Clinical trial NCT03333629: Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes
Official title: Connecting the Dots: An RCT Integrating Standardized ASD Screening, High-Quality Treatment, and Long-Term Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autism Spectrum Disorder
Keywords: Autistic Disorder
Early Detection
Early Intervention
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: University of Connecticut
First posted: 2017-11-07
Enrollment: 2087
Sex: ALL
Minimum age (years): 16
Maximum age (years): 58
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ASD Symptom Severity
timeFrame: Change from pre-treatment to immediately post-treatment; 10 minutes
measure: Change in Cognitive Functioning
timeFrame: Change from pre-treatment to immediately post-treatment; 60 minutes
Secondary outcomes:
measure: Adaptive Functioning
timeFrame: Immediately post-treatment, 48 m, 60 m; 45 minutes
measure: ASD Symptoms - secondary measure1
timeFrame: 48 m, 60 m; 45 minutes
measure: Kindergarten Readiness
timeFrame: 60 m; 45 minutes
measure: Social Engagement
timeFrame: Immediately post-treatment, 48 m, 60 m; 15 minutes
measure: Long-term change in Cognitive Functioning
timeFrame: 48 m, 60 m; 60 minutes
measure: Parent-Child Social Engagement
timeFrame: Immediately post-treatment, 48 m, 60 m; 15 minutes
measure: ASD symptoms - secondary measure2
timeFrame: Immediately post-treatment, 48 m, 60 m; 20 minutes
measure: ASD symptoms - secondary measure3
timeFrame: 48 m, 60 m; 10 minutes
measure: Long-term change in Cognitive Functioning (alternative)
timeFrame: 48 m, 60 m; 60 minutes
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Diana Robins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McClure LA, Lee NL, Sand K, Vivanti G, Fein D, Stahmer A, Robins DL. Connecting the Dots: a cluster-randomized clinical trial integrating standardized autism spectrum disorders screening, high-quality treatment, and long-term outcomes. Trials. 2021 May 2;22(1):319. doi: 10.1186/s13063-021-05286-6.