Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes

Study Overview
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Brief Summary
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Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests. The average age of diagnosis in the US is after the fourth birthday. However, children who start ASD-specific early intervention have better outcomes than children start later. The current study will address a gap identified by the US Prevention Services Task Force, namely that children detected through screening respond positively to early intervention. This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten. Local pediatric providers will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures. Across all sites, 8,000 children will be recruited through their participating pediatric practice. Qualifying children will receive up to one year of early intensive behavioral intervention, after getting an ASD diagnosis. Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points. The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.

Detailed Description
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Autism spectrum disorder (ASD) is a serious neurodevelopmental disorder defined by impaired social engagement and social communication, in addition to the presence of repetitive, restricted, or stereotyped behaviors and interests. Although many cases of ASD can be detected when children are less than two years old, the average age of diagnosis in the US is still after the fourth birthday. However, evidence demonstrates that children who start ASD-specific early intervention have better outcomes than children who do not start treatment until later ages. In 2006 and 2007, American Academy of Pediatrics recommended three early detection approaches to improve identification of children at risk for ASD: ongoing developmental surveillance at every well-child check-up, routine broad developmental screening at three infant/toddler ages, and ASD-specific screening at two toddler ages. When these early detection strategies are used with all children attending well-child check-ups, the age of ASD detection is lower, and children who are diagnosed have the opportunity to start ASD-specific early intervention at younger ages than if they had not been detected. Yet in 2016, the US Preventive Services Task Force (USPSTF) indicated that current evidence is insufficient to recommend universal ASD screening, given the lack of experimental studies demonstrating positive outcomes for treated children that are detected through screening. The current study will address this gap. This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten. The study will be conducted by investigators from three sites: Drexel University; the University of California, Davis; and the University of Connecticut. Local pediatric providers will be enrolled in the study, and their practices will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures. Children attending well-child visits at participating practices will then be enrolled. Across all sites, 8,000 children will be recruited through their participating pediatric practice. As part of the study, qualifying children will receive up to one year of early intensive behavioral intervention, using an evidence-based manualized treatment. Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points. Exploratory outcomes will include children's adaptive functioning, kindergarten readiness, and social reciprocity, as measured by experimental eye tracking and parent-child interaction ratings. This study also will examine the impact of the screening intervention on physician attitudes and on parent empowerment and stress. Finally, investigators will examine potential moderators of outcomes, to determine whether initial symptom severity, cognitive ability, or socioeconomic status affects children's long-term outcomes. The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.

Official Title
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Connecting the Dots: An RCT Integrating Standardized ASD Screening, High-Quality Treatment, and Long-Term Outcomes

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Enhanced early detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child attended 18 m visiting at participating pediatric practice legal guardian is fluent in English or Spanish Exclusion Criteria: child has severe sensory or motor deficit that precludes completing standardized evaluation

Ages Eligible for Study
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Minimum Age: 16 Months
Maximum Age: 58 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced early detection<br>Providers will receive training to administer enhanced early detection strategies. | Behavioral: Enhanced early detection<br>* standardized screening<br>|
| No Intervention: Usual care<br>Providers will not change their early detection strategies, but will be monitored. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ASD Symptom Severity | ASD symptom severity will be measured with the Brief Observation of Social Communication Change (BOSCC) | Change from pre-treatment to immediately post-treatment; 10 minutes | 
| Change in Cognitive Functioning | Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL). | Change from pre-treatment to immediately post-treatment; 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adaptive Functioning | Vineland Adaptive Behavior Scales-3 | Immediately post-treatment, 48 m, 60 m; 45 minutes | 
| ASD Symptoms - secondary measure1 | Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) | 48 m, 60 m; 45 minutes | 
| Kindergarten Readiness | Developmental Indicators for the Assessment of Learning-4 | 60 m; 45 minutes | 
| Social Engagement | Eye tracking paradigms will assess aspects of social engagement (i.e., social orienting, motivation, and cognition) | Immediately post-treatment, 48 m, 60 m; 15 minutes | 
| Long-term change in Cognitive Functioning | Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL) | 48 m, 60 m; 60 minutes | 
| Parent-Child Social Engagement | Parent-child social engagement will be measured with the Joint Engagement Rating Inventory, which is applied to video recordings of the Communication Play Protocol. | Immediately post-treatment, 48 m, 60 m; 15 minutes | 
| ASD symptoms - secondary measure2 | PDD Behavior Inventory | Immediately post-treatment, 48 m, 60 m; 20 minutes | 
| ASD symptoms - secondary measure3 | BOSCC | 48 m, 60 m; 10 minutes | 
| Long-term change in Cognitive Functioning (alternative) | and for children who reach ceiling on the MSEL, we will use the Differential Differential Abilities Scales-II (DAS-II) will be used for children too advanced for Outcome 7 | 48 m, 60 m; 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autistic Disorder, Early Detection, Early Intervention