mg/day. Only 4 of 16 bipolar and autistic subjects (25%) demonstrated reduced aggression without adverse events, and the symptoms of 2 of 4 psychotic subjects improved. Coadministration of sedative medications (particularly guanfacine or clonidine) and weight < 58 kg increased the risk of adverse events, such as increased lability and aggression. All three children < 8.6 years old, all four children < 34 kg, and all five children receiving alpha2-agonists developed adverse events prior to clinical efficacy. Age > 11 years, weight > 58 kg, and absence of sedative medications were associated with a 56% (five of nine) success rate. Until larger, prospective studies are completed, caution is advised when considering aripiprazole for smaller children and children receiving sedative medications.

Hypoalbuminemia with valproic acid administration.

Valproic acid and its derivatives are commonly administered antiepileptic drugs for children and adults. Five residents at a children's long-term care facility manifested hypoalbuminemia while being administered divalproex, although serum liver function test results and urinalysis results were normal. When the patients were free from valproic acid, the serum albumin levels increased into the normal range (17-30% higher than the serum albumin levels while patients were receiving valproic acid) despite the absence of any dietary changes. Comparing the serum albumin levels for eight residents who received divalproex (3.1 gm/dL +/- 0.4 gm/dL) with the serum albumin levels for 13 residents who were not receiving valproic acid or its derivatives (3.8 gm/dL +/- 0.2 gm/dL), the difference was significant (P < 0.001). This difference could not be accounted for by nutritional, environmental, laboratory, or urinary causes. In this study, divalproex administration was a contributing factor in the development of reversible hypoalbuminemia in this population of severely disabled, neurologically injured children and young adults. Further studies are required to determine the exact etiology and clinical significance of valproate-mediated hypoalbuminemia.